Cleared Traditional

K060280 - ICHEM 100 URINE CHEMISTRY ANALYZER

K060280 is an FDA 510(k) clearance for ICHEM 100 URINE CHEMISTRY ANALYZER, manufactured by Iris International, Inc.. The device is a Class 2 Chemistry device with product code JIL cleared through the Traditional 510(k) pathway after a 131-day FDA review.

K060280 · Iris International, Inc. · Chemistry device
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Optimized for regulatory review, auditing and printing
Jun 2006
Decision
131d
Days
Class 2
Risk

K060280 is an FDA 510(k) clearance for the ICHEM 100 URINE CHEMISTRY ANALYZER. Classified as Method, Enzymatic, Glucose (urinary, Non-quantitative) (product code JIL), Class II - Special Controls.

Submitted by Iris International, Inc. (Chatsworth, US). The FDA issued a Cleared decision on June 13, 2006 after a review of 131 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 Iris International, Inc. devices

FDA 510(k) Submission Details - K060280

510(k) Number K060280 FDA.gov
FDA Decision Cleared Substantially Equivalent - Traditional 510(k) (SESE)
Date Received February 02, 2006
Decision Date June 13, 2006
Days to Decision 131 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
43d slower than avg
Panel avg: 88d · This submission: 131d
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)

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