# K101946: Vidas Toxo Igg Avidity

- Pathway: 510(k) (Traditional)
- Applicant: bioMerieux, Inc.
- Decided: May 18, 2011 after 310 days
- Product code: LGD (Enzyme Linked Immunoabsorbent Assay, Toxoplasma Gondii)
- Device class: 2
- Regulation: 21 CFR 866.3780
- Recalls of this device: 1 (0 Class I)
- Data: FDA decisions to Oct 25, 2026; recalls to Oct 12, 2026

## Lineage
Longest line of descent: 1 generation back to K923166 (1993). 1 ancestor in all.
No later device cites it as a predicate yet.
0 of 2 devices in its family (counting itself) have a Class I recall.

## Predicates on the family tree (from the FDA summary)
- K923166: Vidas Toxoplasma Gondii Igm Asssay, Biomerieux Vitek, Inc. (1993) Summary page 4.

## Recalls of this device
- Mar 23, 2018 · Class II · Z-2169-2018: A shipment to Guadeloupe suffered a temperature excursions up to 47.8¿C, exceeding the acceptable limits. After detection of the issue, Global Supply Chain QA asked the bioM¿rieux distributor in Guade

## Indications for use
The VIDAS® TOXO IgG Avidity assay is an automated qualitative test for the determination of anti-toxoplasma IgG avidity in human serum using the ELFA technique (Enzyme Linked Fluorescent Assay). The VIDAS® TOXO IgG Avidity assay is intended for use in conjunction with results from the VIDAS TOXO IgG 11and must have a positive titer (> 8 IU/mL); other laboratory findings and clinical information to aid in the presumptive exclusion of a recently acquired (:S 4 months) Toxoplasma gondii infection in pregnant women and patients with lymphadenopathy. VIDAS TOXO IgG Avidity assay performance has not been established for prenatal screening, for newborn testing, for use in immunocompromised patients and in cases of endogenous or exogenous reinfection by Toxoplasma gondii. This assay has not been cleared or approved by the FDA for blood/plasma donor screening.

Source page: https://510kreport.com/device/K101946
Methodology: https://510kreport.com/methodology