510(k) Report

510(k) · Cleared

Recalled · Class I · 2020

Vitek 2 Gram Positive Cefoxitin Screen

K053097510(k) TraditionalCleared Dec 14, 200541-day reviewClass II21 CFR 866.1645Recalls 2 (1 Class I)

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 Dec 14, 2005 after a 41-day review. The summary cites one number, which could not be confirmed as its predicate (see the table below). 1 of the 6 devices in its family, counting itself, has a Class I recall. 5 later devices descend from it. It has been recalled 2 times, including a Class I recall.

Decided
Dec 14, 2005
Review
41 days
Class
Class II
Product code
LON
Recalls
2 (1 Class I)
Predicates
1

5 later devices descend from it, 2 citing it directly. 1 of the 6 devices in this family, counting this one, has a Class I recall.

Descendants, by year cleared 2022: 1 descendant cleared2008: 1 descendant cleared2011: 1 descendant cleared2018: 1 descendant cleared2026: 1 descendant clearedReference device: K050002 · Vitek 2 Compact · bioMerieux, Inc. · 2005 · recalled20052010201520202025
  1. This deviceK053097 Vitek 2 Gram Positive Cefoxitin ScreenbioMerieux, Inc. · 2005
  2. Descendant · cites it directly · 3 of its ownK080201 Vitek 2 Gram Positive Inducible Clindamycin ResistancebioMerieux, Inc. · 2008
  3. Descendant · 2 generations on · 2 of its ownK111909 Vitek 2 Streptococcus Inducible Clindamycin ResistancebioMerieux, Inc. · 2011
  4. Descendant · 3 generations on · 0 of its ownK260282 VITEK 2 AST-Streptococcus Inducible Clindamycin ResistancebioMerieux, Inc. · 2026
  5. Descendant · cites it directly · 0 of its ownK220805 VITEK 2 AST-Gram Positive Cefoxitin ScreenbioMerieux, Inc. · 2022
  6. Descendant · 3 generations on · 0 of its ownK181766 VITEK 2 AST-Gram Positive Inducible Clindamycin ResistancebioMerieux, Inc. · 2018

Most influential descendants

Showing 5 of 5 · See all
  • K080201Vitek 2 Gram Positive Inducible Clindamycin ResistancebioMerieux, Inc. · 2008 · cites it directly3descendants
  • K111909Vitek 2 Streptococcus Inducible Clindamycin ResistancebioMerieux, Inc. · 2011 · 2 generations on2descendants
  • K260282VITEK 2 AST-Streptococcus Inducible Clindamycin ResistancebioMerieux, Inc. · 2026 · 3 generations on0descendants
  • K220805VITEK 2 AST-Gram Positive Cefoxitin ScreenbioMerieux, Inc. · 2022 · cites it directly0descendants
  • K181766VITEK 2 AST-Gram Positive Inducible Clindamycin ResistancebioMerieux, Inc. · 2018 · 3 generations on0descendants
View FIG. 1 as a table

Line of descent and top descendants

GenerationNumberDeviceApplicantDecidedRecalls
0 (this device)K053097Vitek 2 Gram Positive Cefoxitin ScreenbioMerieux, Inc.2005—
+1K080201Vitek 2 Gram Positive Inducible Clindamycin ResistancebioMerieux, Inc.2008—
+2K111909Vitek 2 Streptococcus Inducible Clindamycin ResistancebioMerieux, Inc.2011—
+3K260282VITEK 2 AST-Streptococcus Inducible Clindamycin ResistancebioMerieux, Inc.2026—
+1K220805VITEK 2 AST-Gram Positive Cefoxitin ScreenbioMerieux, Inc.2022—
+3K181766VITEK 2 AST-Gram Positive Inducible Clindamycin ResistancebioMerieux, Inc.2018—

Descendants by year cleared

Year clearedDevicesWith a Class I recall
200810
201110
201810
202210
202610
FIG. 1 — Lineage of K053097, 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
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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; numbers the summary cites that cannot be its predicate are marked – and kept off the family tree.

TypeNumberDeviceApplicantDecidedRecalls
Kept off the family treeK051113FDA’s K051113 is Quanta System Etrna Giovinezza
Not matched in our reading of the summary (scans can blur digits), so it is kept off the family tree
Quanta System Spa20061
†K050002Vitek 2 CompactbioMerieux, Inc.20056

What descends from it? (5)

2 later devices cite it directly; ranked here by how many devices descend from each in turn.

NumberDeviceApplicantDecidedDescendants
K080201Vitek 2 Gram Positive Inducible Clindamycin ResistancebioMerieux, Inc.20083
K220805VITEK 2 AST-Gram Positive Cefoxitin ScreenbioMerieux, Inc.20220

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

Recalls of this device

DateClassRecallRoot causeReason
Mar 11, 2020Class IIZ-1742-2020Under Investigation by firmThere is a potential for the occurrence of false positive OXSF results for some Staphylococcus aureus strains in conjunction with the VITEK 2 AST-P652 test card (ref. 421857, lot 8021232403). .
Jan 26, 2018Class IZ-2817-2018Under Investigation by firmCustomer reports indicated an increase in the rate of non-detected MRSA in association with the VITEK 2 AST-P631 product.

No ancestor or descendant has a Class I recall.

What does this lineage say?

  • Of its descendants, K080201 (bioMerieux, Inc., 2008) has gone furthest, with 3 descendants of its own.

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.

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 Gram Positive Cefoxitin Screen is a qualitative test designed to predict mecA-mediated resistance in staphylococci. It is intended for use with the VITEK® 2 and VITEK® 2 Compact Systems as a laboratory aid in the determination of in vitro susceptibility to antimicrobial agents.

The VITEK® 2 Antimicrobial Susceptibility Test (AST) is intended to be used with the VITEK® 2 and VITEK® 2 Compact Systems 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 agalactiae,and S. pneumoniae.

Indications for use as stated in the FDA summary.

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/K053097 · printed Nov 4, 2026

Cite this page

510(k) Report. “K053097: Vitek 2 Gram Positive Cefoxitin Screen.” Lineage record from FDA 510(k) data and the FDA summary. Updated Nov 3, 2026. Accessed Nov 4, 2026. https://510kreport.com/device/K053097

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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