510(k) Report

510(k) · Cleared

Cleared

MicroScan Dried Gram-Negative MIC/Combo Panels with Cefepime (CPE) (0.12-64 µg/mL) (MicroScan)

K243804510(k) TraditionalCleared Aug 20, 2025252-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

Beckman Coulter, Inc. · LTT Panels, Test, Susceptibility, Antimicrobial

Cleared on Aug 20, 2025 as substantially equivalent to K202343 (Beckman Coulter, Inc., 2020) after a 252-day review. Its family tree reaches back 4 generations to 2019.

Decided
Aug 20, 2025
Review
252 days
Class
Class II
Product code
LTT
Recalls
None
Predicates
1

Its longest line of descent runs back 4 generations to K190109 (2019). No later device cites it as a predicate yet.

K190109 · MicroScan Dried Gram Negative MIC/Combo Panels with Eravacycline (ERV) (0.016-32 ug/mL) · Beckman Coulter, Inc. · 2019K192355 · MicroScan Dried Gram Negative MIC/Combo Panels with Meropenem (Mer) (0.004-32ug/mL) · Beckman Coulter, Inc. · 2019K193536 · MicroScan Dried Gram Negative MIC/Combo Panels with Ciprofloxacin (Cp) (0.004 - 8µg/mL) · Beckman Coulter, Inc. · 2020K202343 · MicroScan Dried Gram-Negative MIC/Combo Panels with Ceftazidime (Caz) (0.5-64 µg/mL ) · Beckman Coulter, Inc. · 2020 · recalled201620182020202220242026
K202343 · MicroScan Dried Gram-Negative MIC/Combo Panels with Ceftazidime (Caz) (0.5-64 µg/mL ) · Beckman Coulter, Inc. · 2020 · recalledK193536 · MicroScan Dried Gram Negative MIC/Combo Panels with Ciprofloxacin (Cp) (0.004 - 8µg/mL) · Beckman Coulter, Inc. · 2020K192355 · MicroScan Dried Gram Negative MIC/Combo Panels with Meropenem (Mer) (0.004-32ug/mL) · Beckman Coulter, Inc. · 2019K190109 · MicroScan Dried Gram Negative MIC/Combo Panels with Eravacycline (ERV) (0.016-32 ug/mL) · Beckman Coulter, Inc. · 20190
  1. Root · 4 generations backK190109 MicroScan Dried Gram Negative MIC/Combo Panels with Eravacycline…Beckman Coulter, Inc. · 2019
  2. 3 generations backK192355 MicroScan Dried Gram Negative MIC/Combo Panels with Meropenem (Mer)…Beckman Coulter, Inc. · 2019
  3. 2 generations backK193536 MicroScan Dried Gram Negative MIC/Combo Panels with Ciprofloxacin…Beckman Coulter, Inc. · 2020
  4. 1 generation backK202343 MicroScan Dried Gram-Negative MIC/Combo Panels with Ceftazidime…Beckman Coulter, Inc. · 2020 · Recalled
  5. This deviceK243804 MicroScan Dried Gram-Negative MIC/Combo Panels with Cefepime (CPE)…Beckman Coulter, Inc. · 2025
View FIG. 1 as a table

Line of descent and top descendants

GenerationNumberDeviceApplicantDecidedRecalls
−4K190109MicroScan Dried Gram Negative MIC/Combo Panels with Eravacycline (ERV)…Beckman Coulter, Inc.2019—
−3K192355MicroScan Dried Gram Negative MIC/Combo Panels with Meropenem (Mer)…Beckman Coulter, Inc.2019—
−2K193536MicroScan Dried Gram Negative MIC/Combo Panels with Ciprofloxacin (Cp) (0.004…Beckman Coulter, Inc.2020—
−1K202343MicroScan Dried Gram-Negative MIC/Combo Panels with Ceftazidime (Caz) (0.5-64…Beckman Coulter, Inc.20201
0 (this device)K243804MicroScan Dried Gram-Negative MIC/Combo Panels with Cefepime (CPE) (0.12-64…Beckman Coulter, Inc.2025—
FIG. 1 — Lineage of K243804, 2019–2025Source: FDA 510(k) summaries, read by 510(k) Report · 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 summary (predicates and 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 K250084 MicroScan Dried Gram-Negative MIC/Combo Panels…score 10.6 · 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? (1)

Devices the submitter claimed this one is substantially equivalent to (*), and reference devices cited for a specific test or feature (†), as written in the FDA summary.

TypeNumberDeviceApplicantDecidedRecalls
*K202343MicroScan Dried Gram-Negative MIC/Combo Panels with Ceftazidime (Caz) (0.5-64 µg/mL )
Summary page 5
…LTT, JWY, LRG, LTW 510(k) Notification: Updated antimicrobial agent - Cefepime Predicate device: MicroScan Dried Gram-Negative MIC/Combo Panels Ceftazidime – (K202343) 510(k) Summary: Device Description: MicroScan Dried Gram-Negative MIC/Combo Panels are designed for use in determining…
Beckman Coulter, Inc.20201

Also cleared against K202343: 1 other device →

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.

What does this lineage say?

  • The line of descent spans 6 years and passes through 1 company; a new generation was cleared every 8 months on median.
  • 1 of the 4 ancestors has a recall of any class.
  • 1 other device also cites its predicate K202343.

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. 2025, this device’s year, is highlighted.

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 MicroScan Dried Gram-Negative MIC/Combo Panel is used to determine quantitative and qualitative antimicrobial agent susceptibility of colonies grown on solid media of rapidly growing aerobic and facultative anaerobic gram-negative bacilli. After inoculation, panels are incubated for 16-20 hours at 35°C ± 1°C in a non-CO2 incubator, and read either visually or with MicroScan instrumentation, according to the Package Insert. This particular submission…

Read the full statement (159 words)

The MicroScan Dried Gram-Negative MIC/Combo Panel is used to determine quantitative and qualitative antimicrobial agent susceptibility of colonies grown on solid media of rapidly growing aerobic and facultative anaerobic gram-negative bacilli. After inoculation, panels are incubated for 16-20 hours at 35°C ± 1°C in a non-CO2 incubator, and read either visually or with MicroScan instrumentation, according to the Package Insert.

This particular submission is for the addition of the antimicrobial cefepime at concentrations of 0.12-64 µg/mL to the test panel. Testing is indicated for Enterobacterales, Pseudomonas aeruginosa and Aeromonas spp., as recognized by the FDA Susceptibility Test Interpretive Criteria (STIC) webpage.

The MicroScan Dried Gram-Negative MIC/Combo Panels with Cefepime (CPE) (0.12-64µg/mL) has demonstrated acceptable performance with the following organisms:

Enterobacterales (Enterobacter spp., Escherichia coli, Klebsiella pneumoniae, Proteus mirabilis, Citrobacter koseri, (formerly Citrobacter diversus), Citrobacter freundii complex (Citrobacter freudnii, Citrobacter werkmanii and Citrobacter youngae), Klebsiella oxytoca, Morganella morganii, Proteus vulgaris, Providencia stuartii, Providencia rettgeri, Serratia marcescens)

Pseudomonas aeruginosa

Aeromonas spp.

Indications for use as stated in the FDA summary.

Also cleared against K202343

1 other device cites the same predicate.

  • K250084MicroScan Dried Gram-Negative MIC/Combo Panels with Aztreonam (AZT) (0.5-64 µg/mL)Beckman Coulter, Inc. · 2025

More from Beckman Coulter, Inc.

456 FDA decisions under this applicant name. See the company

  • K262597Access BNP IIBeckman Coulter, Inc. · 2026
  • K261109Access MeMed BVBeckman Coulter, Inc. · 2026
  • K262109Access NT-proBNPBeckman Coulter, Inc. · 2026
  • K252169Access BNP IIBeckman Coulter, Inc. · 2026
  • K254059Access anti-HBc IgMBeckman Coulter, Inc. · 2026

Recent decisions in LTT

The LTT category page

  • 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
  • K193536MicroScan Dried Gram Negative MIC/Combo Panels with Ciprofloxacin (Cp) (0.004 - 8µg/mL)Beckman Coulter, Inc. · 2020

https://510kreport.com/device/K243804 · printed Nov 6, 2026

Cite this page

510(k) Report. “K243804: MicroScan Dried Gram-Negative MIC/Combo Panels with Cefepime (CPE) (0.12-64 µg/mL) (MicroScan).” Lineage record from FDA 510(k) data and the FDA summary. Updated Nov 3, 2026. Accessed Nov 6, 2026. https://510kreport.com/device/K243804

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