6.0 510(K) SUMMARY
This summary of 510(k) safety and effectiveness information is being submitted in accordance with the requirements of SMDA 1990 and 21CFR§807.92.
|6.1 Applicant Information|
|Date Prepared:||November 16, 2011|
|Address:||3130 Gateway Drive|
Norcross, Georgia 30071
|Establishment Registration Number:||1034569|
|Contact Person:||Howard Yorek |
Senior Director, Regulatory Affairs
|6.2 Device Information|
|Trade Name:||FMH RapidScreen|
|Common Name:||Screening Test for D Positive Fetal RBC’s|
|Classification Name:||Test, Screening, for D Positive Fetal RBC’s|
6.3 Predicate Device
Fetal Bleed Screening Test: K820647; cleared May 12, 1982
6.4 Device Description
FMH RapidScreen is a test for the detection of D-positive red blood cells in the circulation of a D-negative mother based upon the principle of immune rosetting. FMH RapidScreen consists of four reagents:
- Anti-D Reagent – contains monoclonal IgM anti-D antibodies from the human/murine heterohybridoma cell line GAMA401 grown in fluid culture and suitably diluted in a proprietary diluent. This reagent contains 0.1% sodium azide as a preservative.
- Positive Control Cells – a 2 – 4% suspension of human group O red blood cells, consisting of a mixture of D-positive cells diluted in D-negative cells. The concentration of D-positive cells is approximately 0.6%.
- Negative Control Cells – a 2 – 4% suspension of human group O, D-negative (rr) red blood cells.
- Indicator Cells – an approximate 0.5% suspension of human group O red blood cells from a donor with a presumptive R2r phenotype.
- In order to maintain the integrity of the cell membrane with its antigens, all cells are suspended in a buffered preservative solution. The preservative solution has been specially formulated to preserve red cell integrity and contains neomycin sulfate (0.1 mg/mL), chloramphenicol (0.25 mg/mL), and gentamycin sulfate (0.1 mg/mL) as preservatives.
6.5 Intended Use
FMH RapidScreen is intended for use in the detection of D-positive red blood cells in D-negative mothers.
FMH RapidScreen is substantially equivalent to another currently marketed predicate, the Fetal Bleed Screening Test, as the intended use of these two devices is the same.
FMH RapidScreen contains the same components as the Fetal Bleed Screening Test except that FMH RapidScreen contains a monoclonal IgM anti-D reagent and non-ficin treated R2r indicator red cells whereas the Fetal Bleed Screening Test contains a polyclonal anti-D antiserum and ficin-treated R2R2 indicator red cells.
Clinical Performance Testing demonstrated a 98.2% overall agreement (95% lower CI = 96.9%) between the FMH RapidScreen and the predicate Fetal Bleed Screening Test. FMH RapidScreen was shown to be as effective as the predicate Fetal Bleed Screening Test for detection of D-positive red blood cells in D-negative mothers.
Review of the intended use, technical characteristics, and the results of clinical and non-clinical performance testing demonstrates that the FMH RapidScreen is as safe, as effective, and performs as well as or better than the predicate device (Fetal Bleed Screening Test) when used to screen maternal blood samples for the presence of fetal D-positive red blood cells.