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
Download Printable Device Report (PDF)
Optimized for regulatory review, auditing and printing
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.

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
Combination Product No
PCCP Authorized No
Regulatory Context
Review time vs. panel average
23d slower than avg
Panel avg: 89d · 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 Consultant

Citech
RAYLENE BALARD

The regulatory consultant manages the 510(k) submission process on behalf of the applicant - coordinating technical documentation, predicate strategy and FDA communications. Identifying the consultant behind a submission is a key signal for competitive regulatory intelligence.

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

All 80
Devices cleared under the same product code (JIL) and FDA review panel - the closest regulatory comparables to K063390.
CLINITEK STATUS+ANALYZER AND CLINITEK STATUS CONNECT SYSTEM, MODELS 1780, 1797
K091216 · Siemens Healthcare Diagnostics · Oct 2009
COMBI SCAN 500 URINE TEST STRIP ANALYZER, MODEL A93005
K061812 · Analyticon Biotechnologies AG · Apr 2007
COMBI SCAN100
K061846 · Analyticon Biotechnologies AG · Apr 2007
CLINITEK ADVANTUS, MODEL 1420
K063276 · Bayer Healthcare, LLC · Dec 2006
URYXXON RELAX URINE ANALYZER
K061742 · Macherey-Nagel GmbH & Co. KG · Sep 2006
ICHEM 100 URINE CHEMISTRY ANALYZER
K060280 · Iris International, Inc. · Jun 2006
K063390 · URINE CHEMISTRY ANALYZER UR-50
Download PDF Ind Diagnostic, Inc.