# K974613: Virotrol Iii

- Pathway: 510(k) (Traditional)
- Applicant: Blackhawk Biosystems, Inc.
- Decided: Jan 27, 1998 after 47 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.
3 later devices descend from it; 2 cite it directly.
0 of 4 devices 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.

## Most influential descendants
- K060770: Vitros Immunodiagnostic Products Anti-Hav Igm-Reagent Pack, Calibrator, and Controls (2006), 1 descendant of its own
- K161964: ADVIA Centaur HAV IgM Assay (2016), 0 descendants of its own
- K032993: Vitros Immunodiagnostic Products Anti-HBC Igm Controls (2003), 0 descendants of its own

## Indications for use
VIROTROL III quality assurance reagent is a liquid unassayed human serum based quality control material intended for use with in vitro assay procedures for determination of immunoglobulin M antibodies to Hepatitis A Virus(HAV-IgM), immunoglobulin M antibodies to Hepatitis B core Antigen(HBc-IgM), Hepatitis B e Antigen(HBeAg) and total antibody to Hepatitis A Virus(anti-HAV). VIROTROL III reagents are intended to provide a means of estimating precision and have the potential for detecting systematic deviations from specific laboratory testing procedures.

Source page: https://510kreport.com/device/K974613
Methodology: https://510kreport.com/methodology