Cleared Traditional

K945207 - MECTEST

K945207 is an FDA 510(k) clearance for MECTEST, manufactured by Meco Industries. The device is a Class 2 Toxicology device with product code DIO cleared through the Traditional 510(k) pathway after a 335-day FDA review.

K945207 · Meco Industries · Toxicology device
Download Printable Device Report (PDF)
Optimized for regulatory review, auditing and printing
Sep 1995
Decision
335d
Days
Class 2
Risk

K945207 is an FDA 510(k) clearance for the MECTEST. Classified as Enzyme Immunoassay, Cocaine And Cocaine Metabolites (product code DIO), Class II - Special Controls.

Submitted by Meco Industries (Walnut, US). The FDA issued a Cleared decision on September 25, 1995 after a review of 335 days - an unusually long review period, suggesting complex equivalence evaluation.

This device falls under the Toxicology FDA review panel, regulated under 21 CFR 862.3250 - the FDA toxicology device framework. The Traditional 510(k) pathway establishes clearance through substantial equivalence to a legally marketed predicate device, without requiring clinical trial data.

Device pattern: Standard predicate-based submission. Elevated predicate reliance profile. This clearance follows a standard predicate-based equivalence path within the Toxicology review framework, consistent with the majority of Class II 510(k) submissions.

View all Meco Industries devices

FDA 510(k) Submission Details - K945207

510(k) Number K945207 FDA.gov
FDA Decision Cleared Substantially Equivalent - Traditional 510(k) (SESE)
Date Received October 25, 1994
Decision Date September 25, 1995
Days to Decision 335 days
Submission Type Traditional
Review Panel Toxicology (TX)
Summary Statement
Third-party Review No - reviewed directly by FDA
Regulatory Context
Review time vs. panel average
248d slower than avg
Panel avg: 87d · This submission: 335d
Pathway characteristics
Predicate-based equivalence. No clinical trials required.

DIO Device Classification - Class 2, Special Controls

Product Code DIO Enzyme Immunoassay, Cocaine And Cocaine Metabolites
Device Class Class 2 - Special Controls
CFR Regulation 21 CFR 862.3250
What this classification means

Class II devices require demonstration of substantial equivalence to a legally marketed predicate device. This pathway does not require clinical trials - it relies on engineering equivalence and performance data. Most Toxicology devices follow this clearance model.

Regulatory Peers - DIO Enzyme Immunoassay, Cocaine And Cocaine Metabolites

All 117
Devices cleared under the same product code (DIO) and FDA review panel - the closest regulatory comparables to K945207.
ABUSIGN DOA 3, DOA, COC/THC/OPI, ACCUSIGN DOA 3, BIOSIGN DOA 3, COC/THC/OOPI
K954571 · Princeton BioMeditech Corp. · Nov 1995
ABUSIGN(TM) DOA 4, DOA, THC/OPI/COC/AMP OR MET, BIOSIGN(TM) DOA 4, THC/OPI/COC/AMP OR MET
K945549 · Princeton BioMeditech Corp. · Oct 1995
ABUSIGN DOA 2, DOA, COC/THC, DOA2, BIOSIGN DOA2, COC/THC
K952361 · Princeton BioMeditech Corp. · Oct 1995
AXSYM COCAINE METABOLITE
K951289 · Abbott Laboratories · Aug 1995
VISUALINE II COCAINE
K950369 · Sun Biomedical Laboratories, Inc. · Mar 1995
EMIT IIC COCAINE METABOLITE ASSAY
K935323 · Syva Co. · Feb 1995