# K991063: Qualicode B. Burgdorferi Igg Western Blot Kit, Model DK-C052-024

- Pathway: 510(k) (Traditional)
- Applicant: Immunetics, Inc.
- Decided: Sep 21, 1999 after 174 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
No predicates in its family tree.
No later device cites it as a predicate yet.
0 of 1 device in its family (counting itself) have a Class I recall.

## Predicates on the family tree (from the FDA summary)
- None. The FDA summary names no predicate by number.

## Indications for use
The Immunetics QualiCode™ B. burgdorferi IgG Western Blot Kit is intended for use in testing human serum samples which have demonstrated positive or equivocal responses using EIA or IFA test procedures to provide supportive evidence of infection with Borrelia burgdorferi. The Immunetics QualiCode™ B. burgdorferi IgG Western Blot Kit can be used at any time following onset of symptoms. It should also be used for follow up when (1) only IgM antibodies were originally detected (2) IgG antibodies were detected but were not considered significant or (3) previously tested seronegative individuals are shown to develop antibodies by EIA or IFA test procedures.

Source page: https://510kreport.com/device/K991063
Methodology: https://510kreport.com/methodology