Elecsys Anti-HBe, PreciControl Anti-HBe

FDA Premarket Approval P190005 S001

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 use of the elecsys anti-hbe with the cobas e 801 immunoassay analyzer.

• Device: Elecsys Anti-HBe, PreciControl Anti-HBe
• Generic Name: Test, Hepatitis B (b Core, Be Antigen, Be Antibody, B Core Igm)
• Applicant: Roche Diagnostics
• Date Received: 2021-04-02
• Decision Date: 2021-11-01
• PMA: P190005
• Supplement: S001
• Product Code: LOM
• Advisory Committee: Microbiology
• Supplement Type: Normal 180 Day Track
• Supplement Reason: Change Design/components/specifications/material
• Expedited Review: No
• Combination Product: No
• Applicant Address: Roche Diagnostics 9115 Hague Road indianapolis, IN 46250

Supplemental Filings

Supplement Number	Date	Supplement Type
P190005		Original Filing
S001	2021-04-02	Normal 180 Day Track

NIH GUDID Devices

Device ID	PMA	Supp
04015630938872	P190005	000
04015630938865	P190005	000
04015630940134	P190005	001