# K991532: DRX QT. HCG

- Pathway: 510(k) (Traditional)
- Applicant: Metrika, Inc.
- Decided: Sep 17, 1999 after 137 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: 1 generation back to K850570 (1985). 2 ancestors in all.
No later device cites it as a predicate yet.
0 of 3 devices in its family (counting itself) have a Class I recall.

## Predicates on the family tree (from the FDA summary)
- K850570: Stratus HCG Fluorometric Enzyme Immunoassay, American Dade (1985) Summary page 4.
- K860906: Stratus Immunoassay Controls, Levels I, II, Iii, American Dade (1986) Summary page 5.

## Indications for use
DRx® Qt. hCG is a rapid, single-use, point-of-care device for the quantitative measurement of human chorionic gonadotropin (total BhCG) in capillary and venous whole blood samples. The device is for professional use as an aid in the assessment of pregnancy status. The DRx® Qt. hCG Control Set is a two level, assayed, liquid control containing human chorionic gonadotropin for the evaluation of precision and accuracy of the DRx® Qt. hCG device.

Source page: https://510kreport.com/device/K991532
Methodology: https://510kreport.com/methodology