# K233367: iDart Lyme IgG ImmunoBlot Kit

- Pathway: 510(k) (Traditional)
- Applicant: Id-Fish Technology, Inc.
- Decided: Aug 12, 2024 after 315 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 6.

## Indications for use
The iDart™ Lyme IgG ImmunoBlot Kit is an immunoblot assay intended for the in vitro qualitative detection of IgG antibodies to Borrelia burgdorferi in human serum. The iDart Lyme IgG ImmunoBlot Kit is intended to detect antibodies to LSA and multiple other B. burgdorferi antigens following a modified two-tier test methodology. Positive results from the iDart Lyme IgG ImmunoBlot Kit are supportive evidence for the presence of antibodies and exposure to B. burgdorferi. Negative results do not preclude infection with B. burgdorferi. iDart™ Lyme IgG ImmunoBlot Kit is intended to aid in the diagnosis of Lyme disease and the test kit should only be used on samples from patients with clinical history, signs and symptoms consistent with Lyme disease. The iDart Lyme IgG Immunoblot Kit is not intended as a screen for asymptomatic patients. Test results are to be used in conjunction with information obtained from the patient’s clinical evaluation and other diagnostic procedures. For in vitro diagnostic use only For professional use only For prescription use only

Source page: https://510kreport.com/device/K233367
Methodology: https://510kreport.com/methodology