# K983244: Sensititre 18-24 HR Susceptibility Plates (Addition of Meropenem)

- Pathway: 510(k) (Traditional)
- Applicant: Trek Diagnostic Systems, Inc.
- Decided: Nov 30, 1998 after 75 days
- Product code: JTW (System, Transport, Aerobic)
- Device class: 1
- Regulation: 21 CFR 866.2900
- Recalls of this device: 9 (9 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.
1 of 1 device in its family (counting itself) has 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.

## Recalls of this device
- Oct 20, 2022 · Class I · Z-0327-2023: An internal technical investigation has confirmed that Thermo Scientific" Gram Negative IVD AST Sensititre Plate may lead to false susceptible results for Proteae Tribe (including Proteus spp., Provid
- Oct 20, 2022 · Class I · Z-0329-2023: An internal technical investigation has confirmed that Thermo Scientific" Gram Negative IVD AST Sensititre Plate may lead to false susceptible results for Proteae Tribe (including Proteus spp., Provid
- Oct 20, 2022 · Class I · Z-0334-2023: An internal technical investigation has confirmed that Thermo Scientific" Gram Negative IVD AST Sensititre Plate may lead to false susceptible results for Proteae Tribe (including Proteus spp., Provid
- Oct 20, 2022 · Class I · Z-0330-2023: An internal technical investigation has confirmed that Thermo Scientific" Gram Negative IVD AST Sensititre Plate may lead to false susceptible results for Proteae Tribe (including Proteus spp., Provid
- Oct 20, 2022 · Class I · Z-0328-2023: An internal technical investigation has confirmed that Thermo Scientific" Gram Negative IVD AST Sensititre Plate may lead to false susceptible results for Proteae Tribe (including Proteus spp., Provid
- Oct 20, 2022 · Class I · Z-0331-2023: An internal technical investigation has confirmed that Thermo Scientific" Gram Negative IVD AST Sensititre Plate may lead to false susceptible results for Proteae Tribe (including Proteus spp., Provid
- Oct 20, 2022 · Class I · Z-0332-2023: An internal technical investigation has confirmed that Thermo Scientific" Gram Negative IVD AST Sensititre Plate may lead to false susceptible results for Proteae Tribe (including Proteus spp., Provid
- Oct 20, 2022 · Class I · Z-0333-2023: An internal technical investigation has confirmed that Thermo Scientific" Gram Negative IVD AST Sensititre Plate may lead to false susceptible results for Proteae Tribe (including Proteus spp., Provid
- Oct 20, 2022 · Class I · Z-0335-2023: An internal technical investigation has confirmed that Thermo Scientific" Gram Negative IVD AST Sensititre Plate may lead to false susceptible results for Proteae Tribe (including Proteus spp., Provid

## 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 Meropenem in the dilution range of 0.004 — 8 ug/ml to the Sensititre 18 — 24 hour MIC panel for testing gram negative isolates.

Source page: https://510kreport.com/device/K983244
Methodology: https://510kreport.com/methodology