Cleared Special

K072638 - ROCHE/HITACHI URINARY/CSF PROTEIN WITH MODEL(S) CAT #11877801

K072638 is an FDA 510(k) clearance for ROCHE/HITACHI URINARY/CSF PROTEIN WITH ..., manufactured by Roche Diagnostics Corp.. The device is a Class 2 Chemistry device with product code JGQ cleared through the Special 510(k) pathway after a 31-day FDA review.

K072638 · Roche Diagnostics Corp. · Chemistry device
Download Printable Device Report (PDF) Official FDA 510(k) Summary (PDF)
Optimized for regulatory review, auditing and printing
Oct 2007
Decision
31d
Days
Class 2
Risk

K072638 is an FDA 510(k) clearance for the ROCHE/HITACHI URINARY/CSF PROTEIN WITH MODEL(S) CAT #11877801. Classified as Turbidimetric, Total Protein (product code JGQ), Class II - Special Controls.

Submitted by Roche Diagnostics Corp. (Indianapolis, US). The FDA issued a Cleared decision on October 19, 2007 after a review of 31 days - a notably fast clearance cycle.

This device falls under the Chemistry FDA review panel, regulated under 21 CFR 862.1635 - 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. Low regulatory complexity profile. This Special 510(k) clearance confirms that the manufacturer's modifications remained within the established regulatory envelope of the original cleared device.

FDA 510(k) Submission Details - K072638

510(k) Number K072638 FDA.gov
FDA Decision Cleared Substantially Equivalent - Traditional 510(k) (SESE)
Date Received September 18, 2007
Decision Date October 19, 2007
Days to Decision 31 days
Submission Type Special
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
57d faster than avg
Panel avg: 88d · This submission: 31d
Pathway characteristics
Modification to existing cleared device.

JGQ Device Classification - Class 2, Special Controls

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 11
Devices cleared under the same product code (JGQ) and FDA review panel - the closest regulatory comparables to K072638.
HITACHI S TEST REAGENT CARTRIDGE TOTAL PROTEIN (TP) AND ALBUMIN (ALB)
K131051 · Hitachi Chemical Diagnostics, Inc. · Jun 2013
TOTAL PROTEIN URINE/CSF GEN.3
K071239 · Roche Diagnostics · Sep 2007
UPRO
K981295 · Abbott Laboratories · Oct 1998
UPRO
K981682 · Abbott Laboratories · Sep 1998
TRACE MICROPROTEIN REAGENT
K925794 · Trace America, Inc. · Mar 1993
URINARY/CSF PROTEIN
K913615 · Boehringer Mannheim Corp. · Sep 1991
K072638 · ROCHE/HITACHI URINARY/CSF PROTEIN WITH MODEL(S) CAT #11877801
Download PDF FDA Summary Roche Diagnostics Cor…