FY 2005 OIVD Annual Report - Part 1 - Advances in Patient Care

Last year, the Office of In Vitro Diagnostic Device Evaluation and Safety (OIVD) approved and cleared hundreds of devices used as an aid in diagnosis. Below, we highlight several new medical devices and devices with new indications approved or cleared during this past fiscal year that we believe will have a particular impact on patient care.

Vysis® AutoVysion™ System

Cleared December 13, 2004, Vysis® AutoVysion™ System, manufactured by Vysis, Inc., is a device that consists of an automated scanning microscope, image analysis system and customized software applications for fluorescence in situ hybridization (FISH) assays. This device is intended for in vitro diagnostic use with FISH assays as an aid in the detection, counting and classification of cells based on recognition of cellular color, size and shape and in the detection and enumeration of FISH signals in interphase nuclei of formalin-fixed, paraffin-embedded human tissue specimens. Link to clearance: http://www.fda.gov/MedicalDevices/ProductsandMedicalProcedures/ DeviceApprovalsandClearances/Recently-ApprovedDevices/ucm079390.htm

ADVIA Centaur® HCV and ADVIA Centaur® HVC Quality Control Materials

Approved December 22, 2004, ADVIA Centaur® HCV, manufactured by Bayer Healthcare, LLC, is an in vitro diagnostic immunoassay for the qualitative determination of immunoglobulin G (IgG) antibodies to hepatitis C virus (HCV) in human serum and plasma (EDTA, lithium or sodium heparinized) using the ADVIA Centaur® System. The assay may be used in conjunction with other serological and clinical information to aid in the diagnosis of individuals with symptoms of hepatitis and in individuals at risk for hepatitis C infection. ADVIA HCV Quality Control Materials: For in vitro diagnostic use in monitoring the performance of the HCV assay on the ADVIA Centaur® Systems. The performance of the HCV quality control material has not been established with any other anti-HCV assays. Link to approval: http://www.fda.gov/MedicalDevices/ProductsandMedicalProcedures/ DeviceApprovalsandClearances/Recently-ApprovedDevices/ucm079236.htm

ADVIA Centaur® HBc Total ReadyPack Reagents, and ADVIA Centaur® HBc Total Quality Control Materials

Approved December 22, 2004, ADVIA Centaur® HBc, manufactured by Bayer Healthcare, LLC, is an in vitro diagnostic test for the qualitative determination of total antibodies to the core antigen of the hepatitis B virus (HBc Total) in human serum or plasma (potassium EDTA, or lithium or sodium heparinized) using the ADVIA Centaur® System. This assay can be used as an aid in the diagnosis of individuals with acute or chronic hepatitis B virus (HBV) infection and in the determination of the clinical status of HBV-infected individuals in conjunction with other HBV serological markers for the laboratory diagnosis of HBV disease associated with HBV infection. This assay can also be used as an aid in the differential diagnosis in individuals displaying signs and symptoms of hepatitis in whom etiology is unknown. HBc Total Quality Control Materials: The controls are indicated for in vitro diagnostic use in monitoring the performance of the HBc Total assay on the ADVIA Centaur® Systems. The performance of the HBc Total Quality Control Material has not been established with any other anti-HBc Total assays. Link to approval: http://www.fda.gov/MedicalDevices/ProductsandMedicalProcedures/ DeviceApprovalsandClearances/Recently-ApprovedDevices/ucm078871.htm

ADVIA Centaur® HAV IgM ReadyPack Reagents, and ADVIA Centaur® HAV IgM Quality Control Materials

Approved December 22, 2004, ADVIA Centaur® HAV IgM, manufactured by Bayer Healthcare, LLC, is indicated for use for the ADVIA Centaur® HAV IgM assay and is an in vitro diagnostic immunoassay for the qualitative determination of IgM response to the hepatitis A virus (HAV) in human serum or plasma (potassium EDTA, lithium or sodium heparinized) using the ADVIA Centaur® System. The assay is intended for use as an aid in the diagnosis of acute or recent infection (usually 6 months or less) with hepatitis A virus. HAV IgM Quality Control Materials: The controls are indicated for in vitro diagnostic use in monitoring the performance of the HAV IgM assay on the ADVIA Centaur® Systems. The performance of the HAV IgM quality control material has not been established with any other anti-HAV IgM assays. Link to approval: http://www.fda.gov/MedicalDevices/ProductsandMedicalProcedures/ DeviceApprovalsandClearances/Recently-ApprovedDevices/ucm079227.htm

Affymetrix GeneChip® Microarray Instrumentation System

Cleared December 23, 2004, the Affymetrix GeneChip® Microarray Instrumentation System consisting of GeneChip® 3000Dx scanner with autoloader, FS450Dx fluidics station and GCOSDx software is intended to measure fluorescence signals of labeled DNA target hybridized to GeneChip® arrays. It was cleared for use with the AmpliChip CYP450 Test, manufactured by Roche Molecular Systems as drug metabolizing enzyme genotyping system. Link to clearance: http://www.accessdata.fda.gov/cdrh_docs/pdf4/k042279.pdf

AmpliChip CYP450 Test

Cleared December 23, 2004, the AmpliChip CYP450 Test, manufactured by Roche Molecular Systems, is a drug metabolizing enzyme genotyping system. It is the first microarray cleared by FDA for clinical use and is intended for use in testing DNA to identify the presence or absence of human genotypic markers encoding two drug metabolizing enzymes. The device is used as an aid in determining treatment choice and individualizing treatment dose for therapeutics that are metabolized primarily by the specific enzyme about which the system provides genotypic information. Link to clearance: http://www.fda.gov/MedicalDevices/ProductsandMedicalProcedures/ DeviceApprovalsandClearances/Recently-ApprovedDevices/ucm078879.htm

UroVysion™ Bladder Cancer Kit

Approved January 24, 2005, UroVysion™ Bladder Cancer Kit, manufactured by Vysis, Inc., is designed to detect aneuploidy for chromosomes 3, 7, 17 and loss of the 9p21 locus via fluorescence in situ hybridization (FISH) in urine specimens from persons with hematuria suspected of having bladder cancer. Results from the UroVysion Kit are intended for use in conjunction with and not in lieu of current standard diagnostic procedures, as an aid for initial diagnosis of bladder carcinoma in patients with hematuria and subsequent monitoring for tumor recurrence in patients previously diagnosed with bladder cancer. Link to approval: http://www.fda.gov/MedicalDevices/ProductsandMedicalProcedures/ DeviceApprovalsandClearances/Recently-ApprovedDevices/ucm078663.htm

ADVIA Centaur® HAV Total Assay, and ADVIA Centaur® HAV Total Quality Control Materials

Approved March 7, 2005, ADVIA Centaur® HAV, manufactured by Bayer Healthcare, LLC, is an in vitro diagnostic immunoassay for the qualitative determination of total antibodies to hepatitis A virus (anti-HAV ) in human serum or plasma (potassium EDTA, lithium or sodium heparinized) using the ADVIA Centaur® System. This anti-HAV assay is indicated as an aid in the diagnosis of previous or ongoing hepatitis A viral infection or in the identification of HAV-susceptible individuals for vaccination. Link to approval: http://www.fda.gov/MedicalDevices/ProductsandMedicalProcedures/ DeviceApprovalsandClearances/Recently-ApprovedDevices/ucm078662.htm

PAXgene™ Blood RNA System

Cleared April 18, 2005, PAXgene™ Blood RNA, manufactured by PreAnalytiX GMBH, is intended to collect, store, and transport patient specimens and stabilize intracellular RNA from the specimens for subsequent isolation and purification of the intracellular RNA for RT-PCR used in vitro molecular diagnostic testing. Link to clearance: http://www.fda.gov/MedicalDevices/ProductsandMedicalProcedures/ DeviceApprovalsandClearances/Recently-ApprovedDevices/ucm078637.htm

DakoCytomation Her2 FISH pharmDx™ Kit

Approved May 3, 2005, Her2 FISH pharmDx™ Kit, manufactured by DakoCytomation Denmark A/S, is a direct fluorescence in situ hybridization (FISH) assay designed to quantitatively determine the Her2 gene amplification in formalin-fixed, paraffin-embedded breast cancer tissue specimens. Her2 FISH pharmDx™ Kit is indicated as an aid in the assessment of patients for whom Herceptin® (trastuzumab) treatment is being considered. Results form the Her2 FISH pharmDx™ Kit are intended for use as an adjunct to the clinicopathologic information currently used for estimating prognosis in stage II, node positive breast cancer patients. Link to approval: http://www.fda.gov/MedicalDevices/ProductsandMedicalProcedures/ DeviceApprovalsandClearances/Recently-ApprovedDevices/ucm078623.htm

Tag-It™ Cystic Fibrosis Kit

Cleared May 9, 2005, Tag-It™ Cystic Fibrosis Kit, manufactured by Tm BioScience Corp., is a device used to simultaneously detect and identify a panel of mutations and variants in the CFTR gene. It is intended as an aid in confirmatory diagnostic testing of individuals with suspected cystic fibrosis (CF), carrier identification and newborn screening. This device is not intended for stand-alone diagnostic purposes, prenatal diagnostic, pre-implantation or population screening. Link to clearance: http://www.fda.gov/MedicalDevices/ProductsandMedicalProcedures/ DeviceApprovalsandClearances/Recently-ApprovedDevices/ucm078613.htm

Wako LBA AFP-L3, AFP-L3 Calibrator Set, AFP-L3 Control

Cleared May 19, 2005, Wako LBA Alpha Fetoprotein (AFP)-L3, AFP-L3 Set, manufactured by Wako Chemicals USA, Inc., is an in vitro diagnostic device that consists of reagents and an automated instrument used to quantitatively measure AFP and AFP-L3 subfraction in human serum by immunochemical techniques. The device is intended for in vitro diagnostic use as an aid in the risk assessment of patients with chronic liver disease for progression to hepatocellular carcinoma in conjunction with other laboratory findings, imaging studies and clinical assessment. Link to clearance: http://www.fda.gov/MedicalDevices/ProductsandMedicalProcedures/ DeviceApprovalsandClearances/Recently-ApprovedDevices/ucm078610.htm

ADVIA Centaur® HBsAg ReadyPack Reagents, ADVIA Centaur® HBsAg Confirmatory ReadyPack Reagents, and ADVIA Centaur® HBsAg Quality Control Material

Approved May 26, 2005, ADVIA Centaur® HBsAg, manufactured by Bayer Healthcare, LLC, is an in vitro immunoassay for the qualitative detection of hepatitis B surface antigen (HBsAg) in human serum and plasma (potassium EDTA, lithium or sodium heparinized) using the ADVIA Centaur® system. The assay may be used in conjunction with other serological and clinical information to diagnose individuals with acute or chronic hepatitis B infections. The assay may also be used to screen for hepatitis B infection in pregnant women to identify neonates who are at risk of acquiring hepatitis B during the perinatal period. ADVIA Centaur HBsAg Confirmatory Ready Pack: The ADVIA Centaur® HBsAg Confirmatory assay is an in vitro diagnostic immunoassay for the qualitative confirmation of the presence of hepatitis B surface antigen (HBsAg) in human serum or plasma (EDTA, lithium or sodium heparin) using the ADVIA Centaur® system. The assay is intended to be used to confirm the presence of HBsAg in samples that are repeatedly reactive using the ADVIA Centaur HBsAg assay. ADVIA Centaur® HBsAg Quality Control Material Indications for Use: for monitoring the performance of the HBsAg and HBsAg Confirmatory assays on the ADVIA Centaur® Systems. Link to approval http://www.fda.gov/MedicalDevices/ProductsandMedicalProcedures/ DeviceApprovalsandClearances/Recently-ApprovedDevices/ucm078604.htm

DakoCytomation c-Kit pharmDx™

Approved June 27, 2005, c-Kit pharmDx™, manufactured by DakoCytomation Denmark A/S, is a qualitative immunohistochemical (IHC) kit system used on the Dako Autostainer, for the identification of c-kit protein/CD117 antigen (c-kit protein) expression in normal and neoplastic formalin-fixed paraffin-embedded tissues for histological evaluation. The c-Kit pharmDx™ rabbit polyclonal antibodies specifically detect the c-kit protein in CD117 antigen-expressing cells. The c-Kit pharmDx™ is indicated as an aid in the differential diagnosis of gastrointestinal stromal tumors (GIST). After diagnosis of GIST, results from c-Kit pharmDx™ may be used as an aid in identifying those patients eligible for treatment with Gleevec™/Glivec® (imatinib mesylate). Results from hematoxylin and eosin (H&E) stains and a panel of antibodies can aid in the differential diagnosis of GIST. Interpretation must be made by a qualified pathologist, within the context of a patient’s clinical history, proper controls, and other diagnostic tests. Link to approval: http://www.fda.gov/MedicalDevices/ProductsandMedicalProcedures/ DeviceApprovalsandClearances/Recently-ApprovedDevices/ucm078540.htm

JBAIDS Anthrax Detection System

Cleared July 6, 2005, Joint Biological Agent Identification and Diagnostic System (JBAIDS) Anthrax Detection System, manufactured by Idaho Technology, Inc. The JBAIDS Anthrax Target 1 Assay is a qualitative IVD test for the detection of 1 of 2 DNA sequence targets, both of which are essential for the organism’s pathogenicity. The JBAIDS Anthrax Target 2 Assay is a qualitative IVD test for the detection of the second DNA sequence target, and is run as a confirmatory test after obtaining a Positive result from the Target 1 Assay. The results from these tests are used in conjunction with culture and other laboratory test and clinical information as an aid in the diagnosis of systemic anthrax infection in individuals suspected of having the disease. Link to clearance: http://www.accessdata.fda.gov/cdrh_docs/pdf5/k051713.pdf

Guardian® RT

Approved July 18, 2005, Guardian® RT, manufactured by Medtronic MiniMed, is indicated for continuous or periodic monitoring of glucose levels in the fluid under the skin in adults (ages 18 and older) with diabetes mellitus for the purpose of improving diabetes management. It alerts if a glucose level falls below or rises above preset values. Values are not intended to be used directly for making therapy adjustments, but rather to provide an indication of when a finger stick may be required. All therapy adjustments would be based on measurements obtained using a home glucose monitor and not on Guardian values. Guardian® RT provides real-time glucose values that allow users to track patterns in glucose concentrations and to possibly identify episodes of low and high blood glucose episodes. It also stores the data so that it can be analyzed to track patterns. Glucose data can be further downloaded to PC software for analysis of historical glucose values. Link to approval: http://www.accessdata.fda.gov/scripts/cdrh/cfdocs/cftopic/pma/pma.cfm?num=p980022s011

Gamma Phage Lysis Assay

Cleared August 16, 2005, Gamma Phage Lysis Assay, manufactured by the Office of the Surgeon General, is a lytic phage assay specific for Bacillus anthracis and may be used as an aid for identification of Bacillus anthracis. The Gamma Phage assay can be used on suspect non-hemolytic, aerobic, gram-positive, “ground-glass” appearing colonies from sheep blood agar in conjunction with other markers and testing for the identification of Bacillus anthracis. This assay is not intended for screening of blood or plasma donors. Link to clearance: http://www.accessdata.fda.gov/scripts/cdrh/cfdocs/cfPMN/pmn.cfm

Invader® UGT1A1 Molecular Assay

Cleared August 22, 2005, the Invader® UGT1A1 Molecular Assay, manufactured by Third Wave Technologies, Inc., is a new blood test that will help doctors make personalized drug treatment decisions for some patients. The Invader® UGT1A1 Molecular Assay detects variations in a gene that affects how certain drugs are broken down and cleared by the body. Doctors can use this information to help determine the right drug dosage for individual patients, and minimize harmful drug reactions. The Invader assay is intended to aid a physician in making individualized patient treatment decisions. Link to clearance: http://www.accessdata.fda.gov/cdrh_docs/pdf5/k051824.pdf

Summary Listing

Original PMA / Panel-Track

Document #	Date	Applicant	Device
P040030	12/17/04	BioGenex Laboratories, Inc.	InSite™ Her-2/neu Kit (withdrawn after approval)
P030056	12/22/04	Bayer Healthcare, LLC	ADVIA Centaur® HCV
P040004	12/22/04	Bayer Healthcare, LLC	ADVIA Centaur® HBc Total ReadyPack Reagents
P040018	12/22/04	Bayer Healthcare, LLC	ADVIA Centaur® HAV IgM ReadyPack Reagents
P030052	1/24/05	Vysis, Inc.	UroVysion™ Bladder Cancer Kit
P040017	3/7/05	Bayer Healthcare, LLC	ADVIA Centaur® HAV Total Assay
P040005	5/3/05	DakoCytomation California	DakoCytomation Her2 FISH pharmDx™ Kit
P030049	5/26/05	Bayer Healthcare, LLC	ADVIA Centaur® HBsAg ReadyPack Reagents
P040011	6/27/05	DakoCytomation California	DakoCytomation c-Kit pharmDx™
P980022/S011	7/18/05	Medtronic MiniMed	Guardian® RT

Automatic Evaluation of Class III Designation (Denovo)

Document #	Date	Applicant	Device
K041875	12/13/04	Vysis, Inc.	Vysis® Autovysion™ System
K042279	12/23/04	Affymetrix, Inc.	Affymetrix GeneChip® Microarray Instrumentation System
K042259	12/23/04	Roche Molecular Systems	AmpliChip CYP450 Test
K042613	4/18/05	PreAnalytiX GMBH	PAXgene™ Blood RNA System
K043011	5/9/05	Tm BioScience Corp.	Tag-It™ Cystic Fibrosis Kit
K041847	5/19/05	Wako Chemicals USA, Inc.	Wako LBA AFP-L3

Significant Decisions (510(k))

Document #	Date	Applicant	Device
K051713	7/6/05	Idaho Technology, Inc.	JBAIDS Anthrax Detection System
K051794	8/16/05	Office of the Surgeon General, U.S Army	Gamma Phage Anthracis Lysis Assay
K051824	8/18/05	Third Wave Technologies, Inc.	Invader® UGT1A1 Molecular Assay