Cleared Special

K061742 - URYXXON RELAX URINE ANALYZER

K061742 is an FDA 510(k) clearance for URYXXON RELAX URINE ANALYZER, manufactured by Macherey-Nagel GmbH & Co. KG. The device is a Class 2 Chemistry device with product code JIL cleared through the Special 510(k) pathway after a 78-day FDA review.

K061742 · Macherey-Nagel GmbH & Co. KG · Chemistry device
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Sep 2006
Decision
78d
Days
Class 2
Risk

K061742 is an FDA 510(k) clearance for the URYXXON RELAX URINE ANALYZER. Classified as Method, Enzymatic, Glucose (urinary, Non-quantitative) (product code JIL), Class II - Special Controls.

Submitted by Macherey-Nagel GmbH & Co. KG (Rockville, US). The FDA issued a Cleared decision on September 6, 2006 after a review of 78 days - a notably fast clearance cycle.

This device falls under the Chemistry FDA review panel, regulated under 21 CFR 862.1340 - the FDA in vitro diagnostics and chemistry framework. As a Special 510(k), this submission covers a manufacturer modification to an existing cleared device rather than a new device introduction.

Device pattern: Iterative device modification. Low regulatory complexity profile. This Special 510(k) clearance confirms that the manufacturer's modifications remained within the established regulatory envelope of the original cleared device.

FDA 510(k) Submission Details - K061742

510(k) Number K061742 FDA.gov
FDA Decision Cleared Substantially Equivalent - Traditional 510(k) (SESE)
Date Received June 20, 2006
Decision Date September 06, 2006
Days to Decision 78 days
Submission Type Special
Review Panel Chemistry (CH)
Summary Statement
Third-party Review No - reviewed directly by FDA
Combination Product No
PCCP Authorized No
Regulatory Context
Review time vs. panel average
10d faster than avg
Panel avg: 88d · This submission: 78d
Pathway characteristics
Modification to existing cleared device.

JIL Device Classification - Class 2, Special Controls

Product Code JIL Method, Enzymatic, Glucose (urinary, Non-quantitative)
Device Class Class 2 - Special Controls
CFR Regulation 21 CFR 862.1340
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.

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