Cleared Traditional

K063390 - URINE CHEMISTRY ANALYZER UR-50

K063390 is an FDA 510(k) clearance for URINE CHEMISTRY ANALYZER UR-50, manufactured by Ind Diagnostic, Inc.. The device is a Class 2 Chemistry device with product code JIL cleared through the Traditional 510(k) pathway after a 112-day FDA review.

K063390 · Ind Diagnostic, Inc. · Chemistry device
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Mar 2007
Decision
112d
Days
Class 2
Risk

K063390 is an FDA 510(k) clearance for the URINE CHEMISTRY ANALYZER UR-50. Classified as Method, Enzymatic, Glucose (urinary, Non-quantitative) (product code JIL), Class II - Special Controls.

Submitted by Ind Diagnostic, Inc. (Altamonte Springs, US). The FDA issued a Cleared decision on March 1, 2007 after a review of 112 days - within the typical 510(k) review window.

This device falls under the Chemistry FDA review panel, regulated under 21 CFR 862.1340 - 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 Ind Diagnostic, Inc. devices

FDA 510(k) Submission Details - K063390

510(k) Number K063390 FDA.gov
FDA Decision Cleared Substantially Equivalent - Traditional 510(k) (SESE)
Date Received November 09, 2006
Decision Date March 01, 2007
Days to Decision 112 days
Submission Type Traditional
Review Panel Chemistry (CH)
Summary Statement
Third-party Review Yes - reviewed by an FDA-accredited third party
Regulatory Context
Review time vs. panel average
24d slower than avg
Panel avg: 88d · This submission: 112d
Pathway characteristics
Predicate-based equivalence. No clinical trials required. Third-party reviewed.

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.

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

All 50
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