ACON Quik-Check II Home Pregnancy Test Strip
510(k) K033041
Active
Valid until
No expiry
FDA recalls
None foundDocuments
Trust
Unverified
Regulatory status
| Region | Authorization | Number | Date | Status |
|---|---|---|---|---|
| United States | FDA 510(k)SESE | NumberK033041 | Date21 Nov 2003 | StatusActive |
Recalls
No FDA recalls found in the data synced 22 Oct 2026.
Coverage
- Active
- Expiring
- Withdrawn
- Listed
- Not covered
United States — FDA 510(k) Active
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, 20 Sep 2026
The ACON Quik-Check II Home Pregnancy Test Strip is a qualitative urine pregnancy test kit designed for over-the-counter use. It detects elevated levels of human chorionic gonadotropin (hCG) to aid in the determination of pregnancy, functioning as a lateral flow immunoassay strip. The device employs a combination of monoclonal and polyclonal antibodies with a streptavidin-biotin system for hCG detection.
This single-use, non-reusable device is intended for home testing by non-professionals. Supplied as an over-the-counter product, it requires no regulatory sterilization or specialized storage conditions. The test strip is classified under FDA 510(k) clearance (K033041) and falls under product code LCX, adhering to Class II special controls for pregnancy testing. No MRI safety considerations apply, and the device is packaged for individual use.
Other devices from Acon Laboratories, Inc.
Questions
AI-generated answers, 20 Sep 2026
What is the ACON Quik-Check II Home Pregnancy Test Strip used for and who can use it?
The ACON Quik-Check II Home Pregnancy Test Strip is a qualitative urine test designed to detect elevated levels of human chorionic gonadotropin (hCG), helping determine pregnancy status. It is intended for over-the-counter use by non-professionals in a home setting, meaning it is safe and suitable for individuals without clinical training.
Is the ACON Quik-Check II Home Pregnancy Test Strip reusable or single-use?
The ACON Quik-Check II Home Pregnancy Test Strip is explicitly labeled as a single-use, non-reusable device. Each strip is intended for one test only, ensuring accuracy and hygiene for individual use.
What storage conditions are required for the ACON Quik-Check II Home Pregnancy Test Strip?
The device requires no specialized storage conditions beyond standard over-the-counter packaging. It does not need refrigeration or sterile handling, making it convenient for home use without additional preparation.
How is the ACON Quik-Check II Home Pregnancy Test Strip regulated, and what does that mean for buyers?
The ACON Quik-Check II Home Pregnancy Test Strip holds FDA 510(k) clearance (K033041) under product code LCX, classified as a Class II device with special controls for pregnancy testing. This means it has undergone regulatory review to ensure safety and performance for its intended use as an over-the-counter diagnostic tool, but it does not require prescription or clinical oversight.
Does the ACON Quik-Check II Home Pregnancy Test Strip come in multiple sizes or models?
The provided data does not specify varying sizes or models for the ACON Quik-Check II Home Pregnancy Test Strip. It is described as a single product form (a lateral flow immunoassay strip) without additional variants, so buyers can expect a uniform design for all units.