# K071030: Bionexia HCG Pregnancy Serum/Urine Cassette and Dipstick Tests, Models 08-HCGC and 02-HCGC

- Pathway: 510(k) (Traditional)
- Applicant: Applied Dna Technologies, Inc.
- Decided: Jun 29, 2007 after 79 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: 2 generations back to K993065 (1999). 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)
- K041946: Acon Spectrum Urine/Serum Pregnancy Test Device, ACON Laboratories, Inc. (2004) Summary page 1.

## Indications for use
The Applied DNA Technologies BionexiaTM hCG Pregnancy Serum/Urine Cassette and Dipstick Tests are rapid chromatographic immunoassays for the visual, qualitative detection of human chorionic gonadotropin (hCG) in serum or urine specimen at 20 mlU/mL 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/K071030
Methodology: https://510kreport.com/methodology