# K952095: Vitek Gram Positive Identification Card (Gpi)

- Pathway: 510(k) (Traditional)
- Applicant: Biomerieux Vitek, Inc.
- Decided: Mar 12, 1996 after 313 days
- Product code: LQL (Gram Positive Identification Panel)
- Device class: 1
- Regulation: 21 CFR 866.2660
- Recalls of this device: 2 (0 Class I)
- Data: FDA decisions to Oct 25, 2026; recalls to Oct 12, 2026

## Lineage
No predicates in its family tree.
No later device cites it as a predicate yet.
0 of 1 device in its family (counting itself) have a Class I recall.

## Predicates on the family tree (from the FDA summary)
- None. The FDA summary names no predicate by number.

## Recalls of this device
- Oct 11, 2017 · Class II · Z-0074-2018: Customers have reported, and an internal investigation has confirmed, occurrences of atypical negative O129R reactions for Enterococcus casseliflavus ATCC)R) 700327(TM) in association with three (3) V
- Aug 25, 2017 · Class II · Z-3134-2017: Customer reports have indicated occurrences of atypical negative O129R reactions for Enterococcus casseliflavus ATCC(R) 700327(TM) in association with VITEK(R) 2 GP ID Lot 2420240403 and 2420303403, c

## Indications for use
The VITEK® Gram Positive Identification Card containing new claims for the identification of Enterococcus casseliflavus, Enterococcus gallinarum, and Enterococcus hirae is intended for use in conjunction with the Vitek® System for the automated identification of clinically significant streptococci, staphylococci, and a selected group of Gram positive bacilli.

Source page: https://510kreport.com/device/K952095
Methodology: https://510kreport.com/methodology