RealTime IDH1

Somatic Gene Mutation Detection System

FDA Premarket Approval P170041 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

Additional internal qc testing for the dna sample preparation kit.

• Device: RealTime IDH1
• Classification Name: Somatic Gene Mutation Detection System
• Generic Name: Somatic Gene Mutation Detection System
• Applicant: Abbott Molecular, Inc.
• Date Received: 2019-08-29
• Decision Date: 2019-09-24
• PMA: P170041
• Supplement: S001
• Product Code: OWD
• Advisory Committee: Molecular Genetics
• Supplement Type: 30-day Notice
• Supplement Reason: Process Change - Manufacturer/sterilizer/packager/supplier
• Expedited Review: No
• Combination Product: No
• Applicant Address: Abbott Molecular, Inc. 1300 East Touhy Avenue des Plaines, IL 60018

Supplemental Filings

Supplement Number	Date	Supplement Type
P170041		Original Filing
S006	2021-12-17	Normal 180 Day Track
S005	2021-02-05	30-day Notice
S004
S003	2020-12-21	30-day Notice
S002	2019-10-16	30-day Notice
S001	2019-08-29	30-day Notice

NIH GUDID Devices

Device ID	PMA	Supp
00884999047792	P170041	000
00884999047358	P170041	000
00884999047341	P170041	000