# K972576: Gram Positive Autoidentification Plates, Sensititre AP90

- Pathway: 510(k) (Traditional)
- Applicant: Accumed Intl., Inc.
- Decided: Jan 22, 1998 after 196 days
- Product code: LQL (Gram Positive Identification Panel)
- Device class: 1
- Regulation: 21 CFR 866.2660
- Recalls of this device: none
- 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. FDA’s file for it is a 510(k) statement, which names no predicate.

## Indications for use
The Sensititre AP90 panel is an in vitro diagnostic product intended to be used in conjunction with the Sensititre system for the automated identification of clinically significant gram positive organisms.

Source page: https://510kreport.com/device/K972576
Methodology: https://510kreport.com/methodology