Cleared Traditional

K061683 - TINA-QUANT MYOGLOBIN GEN.2 TEST SYSTEM

K061683 is the FDA 510(k) clearance for TINA-QUANT MYOGLOBIN GEN.2 TEST SYSTEM by Roche Diagnostics Corp.. It is a Class 2 Chemistry device (product code DDR) cleared through the Traditional 510(k) pathway after a 36-day FDA review.

K061683 · Roche Diagnostics Corp. · Chemistry device
Download Printable Device Report (PDF)
Optimized for regulatory review, auditing and printing
Jul 2006
Decision
36d
Days
Class 2
Risk

K061683 is an FDA 510(k) clearance for the TINA-QUANT MYOGLOBIN GEN.2 TEST SYSTEM. Classified as Myoglobin, Antigen, Antiserum, Control (product code DDR), Class II - Special Controls.

Submitted by Roche Diagnostics Corp. (Indianapolis, US). The FDA issued a Cleared decision on July 21, 2006 after a review of 36 days - a notably fast clearance cycle.

This device falls under the Chemistry FDA review panel, regulated under 21 CFR 866.5680 - 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 Corp. devices

Submission Details

510(k) Number K061683 FDA.gov
FDA Decision Cleared Substantially Equivalent - Traditional 510(k) (SESE)
Date Received June 15, 2006
Decision Date July 21, 2006
Days to Decision 36 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
52d faster than avg
Panel avg: 88d · This submission: 36d
Pathway characteristics
Predicate-based equivalence. No clinical trials required.

Device Classification

Product Code DDR Myoglobin, Antigen, Antiserum, Control
Device Class Class 2 - Special Controls
CFR Regulation 21 CFR 866.5680
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 - DDR Myoglobin, Antigen, Antiserum, Control

All 27
Devices cleared under the same product code (DDR) and FDA review panel - the closest regulatory comparables to K061683.
ADVIA CHEMISTRY MYOGLOBIN REAGENT, ADVIA CHEMISTRY MYOGLBIN CALIBRATOR
K122599 · Siemens Healthcare Diagnostics, Inc. · Oct 2012
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K083260 · Roche Diagnostics · Oct 2009
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K080481 · Beckman Coulter, Inc. · Feb 2009
QUANTEX MYOGLOBIN
K042982 · Instrumentation Laboratory CO · Dec 2004
VITROS IMMUNODIAGNOSTIC PRODUCTS MYOGLOBIN REAGENT PACK
K033300 · Ortho-Clinical Diagnostics, Inc. · Nov 2003
MYOGLOBIN AND MYOGLOBIN CALIBRATORS ON THE ACCESS IMMUNOASSAY SYSTEMS, MODEL 973243, 973244
K021229 · Beckman Coulter, Inc. · Jun 2002