510(k) Report

510(k) · Cleared

Cleared

VITEK 2 AST-Gram Positive Dalbavancin (<= 0.015 - >= 1 µg/mL)

K190616510(k) TraditionalCleared Jun 6, 201987-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 Jun 6, 2019 as substantially equivalent to K141149 (bioMerieux, Inc., 2014) after an 87-day review. Its family tree reaches back 3 generations to 2003. 3 later devices descend from it.

Decided
Jun 6, 2019
Review
87 days
Class
Class II
Product code
LON
Recalls
None
Predicates
1

Its longest line of descent runs back 3 generations to K032766 (2003). 3 later devices descend from it, 3 citing it directly.

Descendants, by year cleared 2021: 1 descendant cleared2022: 1 descendant cleared2020: 1 descendant clearedK032766 · Vitek 2 Gram Positive Linezolid · bioMerieux, Inc. · 2003K122547 · Gram Postitve Clindamycin · bioMerieux, Inc. · 2012K141149 · Vitek 2 Ast GP Ceftaroline · bioMerieux, Inc. · 2014200020052010201520202025
Descendants, by generation 1 generation forward: 3 descendants K141149 · Vitek 2 Ast GP Ceftaroline · bioMerieux, Inc. · 2014K122547 · Gram Postitve Clindamycin · bioMerieux, Inc. · 2012K032766 · Vitek 2 Gram Positive Linezolid · bioMerieux, Inc. · 20030
  1. Root · 3 generations backK032766 Vitek 2 Gram Positive LinezolidbioMerieux, Inc. · 2003
  2. 2 generations backK122547 Gram Postitve ClindamycinbioMerieux, Inc. · 2012
  3. 1 generation backK141149 Vitek 2 Ast GP CeftarolinebioMerieux, Inc. · 2014
  4. This deviceK190616 VITEK 2 AST-Gram Positive Dalbavancin (<= 0.015 - >= 1 µg/mL)bioMerieux, Inc. · 2019
  5. Descendant · cites it directly · 0 of its ownK212243 VITEK 2 AST- Gram Positive Telavancin (<=0.015 - >=1 µg/mL)bioMerieux, Inc. · 2022
  6. Descendant · cites it directly · 0 of its ownK202396 VITEK 2 AST-Gram Positive Fosfomycin (<=8 - >=256 ug/mL)bioMerieux, Inc. · 2021
  7. Descendant · cites it directly · 0 of its ownK200590 VITEK 2 AST-Gram Positive Delafloxacin (<=0.015 - >=1 µg/mL)bioMerieux, Inc. · 2020

Most influential descendants

Showing 3 of 3 · See all
  • K212243VITEK 2 AST- Gram Positive Telavancin (<=0.015 - >=1 µg/mL)bioMerieux, Inc. · 2022 · cites it directly0descendants
  • K202396VITEK 2 AST-Gram Positive Fosfomycin (<=8 - >=256 ug/mL)bioMerieux, Inc. · 2021 · cites it directly0descendants
  • K200590VITEK 2 AST-Gram Positive Delafloxacin (<=0.015 - >=1 µg/mL)bioMerieux, Inc. · 2020 · cites it directly0descendants
View FIG. 1 as a table

Line of descent and top descendants

GenerationNumberDeviceApplicantDecidedRecalls
−3K032766Vitek 2 Gram Positive LinezolidbioMerieux, Inc.2003—
−2K122547Gram Postitve ClindamycinbioMerieux, Inc.2012—
−1K141149Vitek 2 Ast GP CeftarolinebioMerieux, Inc.2014—
0 (this device)K190616VITEK 2 AST-Gram Positive Dalbavancin (<= 0.015 - >= 1 µg/mL)bioMerieux, Inc.2019—
+1K212243VITEK 2 AST- Gram Positive Telavancin (<=0.015 - >=1 µg/mL)bioMerieux, Inc.2022—
+1K202396VITEK 2 AST-Gram Positive Fosfomycin (<=8 - >=256 ug/mL)bioMerieux, Inc.2021—
+1K200590VITEK 2 AST-Gram Positive Delafloxacin (<=0.015 - >=1 µg/mL)bioMerieux, Inc.2020—

Descendants by year cleared

Year clearedDevicesWith a Class I recall
202010
202110
202210
FIG. 1 — Lineage of K190616, 2003–2022Source: 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
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
*K141149Vitek 2 Ast GP Ceftaroline
Summary page 3
…AST-GP Dalbavancin (≤0.015 - ≥1 μg/mL) C. Predicate Device: VITEK® 2 AST-GP Ceftaroline (  0.06 – > 4 µg/mL) (K141149) D. 510(k) Summary: VITEK® 2 AST-Gram Positive Dalbavancin is designed for antimicrobial susceptibility testing of Gram positiv…
bioMerieux, Inc.2014—

What descends from it? (3)

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

NumberDeviceApplicantDecidedDescendants
K212243VITEK 2 AST- Gram Positive Telavancin (<=0.015 - >=1 µg/mL)bioMerieux, Inc.20220
K202396VITEK 2 AST-Gram Positive Fosfomycin (<=8 - >=256 ug/mL)bioMerieux, Inc.20210
K200590VITEK 2 AST-Gram Positive Delafloxacin (<=0.015 - >=1 µg/mL)bioMerieux, Inc.20200

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 16 years and passes through 1 company; a new generation was cleared every 5.0 years on median.
  • None of the 3 ancestors has a recall.
  • Of its descendants, K212243 (bioMerieux, Inc., 2022) has gone furthest, with 0 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. 2019, 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-Gram Positive Dalbavancin is designed for antimicrobial susceptibility testing of Gram positive microorganisms and 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. VITEK® 2 AST-Gram Positive Dalbavancin is a quantitative test. Dalbavancin has been shown to be active against most strains of the microorganisms listed below, according to the FDA label for this antimicrobial.

Active both in vitro and in clinical infections

Staphylococcus aureus (including methicillin-resistant isolates)

Enterococcus faecalis (vancomycin-susceptible isolates only)

Streptococcus agalactiae

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/K190616 · printed Nov 5, 2026

Cite this page

510(k) Report. “K190616: VITEK 2 AST-Gram Positive Dalbavancin (<= 0.015 - >= 1 µg/mL).” Lineage record from FDA 510(k) data and the FDA summary. Updated Nov 3, 2026. Accessed Nov 5, 2026. https://510kreport.com/device/K190616

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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