Cleared Traditional

AQT90 FLEX ANALYZER, AQT90 FLEX MYOGLOBIN TEST KIT, AQT90 FLEX LQC MULTI-CHECK, LVLS 1-3, AQT90 FLEX MYO CAL CARTRIDGE.. (K112161) - FDA 510(k) Clearance

Class I Chemistry device.

K112161 · Radiometer Medical Aps · Chemistry device
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Jan 2012
Decision
177d
Days
Class 1
Risk

K112161 is an FDA 510(k) clearance for the AQT90 FLEX ANALYZER, AQT90 FLEX MYOGLOBIN TEST KIT, AQT90 FLEX LQC MULTI-CHEC.... Classified as Fluorometer, For Clinical Use (product code KHO), Class I - General Controls.

Submitted by Radiometer Medical Aps (Broenshoej, DK). The FDA issued a Cleared decision on January 20, 2012 after a review of 177 days - an extended review cycle.

This device falls under the Chemistry FDA review panel, regulated under 21 CFR 862.2560 - 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.

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Submission Details

510(k) Number K112161 FDA.gov
FDA Decision Cleared Substantially Equivalent - Traditional 510(k) (SESE)
Date Received July 27, 2011
Decision Date January 20, 2012
Days to Decision 177 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
89d slower than avg
Panel avg: 88d · This submission: 177d
Pathway characteristics
Predicate-based equivalence.

Device Classification

Product Code KHO Fluorometer, For Clinical Use
Device Class Class 1 - General Controls
CFR Regulation 21 CFR 862.2560
What this classification means

Class I devices are subject to general controls only and most are exempt from 510(k) premarket notification. They represent the lowest regulatory burden in the FDA device framework.