# K103487: Fora PNC100 Digital Pregancy Test, TD-5301 Pregancy Test

- Pathway: 510(k) (Traditional)
- Applicant: Taidoc Technology Corporation
- Decided: Oct 4, 2011 after 312 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 K071930 (2007). 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)
- K071930: One Step HCG Urine Pregnancy Test (Strip), Model B01-S, One Step HCG Urine Pregnancy Test (Cassette) , Model B01C, Blue Cross Bio-Medical Co., Ltd. (2007) Summary page 1.

## Indications for use
The FORA PNC100 Digital Pregnancy Test is an in vitro diagnostic test device for the qualitative determination of human chorionic gonadotropin (hCG) in urine. It is intended for use as an aid in the early detection of pregnancy by lay users. Additional clinical examination should be performed to confirm the pregnancy. This device uses visually read lateral flow technology for the detection of hCG and provides a digitally read result. The device is intended for home use. The TD-5301 Pregnancy Test (Strip) is an in vitro diagnostic test device for the qualitative determination of human chorionic gonadotropin (hCG) in urine. It is intended for use as an aid in the early detection of pregnancy by lay users. Additional clinical examination should be performed to confirm the pregnancy. This device uses visually read lateral flow technology for the detection of hCG. The device is intended for home use.

Source page: https://510kreport.com/device/K103487
Methodology: https://510kreport.com/methodology