# K981913: Prevue (TM) Borrelia Burgdorferi Antibody Detection Assay

- Pathway: 510(k) (Traditional)
- Applicant: Chembio Diagnostic Systems, Inc.
- Decided: Feb 12, 1999 after 256 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 K965131 (1997). 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)
- K965131: Borrelia Burgdorferi Igg/Igm Elisa Test System, Wampole Laboratories (1997) Summary page 1.

## Indications for use
The Wampole PreVue™ Borrelia burgdorferi Antibody Detection Assay is a single use, unitized immunochromatographic test that uses recombinant B. burgdorferi antigens for the qualitative presumptive (first step) detection of IgG and IgM antibodies to B. burgdorferi in human serum or whole blood. This test should be used only in patients with history, signs and symptoms that are consistent with Lyme disease. The Wampole PreVue™ Borrelia burgdorferi Antibody Detection Assay is intended for use in clinical and physicians’ office laboratories.

Source page: https://510kreport.com/device/K981913
Methodology: https://510kreport.com/methodology