# K911590: Immunowell Borrelia (Lyme)Test

- Pathway: 510(k) (Traditional)
- Applicant: General Biometrics, Inc.
- Decided: Dec 20, 1991 after 255 days
- Product code: LSR (Reagent, Borrelia Serological Reagent)
- Device class: 2
- Regulation: 21 CFR 866.3830
- Recalls of this device: 1 (0 Class I)
- 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. FDA has not posted a summary or statement for it, so its predicates are not known.

## Recalls of this device
- Feb 11, 2013 · Class II · Z-0927-2013: Multiple incidents of low-reacting assay plates.

Source page: https://510kreport.com/device/K911590
Methodology: https://510kreport.com/methodology