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U.S. Department of Health and Human Services

Premarket Approval (PMA)

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Note: this medical device record is a supplement. The device description may have changed. Be sure to look at the original PMA to get an up-to-date view of this device.
 
Trade NameVITROS IMMUNODIAGNOSTIC PRODUCTS ANTI-HCV REAGENT PACK AND CALIBRATOR
Classification Nameassay,enzyme linked immunosorbent,hepatitis c virus
Generic Nameanti-hcv assay
ApplicantORTHO-CLINICAL DIAGNOSTICS, INC.
PMA NumberP010021
Supplement NumberS016
Date Received03/30/2009
Decision Date07/15/2009
Product Code
MZO[ Registered Establishments with MZO ]
Advisory Committee Microbiology
Supplement Typenormal 180 day track
Supplement Reason change design/components/specifications - component
Expedited Review Granted? No
Combination Product No
Approval Order Statement 
Approval for revision of the intended use to include use of the vitros 5600 integrated system and vitros 3600 immunodiagnostic system with the anti-hcv assay. The device, as modified, will be marketed under the trade name vitros immunodiagnostic products anti-hcv reagent pack, vitros immunodiagnostic products anti-hcv calibrator and is indicated for: vitros immunodiagnostic products anti-hcv reagent pack: for the in vitro qualitative detection of immunoglobulin g antibody to hepatitis c virus (anti-hcv) in human serum and plasma (heparin, edta and sodium citrate) using the vitros eci/eciq immunodiagnostic systems, the vitros 3600 immunodiagnostic system and the vitros 5600 integrated system. Three recombinant hepatitis c virus encoded antigens are used. Assay results, in conjunction with other laboratory results and clinical information, may be used to provide presumptive evidence of infection with hepatitis c virus, (state or associated disease not determined), in persons with signs or symptoms of hepatitis and in persons at risk for hepatitis c infection. In addition, this assay may be used to screen for hepatitis c infection in pregnant women to identify neonates who are at high risk of acquiring hcv during the prenatal period. Vitros immunodiagnostic products anti-hcv calibrator: for use in the calibration of the vitros eci/eciq immunodiagnostic systems, the vitros 3600 immunodiagnostic system and the vitros 5600 integrated system for the in vitro qualitative detection of immunoglobulin g antibody to hepatitis c virus (anti-hcv) in human serum and plasma (heparin, edta and sodium citrate) using vitros anti-hcv reagent packs. The vitros anti-hcv calibrator has been validated for use only on the vitros eci/eciq immunodiagnostic systems, the vitros 3600 immunodiagnostic system and the vitros 5600 integrated system with the vitros immunodiagnostic products anti-hcv reagent pack.
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