Cleared Special

URYXXON RELAX URINE ANALYZER (K061742) - FDA 510(k) Clearance

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

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.

View all Macherey-Nagel GmbH & Co. KG devices

Submission Details

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
Regulatory Context
Review time vs. panel average
10d faster than avg
Panel avg: 88d · This submission: 78d
Pathway characteristics
Modification to existing cleared device.

Device Classification

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.

Regulatory Peers - JIL Method, Enzymatic, Glucose (urinary, Non-quantitative)

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