Cleared Traditional

K062637 - VITROS CHEMISTRY PRODUCTS METD REAGENT

K062637 is the FDA 510(k) clearance for VITROS CHEMISTRY PRODUCTS METD REAGENT by Ortho-Clinical Diagnostics, Inc.. It is a Class 2 Chemistry device (product code DJR) cleared through the Traditional 510(k) pathway after a 78-day FDA review.

K062637 · Ortho-Clinical Diagnostics, Inc. · Chemistry device
Download Printable Device Report (PDF)
Optimized for regulatory review, auditing and printing
Nov 2006
Decision
78d
Days
Class 2
Risk

K062637 is an FDA 510(k) clearance for the VITROS CHEMISTRY PRODUCTS METD REAGENT, CALIBRATOR KIT 26, DAT PERFORMANCE, V.... Classified as Enzyme Immunoassay, Methadone (product code DJR), Class II - Special Controls.

Submitted by Ortho-Clinical Diagnostics, Inc. (Rochester, US). The FDA issued a Cleared decision on November 22, 2006 after a review of 78 days - a notably fast clearance cycle.

This device falls under the Chemistry FDA review panel, regulated under 21 CFR 862.3620 - the FDA in vitro diagnostics and chemistry framework. The Traditional 510(k) pathway establishes clearance through substantial equivalence to a legally marketed predicate device, without requiring clinical trial data.

Device pattern: Fast-track predicate clearance. Standard predicate reliance. The short review cycle indicates strong predicate alignment - the FDA found sufficient equivalence without extended technical review.

View all Ortho-Clinical Diagnostics, Inc. devices

Submission Details

510(k) Number K062637 FDA.gov
FDA Decision Cleared Substantially Equivalent - Traditional 510(k) (SESE)
Date Received September 05, 2006
Decision Date November 22, 2006
Days to Decision 78 days
Submission Type Traditional
Review Panel Chemistry (CH)
Summary Summary PDF
Third-party Review No - reviewed directly by FDA
Combination Product No
PCCP Authorized No
Regulatory Context
Review time vs. panel average
10d faster than avg
Panel avg: 88d · This submission: 78d
Pathway characteristics
Predicate-based equivalence. No clinical trials required.

Device Classification

Product Code DJR Enzyme Immunoassay, Methadone
Device Class Class 2 - Special Controls
CFR Regulation 21 CFR 862.3620
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 Chemistry devices follow this clearance model.

Regulatory Peers - DJR Enzyme Immunoassay, Methadone

All 47
Devices cleared under the same product code (DJR) and FDA review panel - the closest regulatory comparables to K062637.
RANDOX METABOLITE (EDDP) ASSAY
K092258 · Randox Laboratories, Ltd. · Nov 2010
ONE STEP EDDP (METHADONE METABOLITE) TEST STRIP
K092048 · Biosite Incorporated · Apr 2010
DRI METHADONE METABOLITE (100/300) ASSAY, CALIBRATORS AND CONTROLS
K081378 · Thermo Fisher Scientific · Jan 2009
TRIAGE TOX DRUG SCREEN, MODEL 94400
K060791 · Biosite Incorporated · Jun 2006
METHADONE ORAL FLUID HOMOGENEOUS ENZYME IMMUNOASSAY, CALIBRATORS AND CONTROLS
K051058 · Lin-Zhi International, Inc. · Mar 2006
RANDOX METHADONE ASSAY
K040570 · Randox Laboratories, Ltd. · May 2004