Cleared Traditional

AUTION ELEVEN Semi-Automated Urinalysis System (K160062) - FDA 510(k) Clearance

Class II Chemistry device cleared through predicate-based substantial equivalence - typically does not require clinical trials.

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

Submission Details

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.

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)

All 15
Devices cleared under the same product code (JIL) and FDA review panel - the closest regulatory comparables to K160062.
inui In-Home Urine Analysis Test System
K180356 · Scanadu, Inc. · May 2018
DUS 2GP Reagent Strips, DUS 5 Reagent Strips, DUS 10 Reagent Strips
K181024 · DFI Co., Ltd. · May 2018
DUS R-50S (Urine Chemistry system)
K171521 · DFI Co., Ltd. · Feb 2018
CHEMSTRIP 5 OB, CHEMSTRIP 7 AND CHEMSTRIP 10 MD TEST STRIPS
K032437 · Roche Diagnostics Corp. · Oct 2003
URISYS 2400 URINE TEST STRIP
K012397 · Roche Diagnostics Corp. · Sep 2001
CHEMSTRIP(R) 10 WITH SG URINE TEST STRIPS
K896454 · Boehringer Mannheim Corp. · Jan 1990