• 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

BK110036 Summary

510K SUMMARY

Submitter of 510k:  Emily B. Rossiter on behalf of DiaSpect Medical, GmbH

Contact Person: Emily B. Rossiter
President, Regulatory Resources, Inc.
800 E. Leigh Street, Suite 206-5
Virginia Biotechnology Research Park
Richmond, VA   23219
rri@infionline.net
Date of Summary: September 12, 2011

Date of Summary:     September 12, 2011

Trade Name: DiaSpect Hemoglobin T and DiaSpect Hemoglobin Cuvettes

Classification Name:  Automated Hemoglobin System

Device Product Code:  GKR

Predicate Device:  HemoCue Hb 301 Hb and HemoCue Hb 301 Microcuvettes (K060048)

Intended Use: 

The DiaSpect Hemoglobin T system is designed for quantitative total hemoglobin determination in human blood donation settings, using capillary or venous samples in a specially designed analyzer, the DiaSpect Hemoglobin T analyzer, with specially designed, disposable microcuvettes, DiaSpect Hemoglobin Cuvettes. The Diaspect Hemoglobin T analyzer is only to be used with Diaspect Hemoglobin Cuvettes. For in vitro diagnostic use only.

Device Description:

The Diaspect Hemoglobin T is a single analyte instrument, for use with DiaSpect Hemoglobin Cuvettes, which has self-contained features to perform direct measurement and readout without reagents.

The instrument is a spectrophotometric analyzer for the measurement of total hemoglobin concentration in unaltered human blood. In order to determine the hemoglobin level in a sample of human blood, the cuvette draws a small amount (approximately 10μL) of venous or capillary blood by capillary effect. The user places the filled cuvette in the motor-driven drawer of the DiaSpect Hemoglobin T. The hemoglobin level is determined automatically and appears in the display after a brief measuring time of about 1 second. 

The DiaSpect Hemoglobin Cuvette is injection-molded of optical plastic (PMMA) and contains a cavity volume of approximately10 μl. The optical window permits photometric determination of hemoglobin in undiluted and unaltered blood. The cuvette does not contain any reagents. The DiaSpect Hemoglobin Cuvettes are intended as single use and must be disposed of immediately after sampling in accordance with local regulations for potentially infectious waste.

Comparison Table with Predicate Device:

The DiaSpect Hemoglobin T and DiaSpect Hemoglobin Cuvettes are substantially equivalent to the claims and published specifications of the HemoCue Hb 301 and HemoCue Hb Microcuvettes for blood donor screening (see Table 5-1 on the following page). Both products are currently marketed outside the US and conform to Directive 98/79/EC on In-vitro Diagnostic Devices.

The two systems are similar in design, operating principles and technological characteristics. They have comparable precision and are similarly affected by pre-analytical factors such as fingerstick sampling. Both methods generally show less variability with venous samples than with fingerstick capillary samples.

Laboratory and clinical studies utilizing the hemiglobincyanide (HiCN) reference method according to ICSH, and hematology analyzers traceable to this reference, have demonstrated that the DiaSpect Hemoglobin T and DiaSpect Cuvettes are comparable to a variety of hematology analyzers marketed in the US. 

Table 5-1
Substantial Equivalence Table

Feature

DiaSpect Hemoglobin T and
DiaSpect Hemoglobin Cuvettes

HemoCue Hb 301 Analyzer and HemoCue Hb Microcuvettes (BK060048)
Intended Use/-Indications for Use The DiaSpect Hemoglobin T system is designed for quantitative total hemoglobin determination in human blood donation settings, using capillary or venous samples in a specially designed analyzer, the DiaSpect Hemoglobin T analyzer, with specially designed, disposable microcuvettes, DiaSpect Hemoglobin Cuvettes.  The Diaspect Hemoglobin T analyzer is only to be used with Diaspect Hemoglobin Cuvettes.  For in vitro diagnostic use only.  The HemoCue Hb 301 is designed for quantitative point-of-care whole blood hemoglobin determination in primary care or blood donation settings using a specially designed analyzer and specially designed microcuvettes. For in vitro diagnostic use. The HemoCue Hb 301 Analyzer is only to be used with HemoCue 301 Microcuvettes.
Technological Characteristics Single use microcuvettes serve as capillary pipette and measuring cuvette. Portable photometer with direct, immediate readout; motor driven cuvette holder.  Li-Ion rechargeable battery. Range 0 – 25.5 g/dL Single use microcuvettes serve as capillary pipette and measuring cuvette. Portable photometer uses 4 type AA batteries or power cord with adapter.  Result displayed after approximately 10 seconds. Range 0 – 25.6 g/dL.
Sample/specimen Approximately 10 µL whole blood; capillary or venous Approximately 10 µL whole blood; capillary, venous, or arterial
Principle of operation Measures the absorbance of whole blood at multiple wavelengths, 450 nm to 750 nm. Measures the absorbance of whole blood at Hb/HbO2 isobestic point at the wavelengths 506 nm and 880 nm.
Analyte Hemoglobin Hemoglobin
Cuvettes/Reagent? Single use, poly(methyl methacrylate) plastic cuvette; no reagent or active ingredients. Single use, polystyrene plastic cuvette; no active ingredients

Calibration/
Quality control

Calibrated against the hemiglobincyanide (HiCN) method. Factory calibrated and needs no further calibration.  Self-check (internal quality control) between measurements and when machine is turned on. An error code is displayed if the self-check fails.  A checkmark is shown in display when self-check succeeds Calibrated against the hemiglobincyanide (HiCN) method. Factory calibrated and needs no further calibration. Internal quality control “self-test” when machine is turned on and at regular intervals.  An error code is displayed if the self-test fails.

Electrical Safety
And Electromagnetic Compatibility
(as applicable)

IEC/EN  60950-1
IEC/EN 61010-1, 2001
IEC/EN 61326-1:2006
IEC/EN 61326-2-6:2006
IEC/EN 61000-3-2:2009
IEC/EN 61000-3-3:2008

IEC/EN 61010-1, 2001
IEC/EN 60601-1 2nd edition clause 19, 20, and 57.10
IEC/EN 60601-1-2
IEC/EN 61326
IEC 61000-4-2, 4-4,
IEC/EN 61000-4-5, 4-11

CLIA Status Waived by regulation (January 19, 1993) Waived
Packaging/shelf life Cuvettes packaged in sealed, reclosable foil pouch; stable for 2.5 years in opened or unopened pouch. Cuvettes packaged in sealed vials; stable for 3 months after breaking the seal of the vial.
Sterile? No No
Conformance with Directive 98/79/EC on In-vitro Diagnostic Devices Yes Yes