# K252627: Lyme-ID IgG Test; Bio-ID800

- Pathway: 510(k) (Traditional)
- Applicant: Inanovate, Inc.
- Decided: Nov 14, 2025 after 86 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 K220016 (2022). 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)
- K220016: Viramed Borrela All-In-One ViraChip Test Kit, Viramed Biotech AG (2022) Summary page 8.

## Indications for use
The Inanovate Lyme-ID IgG Test is an in vitro qualitative microarray assay for the detection of IgG antibodies to Borrelia burgdorferi in human serum. The assay is intended for testing serum samples from symptomatic patients or those suspected of Lyme Disease. It is intended to detect antibodies to VlsE and multiple other B.burgdorferi antigens following a modified two-tier test methodology. Positive results from the Lyme-ID IgG Test are supportive evidence for the presence of antibodies and exposure to B. burgdorferi, the causative agent for Lyme disease. Negative results do not preclude infection with B. burgdorferi. Test results are to be used in conjunction with information obtained from the patient’s clinical evaluation and other diagnostic procedures as an aid in diagnosis of Lyme disease. The Inanovate Lyme-ID IgG Test must be used with Inanovate’s Bio-ID800 instrument and Lyme-ID Software.

Source page: https://510kreport.com/device/K252627
Methodology: https://510kreport.com/methodology