# K063720: Vitros Immunodiagnostic Products Total B-HCG II Reagent Pack, Calibrators, Range Verifiers

- Pathway: 510(k) (Traditional)
- Applicant: Ortho-Clinical Diagnostics
- Decided: Apr 9, 2007 after 115 days
- Product code: DHA (System, Test, Human Chorionic Gonadotropin)
- Device class: 2
- Regulation: 21 CFR 862.1155
- Recalls of this device: 1 (0 Class I)
- Data: FDA decisions to Oct 25, 2026; recalls to Oct 12, 2026

## Lineage
Longest line of descent: 1 generation back to K970894 (1997). 3 ancestors in all.
1 later device descends from it; 1 cites it directly.
0 of 5 devices in its family (counting itself) have a Class I recall.

## Predicates on the family tree (from the FDA summary)
- K983424: Abbott Archeitect Total B-HCG, Abbott Laboratories (1998) Summary page 2.
- K970894: Vitros Immunodiagnostics Products Total B-HCG Reagent Pack (Gem.1075), Total B-HCG Calibrators (Gem.C075), Johnson & Johnson Clinical Diagnostics, Inc. (1997) Summary page 2.
- K973517: Vitros Immunodiagnostic Products Range Verifiers, Johnson & Johnson Clinical Diagnostics, Inc. (1997) Summary page 3.

## Most influential descendants
- K233581: VITROS Immunodiagnostic Products Total ß-hCG II Reagent Pack (2024), 0 descendants of its own

## Recalls of this device
- Feb 18, 2016 · Class II · Z-1700-2016: When testing was conducted using certain lots, VITROS¿ Systems generated results within the measuring range for samples known to not contain measurable hCG. The system reported results up to approxima

## Indications for use
For quantitative measurement of human chorionic gonadotropin (hCG) and its n-subunit in human serum and plasma (EDTA or heparin) to aid in the early detection of pregnancy. For use in the calibration of the VITROS Immunodiagnostic System for the quantitative measurement of human chorionic gonadotropin (hCG) and its [-subunit in human serum and plasma (EDTA or heparin). For in vitro use in verifying the calibration range of the VITROS Immunodiagnostic System when used for the measurement of human chorionic gonadotropin (hCG) and its [-subunit.

Source page: https://510kreport.com/device/K063720
Methodology: https://510kreport.com/methodology