Cleared Special

K162395 - MP DOA-10 Panel Test Cup, MP DOA-11 Panel Test Cup

K162395 is an FDA 510(k) clearance for MP DOA-10 Panel Test Cup, manufactured by Mp Biomedicals, LLC. The device is a Class 2 Toxicology device with product code DIO cleared through the Special 510(k) pathway after a 280-day FDA review.

K162395 · Mp Biomedicals, LLC · Toxicology device
Download Printable Device Report (PDF) Official FDA 510(k) Summary (PDF)
Optimized for regulatory review, auditing and printing
Jun 2017
Decision
280d
Days
Class 2
Risk

K162395 is an FDA 510(k) clearance for the MP DOA-10 Panel Test Cup, MP DOA-11 Panel Test Cup. Classified as Enzyme Immunoassay, Cocaine And Cocaine Metabolites (product code DIO), Class II - Special Controls.

Submitted by Mp Biomedicals, LLC (Burlingame, US). The FDA issued a Cleared decision on June 2, 2017 after a review of 280 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. As a Special 510(k), this submission covers a manufacturer modification to an existing cleared device rather than a new device introduction.

Device pattern: Iterative device modification. Standard predicate reliance. This Special 510(k) clearance confirms that the manufacturer's modifications remained within the established regulatory envelope of the original cleared device.

FDA 510(k) Submission Details - K162395

510(k) Number K162395 FDA.gov
FDA Decision Cleared Substantially Equivalent - Traditional 510(k) (SESE)
Date Received August 26, 2016
Decision Date June 02, 2017
Days to Decision 280 days
Submission Type Special
Review Panel Toxicology (TX)
Summary Summary PDF
Third-party Review No - reviewed directly by FDA
Regulatory Context
Review time vs. panel average
193d slower than avg
Panel avg: 87d · This submission: 280d
Pathway characteristics
Modification to existing cleared device.

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 144
Devices cleared under the same product code (DIO) and FDA review panel - the closest regulatory comparables to K162395.
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
Quest Diagnostics HairCheck-DT (Cocaine)
K152232 · Quest Diagnostics Incorporated · Nov 2016
Wondfo Amphetamine Urine Test AMP 500 (Cup, Dipcard), Wondfo Cocaine Urine Test COC 150(Cup, Dipcard), Wondfo Methamphetamine Urine Test MET 500 (Cup, Dipcard)
K161214 · Guangzhou Wondfo Biotech Co., Ltd. · Jun 2016
SAFECARE Urine Test Amphetamine, SAFECARE Urine Test Cocaine, SAFECARE Urine Test Marijuana
K153646 · Safecare Biotech (Hangzhou) Co., Ltd. · Mar 2016
K162395 · MP DOA-10 Panel Test Cup, MP DOA-11 Panel Test Cup
Download PDF FDA Summary Mp Biomedicals, LLC