510(k) Report

510(k) · Cleared

Recalled · Class II · 2022

Vitek 2 Ast Streptococus Vancomycin

K121100510(k) TraditionalCleared Nov 19, 2012222-day reviewClass II21 CFR 866.1645Recalls 1

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 Nov 19, 2012 as substantially equivalent to K063597 (bioMerieux, Inc., 2007) after a 222-day review. Its family tree reaches back 3 generations to 2003. It has been recalled once.

Decided
Nov 19, 2012
Review
222 days
Class
Class II
Product code
LON
Recalls
1
Predicates
1

Its longest line of descent runs back 3 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. · 200720002002200420062008201020122014
K063597 · 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. · 20030
  1. Root · 3 generations backK031865 Vitek 2 Gram Positive Moxifloxacin for Strepococcus PneumoniaebioMerieux, Inc. · 2003
  2. 2 generations backK053186 Vitek 2 Gram Positive Telithromycin for Streptococcus PneumoniaebioMerieux, Inc. · 2005
  3. 1 generation backK063597 Vitek 2 Gram Positive Amoxicillin for Streptococcus PneumoniaebioMerieux, Inc. · 2007
  4. This deviceK121100 Vitek 2 Ast Streptococus VancomycinbioMerieux, Inc. · 2012
View FIG. 1 as a table

Line of descent and top descendants

GenerationNumberDeviceApplicantDecidedRecalls
−3K031865Vitek 2 Gram Positive Moxifloxacin for Strepococcus PneumoniaebioMerieux, Inc.2003—
−2K053186Vitek 2 Gram Positive Telithromycin for Streptococcus PneumoniaebioMerieux, Inc.2005—
−1K063597Vitek 2 Gram Positive Amoxicillin for Streptococcus PneumoniaebioMerieux, Inc.2007—
0 (this device)K121100Vitek 2 Ast Streptococus VancomycinbioMerieux, Inc.2012—
FIG. 1 — Lineage of K121100, 2003–2012Source: 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
*K063597Vitek 2 Gram Positive Amoxicillin for Streptococcus Pneumoniae
Summary page 1
…Device, 21 CER 866.1645 Common Name: VITEK 2 AST-ST Vancomycin C. Predicate Device: VITEK 2 AST-GP Amoxicillin K(063597 D. 510(k) Summary: VITEK® 2 AST Streptococcus Vancomycin is designed for antimicrobial susceptibility testing of Streptococcus…
bioMerieux, Inc.2007—

Also cleared against K063597: 11 other devices →

What descends from it?

No later submission names this one as a predicate yet.

Has anything in its family been recalled? (0 Class I)

Recalls of this device

DateClassRecallRoot causeReason
Nov 9, 2022Class IIZ-0848-2023StorageAs the temperature and time out of range was exceeded, product performances cannot be guaranteed

No ancestor or descendant has a Class I recall.

What does this lineage say?

  • The line of descent spans 9 years and passes through 1 company; a new generation was cleared every 2.3 years on median.
  • None of the 3 ancestors has a recall.
  • 11 other devices also cite its predicate K063597.

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. 2012, 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?

VITEet 2 AST Streptococcus Vancomycin isdesigned for antimicrobial susceptibility testing of Streptococcus species. VITEK® 2 AST Streptococcus Vancomycin isa quantitative test intended for use with the VITEK® 2 and VITEK0 2 Compact Systems as a laboratory aid in the determination of in vitro susceptibility to antimicrobial agents. Vancomycin has been shown to be active against most strains of the microorganisms listed below, according to the FDA label…

Read the full statement (140 words)

VITEet 2 AST Streptococcus Vancomycin isdesigned for antimicrobial susceptibility testing of Streptococcus species. VITEK® 2 AST Streptococcus Vancomycin isa quantitative test intended for use with the VITEK® 2 and VITEK0 2 Compact Systems as a laboratory aid in the determination of in vitro susceptibility to antimicrobial agents. Vancomycin has been shown to be active against most strains of the microorganisms listed below, according to the FDA label for this antimicrobial.

Active in vitro and in clinical infections

Viridans group streptococci

In vitro data are available, but their clinical sgnificance is unknown

Streptococcus agalaetiae

Streptococcuspyogenes

The VITEle 2 Antimicrobial Susceptibility Test (AST) is intended to be used with the VITEK® 2 System for the automated quantitative or qualitative susceptibility testing of isolated colonies for the most clinically significant aerobic gram-negative bacilli, Staphylococcus spp., Enterococcus spp., Streptococcus spp. and clinically significant yeast.

Indications for use as stated in the FDA summary.

Also cleared against K063597

11 other devices cite the same predicate.

  • K122359Vitek 2 Strptococcus CeftriaxonebioMerieux, Inc. · 2012
  • K121863Vitek 2 Ast-ST CefotaximebioMerieux, Inc. · 2012
  • K113783Vitek 2 Ast- Gram Postive Penicillin for Streptococcus PneumoniaebioMerieux, Inc. · 2012
  • K111893Vitek (R) 2 Streptococcus TetracyclinebioMerieux, Inc. · 2012
  • K111976Vitek 2 Streptococcus ErythromycinbioMerieux, Inc. · 2012
  • K113305Vitek 2 Streptococcus Trimethoprim/SulfamethoxazolebioMerieux, Inc. · 2012

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
  • K260282VITEK 2 AST-Streptococcus Inducible Clindamycin ResistancebioMerieux, Inc. · 2026
  • K251579VITEK 2 AST-Gram Negative Cefazolin (=<1-=>32 µg/mL)bioMerieux, Inc. · 2025
  • K234012Vitek Compact ProbioMerieux, Inc. · 2025

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
  • 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

https://510kreport.com/device/K121100 · printed Nov 5, 2026

Cite this page

510(k) Report. “K121100: Vitek 2 Ast Streptococus Vancomycin.” Lineage record from FDA 510(k) data and the FDA summary. Updated Nov 3, 2026. Accessed Nov 5, 2026. https://510kreport.com/device/K121100

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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