Mectest
510(k) K973986
Active
Valid until
No expiry
FDA recalls
None foundDocuments
Trust
Unverified
Regulatory status
| Region | Authorization | Number | Date | Status |
|---|---|---|---|---|
| United States | FDA 510(k)SESE | NumberK973986 | Date24 Apr 1998 | 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- Withdrawn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
- DIO
- Device Class
- Class II
- Regulation
- 21 CFR Part 862.3250
- Advisory Committee
- Clinical Toxicology
- FDA Decision
- SESE Substantially Equivalent
Overview
AI-generated summary, 1 Oct 2026
The Mectest Enzyme Immunoassay Kit is a diagnostic device classified as an enzyme immunoassay for detecting cocaine and its metabolites in meconium samples. It employs immunoassay technology to provide semiquantitative results, enabling clinical toxicology assessments for substance exposure during prenatal development. This device is specifically designed to identify cocaine and related compounds, supporting forensic and medical evaluations in toxicology.
The kit is intended for use in clinical toxicology laboratories and is supplied as a single-use, non-sterile reagent kit. It requires processing in a controlled laboratory environment and is not intended for MRI use. The device is authorized under FDA 510(k) clearance (K945207) and falls under product code DIO, adhering to regulatory standards for enzyme immunoassays. Storage and handling must comply with manufacturer guidelines to ensure accurate and reliable test results.
Other devices from Meco Industries
Questions
AI-generated answers, 1 Oct 2026
What is the Mectest Enzyme Immunoassay Kit used for?
The Mectest Enzyme Immunoassay Kit is designed specifically for detecting cocaine and its metabolites in meconium samples. Meconium is the first stool passed by a newborn, and its analysis helps assess prenatal exposure to substances like cocaine. This kit supports clinical toxicology evaluations, aiding forensic and medical assessments to determine potential substance exposure during fetal development.
How is the Mectest Enzyme Immunoassay Kit supplied and intended for use?
The Mectest kit is supplied as a single-use, non-sterile reagent kit. It is intended exclusively for use in controlled clinical toxicology laboratories. The kit employs immunoassay technology to provide semiquantitative results, requiring proper laboratory processing and handling to ensure accurate and reliable outcomes. It is not intended for use outside of a laboratory setting, such as in-home or point-of-care testing.
Is the Mectest Enzyme Immunoassay Kit sterile?
No, the Mectest Enzyme Immunoassay Kit is explicitly labeled as non-sterile. Since it is designed for use in clinical toxicology laboratories, proper handling and processing protocols must be followed to prevent contamination and ensure accurate test results. Sterility is not required for this type of diagnostic reagent kit.
Can the Mectest kit be reused?
The Mectest Enzyme Immunoassay Kit is intended for single-use only. Reusing the kit could compromise the integrity of the test results due to potential contamination or degradation of reagents. Laboratories must adhere to the manufacturer’s guidelines for proper disposal and replacement of the kit after each use to maintain accuracy and reliability.
What regulatory approval does the Mectest Enzyme Immunoassay Kit hold?
The Mectest Enzyme Immunoassay Kit holds FDA 510(k) clearance under the reference number K973986. This clearance indicates that the device has been determined to be substantially equivalent to a legally marketed predicate device and adheres to regulatory standards for enzyme immunoassays. The kit falls under product code DIO, which categorizes it within the regulatory framework for diagnostic immunoassay devices.