Cleared Traditional

K191638 - Pointe Scientific Cocaine Metabolite Enzyme Immunoassay

K191638 is an FDA 510(k) clearance for Pointe Scientific Cocaine Metabolite En..., manufactured by Medtest DX. The device is a Class 2 Toxicology device with product code DIO cleared through the Traditional 510(k) pathway after a 267-day FDA review.

K191638 · Medtest DX · Toxicology device
Download Printable Device Report (PDF)
Optimized for regulatory review, auditing and printing
Mar 2020
Decision
267d
Days
Class 2
Risk

K191638 is an FDA 510(k) clearance for the Pointe Scientific Cocaine Metabolite Enzyme Immunoassay. Classified as Enzyme Immunoassay, Cocaine And Cocaine Metabolites (product code DIO), Class II - Special Controls.

Submitted by Medtest DX (Lincoln Park, US). The FDA issued a Cleared decision on March 12, 2020 after a review of 267 days - an extended review cycle.

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

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FDA 510(k) Submission Details - K191638

510(k) Number K191638 FDA.gov
FDA Decision Cleared Substantially Equivalent - Traditional 510(k) (SESE)
Date Received June 19, 2019
Decision Date March 12, 2020
Days to Decision 267 days
Submission Type Traditional
Review Panel Toxicology (TX)
Summary Summary PDF
Third-party Review No - reviewed directly by FDA
Combination Product No
PCCP Authorized No
Regulatory Context
Review time vs. panel average
180d slower than avg
Panel avg: 87d · This submission: 267d
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 116
Devices cleared under the same product code (DIO) and FDA review panel - the closest regulatory comparables to K191638.
Carolina Liquid Chemistries Cocaine and Cocaine Metabolite Enzyme Immunoassay (COCM) Test System
K213211 · Carolina Liquid Chemistries Corp. · Jan 2022
DRI Cocaine Metabolite Assay
K211973 · Microgenics Corporation · Sep 2021
DRI Cocaine Metabolite Assay
K181499 · Microgenics Corporation · Jul 2018
Emit II Plus Cocaine Metabolite Assay
K170293 · Siemens Healthcare Diagnostics, Inc. · Oct 2017
Carolina Liquid Chemistries Cocaine and Cocaine Metabolite Test System (COCM)
K163570 · Carolina Liquid Chemistries Corporation · Aug 2017
MP DOA-10 Panel Test Cup, MP DOA-11 Panel Test Cup
K162395 · Mp Biomedicals, LLC · Jun 2017