Cleared Traditional

K123965 - COBAS INTEGRA BILIRUBIN DIRECT GEN.2

K123965 is an FDA 510(k) clearance for COBAS INTEGRA BILIRUBIN DIRECT GEN.2, manufactured by Roche Diagnostics. The device is a Class 2 Chemistry device with product code CIG cleared through the Traditional 510(k) pathway after a 64-day FDA review.

K123965 · Roche Diagnostics · Chemistry device
Download Printable Device Report (PDF)
Optimized for regulatory review, auditing and printing
Feb 2013
Decision
64d
Days
Class 2
Risk

K123965 is an FDA 510(k) clearance for the COBAS INTEGRA BILIRUBIN DIRECT GEN.2. Classified as Diazo Colorimetry, Bilirubin (product code CIG), Class II - Special Controls.

Submitted by Roche Diagnostics (Indianapolis, US). The FDA issued a Cleared decision on February 28, 2013 after a review of 64 days - a notably fast clearance cycle.

This device falls under the Chemistry FDA review panel, regulated under 21 CFR 862.1110 - 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 Roche Diagnostics devices

FDA 510(k) Submission Details - K123965

510(k) Number K123965 FDA.gov
FDA Decision Cleared Substantially Equivalent - Traditional 510(k) (SESE)
Date Received December 26, 2012
Decision Date February 28, 2013
Days to Decision 64 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
24d faster than avg
Panel avg: 88d · This submission: 64d
Pathway characteristics
Predicate-based equivalence. No clinical trials required.

CIG Device Classification - Class 2, Special Controls

Product Code CIG Diazo Colorimetry, Bilirubin
Device Class Class 2 - Special Controls
CFR Regulation 21 CFR 862.1110
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 - CIG Diazo Colorimetry, Bilirubin

All 213
Devices cleared under the same product code (CIG) and FDA review panel - the closest regulatory comparables to K123965.
COBAS C BILIRUBIN TOTAL GEN.3
K131544 · Roche Diagnostics · Jul 2013
S TEST REAGENT CARTRIDGE TOTAL BILIRUBIN
K131217 · Hitachi Chemical Diagnostics, Inc. · Jun 2013
EASYRA TBIL REAGENT, EASYRA DBII REAGENT, EASYRA CK REAGENT
K123802 · Medica Corp. · Mar 2013
ARCHITECT TOTAL BILIRUBIN
K121985 · Abbott Laboratories · Feb 2013
ELITECH CLINICAL SYSTEMS BILIRUBIN TOTAL 4+1, ELITECH CLINICAL SYSTEMS ELICAL 2, ELITECH CLINICAL SYSTMES ELITROL I & II
K110780 · Elitechgroup · Oct 2011
POLY-CHEM 90 TOTAL BILIRUBIN
K111143 · Polymedco, Inc. · Sep 2011