# K071930: One Step HCG Urine Pregnancy Test (Strip), Model B01-S, One Step HCG Urine Pregnancy Test (Cassette) , Model B01C

- Pathway: 510(k) (Traditional)
- Applicant: Blue Cross Bio-Medical Co., Ltd.
- Decided: Dec 18, 2007 after 158 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
No predicates in its family tree.
5 later devices descend from it; 3 cite it directly.
0 of 6 devices in its family (counting itself) have a Class I recall.

## Predicates on the family tree (from the FDA summary)
- None. FDA lists a 510(k) statement for it but has not posted the file, so its predicates are not known.

## Most influential descendants
- K132085: One Step HCG Test Strip, One Step HCG Test Cassette, One Step HCG Test Midstream (2013), 2 descendants of its own
- K213808: Co-Innovation One Step Human Chorionic Gonadotropin (HCG) Test Strip, Co-Innovation One Step Human Chorionic Gonadotropin (HCG) Test Cassette, Co-Innovation One Step Human Chorionic Gonadotropin (HCG) Test Midstream (2022), 0 descendants of its own
- K203246: Atlas One Step hCG Urine Pregnancy Test (Strip), Atlas One Step hCG Urine Pregnancy Test (Cassette), Atlas One Step hCG Urine Pregnancy Test (Midstream) (2021), 0 descendants of its own
- K183097: Kangzhou One Step hCG Test Strip, Kangzhou One Step hCG Test Cassette, Kangzhou One Step hCG Test Midstream (2019), 0 descendants of its own
- K103487: Fora PNC100 Digital Pregancy Test, TD-5301 Pregancy Test (2011), 0 descendants of its own

Source page: https://510kreport.com/device/K071930
Methodology: https://510kreport.com/methodology