510(k) Report

510(k) · Cleared

Cleared

Vidas H. Pylori Igg (Hpy) Assay, Model 30 192

K001460510(k) TraditionalCleared Oct 4, 2000147-day reviewClass I21 CFR 866.3110

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

bioMerieux, Inc. · LYR Helicobacter Pylori

Cleared on Oct 4, 2000 after a 147-day review. FDA has not posted a summary or statement for it, so its predicates are not known. 1 later device descends from it.

Decided
Oct 4, 2000
Review
147 days
Class
Class I
Product code
LYR
Recalls
None
Predicates
0

1 later device descends from it, 1 citing it directly.

Descendants, by year cleared 2015: 1 descendant cleared200020052010201520202025
  1. This deviceK001460 Vidas H. Pylori Igg (Hpy) Assay, Model 30 192bioMerieux, Inc. · 2000
  2. Descendant · cites it directly · 0 of its ownK141133 VIDAS H. pylori IgG, VIDAS 3, VIDAS Lyme IgG II, VIDAS RUB IgG…Biomerieux · 2015 · Recalled

Most influential descendants

Showing 1 of 1 · See all
  • K141133VIDAS H. pylori IgG, VIDAS 3, VIDAS Lyme IgG II, VIDAS RUB IgG, VIDAS TOXO M, VIDAS…Biomerieux · 2015 · cites it directly0descendants
View FIG. 1 as a table

Line of descent and top descendants

GenerationNumberDeviceApplicantDecidedRecalls
0 (this device)K001460Vidas H. Pylori Igg (Hpy) Assay, Model 30 192bioMerieux, Inc.2000—
+1K141133VIDAS H. pylori IgG, VIDAS 3, VIDAS Lyme IgG II, VIDAS RUB IgG, VIDAS TOXO M…Biomerieux20154

Descendants by year cleared

Year clearedDevicesWith a Class I recall
201510
FIG. 1 — Lineage of K001460, 2000–2015Source: 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), FDA recall and enforcement reports, and MAUDE; processed by 510(k) Report. Verify on FDA.gov · Methodology and accuracy.

Planning a device in LYR? 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 LYR device

  1. #1 K232892 Hp Detect™ Stool Antigen ELISAscore 7.1 · 3 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?

FDA has not posted a summary or statement for it, so its predicates are not known.

What descends from it? (1)

1 later device cites it directly; ranked here by how many devices descend from each in turn.

NumberDeviceApplicantDecidedDescendants
K141133VIDAS H. pylori IgG, VIDAS 3, VIDAS Lyme IgG II, VIDAS RUB IgG, VIDAS TOXO M, VIDAS…Biomerieux20150

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?

  • Of its descendants, K141133 (Biomerieux, 2015) has gone furthest, with 0 descendants of its own.

How does its category compare?

All LYR devices

LYR Helicobacter Pylori: FDA decisions, review times, recalls and adverse event reports over 20 years.

FDA decisions per year · LYR

2in 2023

2012: 22015: 22016: 22018: 42019: 12020: 12023: 2
2007high 4 (2018) · low 0 (2007)2026

2026 to Oct 25, outlined.

Median 510(k) review, days · LYR

86in 2018

2018: 86 days median
2007high 86 (2018)2026

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

Recalls per year · LYR

2in 2025

2008: 22010: 12022: 32023: 12025: 2
2007high 3 (2022) · low 0 (2007)2026

Class I (0 since 2007) Class II/III not classified

Adverse event reports per year · LYR

2in 2023

2010: 12011: 22015: 22016: 42017: 12020: 42021: 12023: 2
2007high 4 (2016) · low 0 (2007)2025

MAUDE reports naming product code LYR, 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
20070—00
20080—20
20090—00
20100—11
20110—02
20122—00
20130—00
20140—00
20152—02
20162—04
20170—01
201848600
20191—00
20201—04
20210—01
20220—30
20232—12
20240—00
20250—20
20260—0—

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 LYR

The LYR category page

  • K232892Hp Detect™ Stool Antigen ELISABiomerica, Inc. · 2023
  • K230901Premier HpSA Flex (619096)Meridian Bioscience, Inc. · 2023
  • K192817Curian HpSA, Curian AnalyzerMeridian Bioscience, Inc. · 2020
  • K183573Vstrip H. pylori Antigen Rapid TestPanion & BF Biotech, Inc. · 2019
  • K182559PREMIER Platinum HpSA PLUSMeridian Bioscience, Inc. · 2018

https://510kreport.com/device/K001460 · printed Nov 6, 2026

Cite this page

510(k) Report. “K001460: Vidas H. Pylori Igg (Hpy) Assay, Model 30 192.” Lineage record from FDA 510(k) data and the FDA summary. Updated Nov 3, 2026. Accessed Nov 6, 2026. https://510kreport.com/device/K001460

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Record history
  • FDA decision record loaded May 2, 2026
  • Lineage and recalls computed Nov 3, 2026
  • Page last updated Nov 3, 2026