Cleared Traditional

K101752 - THERMO SCIENTIFIC CEDIA MULTI-DRUG OFT ...

K101752 is the FDA 510(k) clearance for THERMO SCIENTIFIC CEDIA MULTI-DRUG OFT ... by Microgenics Corp.. It is a Class 2 Chemistry device (product code DKB) cleared through the Traditional 510(k) pathway after a 290-day FDA review.

K101752 · Microgenics Corp. · Chemistry device
Download Printable Device Report (PDF)
Optimized for regulatory review, auditing and printing
Apr 2011
Decision
290d
Days
Class 2
Risk

K101752 is an FDA 510(k) clearance for the THERMO SCIENTIFIC CEDIA MULTI-DRUG OFT CALIBRATORS. Classified as Calibrators, Drug Mixture (product code DKB), Class II - Special Controls.

Submitted by Microgenics Corp. (Fremont Blvd., US). The FDA issued a Cleared decision on April 8, 2011 after a review of 290 days - an extended review cycle.

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 Microgenics Corp. devices

Submission Details

510(k) Number K101752 FDA.gov
FDA Decision Cleared Substantially Equivalent - Traditional 510(k) (SESE)
Date Received June 22, 2010
Decision Date April 08, 2011
Days to Decision 290 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
202d slower than avg
Panel avg: 88d · This submission: 290d
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 77
Devices cleared under the same product code (DKB) and FDA review panel - the closest regulatory comparables to K101752.
LZI MULTIPLE ANALYTE SET A
K133710 · Lin-Zhi International, Inc. · Feb 2014
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
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