# K013702: Victorch HCG Test Strip

- Pathway: 510(k) (Traditional)
- Applicant: Victorch Meditek, Inc.
- Decided: Dec 27, 2001 after 49 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
No predicates in its family tree.
No later device cites it as a predicate yet.
0 of 1 device in its family (counting itself) have a Class I recall.

## Predicates on the family tree (from the FDA summary)
- None. The FDA summary names its predicate without a number.
- (no number) ABI's SureStrip™ hCG pregnancy rapid test devices: named in the summary without a submission number

## Indications for use
The VicTorch Meditek Human Chorionic Gonadotropin (hCG) Urinary Pregnancy Test Strip device (also known as: VicTorch hCG Test Strip) is designed as a rapid in vitro diagnostic (IVD) qualitative lateral flow color-conjugated immuno-chromatographic (CCl) assay for the early detection of pregnancy, providing a quick direct visual test for the placental hormone, hCG, at the required cut-off level of 20 mIU hCG/ml of human urine. VicTorch hCG Test Strip devices are intended to meet all requirements for yielding rapid, easily read, qualitative results for the purpose of early pregnancy detection via CCl assay of hCG, a placental hormone that may be present in human plasma or urine, according to the requirements set forth in Title 21, section 862.1155 of the Code of Federal Regulation or CFR, and in subsequent federal Guidance Documents. VicTorch hCG Test Strip devices are not intended for quantitative results, nor for over the counter (OTC) sales. VicTorch hCG Test Strip devices are designed for professional use only, and provide only preliminary analytical data. For a final diagnosis of pregnancy, a more specific alternative clinical method must be used to obtain a confirmed analytical resuit.

Source page: https://510kreport.com/device/K013702
Methodology: https://510kreport.com/methodology