510(k) Report

510(k) · Cleared

Cleared

VITEK 2 AST-Streptococcus Cefuroxime (<=0.125 - >=8 µg/mL)

K260281510(k) TraditionalCleared Mar 26, 202656-day reviewClass II21 CFR 866.1645

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

Biomerieux · LON System, Test, Automated, Antimicrobial Susceptibility, Short Incubation

Cleared on Mar 26, 2026 as substantially equivalent to K232201 (bioMerieux, Inc., 2023) after a 56-day review. Its family tree reaches back 5 generations to 2003.

Decided
Mar 26, 2026
Review
56 days
Class
Class II
Product code
LON
Recalls
None
Predicates
1

Its longest line of descent runs back 5 generations to K031865 (2003). No later device cites it as a predicate yet.

K031865 · Vitek 2 Gram Positive Moxifloxacin for Strepococcus Pneumoniae · bioMerieux, Inc. · 2003K053186 · Vitek 2 Gram Positive Telithromycin for Streptococcus Pneumoniae · bioMerieux, Inc. · 2005K063597 · Vitek 2 Gram Positive Amoxicillin for Streptococcus Pneumoniae · bioMerieux, Inc. · 2007K112000 · Vitek 2 Streptococcus Penicillin · bioMerieux, Inc. · 2011K232201 · VITEK 2 AST-Streptococcus Penicillin (<=0.06 - =>8 µg/mL), VITEK 2 Streptococcus Penicillin (<=0.06 - >=8 µg/mL), VITEK 2 Streptococcus Penicillin · bioMerieux, Inc. · 2023200020052010201520202025
K232201 · VITEK 2 AST-Streptococcus Penicillin (<=0.06 - =>8 µg/mL), VITEK 2 Streptococcus Penicillin (<=0.06 - >=8 µg/mL), VITEK 2 Streptococcus Penicillin · bioMerieux, Inc. · 2023K112000 · Vitek 2 Streptococcus Penicillin · bioMerieux, Inc. · 2011K063597 · Vitek 2 Gram Positive Amoxicillin for Streptococcus Pneumoniae · bioMerieux, Inc. · 2007K053186 · Vitek 2 Gram Positive Telithromycin for Streptococcus Pneumoniae · bioMerieux, Inc. · 2005K031865 · Vitek 2 Gram Positive Moxifloxacin for Strepococcus Pneumoniae · bioMerieux, Inc. · 2003−50
  1. Root · 5 generations backK031865 Vitek 2 Gram Positive Moxifloxacin for Strepococcus PneumoniaebioMerieux, Inc. · 2003
  2. 4 generations backK053186 Vitek 2 Gram Positive Telithromycin for Streptococcus PneumoniaebioMerieux, Inc. · 2005
  3. 3 generations backK063597 Vitek 2 Gram Positive Amoxicillin for Streptococcus PneumoniaebioMerieux, Inc. · 2007
  4. 2 generations backK112000 Vitek 2 Streptococcus PenicillinbioMerieux, Inc. · 2011
  5. 1 generation backK232201 VITEK 2 AST-Streptococcus Penicillin (<=0.06 - =>8 µg/mL), VITEK 2…bioMerieux, Inc. · 2023
  6. This deviceK260281 VITEK 2 AST-Streptococcus Cefuroxime (<=0.125 - >=8 µg/mL)Biomerieux · 2026
View FIG. 1 as a table

Line of descent and top descendants

GenerationNumberDeviceApplicantDecidedRecalls
−5K031865Vitek 2 Gram Positive Moxifloxacin for Strepococcus PneumoniaebioMerieux, Inc.2003—
−4K053186Vitek 2 Gram Positive Telithromycin for Streptococcus PneumoniaebioMerieux, Inc.2005—
−3K063597Vitek 2 Gram Positive Amoxicillin for Streptococcus PneumoniaebioMerieux, Inc.2007—
−2K112000Vitek 2 Streptococcus PenicillinbioMerieux, Inc.2011—
−1K232201VITEK 2 AST-Streptococcus Penicillin (<=0.06 - =>8 µg/mL), VITEK 2…bioMerieux, Inc.2023—
0 (this device)K260281VITEK 2 AST-Streptococcus Cefuroxime (<=0.125 - >=8 µg/mL)Biomerieux2026—
FIG. 1 — Lineage of K260281, 2003–2026Source: 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 LON? 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 LON device

  1. #1 K260619 VITEK 2 AST-Streptococcus Cefepime (<=0.06 –…score 13.3 · 5 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
*K232201VITEK 2 AST-Streptococcus Penicillin (<=0.06 - =>8 µg/mL), VITEK 2 Streptococcus…
Summary page 5
…TT, LTW Common Name: VITEK® 2 AST-ST Cefuroxime C. Predicate Device: VITEK® 2 AST-Streptococcus Penicillin (K232201) D. Device Description: The principle of the VITEK® 2 AST cards is based on the microdilution minimum inhibitory concentration…
bioMerieux, Inc.2023—

Also cleared against K232201: 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 23 years and passes through 2 companies; a new generation was cleared every 2.4 years on median.
  • None of the 5 ancestors has a recall.
  • 1 other device also cites its predicate K232201.

How does its category compare?

All LON devices

LON System, Test, Automated, Antimicrobial Susceptibility, Short Incubation: FDA decisions, review times, recalls and adverse event reports over 20 years. 2026, this device’s year, is highlighted.

FDA decisions per year · LON

5in 2025

2007: 192008: 72009: 82010: 12011: 82012: 102013: 72014: 42016: 32017: 102018: 42019: 82020: 52021: 52022: 82023: 112024: 22025: 52026 (partial year): 4
2007high 19 (2007) · low 0 (2015)2026

2026 to Oct 25, outlined.

Median 510(k) review, days · LON

90in 2025

2007: 50 days median2008: 66 days median2009: 76 days median2011: 85 days median2012: 200 days median2013: 115 days median2014: 90 days median2016: 242 days median2017: 89 days median2018: 88 days median2019: 84 days median2020: 81 days median2021: 268 days median2022: 189 days median2023: 210 days median2025: 90 days median2026 (partial year): 146 days median
2007high 268 (2021) · low 50 (2007)2026

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

Recalls per year · LON

1in 2025

2008: 12010: 1162011: 32012: 32014: 2, 2 Class I2016: 22017: 12018: 62019: 12020: 82022: 152024: 12025: 12026 (partial year): 6
2007high 116 (2010) · low 0 (2007)2026

Class I (2 since 2007) Class II/III not classified

Adverse event reports per year · LON

690in 2025

2007: 32008: 12010: 32011: 42012: 92013: 32014: 102015: 412016: 942017: 1972018: 5122019: 3152020: 2182021: 2322022: 1802023: 4532024: 4182025: 690
2007high 690 (2025) · low 0 (2009)2025

MAUDE reports naming product code LON, 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
2007195003
200876611
200987600
20101—1163
201188534
20121020039
2013711503
20144902 (2)10
20150—041
20163242294
201710891197
20184886512
20198841315
20205818218
202152680232
2022818915180
2023112100453
20242—1418
20255901690
202641466—

What is it indicated for?

VITEK 2 AST-Streptococcus Cefuroxime (≤0.125 - ≥8) is designed for antimicrobial susceptibility testing of Streptococcus species and is intended for use with the VITEK 2 Systems as a laboratory aid in the determination of in vitro susceptibility to antimicrobial agents. VITEK 2 AST-Streptococcus Cefuroxime (≤0.125 - ≥8) is a quantitative test. Testing is indicated for Streptococcus pneumoniae as recognized by the FDA Susceptibility Test Interpretive…

Read the full statement (128 words)

VITEK 2 AST-Streptococcus Cefuroxime (≤0.125 - ≥8) is designed for antimicrobial susceptibility testing of Streptococcus species and is intended for use with the VITEK 2 Systems as a laboratory aid in the determination of in vitro susceptibility to antimicrobial agents.

VITEK 2 AST-Streptococcus Cefuroxime (≤0.125 - ≥8) is a quantitative test. Testing is indicated for Streptococcus pneumoniae as recognized by the FDA Susceptibility Test Interpretive Criteria (STIC).

VITEK 2 AST-Streptococcus Cefuroxime (≤0.125 - ≥8) has demonstrated acceptable performance with the following organism:

Streptococcus pneumoniae

The VITEK 2 Antimicrobial Susceptibility Test (AST) is intended to be used with the VITEK 2 Systems in clinical laboratories as an in vitro test to determine the susceptibility of Streptococcus pneumoniae, beta-hemolytic Streptococcus and Viridans Streptococcus to antimicrobial agents when used as instructed.

Indications for use as stated in the FDA summary.

Also cleared against K232201

1 other device cites the same predicate.

  • K260619VITEK 2 AST-Streptococcus Cefepime (<=0.06 – >=4 µg/mL)Biomérieux, Inc. · 2026

More from Biomerieux

3 FDA decisions under this applicant name. See the company

  • K141133VIDAS H. pylori IgG, VIDAS 3, VIDAS Lyme IgG II, VIDAS RUB IgG, VIDAS TOXO M, VIDAS Human Chorionic…Biomerieux · 20154 recalls
  • K102668Etest Tobramycin 0.016-256 UG/ML and 0.064-1024 UG/MLBiomerieux · 20102 recalls

Recent decisions in LON

The LON category page

  • K260283VITEK 2 AST-Streptococcus Meropenem (=0.06 - =4 µg/mL)bioMerieux, Inc. · 2026
  • K260619VITEK 2 AST-Streptococcus Cefepime (<=0.06 – >=4 µg/mL)Biomérieux, Inc. · 2026
  • K260282VITEK 2 AST-Streptococcus Inducible Clindamycin ResistancebioMerieux, Inc. · 2026
  • K251579VITEK 2 AST-Gram Negative Cefazolin (=<1-=>32 µg/mL)bioMerieux, Inc. · 2025
  • K251713BD Phoenix Automated Microbiology System - GN Eravacycline (0.125-2 µg/mL)Becton, Dickinson and Company · 2025

https://510kreport.com/device/K260281 · printed Nov 6, 2026

Cite this page

510(k) Report. “K260281: VITEK 2 AST-Streptococcus Cefuroxime (<=0.125 - >=8 µg/mL).” Lineage record from FDA 510(k) data and the FDA summary. Updated Nov 3, 2026. Accessed Nov 6, 2026. https://510kreport.com/device/K260281

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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