Cleared Traditional

K062460 - VITROS CHEMISTRY PRODUCTS OP REAGENT

K062460 is the FDA 510(k) clearance for VITROS CHEMISTRY PRODUCTS OP REAGENT by Ortho-Clinical Diagnostics, Inc.. It is a Class 2 Chemistry device (product code DJG) cleared through the Traditional 510(k) pathway after a 114-day FDA review.

K062460 · Ortho-Clinical Diagnostics, Inc. · Chemistry device
Download Printable Device Report (PDF)
Optimized for regulatory review, auditing and printing
Dec 2006
Decision
114d
Days
Class 2
Risk

K062460 is an FDA 510(k) clearance for the VITROS CHEMISTRY PRODUCTS OP REAGENT, CALIBRATOR KIT 26 AND DAT PERFORMANCE V.... Classified as Enzyme Immunoassay, Opiates (product code DJG), Class II - Special Controls.

Submitted by Ortho-Clinical Diagnostics, Inc. (Rochester, US). The FDA issued a Cleared decision on December 15, 2006 after a review of 114 days - within the typical 510(k) review window.

This device falls under the Chemistry FDA review panel, regulated under 21 CFR 862.3650 - 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: Standard predicate-based submission. Standard predicate reliance. This clearance follows a standard predicate-based equivalence path within the Chemistry review framework, consistent with the majority of Class II 510(k) submissions.

View all Ortho-Clinical Diagnostics, Inc. devices

Submission Details

510(k) Number K062460 FDA.gov
FDA Decision Cleared Substantially Equivalent - Traditional 510(k) (SESE)
Date Received August 23, 2006
Decision Date December 15, 2006
Days to Decision 114 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
26d slower than avg
Panel avg: 88d · This submission: 114d
Pathway characteristics
Predicate-based equivalence. No clinical trials required.

Device Classification

Product Code DJG Enzyme Immunoassay, Opiates
Device Class Class 2 - Special Controls
CFR Regulation 21 CFR 862.3650
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 - DJG Enzyme Immunoassay, Opiates

All 136
Devices cleared under the same product code (DJG) and FDA review panel - the closest regulatory comparables to K062460.
BUPRENORPHINE ENZYME IMMUNOASSAY WITH NORBUPRENORPHINE CALIBRATORS AND CONTROLS
K090844 · Lin-Zhi International, Inc. · Jul 2009
BUPRENORPHINE ENZYME IMMUNOASSAY, CALIBRATORS AND CONTROLS FOR BECKMAN COULTER SYNCHRON SYSTEMS
K081008 · Lin-Zhi International, Inc. · Dec 2008
MULTI-DRUG OF ABUSE URINE TEST,URINE CUP TEST, AMPHETAMINE URINE TEST(CASSETTE, DIP-STRIP), COCAINE, METHAMPHETAMINE
K063545 · Alfa Scientific Designs, Inc. · May 2007
INSTANT-VIEW BUP/NBUP URINE TEST. INSTANT-VERDICT BUP/NBUP URINE TEST
K060527 · Alfa Scientific Designs, Inc. · Jul 2006
ACON BUP ONE STEP BUPRENORPHINE TEST STRIP AND ACRON BUP ONE STEP BUPRENORPHINE TEST DEVICE
K060466 · ACON Laboratories, Inc. · Apr 2006
IMMUNALYSIS OPIATES ELISA FOR ORAL FLUIDS
K051626 · Immunalysis Corporation · Oct 2005