Cleared Traditional

K183432 - cobas u 601 urinalysis test system

K183432 is an FDA 510(k) clearance for cobas u 601 urinalysis test system, manufactured by Roche Diagnostics. The device is a Class 2 Chemistry device with product code JIL cleared through the Traditional 510(k) pathway after a 147-day FDA review.

K183432 · Roche Diagnostics · Chemistry device
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May 2019
Decision
147d
Days
Class 2
Risk

K183432 is an FDA 510(k) clearance for the cobas u 601 urinalysis test system. Classified as Method, Enzymatic, Glucose (urinary, Non-quantitative) (product code JIL), Class II - Special Controls.

Submitted by Roche Diagnostics (Indianapolis, US). The FDA issued a Cleared decision on May 7, 2019 after a review of 147 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.

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FDA 510(k) Submission Details - K183432

510(k) Number K183432 FDA.gov
FDA Decision Cleared Substantially Equivalent - Traditional 510(k) (SESE)
Date Received December 11, 2018
Decision Date May 07, 2019
Days to Decision 147 days
Submission Type Traditional
Review Panel Chemistry (CH)
Summary Summary PDF
Third-party Review No - reviewed directly by FDA
Combination Product No
PCCP Authorized No
Regulatory Context
Review time vs. panel average
59d slower than avg
Panel avg: 88d · This submission: 147d
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 37
Devices cleared under the same product code (JIL) and FDA review panel - the closest regulatory comparables to K183432.
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