# K972307: Accurun 119 Anti-Hepatitis B E Antigen (Anti-Hbe) Positive Control

- Pathway: 510(k) (Traditional)
- Applicant: Boston Biomedica, Inc.
- Decided: Aug 7, 1997 after 49 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
ACCURUN 119 Anti-Hepatitis B e Antigen (Anti-HBe) Positive Control is a human blood based single analyte run control designed to be used as an independent run control with tests for the detection of antibodies to Hepatitis B e Antigen (HBeAg). This control is not intended as a substitute for controls provided with test kits. ACCURUN 119 control is intended to estimate laboratory testing precision and can be used to detect errors in laboratory testing procedures.

Source page: https://510kreport.com/device/K972307
Methodology: https://510kreport.com/methodology