Victorch HCG Test Strip
by Victorch Meditek, Inc. 510(k)
Active
510(k) K013702
Overview
The Victorch HCG Test Strip is a visual, pregnancy HCG test strip device intended for prescription use. It is a rapid in vitro diagnostic qualitative lateral flow color-conjugated immuno-chromatographic assay for the early detection of pregnancy.
The device provides only preliminary analytical data and is not intended for quantitative results or over-the-counter sales. It is supplied for professional use only and requires a more specific alternative clinical method to confirm results. The device has received FDA 510(k) clearance under K013702 and is classified as a Class II medical device.
Regulatory status
| Region | Authorization | Number | Date | Status |
|---|---|---|---|---|
| United States | FDA 510(k)SESE | NumberK013702 | Date27 Dec 2001 | StatusActive |
Coverage
- Active
- Expiring
- Withdrawn
- Listed
- Not known
- Not covered
United States — FDA 510(k) Active
Recalls
No FDA recalls on record, checked 22 Oct 2026.
Specification
- 510(k) Number
- FDA Product Code
- JHI
- Device Class
- Class II
- Regulation
- 21 CFR Part 862.1155
- Advisory Committee
- Clinical Chemistry
- FDA Decision
- SESE Substantially Equivalent
Other devices from Victorch Meditek, Inc.
Questions
What is the Victorch HCG Test Strip used for?
The Victorch HCG Test Strip is intended for the early detection of pregnancy through qualitative detection of human chorionic gonadotropin (hCG) in urine. It provides preliminary analytical results and is not meant for quantitative measurement or as a standalone diagnostic tool.
Is the Victorch HCG Test Strip available for over-the-counter use?
No, the Victorch HCG Test Strip is supplied for professional use only and is not intended for over-the-counter sales. It requires prescription use and should be administered by trained healthcare personnel in a clinical setting.
What type of test is the Victorch HCG Test Strip and how does it work?
It is a rapid in vitro diagnostic qualitative lateral flow color-conjugated immuno-chromatographic assay. The test visually detects hCG in urine through capillary action and color development on a strip, indicating pregnancy status based on the presence of the hormone.
Does the Victorch HCG Test Strip provide quantitative results?
No, the device provides only preliminary qualitative data and is not intended for quantitative results. A more specific clinical method is required to confirm any preliminary findings obtained from the test strip.
What regulatory clearance does the Victorch HCG Test Strip have?
The Victorch HCG Test Strip has received FDA 510(k) clearance under submission number K013702 and is classified as a Class II medical device. It was found substantially equivalent to a legally marketed predicate device.