RealTime IDH2

Somatic Gene Mutation Detection System

FDA Premarket Approval P170005 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 of an additional internal qc testing for the dna sample preparation kit.

• Device: RealTime IDH2
• 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: P170005
• 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 E. Touhy Avenue des Plaines, IL 60018

Supplemental Filings

Supplement Number	Date	Supplement Type
P170005		Original Filing
S004	2022-03-10	Special (immediate Track)
S003	2021-02-05	30-day Notice
S002	2020-12-21	30-day Notice
S001	2019-08-29	30-day Notice

NIH GUDID Devices

Device ID	PMA	Supp
00884999047051	P170005	000
00884999047044	P170005	000
00884999047037	P170005	000