# K973986: Mectest

- Pathway: 510(k) (Traditional)
- Applicant: Meco Industries
- Decided: Apr 24, 1998 after 186 days
- Product code: DIO (Enzyme Immunoassay, Cocaine And Cocaine Metabolites)
- Device class: 2
- Regulation: 21 CFR 862.3250
- Recalls of this device: none
- Data: FDA decisions to Oct 25, 2026; recalls to Oct 12, 2026

## Lineage
No predicates in its family tree.
No later device cites it as a predicate yet.
0 of 1 device in its family (counting itself) have a Class I recall.

## Predicates on the family tree (from the FDA summary)
- None. FDA’s file for it is a 510(k) statement, which names no predicate.

## Indications for use
MECTEST is a kit for the processing and semiquantitative analysis of meconium for cocaine, opiate and cannabinoid by radioimmunoassay and for the processing and semiquantitative analysis of cocaine and opiate by enzyme immunoassay (EMIT) and by fluorescence polarization (FPIA). MECTEST is for hospital and laboratory use only. MECTEST is an in vitro diagnostic device intended to prospectively screen and identify newborn infants exposed to drugs (cocaine, opiate and cannabinoid) in utero. Meconium drug testing via MECTEST is an idea and important diagnostic tool for clinical and research applications. MECTEST offers a positive alternmative to urine analysis because (1) it is highly sensitive and specific, (2) the test can be performed using commong laboratory techniques for purposes of mass screening with capabilities of GC/MS confirmation, (3) collection of meconium is easy and non invasive, (4) analysis of serial meconium can reflect the type, chronology and amount of in utero drug exposure of the infant, and, (5) drugs in meconium are present up to the third day after birth; thus late testing of the infant for drugs is possible.

Source page: https://510kreport.com/device/K973986
Methodology: https://510kreport.com/methodology