PTK Healthcheck Pregnancy Test Kit
by Healthcheck Corp. 510(k)
Active
510(k) K844281
Regulatory status
| Region | Authorization | Number | Date | Status |
|---|---|---|---|---|
| United States | FDA 510(k)SESE | NumberK844281 | Date10 Dec 1984 | StatusActive |
Coverage
- Active
- Expiring
- Withdrawn
- Listed
- 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
- LCX
- Device Class
- Class II
- Regulation
- 21 CFR Part 862.1155
- Advisory Committee
- Clinical Chemistry
- FDA Decision
- SESE Substantially Equivalent
Overview
AI-generated summary, 22 Sep 2026
The PTK Healthcheck Pregnancy Test Kit is a kit, test, pregnancy, hcg, over the counter device used for detecting human chorionic gonadotropin (hCG) in urine to determine pregnancy status. It is classified under the Clinical Chemistry medical specialty and has been determined to be substantially equivalent to a legally marketed predicate device.
The device is supplied as an over-the-counter test kit and is intended for use in non-clinical settings such as home use. It received FDA 510(k) clearance under regulation number 862.1155 with product code LCX and decision date December 10, 1984. The device is classified as Class II and is not sterile, single-use, or reusable based on the provided data; no MRI safety information is specified.
Other devices from Healthcheck Corp.
Questions
AI-generated answers, 22 Sep 2026
What is the PTK Healthcheck Pregnancy Test Kit used for?
The PTK Healthcheck Pregnancy Test Kit is used to detect human chorionic gonadotropin (hCG) in urine to determine pregnancy status. It is intended for over-the-counter use in non-clinical settings such as home use, allowing individuals to test for pregnancy privately and conveniently.
Is the PTK Healthcheck Pregnancy Test Kit sterile or reusable?
The device is not sterile, single-use, or reusable based on the provided data. As an over-the-counter pregnancy test kit, it is designed for one-time use and does not require sterilization, as it is intended for disposal after each test to prevent cross-contamination and ensure accurate results.
How is the PTK Healthcheck Pregnancy Test Kit supplied and regulated?
The device is supplied as an over-the-counter test kit for home use and received FDA 510(k) clearance under regulation number 862.1155 with product code LCX on December 10, 1984. It is classified as Class II and was determined to be substantially equivalent to a legally marketed predicate device, meaning it met safety and effectiveness requirements through this regulatory pathway.