ELECSYS ANTI-HCV II IMMUNOASSAY, ELECSYS PRECICONTROL ANTI-HCV

Assay, Enzyme Linked Immunosorbent, Hepatitis C Virus

FDA Premarket Approval P140021

This medical device has supplements. The device description/function or indication may have changed. Be sure to look at the supplements to get an up-to-date information on device changes. The labeling included below is the version at time of approval of the original pma or panel track supplement and may not represent the most recent labeling.

Pre-market Approval Supplement Details

Approval for the elecsys anti-hcv ii immunoassay and elecsys precicontrol anti-hcv. This device is indicated for: elecsys anti-hcv ii immunoassayimmunoassay for the in vitro qualitative detection of antibodies to hepatitis c virus (hcv) in human adult and pediatric (ages 18 months through 21 years) serum and plasma (potassium edta, lithium heparin, sodium heparin, and sodium citrate). Assay results, in conjunction with other laboratory results and clinical information, may be used to aid in the presumptive diagnosis of hcv infection in persons with signs and symptoms of hepatitis and in persons at risk for hepatitis c infection. The test does not determine the state of infection or associated disease. The electroluminescence immunoassay eclia is intended for use on the roche cobas e 601 immunoassay analyzer. Elecsys precicontrol anti-hcv elecsys precicontrol anti-hcv is used for quality control of the elecsys anti-hcv immunoassay on the cobas e 601 and cobas e 602 immunoassay analyzers and the elecsys anti-hcv ii immunoassay on the cobas e 601 immunoassay analyzer.

DeviceELECSYS ANTI-HCV II IMMUNOASSAY, ELECSYS PRECICONTROL ANTI-HCV
Classification NameAssay, Enzyme Linked Immunosorbent, Hepatitis C Virus
Generic NameAssay, Enzyme Linked Immunosorbent, Hepatitis C Virus
ApplicantROCHE DIAGNOSTICS OPERATIONS INC
Date Received2014-10-01
Decision Date2015-06-11
Notice Date2015-07-10
PMAP140021
SupplementS
Product CodeMZO
Docket Number15M-2217
Advisory CommitteeMicrobiology
Expedited ReviewNo
Combination Product No
Applicant Address ROCHE DIAGNOSTICS OPERATIONS INC 9115 Hague Road p.o. Box 50416 indianapolis, IN 46250-0416
Summary:Summary of Safety and Effectiveness
Labeling: Labeling
Approval Order: Approval Order

Supplemental Filings

Supplement NumberDateSupplement Type
P140021Original Filing
S016 2018-10-26 Normal 180 Day Track No User Fee
S015 2018-10-09 30-day Notice
S014 2018-04-17 Real-time Process
S013 2018-03-01 Real-time Process
S012 2017-10-11 Real-time Process
S011 2017-08-03 30-day Notice
S010 2017-07-03 Normal 180 Day Track
S009 2017-05-24 30-day Notice
S008 2017-03-21 Normal 180 Day Track
S007 2016-09-30 Real-time Process
S006 2016-02-16 30-day Notice
S005 2016-01-29 Normal 180 Day Track
S004 2016-01-27 30-day Notice
S003 2016-01-27 135 Review Track For 30-day Notice
S002 2015-12-17 Normal 180 Day Track
S001 2015-10-07 30-day Notice

NIH GUDID Devices

Device IDPMASupp
04015630936670 P140021 008
04015630936663 P140021 008

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