510(k) Report

510(k) · Cleared

Cleared

Haemophilus/Streptococcus Pneumoniae (HP) Mic Plate

K013368510(k) TraditionalCleared Nov 20, 200140-day reviewClass II21 CFR 866.1640

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. · LTT Panels, Test, Susceptibility, Antimicrobial

Cleared on Nov 20, 2001 after a 40-day review. FDA’s file for it is a 510(k) statement, which names no predicate.

Decided
Nov 20, 2001
Review
40 days
Class
Class II
Product code
LTT
Recalls
None
Predicates
0

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

FIG. 1 — Lineage of K013368Source: 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.

Planning a device in LTT? A 510(k) Report weighs predicate choices, recall history and review times for a new device like this one.

Top candidate predicates for a new LTT device

  1. #1 K243804 MicroScan Dried Gram-Negative MIC/Combo Panels…score 10.8 · 4 generations · no Class I recall
  2. #2 Held for the reportin the report
  3. #3 Held for the reportin 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? (0 Class I)

No FDA recall names this device.

No ancestor or descendant has a Class I recall.

How does its category compare?

All LTT devices

LTT Panels, Test, Susceptibility, Antimicrobial: FDA decisions, review times, recalls and adverse event reports over 20 years.

FDA decisions per year · LTT

3in 2025

2009: 22010: 12011: 12013: 22015: 12017: 42019: 12020: 42025: 3
2007high 4 (2017) · low 0 (2007)2026

2026 to Oct 25, outlined.

Median 510(k) review, days · LTT

219in 2025

2017: 132 days median2020: 90 days median2025: 219 days median
2007high 219 (2025) · low 90 (2020)2026

Receipt to decision; years with fewer than 3 clearances left blank.

Recalls per year · LTT

7in 2015

2015: 7
2007high 7 (2015) · low 0 (2007)2026

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

Adverse event reports per year · LTT

3in 2017

2007: 72008: 42009: 12010: 12011: 12013: 52014: 92015: 102016: 12017: 3
2007high 10 (2015) · low 0 (2012)2025

MAUDE reports naming product code LTT, 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—07
20080—04
20092—01
20101—01
20111—01
20120—00
20132—05
20140—09
20151—710
20160—01
2017413203
20180—00
20191—00
202049000
20210—00
20220—00
20230—00
20240—00
2025321900
20260—0—

What is it indicated for?

The Sensititre Haemophilus/Streptococcus pneumoniae (HP) MIC Susceptibility plate is an in vitro diagnostic product for clinical susceptibility testing of Streptococcus pneumoniae and Haemophilus influenzae.

This 510(k) is for the addition of Amoxicillin/Clavulanic Acid in the dilution range of 0.016/0.008 - 16/8 pug/ml to the Sensititre Haemophilus/Streptococcus pneumoniae MIC panel for testing Streptococcus pneumoniae and Haemophilus influenzae isolates. The “Indications for Use" and clinical significance of Ameoxicillin/Clavulanic Acid is for:

Streptococcus pneumoniae

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 LTT

The LTT category page

  • K243804MicroScan Dried Gram-Negative MIC/Combo Panels with Cefepime (CPE) (0.12-64 µg/mL) (MicroScan)Beckman Coulter, Inc. · 2025
  • K250036MicroScan Dried Gram-Positive MIC/Combo Panels with Daptomycin (DAP) (0.06-32 µg/mL)Beckman Coulter, Inc. · 2025
  • K250084MicroScan Dried Gram-Negative MIC/Combo Panels with Aztreonam (AZT) (0.5-64 µg/mL)Beckman Coulter, Inc. · 2025
  • K202343MicroScan Dried Gram-Negative MIC/Combo Panels with Ceftazidime (Caz) (0.5-64 µg/mL )Beckman Coulter, Inc. · 20201 recall
  • K201423MicroScan Dried Gram-Negative MIC/Combo Panels with Meropenem (Mer) (0.004-32 µg/mL)Beckman Coulter, Inc. · 2020

https://510kreport.com/device/K013368 · printed Nov 4, 2026

Cite this page

510(k) Report. “K013368: Haemophilus/Streptococcus Pneumoniae (HP) Mic Plate.” Lineage record from FDA 510(k) data and the FDA summary. Updated Nov 3, 2026. Accessed Nov 4, 2026. https://510kreport.com/device/K013368

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Record history
  • FDA decision record loaded May 2, 2026
  • Summary read Oct 30, 2026 (extraction version 2d9447fa9ea4)
  • Page last updated Nov 3, 2026