# 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 - Pathway: 510(k) (Traditional) - Applicant: Biomerieux - Decided: Jul 9, 2015 after 434 days - Product code: LYR (Helicobacter Pylori) - Device class: 1 - Regulation: 21 CFR 866.3110 - Recalls of this device: 4 (0 Class I) - Data: FDA decisions to Oct 25, 2026; recalls to Oct 12, 2026 ## Lineage Longest line of descent: 5 generations back to K862156 (1986). 19 ancestors in all. No later device cites it as a predicate yet. 0 of 20 devices in its family (counting itself) have a Class I recall. ## Predicates on the family tree (from the FDA summary) - K001460: Vidas H. Pylori Igg (Hpy) Assay, Model 30 192, bioMerieux, Inc. (2000) Summary page 5. - K891385: Vitek Immunodiagnostic Assay System (Vidas), Vitek Systems, Inc. (1989) Summary page 10. - K122986: Vidas Lyme Igg, Biomerieux S.A. (2013) Summary page 13. - K080766: Vidas Rub Igg, bioMerieux, Inc. (2008) Summary page 16. - K923166: Vidas Toxoplasma Gondii Igm Asssay, Biomerieux Vitek, Inc. (1993) Summary page 22. - K921302: Vitek Immunodiagnostic Assay System, Vitek Systems, Inc. (1992) Summary page 25. - K926393: Vidas Thyroxine (T4) Assay (T4), Biomerieux Vitek, Inc. (1993) Summary page 29. - K021326: Vidas Testosterone (Tes), Model 30 418, bioMerieux, Inc. (2002) Summary page 32. - K921816: Vitek Immun Assay Sys (Vidas) Thyroi Stim Hor Assay, Biomerieux Vitek, Inc. (1992) Summary page 36. - K112818: Vidas D-Dimer Exclusion II (DEX2), bioMerieux, Inc. (2012) Summary page 40. ## Recalls of this device - Nov 9, 2022 · Class II · Z-0797-2023: As the temperature and time out of range was exceeded, product performances cannot be guaranteed - Nov 9, 2022 · Class II · Z-0864-2023: As the temperature and time out of range was exceeded, product performances cannot be guaranteed - Sep 22, 2021 · Class II · Z-0427-2022: 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 r - Oct 22, 2019 · Class II · Z-0928-2020: 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 ca ## Indications for use 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. Source page: https://510kreport.com/device/K141133 Methodology: https://510kreport.com/methodology