# K971657: Accurun 121 Hav Igm Positive Control

- Pathway: 510(k) (Traditional)
- Applicant: Boston Biomedica, Inc.
- Decided: Aug 12, 1997 after 98 days
- Product code: JJY (Multi-Analyte Controls, All Kinds (Assayed))
- Device class: 1
- Regulation: 21 CFR 862.1660
- 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. FDA’s file for it is a 510(k) statement, which names no predicate.

## Indications for use
Boston Biomedica intends to manufacture and market ACCURUN 121 HAV IgM Positive Control, which is a human blood based single analyte run control designed to be used as an independent run control with tests for the detection of IgM antibodies to Hepatitis A Virus (HAV). This control is not intended as a substitute for controls provided with test kits. This product will be made available to clinical laboratory professionals in blood banks, public health laboratories and clinical laboratories for use with in vitro diagnostic tests for the detection of IgM antibodies to HAV in human serum and plasma.

Source page: https://510kreport.com/device/K971657
Methodology: https://510kreport.com/methodology