# K102760: Atlas Home Pregnancy Test (Midstream Format) Model 70172001

- Pathway: 510(k) (Traditional)
- Applicant: Atlas Medical
- Decided: Aug 3, 2011 after 314 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: 1 generation back to K993317 (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)
- K993317: Acon HCG One Step Pregnancy Test Device (Urine), ACON Laboratories, Inc. (1999) Summary page 1.

## Indications for use
Atlas Home Pregnancy Test (Midstream Format) is a home use (OTC) rapid chromatographic immunoassay for the qualitative detection of human Chorionic Gonadotropin (hCG) in the urine to aid in the early detection of pregnancy.

Source page: https://510kreport.com/device/K102760
Methodology: https://510kreport.com/methodology