Not Cleared Post-NSE

TINA-QUANT HBA1C GEN. 2 TEST SYSTEM (DEN130002) - FDA 510(k) Clearance

Class II Chemistry device cleared through the Post-NSE 510(k) pathway - typically does not require clinical trials.

DEN130002 · Roche Diagnostics · Chemistry device
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May 2013
Decision
59d
Days
Class 2
Risk

DEN130002 is an FDA 510(k) submission (not cleared) for the TINA-QUANT HBA1C GEN. 2 TEST SYSTEM. Classified as Hemoglobin A1c Test System (product code PDJ), Class II - Special Controls.

Submitted by Roche Diagnostics (Indianapolis, US). The FDA issued a Not Cleared (DENG) decision on May 23, 2013 after a review of 59 days.

This device falls under the Chemistry FDA review panel, regulated under 21 CFR 862.1373 - the FDA in vitro diagnostics and chemistry framework. The Traditional 510(k) pathway requires demonstration of substantial equivalence to a legally marketed predicate device - a standard the FDA determined was not met in this submission.

Device pattern: High-complexity regulatory submission. Elevated predicate reliance profile. This submission did not achieve clearance, indicating the FDA determined the device lacked sufficient predicate equivalence under the Chemistry review framework.

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Submission Details

510(k) Number DEN130002 FDA.gov
FDA Decision Not Cleared Not Substantially Equivalent (DENG)
Date Received March 25, 2013
Decision Date May 23, 2013
Days to Decision 59 days
Submission Type Post-NSE
Review Panel Chemistry (CH)
Summary -
Third-party Review No - reviewed directly by FDA
Regulatory Context
Review time vs. panel average
29d faster than avg
Panel avg: 88d · This submission: 59d
Pathway characteristics

Device Classification

Product Code PDJ Hemoglobin A1c Test System
Device Class Class 2 - Special Controls
CFR Regulation 21 CFR 862.1373
Definition Quantitative Determination Of Hemoglobin A1c To Aid In The Diagnosis Of Diabetes.
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 - PDJ Hemoglobin A1c Test System

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