# K983310: Sensititre 18-24 Hour Susceptibility Plates with Sparfloxacin

- Pathway: 510(k) (Traditional)
- Applicant: Accumed Intl., Inc.
- Decided: Dec 17, 1998 after 87 days
- Product code: JTT (Susceptibility Test Powders, 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 Sparfloxacin in the dilution range of 0.002 - 4 pg/ml to the Sensititre 18 — 24 hour MIC panel for testing non-fastidious gram negative isolates. Organisms indicated for testing in the approved FDA Sparfloxacin package insert include Enterobacter cloacae and Klebsiella pneumoniae.

Source page: https://510kreport.com/device/K983310
Methodology: https://510kreport.com/methodology