Cleared Abbreviated

ABBOTT TDM MULTICONSTITUENT CALIBRATOR, THERMO SCIENTIFIC QMS MULTI-CONSTITUENT CALIBRATORS (K120936) - FDA 510(k) Clearance

Class II Toxicology device cleared through the Abbreviated 510(k) pathway - typically does not require clinical trials.

K120936 · Microgenics Corporation · Toxicology device
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Dec 2012
Decision
260d
Days
Class 2
Risk

K120936 is an FDA 510(k) clearance for the ABBOTT TDM MULTICONSTITUENT CALIBRATOR, THERMO SCIENTIFIC QMS MULTI-CONSTITUE.... Classified as Calibrators, Drug Mixture (product code DKB), Class II - Special Controls.

Submitted by Microgenics Corporation (Fremont Blvd., US). The FDA issued a Cleared decision on December 13, 2012 after a review of 260 days - an extended review cycle.

This device falls under the Toxicology FDA review panel, regulated under 21 CFR 862.3200 - the FDA toxicology device framework. The Abbreviated 510(k) pathway was used, relying on FDA-recognized standards to demonstrate substantial equivalence.

Device pattern: Standards-based predicate clearance. Standards-verified equivalence. The Abbreviated pathway signals strong alignment with FDA-recognized performance standards - typically associated with lower review burden and faster clearance cycles.

View all Microgenics Corporation devices

Submission Details

510(k) Number K120936 FDA.gov
FDA Decision Cleared Substantially Equivalent - Traditional 510(k) (SESE)
Date Received March 28, 2012
Decision Date December 13, 2012
Days to Decision 260 days
Submission Type Abbreviated
Review Panel Toxicology (TX)
Summary Summary PDF
Third-party Review No - reviewed directly by FDA
Regulatory Context
Review time vs. panel average
173d slower than avg
Panel avg: 87d · This submission: 260d
Pathway characteristics
Standards-based clearance path.

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 Toxicology devices follow this clearance model.

Regulatory Peers - DKB Calibrators, Drug Mixture

All 58
Devices cleared under the same product code (DKB) and FDA review panel - the closest regulatory comparables to K120936.
RANDOX METHAMPHETAMINE ASSAY
K092266 · Randox Laboratories, Ltd. · May 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
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
PRECISET DAT PLUS I, PRECISET DAT PLUS II AND CFAS DAT QUALITATIVE PLUS CALIBRATORS
K060645 · Roche Diagnostics Corp. · May 2006
PRECISET DAT PLUS II AND CFAS DAT QUALITATIVE PLUS CALIBRATORS
K033306 · Roche Diagnostics Corp. · Dec 2003