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U.S. Department of Health and Human Services

Premarket Approval (PMA)

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Note: this medical device has supplements. The device description may have changed. Be sure to look at the supplements to get an up-to-date view of this device.
 
Trade NameARCHITECT ANTI-HCV ASSAY; ARCHITECT ANTI-HCV CALIBRATOR; ARCHITECT ANTI-HCV CONTROL
Classification Nameassay,enzyme linked immunosorbent,hepatitis c virus
ApplicantABBOTT LABORATORIES INC
PMA NumberP050042
Date Received11/29/2005
Decision Date06/07/2006
Product Code
MZO[ Registered Establishments with MZO ]
Docket Number 06M-0389
Notice Date 09/26/2006
Advisory Committee Microbiology
Expedited Review Granted? No
Combination Product No
Information About: Labeling, Approval Order, Summary of Safety and Effectiveness
Recalls CDRH Recalls
Approval Order Statement 
Approval for the abbott architect anti-hcv. This device is indicated for: the architect anti-hcv assay is a chemiluminescent microparticle immunoassay (cmia) for the qualitative detection of immunoglobulin g (igg) and immunoglobulin m (igm) antibodies to hepatitis c virus (anti-hcv) in human adult serum and plasma (potassium edta, lithium heparin, and sodium heparin). Assay results, in conjunction with other laboratory results and clinical information, may be used to provide presumptive evidence of infection with hcv (state of infection or associated disease not determined) in persons with signs and symptoms of hepatitis and in persons at risk for hepatitis c infection. The architect anti-hcv calibrator is used for the calibration of the architect i system when the system is used for the qualitative detection of immunoglobulin g (igg) and immunoglobulin m (igm) antibodies to hepatitis c virus (anti-hcv) in human adult serum and plasma (potassium edta, lithium heparin, and sodium heparin). The architect anti-hcv calibrator has been validated for use only on the architect i system with the architect anti-hcv reagent kit. Refer to the architect anti-hcv assay reagent package insert for the full listing of information regarding the assay. The architect anti-hcv controls are used to provide an estimation of test precision and to detect systematic analytical deviations of the architect i system (reagents, calibrator, and instrument (when the system is used for the qualitative detection of immunoglobulin g (igg) and immunoglobulin m (igm) antibodies to hepatitis c virus (anti-hcv) in human adult serum and plasma (potassium edta, lithium heparin, and sodium heparin). The architect anti-hcv controls have been validated for use only on the architect i system with the architect anti-hcv reagent kit.
Approval Order Approval Order
Supplements: S001 S002 S003 S004 S005 S006 S007 S008 S009 
S010 S011 S012 S013 S014 S015 S016 S017 S018 
S019 S020 S021 S022 S023 S024 S025 S026 S027 
S028 S029 S030 
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