# K974811: Accurun (TM) 150 HSV Igg Positive Control

- Pathway: 510(k) (Traditional)
- Applicant: Boston Biomedica, Inc.
- Decided: Feb 10, 1998 after 49 days
- Product code: JJX (Single (Specified) Analyte Controls (Assayed And Unassayed))
- 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. The FDA summary names no predicate by number.

## Indications for use
Boston Biomedica intends to manufacture and market ACCURUN™ 150 HSV IgG Positive Control, which is a human blood based single analytc unassayed run control designed to be used as an independent run control with tests for the detection of IgG antibodies to herpes simplex virus (HSV). Thia coptrol 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 virro diagnostic tests for the detection of JgG antibodies to HSV in human serum.

Source page: https://510kreport.com/device/K974811
Methodology: https://510kreport.com/methodology