510(k) Report

510(k) · Cleared

Cleared

VITEK 2 AST-Streptococcus Inducible Clindamycin Resistance

K260282510(k) TraditionalCleared Apr 15, 202676-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, Inc. · LON System, Test, Automated, Antimicrobial Susceptibility, Short Incubation

Cleared on Apr 15, 2026 as substantially equivalent to K111909 (bioMerieux, Inc., 2011) after a 76-day review. Its family tree reaches back 3 generations to 2005. 1 of the 4 devices in its family, counting itself, has a Class I recall.

Decided
Apr 15, 2026
Review
76 days
Class
Class II
Product code
LON
Recalls
None
Predicates
1

Its longest line of descent runs back 3 generations to K053097 (2005). No later device cites it as a predicate yet. 1 of the 4 devices in this family, counting this one, has a Class I recall.

K053097 · Vitek 2 Gram Positive Cefoxitin Screen · bioMerieux, Inc. · 2005 · Class I recallK080201 · Vitek 2 Gram Positive Inducible Clindamycin Resistance · bioMerieux, Inc. · 2008K111909 · Vitek 2 Streptococcus Inducible Clindamycin Resistance · bioMerieux, Inc. · 201120052010201520202025
K111909 · Vitek 2 Streptococcus Inducible Clindamycin Resistance · bioMerieux, Inc. · 2011K080201 · Vitek 2 Gram Positive Inducible Clindamycin Resistance · bioMerieux, Inc. · 2008K053097 · Vitek 2 Gram Positive Cefoxitin Screen · bioMerieux, Inc. · 2005 · Class I recall0
  1. Root · 3 generations backK053097 Vitek 2 Gram Positive Cefoxitin ScreenbioMerieux, Inc. · 2005 · Recalled (Class I)
  2. 2 generations backK080201 Vitek 2 Gram Positive Inducible Clindamycin ResistancebioMerieux, Inc. · 2008
  3. 1 generation backK111909 Vitek 2 Streptococcus Inducible Clindamycin ResistancebioMerieux, Inc. · 2011
  4. This deviceK260282 VITEK 2 AST-Streptococcus Inducible Clindamycin ResistancebioMerieux, Inc. · 2026

Class I recalls in this family

  • K053097 Vitek 2 Gram Positive Cefoxitin Screen3 generations back · 2005
View FIG. 1 as a table

Line of descent and top descendants

GenerationNumberDeviceApplicantDecidedRecalls
−3K053097Vitek 2 Gram Positive Cefoxitin ScreenbioMerieux, Inc.2005Class I
−2K080201Vitek 2 Gram Positive Inducible Clindamycin ResistancebioMerieux, Inc.2008—
−1K111909Vitek 2 Streptococcus Inducible Clindamycin ResistancebioMerieux, Inc.2011—
0 (this device)K260282VITEK 2 AST-Streptococcus Inducible Clindamycin ResistancebioMerieux, Inc.2026—
FIG. 1 — Lineage of K260282, 2005–2026Source: 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.

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.

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
Get a 510(k) Report

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
*K111909Vitek 2 Streptococcus Inducible Clindamycin Resistance
Summary page 5
…ndamycin Resistance C. Predicate Device: VITEK® 2 Streptococcus Inducible Clindamycin Resistance (K111909) D. Device Description: The principle of the VITEK® 2 AST-ST cards is based on the microdilution minimum inhibitory concentratio…
bioMerieux, Inc.2011—

Also cleared against K111909: 1 other device →

What descends from it?

No later submission names this one as a predicate yet.

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

No FDA recall names this device.

Relatives with a Class I recall

Class I is FDA’s most serious recall class. A recall in the family tree is context for this device, not evidence about it.

  • K053097Vitek 2 Gram Positive Cefoxitin ScreenbioMerieux, Inc. · 2005 · 3 generations back · ◆ on the line of descent in FIG. 11 Class I recall

What does this lineage say?

  • The line of descent spans 21 years and passes through 1 company; a new generation was cleared every 3.5 years on median.
  • 1 of the 3 ancestors has a recall of any class; 1 has a Class I recall.
  • 1 other device also cites its predicate K111909.

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 Inducible Clindamycin Resistance 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 Inducible Clindamycin Resistance is a qualitative test. Testing is indicated for Streptococcus pneumoniae and Streptococcus spp. β-hemolytic group. VITEK…

Read the full statement (137 words)

VITEK 2 AST Streptococcus Inducible Clindamycin Resistance 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 Inducible Clindamycin Resistance is a qualitative test. Testing is indicated for Streptococcus

pneumoniae and Streptococcus spp. β-hemolytic group.

VITEK 2 AST Streptococcus Inducible Clindamycin Resistance has demonstrated acceptable performance with the

following organisms:

Streptococcus pneumoniae

Streptococcus spp. β-hemolytic group (Streptococcus pyogenes, Streptococcus agalactiae, Streptococcus canis,

Streptococcus dysgalactiae equisimilis, Streptococcus equi zooepidemicus)

The VITEK 2 Streptococcus Susceptibility Card is intended for use 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 K111909

1 other device cites the same predicate.

  • K181766VITEK 2 AST-Gram Positive Inducible Clindamycin ResistancebioMerieux, Inc. · 2018

More from bioMerieux, Inc.

281 FDA decisions under this applicant name. See the company

  • K260283VITEK 2 AST-Streptococcus Meropenem (=0.06 - =4 µg/mL)bioMerieux, Inc. · 2026
  • K260160VITEK REVEAL GN AST Assay and VITEK REVEAL AST SystembioMerieux, Inc. · 2026
  • K251579VITEK 2 AST-Gram Negative Cefazolin (=<1-=>32 µg/mL)bioMerieux, Inc. · 2025
  • K234012Vitek Compact ProbioMerieux, Inc. · 2025
  • K232967VITEK 2 AST-Yeast Voriconazole (<= 0.03125 - >= 4 µg/mL)bioMerieux, Inc. · 2024

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
  • K260281VITEK 2 AST-Streptococcus Cefuroxime (<=0.125 - >=8 µg/mL)Biomerieux · 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/K260282 · printed Nov 6, 2026

Cite this page

510(k) Report. “K260282: VITEK 2 AST-Streptococcus Inducible Clindamycin Resistance.” Lineage record from FDA 510(k) data and the FDA summary. Updated Nov 3, 2026. Accessed Nov 6, 2026. https://510kreport.com/device/K260282

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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