• Decrease font size
  • Return font size to normal
  • Increase font size
U.S. Department of Health and Human Services

Vaccines, Blood & Biologics

  • Print
  • Share
  • E-mail

BK130006 Letter

DEPARTMENT OF HEALTH & HUMAN SERVICES                                                     Public Health Service
 


                                                                                                                            Food and Drug Administration
1401 Rockville Pike
Rockville, MD 20852-1448

 May 23, 2013

Ortho-Clinical Diagnostics, Inc.
Attention: Ms. Kristine Tkacs
1001 U.S. Highway 202
P.O. Box 350
Raritan, NJ 08869-0606
 
Re:                              BK130006
Trade/Device Name: ORTHOVERSEIA® Integrated Processor (VIP) as part of the ORTHO® Summit System (OSS)
Classification Name:  Automated Bloodborne Pathogen Test Equipment
Regulatory Class:       Class II
Product Code:             MZA
Dated:                        April 15, 2013
Received:                    April 25, 2013
 
Dear Ms. Tkacs:
 
We have reviewed your Section 510(k) premarket notification of intent to market the device referenced above and have determined the device is substantially equivalent (for the indications for use stated in the enclosure) to legally marketed predicate devices marketed in interstate commerce prior to May 28, 1976, the enactment date of the Medical Device Amendments, or to devices that have been reclassified in accordance with the provisions of the Federal Food, Drug, and Cosmetic Act (the Act) that do not require approval of a premarket approval application (PMA).  You may, therefore, market the device, subject to the general controls provisions of the Act.  The general controls provisions of the Act include requirements for annual registration, listing of devices, good manufacturing practice, labeling, and prohibitions against misbranding and adulteration. Please note: CBER does not evaluate information related to contract liability warranties. We remind you; however, that device labeling must be truthful and not misleading.
 
If your device has been classified (see above) into either class II (Special Controls) or class III (PMA), it may be subject to such additional controls.  Existing major regulations affecting your device can be found in the Code of Federal Regulations, Title 21, Parts 800 to 898.  In addition, FDA may publish further announcements concerning your device in the Federal Register.
 
Please be advised that FDA’s issuance of a substantial equivalence determination does not mean that FDA has made a determination that your device complies with other requirements of the Act or any Federal statutes and regulations administered by other Federal agencies. You must comply with all the Act’s requirements, including, but not limited to: registration and listing (21 CFR Part 807); labeling (21 CFR Part 801); good manufacturing practice requirements as set forth in the quality systems (QS) regulation (21 CFR Part 820); and if applicable, the electronic product radiation control provisions (Sections 531-542 of the Act); 21 CFR 1000-1050.
 
If you desire specific advice for your device on our labeling regulation (21 CFR Part 801), please go to http://www.fda.gov/AboutFDA/CentersOffices/CDRH/CDRHOffices/ucm115809.htm for the Center for Devices and Radiological Health’s (CDRH’s) Office of Compliance.  Also, please note the regulation entitled, ²Misbranding by reference to premarket notification² (21CFR Part 807.97). For questions regarding the reporting of adverse events under the MDR regulation (21 CFR Part 803), please go to http://www.fda.gov/MedicalDevices/Safety/ReportaProblem/default.htm for the CDRH’s Office of Surveillance and Biometrics/Division of Postmarket Surveillance. 
 
You may obtain other general information on your responsibilities under the Act from the Division of Small Manufacturers, International and Consumer Assistance at its toll-free number (800) 638‑2041 or (301) 796-7100 or at its Internet address http://www.fda.gov/MedicalDevices/ResourcesforYou/Industry/default.htm.
 
Sincerely yours,
 
 
 
Hira L. Nakhasi, PhD
Director
Division of Emerging and
 Transfusion Transmitted Diseases
Office of Blood Research and Review
Center for Biologics
 Evaluation and Research
 
 
 
Enclosure



Indications for Use
 
 
510(k) Number: BK130006
 
Device Name: ORTHO VERSEIA® Integrated Processor (VIP) as part of the ORTHO® Summit System (OSS)
 
Indications for Use:
 
The ORTHO® Summit System (OSS) is a modular, integrated system for use with licensed blood screening tests. Consisting of networked processors and instruments linked together via a local area network, assay-specific pipetting protocols and OrthoâAssay Software (OAS), OSS automates many of the processing functions and data management requirements associated with ELISA (enzyme-linked immunosorbent assay) microplate testing. Only assays licensed for use on the OSS may be used with this system.
 

The ORTHO VERSEIA® Integrated Processor (VIP) is an automated pipetting and processing system comprised of an ORTHO VERSEIA® Pipetter (Verseia) and an ORTHO® Summit Processor (OSP) joined together to enable integrated end-to-end pipetting and processing. The ORTHO VERSEIA® Integrated Processor is to be used with licensed blood screening tests distributed by Ortho-Clinical Diagnostics, Inc. for in vitro diagnostic use.