# K983306: Sensititre 18-24 Hour Susceptibility Plates with Grepafloxacin

- Pathway: 510(k) (Traditional)
- Applicant: Accumed Intl., Inc.
- Decided: Dec 18, 1998 after 88 days
- Product code: LTT (Panels, Test, Susceptibility, Antimicrobial)
- Device class: 2
- Regulation: 21 CFR 866.1640
- 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 18 hour MIC or Breakpoint Susceptibility system is an in vitro diagnostic product for clinical susceptibility testing of gram negative and gram positive organisms. This 510(k) is for the addition of Grepafloxacin in the dilution range of 0.002 - 4 ng/ml to the Sensititre 18 — 24 hour MIC panel for testing non-fastidious gram negative isolates. There are no approved primary “indications for use” and the clinical significance of Grepafloxacin is unknown when evaluating Enterobacteriaceae, Pseudomonas, or any other non-fastidious gram negative rods.

Source page: https://510kreport.com/device/K983306
Methodology: https://510kreport.com/methodology