# K070921: Bionexia HCG Pregnancy Cassette and Dipstick Tests, Model 08-HCG and 02-HCG

- Pathway: 510(k) (Traditional)
- Applicant: Applied Dna Technologies, Inc.
- Decided: Jun 29, 2007 after 88 days
- Product code: JHI (Visual, Pregnancy Hcg, Prescription Use)
- 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 K993203 (1999). 1 ancestor in all.
No later device cites it as a predicate yet.
0 of 2 devices in its family (counting itself) have a Class I recall.

## Predicates on the family tree (from the FDA summary)
- K993203: Acon One Step Pregnancy Test Strip (Urine), ACON Laboratories, Inc. (1999) Summary page 1.

## Indications for use
The Applied DNA Technologies Bionexia TM hCG Pregnancy Cassette and Dipstick Tests are rapid chromatographic immunoassays for the visual, qualitative detection of human chorionic gonadotropin (hCG) in urine at 20 mIU/mnL and above to help in the early determination of pregnancy. The test kits are for health care professionals use including professionals at physician's office labs (POLs). For a final Diagnosis of pregnancy, a more specific alternative clinical method must be used to obtain a confirmed analytical result.

Source page: https://510kreport.com/device/K070921
Methodology: https://510kreport.com/methodology