# K112315: Home Pregnancy Test

- Pathway: 510(k) (Traditional)
- Applicant: Newscen Coast Bio-Pharmaceutical Co., Ltd.
- Decided: Apr 23, 2012 after 256 days
- Product code: JHI (Visual, Pregnancy Hcg, Prescription Use)
- 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 K993203 (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)
- K993203: Acon One Step Pregnancy Test Strip (Urine), ACON Laboratories, Inc. (1999) Summary page 1.

## Indications for use
The y.b.t. Pregnancy Test Strip is an immunochromatographic assay for the qualitative determination of HCG in human urine. The test is intended for use as an aid in the early detection of pregnancy. The y.b.t. Pregnancy Test Cassette is an immunochromatographic assay for the qualitative determination of HOG in human urine. The test is intended for use as an aid in the early detection of pregnancy.

Source page: https://510kreport.com/device/K112315
Methodology: https://510kreport.com/methodology