# K180771: Acro HCG Pregnancy Rapid Test

- Pathway: 510(k) (Traditional)
- Applicant: Acro Biotech, Inc.
- Decided: May 18, 2018 after 56 days
- Product code: LCX (Kit, Test, Pregnancy, Hcg, Over The Counter)
- 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: 3 generations back to K914253 (1991). 3 ancestors in all.
No later device cites it as a predicate yet.
0 of 4 devices in its family (counting itself) have a Class I recall.

## Predicates on the family tree (from the FDA summary)
- K172512: ACRO HCG Pregnancy Rapid Test, Acro Biotech, Inc. (2018) Summary page 5.

## Indications for use
The ACRO hCG Pregnancy Rapid Test is for use by the over the counter consumers for the visual qualitative detection of Human Chorionic Gonadotropin (hCG) in urine. It is to be used in either dip mode or midstream mode for the early detection of pregnancy.

Source page: https://510kreport.com/device/K180771
Methodology: https://510kreport.com/methodology