# K060678: Vitros Immunodiagnostic Products Anti-Hav Total Reagent Pack,Calibrator,Controls

- Pathway: 510(k) (Traditional)
- Applicant: Ortho-Clinical Diagnostics, Inc.
- Decided: Sep 14, 2006 after 184 days
- Product code: LOL (Hepatitis A Test (Antibody And Igm Antibody))
- Device class: 2
- Regulation: 21 CFR 866.3310
- Recalls of this device: none
- Data: FDA decisions to Oct 25, 2026; recalls to Oct 12, 2026

## Lineage
Longest line of descent: 1 generation back to P780012 (1979). 2 ancestors in all.
1 later device descends from it; 1 cites 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)
- P780012: HAVAB, Abbott Laboratories (1979) Summary page 1.
- K960085: Ise Calibrant a & B, Ise Liquid Reagent for Paramax Clinak Systems, Alko Diagnostic Corp. (1996) Summary page 1.

## Most influential descendants
- K142758: ADVIA Centaur HAV total assay (2014), 0 descendants of its own

## Indications for use
VITROS Anti-HAV Total Reagent Pack: For the in vitro qualitative detection of total antibody (IgG and IgM) to hepatitis A virus (anti-HAV) in human adult and pediatric serum and plasma (EDTA, heparin or citrate) using the VITROS ECi/ECiQ Immunodiagnostic System. The assay is indicated, in conjunction with other serological and clinical information, as an aid in the clinical laboratory diagnosis of individuals with acute or past hepatitis A virus infection, or as an aid in the identification of HAV-susceptible individuals prior to HAV vaccination. The detection of HAV-specific antibodies in human serum or plasma is laboratory evidence of acute or recent HAV infection. VITROS Anti-HAV Total Calibrator For in vitro use in the calibration of the VITROS Immunodiagnostic System for the qualitative detection of antibodies to hepatitis A virus (anti-HAV) in human serum and plasma (EDTA, heparin or citrate). VITROS Anti-HAV Total Controls For in vitro use in monitoring the performance of the VITROS Immunodiagnostic System when used for the detection of Htepatitis A virus (anti-HAV).

Source page: https://510kreport.com/device/K060678
Methodology: https://510kreport.com/methodology