# K172512: ACRO HCG Pregnancy Rapid Test

- Pathway: 510(k) (Special)
- Applicant: Acro Biotech, Inc.
- Decided: Feb 2, 2018 after 165 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: 2 generations back to K914253 (1991). 2 ancestors in all.
1 later device descends from it; 1 cites it directly.
0 of 4 devices in its family (counting itself) have a Class I recall.

## Predicates on the family tree (from the FDA summary)
- K960733: Ministick Pregnancy Test, Vanguard Biomedical Corp. (1996) Summary page 5.

## Most influential descendants
- K180771: Acro HCG Pregnancy Rapid Test (2018), 0 descendants of its own

## Indications for use
The ACRO hCG Pregnancy Rapid Test is used by the consumer for the visual qualitative detection of Human Chorionic Gonadotropin (hCG) in urine. It is used to detect the pregnancy of HCG in urine as an indication of pregnancy.

Source page: https://510kreport.com/device/K172512
Methodology: https://510kreport.com/methodology