Cleared Traditional

K160062 - AUTION ELEVEN Semi-Automated Urinalysis...

K160062 is an FDA 510(k) clearance for AUTION ELEVEN Semi-Automated Urinalysis..., manufactured by Arkray, Inc.. The device is a Class 2 Chemistry device with product code JIL cleared through the Traditional 510(k) pathway after a 269-day FDA review.

K160062 · Arkray, Inc. · Chemistry device
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Oct 2016
Decision
269d
Days
Class 2
Risk

K160062 is an FDA 510(k) clearance for the AUTION ELEVEN Semi-Automated Urinalysis System. Classified as Method, Enzymatic, Glucose (urinary, Non-quantitative) (product code JIL), Class II - Special Controls.

Submitted by Arkray, Inc. (Kamigyo-Ku, JP). The FDA issued a Cleared decision on October 7, 2016 after a review of 269 days - an extended review cycle.

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 Arkray, Inc. devices

FDA 510(k) Submission Details - K160062

510(k) Number K160062 FDA.gov
FDA Decision Cleared Substantially Equivalent - Traditional 510(k) (SESE)
Date Received January 12, 2016
Decision Date October 07, 2016
Days to Decision 269 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
181d slower than avg
Panel avg: 88d · This submission: 269d
Pathway characteristics
Predicate-based equivalence. No clinical trials required.

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 38
Devices cleared under the same product code (JIL) and FDA review panel - the closest regulatory comparables to K160062.
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