Qualitative Enzyme Immunoassay-Detect (LCX)
by Btc Diagnostics, Inc. 510(k)
Active
510(k) K832905
Overview
The Qualitative Enzyme Immunoassay-Detect (LCX) is a pregnancy test kit designed for the qualitative detection of human chorionic gonadotropin (hCG) in urine. It operates as an enzyme-linked immunosorbent assay (ELISA) to provide a qualitative result indicating the presence or absence of hCG, a hormone associated with pregnancy. This device falls under the category of diagnostic test kits, specifically for over-the-counter use in clinical chemistry applications.
The Qualitative Enzyme Immunoassay-Detect (LCX) is intended for single-use in home or clinical settings, requiring no specialized equipment beyond the provided test components. Supplied as a non-sterile, ready-to-use kit, it adheres to FDA 510(k) clearance (K832905) under the regulation number 862.1155, classified as a Class II device. The product is distributed in various registration numbers and FEI numbers, reflecting its regulatory compliance and distribution channels. Storage conditions are not specified in the provided data.
Regulatory status
| Region | Authorization | Number | Date | Status |
|---|---|---|---|---|
| United States | FDA 510(k)SESE | NumberK832905 | Date3 Feb 1984 | 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- Withdrawn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
- Full name
- Qualitative Enzyme Immunoassay-Detect
- 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
Other devices from Btc Diagnostics, Inc.
Questions
What is the Qualitative Enzyme Immunoassay-Detect (LCX) used for?
The Qualitative Enzyme Immunoassay-Detect (LCX) is designed for the qualitative detection of human chorionic gonadotropin (hCG) in urine. hCG is a hormone produced during pregnancy, so this test provides a result indicating the presence or absence of hCG, which helps determine whether pregnancy may be occurring. It is intended for use in both home and clinical settings.
How is the Qualitative Enzyme Immunoassay-Detect (LCX) supplied and prepared for use?
The Qualitative Enzyme Immunoassay-Detect (LCX) is supplied as a non-sterile, ready-to-use kit. No additional preparation or specialized equipment is required beyond the components included in the kit. Simply follow the instructions provided to perform the test using a urine sample.
Is the Qualitative Enzyme Immunoassay-Detect (LCX) single-use or reusable?
The Qualitative Enzyme Immunoassay-Detect (LCX) is intended for single-use only. Each kit is designed to provide one qualitative result for detecting hCG in a urine sample. Reusing the kit is not recommended, as it may compromise the accuracy and reliability of the test.
What are the regulatory details for the Qualitative Enzyme Immunoassay-Detect (LCX)?
The Qualitative Enzyme Immunoassay-Detect (LCX) holds FDA 510(k) clearance under the classification number 862.1155, categorized as a Class II device. It was reviewed by the Clinical Chemistry (CH) Advisory Committee and granted a decision of Substantially Equivalent (SESE) in 1984. The product is distributed through various registration numbers and FEI numbers, ensuring compliance with regulatory requirements.
Are there any specific storage instructions for the Qualitative Enzyme Immunoassay-Detect (LCX)?
The provided data does not specify any particular storage conditions for the Qualitative Enzyme Immunoassay-Detect (LCX). However, it is generally recommended to store diagnostic test kits in a cool, dry place, away from direct sunlight and extreme temperatures, to maintain their integrity and accuracy until use.