Cleared Traditional

K171083 - iChemVELOCITY Automated Urine Chemistry...

K171083 is the FDA 510(k) clearance for iChemVELOCITY Automated Urine Chemistry... by Iris Diagnostics, A Division of Iris International, Inc.. It is a Class 2 Chemistry device (product code JIL) cleared through the Traditional 510(k) pathway after a 31-day FDA review.

K171083 · Iris Diagnostics, A Division of Iris International, Inc. · Chemistry device
Download Printable Device Report (PDF)
Optimized for regulatory review, auditing and printing
May 2017
Decision
31d
Days
Class 2
Risk

K171083 is an FDA 510(k) clearance for the iChemVELOCITY Automated Urine Chemistry System. Classified as Method, Enzymatic, Glucose (urinary, Non-quantitative) (product code JIL), Class II - Special Controls.

Submitted by Iris Diagnostics, A Division of Iris International, Inc. (Chatsworth, US). The FDA issued a Cleared decision on May 12, 2017 after a review of 31 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. The Traditional 510(k) pathway establishes clearance through substantial equivalence to a legally marketed predicate device, without requiring clinical trial data.

Device pattern: Fast-track predicate clearance. Standard predicate reliance. The short review cycle indicates strong predicate alignment - the FDA found sufficient equivalence without extended technical review.

View all Iris Diagnostics, A Division of Iris International, Inc. devices

Submission Details

510(k) Number K171083 FDA.gov
FDA Decision Cleared Substantially Equivalent - Traditional 510(k) (SESE)
Date Received April 11, 2017
Decision Date May 12, 2017
Days to Decision 31 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
57d faster than avg
Panel avg: 88d · This submission: 31d
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 27
Devices cleared under the same product code (JIL) and FDA review panel - the closest regulatory comparables to K171083.
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
TC-THUNDERBOLT AUTOMATED URINE ANALYZER SYSTEM AND TC-THUNDERBOLT URS-10 STRIPS
K141289 · Teco Diagnostics · Jul 2015
URS-2GP (GLUCOSE PROTEIN) URINE STRIPS
K131600 · Teco Diagnostics · May 2014
FORESIGHT U120 URINE ANALYZER
K120124 · ACON Laboratories, Inc. · Mar 2012