# K233581: VITROS Immunodiagnostic Products Total ß-hCG II Reagent Pack

- Pathway: 510(k) (Traditional)
- Applicant: Ortho Clinical Diagnostics
- Decided: May 8, 2024 after 183 days
- Product code: DHA (System, Test, Human Chorionic Gonadotropin)
- Device class: 2
- Regulation: 21 CFR 862.1155
- Recalls of this device: none
- Data: FDA decisions to Oct 25, 2026; recalls to Oct 12, 2026

## Lineage
Longest line of descent: 2 generations back to K970894 (1997). 4 ancestors in all.
No later device cites it as a predicate yet.
0 of 5 devices in its family (counting itself) have a Class I recall.

## Predicates on the family tree (from the FDA summary)
- K063720: Vitros Immunodiagnostic Products Total B-HCG II Reagent Pack, Calibrators, Range Verifiers, Ortho-Clinical Diagnostics (2007) Summary page 4.

## Indications for use
For in vitro diagnostic use only. For the quantitative measurement of human chorionic gonadotropin (hCG) and its β-subunit in human serum and plasma (heparin and EDTA) using the VITROS 5600 Integrated System to aid in the early detection of pregnancy.

Source page: https://510kreport.com/device/K233581
Methodology: https://510kreport.com/methodology