# K060621: Susceptibility Test Plate for Ertapenem 0.002-16UG/ML for Gram Negative.  Susceptibility Test Plate for Ertapenem 0.015-

- Pathway: 510(k) (Traditional)
- Applicant: Tds Holdings, Inc.
- Decided: Apr 21, 2006 after 44 days
- Product code: JWY (Manual Antimicrobial Susceptibility Test Systems)
- Device class: 2
- Regulation: 21 CFR 866.1640
- 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 - 24 hour MIC or Breakpoint Susceptibility System is an in vitro diagnostic product for clinical susceptibility testing of gram positive and gram negative organisms. This 510(k) is for the addition of Ertapenem in the dilution range of 0.002 - 16 gg/ml for gram negative organisms and 0.0115-64p.ig/ml for gram positive organisms to the Sensititre 18 - 24 hour MIC panel for testing gram positive and gram negative isolates. The approved primary "Indications for Use" and clinical significance of Ertapenem is for: Staphylococcus species (methicillin-susceptible strains),Streptococcusagalactiae, Steptococcus pyogenes, Escherichiacoai, and Klebsiella pneumoniae. In vitro data, without clinical correlation is provided for: Citrobacter freundii, Citrobacter koseri, Enterobacter aerogenes, Enterobacter cloacae, Klebsiella oxytoca, Morganella morganii, Proteus mirabilis, Proteus vulgaris, and Serratia marcescens.

Source page: https://510kreport.com/device/K060621
Methodology: https://510kreport.com/methodology