# K080012: Platelia Lyme Igg Assay

- Pathway: 510(k) (Traditional)
- Applicant: Bio-Rad
- Decided: May 8, 2008 after 126 days
- Product code: LSR (Reagent, Borrelia Serological Reagent)
- Device class: 2
- Regulation: 21 CFR 866.3830
- Recalls of this device: none
- Data: FDA decisions to Oct 25, 2026; recalls to Oct 12, 2026

## Lineage
Longest line of descent: 1 generation back to K894224 (1989). 1 ancestor in all.
5 later devices descend from it; 1 cites it directly.
0 of 7 devices in its family (counting itself) have a Class I recall.

## Predicates on the family tree (from the FDA summary)
- K894224: Mardx Lyme Disease Eia (Igg) Test System, Mardx Diagnostics, Inc. (1989) Summary page 1.

## Most influential descendants
- K122986: Vidas Lyme Igg (2013), 4 descendants of its own
- K173691: Sofia Lyme FIA, Sofia 2 analyzer, Sofia 2 Installation Pack (2018), 1 descendant of its own
- K254295: Sofia Lyme FIA; Sofia 2 Campylobacter FIA (2026), 0 descendants of its own
- K163713: Sofia Lyme FIA, Sofia Lyme Control Set (2017), 0 descendants of its own
- 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 (2015), 0 descendants of its own

## Indications for use
The Platelia Lyme IgG assay is a qualitative test intended for use in the presumptive detection of human IgG antibodies to Borrelia burgdorferi in human serum or plasma (K 3 EDTA, sodium heparin or sodium citrate). The EIA test system should be used to test serum or plasma from patients with a history and symptoms of infection with B. burgdorferi. All positive and equivocal specimens should be re-tested with a specific, second-tier test such as Western blot. Positive second-tier results are supportive evidence of infection with B. burgdorferi. The diagnosis of Lyme disease should be made based on history and symptoms (such as erythema migrans), and other laboratory data, in addition to the presence of antibodies to B. burgdorferi. Negative results (either first or second-tier) should not be used to exclude Lyme disease.

Source page: https://510kreport.com/device/K080012
Methodology: https://510kreport.com/methodology