510(k) · Cleared
ClearedMectest
Data to Oct 25, 2026 (FDA decisions) Oct 12, 2026 (recalls) Sep 30, 2026 (MAUDE) refreshed weekly
Meco Industries · DIO Enzyme Immunoassay, Cocaine And Cocaine Metabolites
Cleared on Apr 24, 1998 after a 186-day review. FDA’s file for it is a 510(k) statement, which names no predicate.
- Decided
- Apr 24, 1998
- Review
- 186 days
- Class
- Class II
- Product code
- DIO
- Recalls
- None
- Predicates
- 0
FDA’s file for it is a 510(k) statement, which names no predicate.
Sources: FDA 510(k) database (decision fields), the FDA 510(k) statement (indications), FDA recall and enforcement reports, and MAUDE; processed by 510(k) Report. Verify on FDA.gov · Methodology and accuracy.
Planning a device in DIO? A 510(k) Report weighs predicate choices, recall history and review times for a new device like this one.
Top candidate predicates for a new DIO device
- #1 K213211 Carolina Liquid Chemistries Cocaine and…score 3.0 · 2 generations · no Class I recall
- #2 Held for the reportin the report
- #3 Held for the reportin the report
What was it cleared against?
FDA’s file for it is a 510(k) statement, which names no predicate.
What descends from it?
No later submission names this one as a predicate yet.
Has anything in its family been recalled? (0 Class I)
No FDA recall names this device.
No ancestor or descendant has a Class I recall.
How does its category compare?
All DIO devicesDIO Enzyme Immunoassay, Cocaine And Cocaine Metabolites: FDA decisions, review times, recalls and adverse event reports over 20 years.
FDA decisions per year · DIO
1in 2022
2026 to Oct 25, outlined.
Median 510(k) review, days · DIO
267in 2017
Receipt to decision; years with fewer than 3 clearances left blank.
Recalls per year · DIO
1in 2013
Class I (0 since 2007) Class II/III not classified
Adverse event reports per year · DIO
1in 2023
MAUDE reports naming product code DIO, not matched to any one device; reports are not rates.
View these four charts as a table
| Year | Decisions | Median 510(k) review, days | Recalls (Class I) | MAUDE reports |
|---|---|---|---|---|
| 2007 | 0 | — | 0 | 0 |
| 2008 | 0 | — | 0 | 0 |
| 2009 | 1 | — | 0 | 0 |
| 2010 | 0 | — | 0 | 0 |
| 2011 | 5 | 65 | 0 | 4 |
| 2012 | 5 | 139 | 0 | 0 |
| 2013 | 2 | — | 1 | 0 |
| 2014 | 2 | — | 0 | 1 |
| 2015 | 2 | — | 0 | 7 |
| 2016 | 3 | 88 | 0 | 9 |
| 2017 | 3 | 267 | 0 | 16 |
| 2018 | 1 | — | 0 | 12 |
| 2019 | 0 | — | 0 | 22 |
| 2020 | 1 | — | 0 | 0 |
| 2021 | 1 | — | 0 | 0 |
| 2022 | 1 | — | 0 | 1 |
| 2023 | 0 | — | 0 | 1 |
| 2024 | 0 | — | 0 | 0 |
| 2025 | 0 | — | 0 | 0 |
| 2026 | 0 | — | 0 | — |
What is it indicated for?
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…
Read the full statement (177 words)
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.
Indications for use read by OCR from a scanned FDA 510(k) statement, so letters may be misread. Check the PDF before quoting it.
https://510kreport.com/device/K973986 · printed Nov 6, 2026
Cite this page
510(k) Report. “K973986: Mectest.” Lineage record from FDA 510(k) data and the FDA summary. Updated Nov 3, 2026. Accessed Nov 6, 2026. https://510kreport.com/device/K973986
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Record history
- FDA decision record loaded May 2, 2026
- Summary read Oct 13, 2026 (extraction version 9eaa42aa01ed)
- Page last updated Nov 3, 2026