Cleared Special

TOTAL PROTEIN URINE/CSF GEN.3 (K071239) - FDA 510(k) Clearance

Class II Chemistry device cleared through the Special 510(k) pathway - typically does not require clinical trials.

K071239 · Roche Diagnostics · Chemistry device
Download Printable Device Report (PDF)
Optimized for regulatory review, auditing and printing
Sep 2007
Decision
134d
Days
Class 2
Risk

K071239 is an FDA 510(k) clearance for the TOTAL PROTEIN URINE/CSF GEN.3. Classified as Turbidimetric, Total Protein (product code JGQ), Class II - Special Controls.

Submitted by Roche Diagnostics (Indianapolis, US). The FDA issued a Cleared decision on September 14, 2007 after a review of 134 days - within the typical 510(k) review window.

This device falls under the Chemistry FDA review panel, regulated under 21 CFR 862.1635 - the FDA in vitro diagnostics and chemistry framework. As a Special 510(k), this submission covers a manufacturer modification to an existing cleared device rather than a new device introduction.

Device pattern: Iterative device modification. Standard predicate reliance. This Special 510(k) clearance confirms that the manufacturer's modifications remained within the established regulatory envelope of the original cleared device.

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Submission Details

510(k) Number K071239 FDA.gov
FDA Decision Cleared Substantially Equivalent - Traditional 510(k) (SESE)
Date Received May 03, 2007
Decision Date September 14, 2007
Days to Decision 134 days
Submission Type Special
Review Panel Chemistry (CH)
Summary Summary PDF
Third-party Review No - reviewed directly by FDA
Regulatory Context
Review time vs. panel average
46d slower than avg
Panel avg: 88d · This submission: 134d
Pathway characteristics
Modification to existing cleared device.

Device Classification

Product Code JGQ Turbidimetric, Total Protein
Device Class Class 2 - Special Controls
CFR Regulation 21 CFR 862.1635
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 - JGQ Turbidimetric, Total Protein

All 12
Devices cleared under the same product code (JGQ) and FDA review panel - the closest regulatory comparables to K071239.
ROCHE/HITACHI URINARY/CSF PROTEIN WITH MODEL(S) CAT #11877801
K072638 · Roche Diagnostics Corp. · Oct 2007
UPRO
K981295 · Abbott Laboratories · Oct 1998
UPRO
K981682 · Abbott Laboratories · Sep 1998
URINARY/CSF PROTEIN
K913615 · Boehringer Mannheim Corp. · Sep 1991
PARAMAX CEREBROSPINAL FLUID/URINE PROTEIN BLANK
K903914 · Baxter Healthcare Corp · Oct 1990
EMDS(TM) CEREBROSPINAL FLUID PROTEIN, #67668/95
K901083 · Em Diagnostic Systems, Inc. · Apr 1990