ELECSYS ANTI-HCV II TEST SYSTEM

Assay, Enzyme Linked Immunosorbent, Hepatitis C Virus

FDA Premarket Approval P140021 S005

This medical device record is a pma supplement. A supplement may have changed the device description/function or indication from that approved in the original pma. Be sure to look at the original pma record for more information.

Pre-market Approval Supplement Details

Approval for the migration of claims from the fda approved elecsys anti-hcv ii immunoassay and elecsys precicontrol anti-hcv on the cobas e 601 immunoassay analyzer to the modular analytics e170 analyzer. The device, as modified, will be marketed under the trade name elecsys anti-hcv ii immunoassay and elecsys precicontrol anti-hcv and is indicated for: elecsys anti-hcv ii immunoassay: immunoassay 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 electrochemiluminescence immunoassay eclia is intended for use on the cobas e 601 and modular analytics e170 immunoassay analyzers. Elecsys precicontrol anti-hcv: elecsys precicontrol anti-hcv is used for quality control of the elecsys anti-hcv and the elecsys anti-hcv ii immunoassays on the cobas e 601 and the modular analytics e170 immunoassay analyzers.

DeviceELECSYS ANTI-HCV II TEST SYSTEM
Classification NameAssay, Enzyme Linked Immunosorbent, Hepatitis C Virus
Generic NameAssay, Enzyme Linked Immunosorbent, Hepatitis C Virus
ApplicantROCHE DIAGNOSTICS OPERATIONS INC
Date Received2016-01-29
Decision Date2016-07-25
PMAP140021
SupplementS005
Product CodeMZO
Advisory CommitteeMicrobiology
Supplement TypeNormal 180 Day Track
Expedited ReviewNo
Combination Product No
Applicant Address ROCHE DIAGNOSTICS OPERATIONS INC 9115 Hague Road p.o. Box 50416 indianapolis, IN 46250-0416

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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