# K123050: Egens One Step HCG Urine Pregnancy Test Kit (S) (Strip, Cassette, Midstream I and Midstream II)

- Pathway: 510(k) (Traditional)
- Applicant: Nantong Biotechnology Co., Ltd.
- Decided: Feb 5, 2013 after 130 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.
2 later devices descend 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)
- K993317: Acon HCG One Step Pregnancy Test Device (Urine), ACON Laboratories, Inc. (1999) Summary page 1.

## Most influential descendants
- K193132: CLUNGENE HCG Pregnancy Rapid Test Cassette, CLUNGENE HCG Pregnancy Rapid Test Strip, CLUNGENE HCG Pregnancy Rapid Test Midstream (2019), 1 descendant of its own
- K212447: SEJOY hCG One Step Pregnancy Test Strip, SEJOY hCG One Step Pregnancy Test Cassette, SEJOY hCG One Step Pregnancy Test Midstream (2022), 0 descendants of its own

## Indications for use
EGENS One Step HCG Urine Pregnancy Test Kit (Strip) is a rapid chromatographic immunoassay for the qualitative detection of human Chorionic Gonadotropin (hCG) in urine samples to aid in the early detection of pregnancy by both professional and home users. EGENS One Step HCG Urine Pregnancy Test Kit (Cassette) is a rapid chromatographic immunoassay for the qualitative detection of human Chorionic Gonadotropin (hCG) in urine samples to aid in the early detection of pregnancy by both professional and home users. EGENS One Step HCG Urine Pregnancy Test Kit (Midstream 1)is a rapid chromatographic immunoassay for the qualitative detection of human Chorionic Gonadotropin (hCG) in urine samples to aid in the early detection of pregnancy by home users. EGENS One Step HCG Urine Pregnancy Test Kit (Midstream 11) is a rapid chromatographic immunoassay for the qualitative detection of human Chorionic Gonadotropin (hCG) in urine samples to aid in the early detection of pregnancy by home users.

Source page: https://510kreport.com/device/K123050
Methodology: https://510kreport.com/methodology