Cleared Traditional

K112161 - AQT90 FLEX ANALYZER

K112161 is the FDA 510(k) clearance for AQT90 FLEX ANALYZER by Radiometer Medical Aps. It is a Class 1 Chemistry device (product code KHO) cleared through the Traditional 510(k) pathway after a 177-day FDA review.

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.

View all Radiometer Medical Aps devices

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.

Regulatory Peers - KHO Fluorometer, For Clinical Use

All 25
Devices cleared under the same product code (KHO) and FDA review panel - the closest regulatory comparables to K112161.
TRIAGE STATMETER
K973547 · Biosite Incorporated · Jan 1998
AIA NEXIA-AUTOMATED ENZYME IMMUNOASSAY SYSTEM
K971103 · Tosoh Medics, Inc. · Jun 1997
FLUOROSCAN NEONATAL
K950415 · Isolab, Inc. · Sep 1995
OPUS MAGNUM ANALYZER
K926131 · Pb Diagnostic Systems, Inc. · Jun 1993
MICROLITE MICROTITER PLATE LUMINOMETER ML2200
K920888 · Dynatech Laboratories, Inc. · Mar 1992
STRATUS IINTELLECT IMMUNOASSAY SYSTEM
K913130 · Baxter Healthcare Corp · Sep 1991