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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 NameABBOTT REALTIME HCV GENOTYPE II, ABBOTT REALTIME HCV GENOTYPE II CONTROL KIT, URACIL-N-GLYCOSYLASE (UNG)
Classification Nameassay, genotyping, hepatitis c virus
ApplicantABBOTT MOLECULAR
PMA NumberP120012
Date Received07/12/2012
Decision Date06/20/2013
Product Code
OBF[ Registered Establishments with OBF ]
Docket Number 13M-0758
Notice Date 06/24/2013
Advisory Committee Microbiology
Clinical Trials NCT00351403
Expedited Review Granted? No
Combination Product No
Information About: Labeling, Approval Order, Summary of Safety and Effectiveness
Approval Order Statement 
Approval for the abbott realtime hcv genotype ii, abbott realtime hcv genotype ii control kit, and uracil-glycosylase (ung). This device is indicated for: abbott realtime hcv genotype ii the abbott realtime hcv genotype ii is an in vitro reverse transcription-polymerase chain reaction (rt-pcr) assay for use with the abbott msample preparation system reagents and with the abbott m2000sp and m2000rt instruments for the qualitative identification of hepatitis c virus (hcv) genotypes 1, 1a, 1b, and 2 - 5 in plasma or serum from individuals chronically infected with hcv. The abbott realtime hcv genotype ii is intended for use as an aid in the management of hcv-infected individuals and in guiding the selection of therapeutic treatment indicated for the above listed genotypes. The assay is intended for use on patients who are chronically infected with hcv, are being considered for antiviral treatment, and are positive for hcv rna. The abbott realtime hcv genotype ii assay is not for screening blood, plasma, serum or tissue donors for hcv. Abbott realtime hcv genotype ii control kit the abbott realtime hcv genotype ii controls are used to establish run validity of the abbott realtime hcv genotype ii assay when used for determining the genotype(s) of hepatitis c virus (hcv) in plasma or serum from individuals chronically infected with hcv. Uracil-n-glycosylase (ung) the uracil-n-glycosylase (ung) procedure is to be used in conjunction with abbott realtime hcv genotype ii assay as an optional contamination control for customer laboratories that are currently using or have previously used amplification technologies that incorporate uracil into the amplification product.
Approval Order Approval Order
Supplements: S001 S002 S003 S004 
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