# K974810: Accurun (TM) 132 Borrelia Burdorferi Igm Positive Control

- Pathway: 510(k) (Traditional)
- Applicant: Boston Biomedica, Inc.
- Decided: Feb 5, 1998 after 44 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
Boston Biomedica intends to manufacture and market ACCURUN™ 132 Borrelia burgdorferi IgM Positive Control, which is a human blood based single analyte unassayed run control designed to be used as an independent run control with tests for the detection of IgM antibodies to Borrelia burgdorferi (Lyme Disease). This control is not intended as a substitute for controls provided with test kits. This product is not FDA cleared for use in testing blood or plasma donors. This product will be made available to clinical laboratory professionals in public health laboratories and clinical laboratories for use with in vitro diagnostic tests for the detection of IgM antibodies to Borrelia burgdorferi in human serum.

Source page: https://510kreport.com/device/K974810
Methodology: https://510kreport.com/methodology