510(k) · Cleared
Recalled · Class II · 2022VIDAS H. pylori IgG, VIDAS 3, VIDAS Lyme IgG II, VIDAS RUB IgG, VIDAS TOXO M, VIDAS Human Chorionic Gonadotropin, VIDAS T4, VIDAS Testosterone, VIDAS TSH, and VIDAS D-Dimer Exclusion II
Data to Oct 25, 2026 (FDA decisions) Oct 12, 2026 (recalls) Sep 30, 2026 (MAUDE) refreshed weekly
Biomerieux · LYR Helicobacter Pylori
Cleared on Jul 9, 2015 as substantially equivalent to K001460 (bioMerieux, Inc., 2000) and 9 other predicates after a 434-day review. Its family tree reaches back 5 generations to 1986. It has been recalled 4 times.
- Decided
- Jul 9, 2015
- Review
- 434 days
- Class
- Class I
- Product code
- LYR
- Recalls
- 4
- Predicates
- 10
Its longest line of descent runs back 5 generations to K862156 (1986). 19 ancestors in all, the oldest K813401 (1981). No later device cites it as a predicate yet.
- Root · 5 generations backK862156 Asserachrom D-DI KitAmerican Bioproducts Co. · 1986
- 4 generations backK973819 Vidas D-Dimer (DD) AssayBiomerieux Vitek, Inc. · 1998
- 3 generations backK020810 Vidas D-Dimer New (DD2) Assay Model#30 442bioMerieux, Inc. · 2002
- 2 generations backK040882 Vidas D-Dimer Exclusion Assay, Model 30 442bioMerieux, Inc. · 2004
- 1 generation backK112818 Vidas D-Dimer Exclusion II (DEX2)bioMerieux, Inc. · 2012 · Recalled
- This deviceK141133 VIDAS H. pylori IgG, VIDAS 3, VIDAS Lyme IgG II, VIDAS RUB IgG…Biomerieux · 2015
View FIG. 1 as a table
Line of descent and top descendants
| Generation | Number | Device | Applicant | Decided | Recalls |
|---|---|---|---|---|---|
| −5 | K862156 | Asserachrom D-DI Kit | American Bioproducts Co. | 1986 | — |
| −4 | K973819 | Vidas D-Dimer (DD) Assay | Biomerieux Vitek, Inc. | 1998 | — |
| −3 | K020810 | Vidas D-Dimer New (DD2) Assay Model#30 442 | bioMerieux, Inc. | 2002 | — |
| −2 | K040882 | Vidas D-Dimer Exclusion Assay, Model 30 442 | bioMerieux, Inc. | 2004 | — |
| −1 | K112818 | Vidas D-Dimer Exclusion II (DEX2) | bioMerieux, Inc. | 2012 | 1 |
| 0 (this device) | K141133 | VIDAS H. pylori IgG, VIDAS 3, VIDAS Lyme IgG II, VIDAS RUB IgG, VIDAS TOXO M… | Biomerieux | 2015 | — |
Other ancestors by year cleared
| Year cleared | Devices | With a Class I recall |
|---|---|---|
| 1981 | 1 | 0 |
| 1989 | 2 | 0 |
| 1992 | 2 | 0 |
| 1993 | 3 | 0 |
| 1996 | 1 | 0 |
| 2000 | 1 | 0 |
| 2002 | 1 | 0 |
| 2008 | 2 | 0 |
| 2013 | 1 | 0 |
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 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 K232892 Hp Detect™ Stool Antigen ELISAscore 7.1 · 3 generations · no Class I recall
- #2 Held for the reportin the report
- #3 Held for the reportin the report
What was it cleared against? (10)
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.
| Type | Number | Device | Decided |
|---|---|---|---|
| * | K001460 | Vidas H. Pylori Igg (Hpy) Assay, Model 30 192Summary page 5…Governing Regulation: 21 CFR 866.3110 Device Classification: Class I Product code: LYR C1. Predicate Device VIDAS H.pylori IgG (K001460) D1. Device Description The assay principle combines a 2-step enzyme immunoassay sandwich method with a final fluorescent detect… | 2000 |
| * | K891385 | Vitek Immunodiagnostic Assay System (Vidas)Summary page 10…al device for professional use only. F2. Technological Performances Summary New Device Predicate (K891385) Component VIDAS 3 VIDAS Instrument Trade Name… | 1989 |
| * | K122986 | Vidas Lyme IggSummary page 13…egulation: 21 CFR 866.3830 Device Classification: Class II Product code: LSR C3. Predicate Device ® VIDAS Lyme IgG (K122986) D3. Device Description The VIDAS Lyme IgG II assay principle combines a 2-step enzyme immunoassay sandwich method with a fina… | 2013 |
| * | K080766 | Vidas Rub IggSummary page 16…ng Regulation: 21 CFR 866.3510 Device Classification: Class II Product code: LFX C4. Predicate Device ® VIDAS RUB IgG (K080766) D4. Device Description The VIDAS® RUB IgG (RBG) assay is an enzyme-linked fluorescent immunoassay (ELFA) that consists of a t… | 2008 |
| * | K923166 | Vidas Toxoplasma Gondii Igm AsssaySummary page 22…ing Regulation: 21 CFR 866.3780 Device Classification: Class II Product code: LGD C5. Predicate Device ® VIDAS TOXO M (K923166) D5. Device Description The VIDAS TOXO IgM (TXM) assay is an enzyme-linked fluorescent immunoassay (ELFA) that is performed in… | 1993 |
| * | K921302 | Vitek Immunodiagnostic Assay SystemSummary page 25…erning Regulation: 21 CFR 862.1155 Device Classification: Class II Product code: DHA C6. Predicate Device ® VIDAS HCG (K921302) D6. Device Description The VIDAS HCG (HCG) assay is an enzyme-linked fluorescent immunoassay (ELFA) that is performed in an a… | 1992 |
| * | K926393 | Vidas Thyroxine (T4) Assay (T4)Summary page 29…verning Regulation: 21 CFR 862.1700 Device Classification: Class II Product code: KLI C7. Predicate Device ® VIDAS T4 (K926393) D7. Device Description The VIDAS T4 (T4) assay is an enzyme-linked fluorescent immunoassay (ELFA) that is performed in an aut… | 1993 |
| * | K021326 | Vidas Testosterone (Tes), Model 30 418Summary page 32…lation: 21 CFR 862.1680 Device Classification: Class I Product code: CDZ C8. Predicate Device ® VIDAS Testosterone (K021326) D8. Device Description The assay principle combines an enzyme immunoassay competition method with a final fluorescent detecti… | 2002 |
| * | K921816 | Vitek Immun Assay Sys (Vidas) Thyroi Stim Hor AssaySummary page 36…erning Regulation: 21 CFR 862.1690 Device Classification: Class II Product code: JLW C9. Predicate Device ® VIDAS TSH (K921816) D9. Device Description The VIDAS TSH (TSH) assay is an enzyme-linked fluorescent immunoassay (ELFA) that is performed in an a… | 1992 |
| * | K112818 | Vidas D-Dimer Exclusion II (DEX2)Summary page 40…21 CFR 864.7320 Device Classification: Class II Product code: DAP C10. Predicate Device ® VIDAS D-Dimer Exclusion II (K112818) D10. Device Description The VIDAS D-Dimer Exclusion II (DEXII) assay is an enzyme-linked fluorescent immunoassay (ELFA) pe… | 2012 |
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
| Date | Class | Recall | Root cause | Reason |
|---|---|---|---|---|
| Nov 9, 2022 | Class II | Z-0797-2023 | Storage | As the temperature and time out of range was exceeded, product performances cannot be guaranteed |
| Nov 9, 2022 | Class II | Z-0864-2023 | Storage | As the temperature and time out of range was exceeded, product performances cannot be guaranteed |
| Sep 22, 2021 | Class II | Z-0427-2022 | Nonconforming Material/Component | bioMerieux has been receiving an increasing number of complaints linked to a VIDAS substrate error. It prevents the test from being run, therefore leads to potential delayed results as the user must run another test. |
| Oct 22, 2019 | Class II | Z-0928-2020 | Software design | Following Customers complaints, investigations have been initiated on potentially false results obtained on VIDAS 3 with an expired calibration. Indeed, the calibrations of assays were valid in the calibration menu whereas in fact the… |
No ancestor or descendant has a Class I recall.
What does this lineage say?
- The line of descent spans 29 years and passes through 4 companies; a new generation was cleared every 4.6 years on median.
- 3 of the 19 ancestors have a recall of any class.
How does its category compare?
All LYR devicesLYR Helicobacter Pylori: FDA decisions, review times, recalls and adverse event reports over 20 years. 2015, this device’s year, is highlighted.
FDA decisions per year · LYR
2in 2023
2026 to Oct 25, outlined.
Median 510(k) review, days · LYR
86in 2018
Receipt to decision; years with fewer than 3 clearances left blank.
Recalls per year · LYR
2in 2025
Class I (0 since 2007) Class II/III not classified
Adverse event reports per year · LYR
2in 2023
MAUDE reports naming product code LYR, not matched to any one device; reports are not rates.
View these four charts as a table
| Year | Decisions | Median 510(k) review, days | Recalls (Class I) | MAUDE reports |
|---|---|---|---|---|
| 2007 | 0 | — | 0 | 0 |
| 2008 | 0 | — | 2 | 0 |
| 2009 | 0 | — | 0 | 0 |
| 2010 | 0 | — | 1 | 1 |
| 2011 | 0 | — | 0 | 2 |
| 2012 | 2 | — | 0 | 0 |
| 2013 | 0 | — | 0 | 0 |
| 2014 | 0 | — | 0 | 0 |
| 2015 | 2 | — | 0 | 2 |
| 2016 | 2 | — | 0 | 4 |
| 2017 | 0 | — | 0 | 1 |
| 2018 | 4 | 86 | 0 | 0 |
| 2019 | 1 | — | 0 | 0 |
| 2020 | 1 | — | 0 | 4 |
| 2021 | 0 | — | 0 | 1 |
| 2022 | 0 | — | 3 | 0 |
| 2023 | 2 | — | 1 | 2 |
| 2024 | 0 | — | 0 | 0 |
| 2025 | 0 | — | 2 | 0 |
| 2026 | 0 | — | 0 | — |
What is it indicated for?
For VIDAS H. pylori IgG: VIDAS® H. pylori IgG (HPY) is an automated qualitative test for use on the instruments of the VIDAS family, for the detection of anti-Helicobacter pylori IgG antibodies in human serum or plasma (EDTA) using the ELFA technique (Enzyme Linked Fluorescent Assay). The VIDAS HPY assay is intended as an aid in diagnosis of H. pylori infection in an adult symptomatic population. This device is an in vitro diagnostic medical device for…
Read the full statement (834 words)
For VIDAS H. pylori IgG:
VIDAS® H. pylori IgG (HPY) is an automated qualitative test for use on the instruments of the VIDAS family, for the detection of anti-Helicobacter pylori IgG antibodies in human serum or plasma (EDTA) using the ELFA technique (Enzyme Linked Fluorescent Assay). The VIDAS HPY assay is intended as an aid in diagnosis of H. pylori infection in an adult symptomatic population.
This device is an in vitro diagnostic medical device for professional use only.
For VIDAS 3:
The VIDAS 3 system is a complete standalone immunodiagnostic system intended for trained and qualified laboratory technicians (daily routine use) and laboratory administrators (application configuration).
This device is an in vitro diagnostic medical device for professional use only.
For VIDAS Lyme IgG II:
The VIDAS Lyme IgG II (LYG) assay is an automated qualitative enzyme immunoassay intended for use on the instruments of the VIDAS family in the presumptive detection of human IgG antibodies to Borrelia burgdorferi in human serum (plain or separation gel) or plasma (sodium heparin or lithium heparin). It should be used to test patients with a history and/or symptoms of infection with B. burgdorferi. All VIDAS Lyme IgG II positive specimens should be further tested with a Western Blot IgG assay to obtain supportive evidence of infection with B. burgdorfei.
This device is an in vitro diagnostic medical device for professional use only.
For VIDAS RUB IgG:
The VIDAS® RUB IgG (RBG) assay uses Enzyme Linked Fluorescent Assay (ELFA) technology on the instruments of the VIDAS family for the in vitro quantitative and qualitative measurement of IgG antibodies to rubella virus in human serum. The VIDAS RUB IgG (RBG) assay is intended as an aid in the determination of immune status to rubella. The performance of this device has not been established for screening of cord blood, or for neonatal samples. Likewise, performance characteristics of the assay have not been established for immunocompromised or immunosuppressed individuals.
This device is an in vitro diagnostic medical device for professional use only.
For VIDAS TOXO IgM:
The VIDAS® TOXO IgM (TXM) assay is intended for use on the instruments of the VIDAS family (VITEK ImmunoDiagnostic Assay System) as an automated enzyme-linked fluorescent immunoassay (ELFA) for the presumptive qualitative detection of anti-Toxoplasma gondii IgM antibodies in human serum, as an aid in the diagnosis of acute, recent, or reactivated Toxoplasma gondii infection. This assay must be performed in conjunction with an anti-Toxoplasma gondii lgG antibody assay. VIDAS TOXO IgM (TXM) assay performance has not been established for prenatal screening or newborn testing. This assay has not been cleared by the FDA for blood/plasma donor screening.
This device is an in vitro diagnostic medical device for professional use only.
For VIDAS Human Chorionic Gonadotropin:
The VIDAS® HCG (HCG) assay is intended for use on the instruments of the VIDAS family as an automated quantitative enzyme linked fluorescent immunoassay (ELFA) for the determination of human Chorionic Gonadotropin (hCG) concentration in human serum or plasma. The VIDAS HCG (HCG) assay is intended to aid in the early detection of pregnancy.
This device is an in vitro diagnostic medical device for professional use only.
For VIDAS T4:
The VIDAS® T4 (T4) assay is intended for use on the instruments of the VIDAS family as an automated quantitative enzyme-linked fluorescent immunoassay for the determination of human thyroxine (T4) concentration in serum or plasma (heparin). It is intended for use as an aid in the diagnosis and treatment of thyroid disorders.
This device is an in vitro diagnostic medical device for professional use only.
For VIDAS Testosterone:
The VIDAS Testosterone (TES) assay is an automated quantitative test for use on the instruments of the VIDAS family for the enzyme immunoassay measure of total testosterone in human serum or plasma (lithium heparin), using the ELFA technique (Enzyme Linked Fluorescent Assay). It is intended as an aid in the diagnosis and management of conditions involving excess or deficiency of this androgen.
This device is an in vitro diagnostic medical device for professional use only.
For VIDAS TSH:
The VIDAS® TSH (TSH) assay is intended for use on the instruments of the VIDAS family as an automated quantitative enzyme-linked fluorescent immunoassay (ELFA) for the determination of human thyroid stimulating hormone- (TSH) concentration in human serum or plasma (heparin). It is intended for use as an aid in the diagnosis of thyroid or pituitary disorders.
This device is an in vitro diagnostic medical device for professional use only.
For VIDAS D-Dimer Exclusion II:
VIDAS® D-Dimer Exclusion II™ is an automated quantitative test for use on the instruments of the VIDAS family for the immunoenzymatic determination of fibrin degradation products (FbDP) in human plasma (sodium citrate, CTAD) using the ELFA technique (Enzyme Linked Fluorescent Assay).
VIDAS D-Dimer Exclusion II is indicated for use in conjunction with a clinical pretest probability assessment model to exclude deep vein thrombosis (DVT) and pulmonary embolism (PE) disease in outpatients suspected of DVT or PE.
This device is an in vitro diagnostic medical device for professional use only.
Indications for use as stated in the FDA summary.
https://510kreport.com/device/K141133 · printed Nov 6, 2026
Cite this page
510(k) Report. “K141133: VIDAS H. pylori IgG, VIDAS 3, VIDAS Lyme IgG II, VIDAS RUB IgG, VIDAS TOXO M, VIDAS Human Chorionic Gonadotropin, VIDAS T4, VIDAS Testosterone, VIDAS TSH, and VIDAS D-Dimer Exclusion II.” Lineage record from FDA 510(k) data and the FDA summary. Updated Nov 3, 2026. Accessed Nov 6, 2026. https://510kreport.com/device/K141133
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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