# K081150: Rapidan Optima Early Pregnancy Test and Toyo Pregnancy Test

- Pathway: 510(k) (Traditional)
- Applicant: Turklab Medical Devices, Inc.
- Decided: Jun 16, 2009 after 419 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: 4 generations back to K941090 (1994). 8 ancestors in all.
No later device cites it as a predicate yet.
0 of 9 devices in its family (counting itself) have a Class I recall.

## Predicates on the family tree (from the FDA summary)
- K043443: One Step HCG Urine Pregnancy Test, Guangzhou Wondfo Biotech Co., Ltd. (2005) Summary page 1.

## Indications for use
Rapidan Optima Early One Step hCG Urine Pregnancy Test is an in-vitro diagnostic test for qualitative determination of human chorionic gonadotrophin (hCG) in human urine. It is intended for over the counter use to detect elevated (over the cut-off value of 20 IU/L) levels of human chorionic gonadotrophin (hCG) in human urine to aid in the detection of pregnancy. Toyo One Step hCG Urine Pregnancy Test is an in-vitro diagnostic test for qualitative determination of human chorionic gonadotrophin (hCG) in human urine. It is intended for over the counter use and for professional / laboratory use to detect elevated (over the cut-off value of 25 IU/L) levels of human chorionic gonadotrophin (hCG) in human urine to aid in the detection of pregnancy. Toyo Pregnancy Test has two formats, a cassette and a test strip format.

Source page: https://510kreport.com/device/K081150
Methodology: https://510kreport.com/methodology