Cleared Traditional

K141928 - COBAS C ACETAMINOPHEN GEN.2 ASSAY, ACET2 CALIBRATOR

K141928 is an FDA 510(k) clearance for COBAS C ACETAMINOPHEN GEN.2 ASSAY, manufactured by Roche Diagnostics Operations (Rdo). The device is a Class 2 Chemistry device with product code DKB cleared through the Traditional 510(k) pathway after a 132-day FDA review.

K141928 · Roche Diagnostics Operations (Rdo) · Chemistry device
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Nov 2014
Decision
132d
Days
Class 2
Risk

K141928 is an FDA 510(k) clearance for the COBAS C ACETAMINOPHEN GEN.2 ASSAY, ACET2 CALIBRATOR. Classified as Calibrators, Drug Mixture (product code DKB), Class II - Special Controls.

Submitted by Roche Diagnostics Operations (Rdo) (Indianapolis, US). The FDA issued a Cleared decision on November 25, 2014 after a review of 132 days - within the typical 510(k) review window.

This device falls under the Chemistry FDA review panel, regulated under 21 CFR 862.3200 - 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 Roche Diagnostics Operations (Rdo) devices

FDA 510(k) Submission Details - K141928

510(k) Number K141928 FDA.gov
FDA Decision Cleared Substantially Equivalent - Traditional 510(k) (SESE)
Date Received July 16, 2014
Decision Date November 25, 2014
Days to Decision 132 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
44d slower than avg
Panel avg: 88d · This submission: 132d
Pathway characteristics
Predicate-based equivalence. No clinical trials required.

DKB Device Classification - Class 2, Special Controls

Product Code DKB Calibrators, Drug Mixture
Device Class Class 2 - Special Controls
CFR Regulation 21 CFR 862.3200
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 - DKB Calibrators, Drug Mixture

All 87
Devices cleared under the same product code (DKB) and FDA review panel - the closest regulatory comparables to K141928.
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