Cleared Traditional

K141928 - COBAS C ACETAMINOPHEN GEN.2 ASSAY

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

K141928 · Roche Diagnostics Operations (Rdo) · Chemistry device
Download Printable Device Report (PDF)
Optimized for regulatory review, auditing and printing
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

Submission Details

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
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.

Device Classification

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 70
Devices cleared under the same product code (DKB) and FDA review panel - the closest regulatory comparables to K141928.
RANDOX METHAMPHETAMINE ASSAY
K092266 · Randox Laboratories, Ltd. · May 2011
THERMO SCIENTIFIC CEDIA MULTI-DRUG OFT CALIBRATORS
K101752 · Microgenics Corp. · Apr 2011
ROCHE C.F.A.S. DAT QUALITATIVE PLUS CLINICAL CALIBRATOR AND CONTROL SET DAT CLINICAL, MODELS 04590856 190, 04500873 190
K090939 · Roche Diagnostics · Jun 2009
ADVIA CHEMISTRY DRUG CALIBRATOR II, MODEL 10376771
K090900 · Siemens Healthcare Diagnostics · Jun 2009
DIMENSION VISTA SYSTEM DRUGS OF ABUSE CALIBRATOR (UDAT CAL - KC510)
K062162 · Dade Behring, Inc. · Sep 2006
DIMENSION VISTA SYSTEM DRUG 2 CALIBRATOR (DRUG 2 CAL - KC420)
K062121 · Dade Behring, Inc. · Aug 2006