ELECSYS ANTI-HCV II IMMUNOASSAY.

Assay, Enzyme Linked Immunosorbent, Hepatitis C Virus

FDA Premarket Approval P140021 S007

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 addition of k3-edta plasma as a specimen type for the elecsys® anti-hcv ii immunoassay.

• Device: ELECSYS ANTI-HCV II IMMUNOASSAY.
• Classification Name: Assay, Enzyme Linked Immunosorbent, Hepatitis C Virus
• Generic Name: Assay, Enzyme Linked Immunosorbent, Hepatitis C Virus
• Applicant: ROCHE DIAGNOSTICS OPERATIONS INC
• Date Received: 2016-09-30
• Decision Date: 2016-11-10
• PMA: P140021
• Supplement: S007
• Product Code: MZO
• Advisory Committee: Microbiology
• Supplement Type: Real-time Process
• Supplement Reason: Change Design/components/specifications/material
• Expedited Review: No
• Combination Product: No
• Applicant Address: ROCHE DIAGNOSTICS OPERATIONS INC 9115 Hague Road p.o. Box 50416 indianapolis, IN 46250-0416

Supplemental Filings

Supplement Number	Date	Supplement Type
P140021		Original 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 ID	PMA	Supp
04015630936670	P140021	008
04015630936663	P140021	008