510(k) Report

510(k) · Cleared

Recalled · Class I · 2022

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

K983244510(k) TraditionalCleared Nov 30, 199875-day reviewClass I21 CFR 866.2900Recalls 9 (9 Class I)

Data to Oct 25, 2026 (FDA decisions) Oct 12, 2026 (recalls) Sep 30, 2026 (MAUDE) refreshed weekly, last Nov 3, 2026

Trek Diagnostic Systems, Inc. · JTW System, Transport, Aerobic

Cleared on Nov 30, 1998 after a 75-day review. FDA’s file for it is a 510(k) statement, which names no predicate. It has a Class I recall. It has been recalled 9 times, including 9 Class I recalls.

Decided
Nov 30, 1998
Review
75 days
Class
Class I
Product code
JTW
Recalls
9 (9 Class I)
Predicates
0

FDA’s file for it is a 510(k) statement, which names no predicate.

FIG. 1 — Lineage of K983244Source: FDA 510(k) database · How lineage is built

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Notable FDA decisions, review times and new Class I recalls. See an issue.

Sources: FDA 510(k) database (decision fields), the FDA 510(k) statement (indications), FDA recall and enforcement reports, and MAUDE; processed by 510(k) Report. Verify on FDA.gov · Methodology and accuracy.

1 device in this family has a Class I recall. A 510(k) Report weighs predicate choices, recall history and review times for a new device like this one.

  • Candidate predicates for a device like this, rankedin the report
  • Recall history across each candidate’s familyin the report
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What was it cleared against?

FDA’s file for it is a 510(k) statement, which names no predicate.

What descends from it?

No later submission names this one as a predicate yet.

Has anything in its family been recalled? (1 Class I)

Recalls of this device

DateClassRecallRoot causeReason
Oct 20, 2022Class IZ-0327-2023Process controlAn 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., Providencia spp., Morganella Morganii) when…
Oct 20, 2022Class IZ-0329-2023Process controlAn 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., Providencia spp., Morganella Morganii) when…
Oct 20, 2022Class IZ-0334-2023Process controlAn 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., Providencia spp., Morganella Morganii) when…
Oct 20, 2022Class IZ-0330-2023Process controlAn 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., Providencia spp., Morganella Morganii) when…
Oct 20, 2022Class IZ-0328-2023Process controlAn 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., Providencia spp., Morganella Morganii) when…
Oct 20, 2022Class IZ-0331-2023Process controlAn 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., Providencia spp., Morganella Morganii) when…
Oct 20, 2022Class IZ-0332-2023Process controlAn 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., Providencia spp., Morganella Morganii) when…
Oct 20, 2022Class IZ-0333-2023Process controlAn 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., Providencia spp., Morganella Morganii) when…
Oct 20, 2022Class IZ-0335-2023Process controlAn 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., Providencia spp., Morganella Morganii) when…

The 5 latest of 9 recalls; the web page lists all.

No ancestor or descendant has a Class I recall.

How does its category compare?

All JTW devices

JTW System, Transport, Aerobic: FDA decisions, review times, recalls and adverse event reports over 20 years.

FDA decisions per year · JTW

1in 2012

2012: 1
2007high 1 (2012) · low 0 (2007)2026

2026 to Oct 25, outlined.

Median 510(k) review, days · JTW

Too few JTW 510(k)s in any year since 2007 to give a median.

Recalls per year · JTW

1in 2022

2009: 12018: 42022: 1
2007high 4 (2018) · low 0 (2007)2026

Class I (0 since 2007) Class II/III not classified

Adverse event reports per year · JTW

36in 2025

2011: 22012: 22013: 12014: 32015: 22016: 22017: 142018: 322019: 82020: 122021: 72022: 52023: 222024: 372025: 36
2007high 37 (2024) · low 0 (2007)2025

MAUDE reports naming product code JTW, not matched to any one device; reports are not rates.

View these four charts as a table
YearDecisionsMedian 510(k) review, daysRecalls (Class I)MAUDE reports
20070—00
20080—00
20090—10
20100—00
20110—02
20121—02
20130—01
20140—03
20150—02
20160—02
20170—014
20180—432
20190—08
20200—012
20210—07
20220—15
20230—022
20240—037
20250—036
20260—0—

What is it indicated for?

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.

Indications for use read by OCR from a scanned FDA 510(k) statement, so letters may be misread. Check the PDF before quoting it.

More from Trek Diagnostic Systems, Inc.

62 FDA decisions under this applicant name. See the company

  • K093865Sensititre 18-24HR Susceptibility PlatesTrek Diagnostic Systems, Inc. · 2010
  • K090968Sensititre Yeastone Susceptibility PlatesTrek Diagnostic Systems, Inc. · 20091 recall
  • K083606Sensititre 18-24 Hour Suseceptibility PlatesTrek Diagnostic Systems, Inc. · 2009
  • K081063Sensititre Yeastone Susceptibility Plates- Additional AntimicrobicsTrek Diagnostic Systems, Inc. · 2009
  • K081520Sensititre VizionTrek Diagnostic Systems, Inc. · 2008

Recent decisions in JTW

The JTW category page

  • K121039Copan Mswab Collection, Transport and Preservation SystemCopan Flock Technologies · 2012
  • K061301Copan Liquid Amies Elution Swab (Eswab) Collection and Transport SystemCopan Diagnostics, Inc. · 2006
  • K022874Gen-Probe Aptima Combo 2 AssayGen-Probe, Inc. · 2002
  • K013819Urine Collection, Preservation and Transport SystemSierra Diagnostic, LLC · 2002
  • K993161Copan Easy-Swab Collection and Transport SystemCopan Diagnostics, Inc. · 19991 recall

https://510kreport.com/device/K983244 · printed Nov 4, 2026

Cite this page

510(k) Report. “K983244: Sensititre 18-24 HR Susceptibility Plates (Addition of Meropenem).” Lineage record from FDA 510(k) data and the FDA summary. Updated Nov 3, 2026. Accessed Nov 4, 2026. https://510kreport.com/device/K983244

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Record history
  • FDA decision record loaded May 2, 2026
  • Summary read Oct 13, 2026 (extraction version 9eaa42aa01ed)
  • Page last updated Nov 3, 2026