Cleared Special

K141925 - TOTAL PROTEIN URINE/CSF GEN.3

K141925 is an FDA 510(k) clearance for TOTAL PROTEIN URINE/CSF GEN.3, manufactured by Roche Diagnostics Operations (Rdo). The device is a Class 1 Chemistry device with product code JIQ cleared through the Special 510(k) pathway after a 146-day FDA review.

K141925 · Roche Diagnostics Operations (Rdo) · Chemistry device
Download Printable Device Report (PDF)
Optimized for regulatory review, auditing and printing
Dec 2014
Decision
146d
Days
Class 1
Risk

K141925 is an FDA 510(k) clearance for the TOTAL PROTEIN URINE/CSF GEN.3. Classified as Turbidimetric Method, Protein Or Albumin (urinary, Non-quant.) (product code JIQ), Class I - General Controls.

Submitted by Roche Diagnostics Operations (Rdo) (Indianapolis, US). The FDA issued a Cleared decision on December 9, 2014 after a review of 146 days - within the typical 510(k) review window.

This device falls under the Chemistry FDA review panel, regulated under 21 CFR 862.1645 - 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.

View all Roche Diagnostics Operations (Rdo) devices

FDA 510(k) Submission Details - K141925

510(k) Number K141925 FDA.gov
FDA Decision Cleared Substantially Equivalent - Traditional 510(k) (SESE)
Date Received July 16, 2014
Decision Date December 09, 2014
Days to Decision 146 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
58d slower than avg
Panel avg: 88d · This submission: 146d
Pathway characteristics
Modification to existing cleared device.

JIQ Device Classification - Class 1, General Controls

Product Code JIQ Turbidimetric Method, Protein Or Albumin (urinary, Non-quant.)
Device Class Class 1 - General Controls
CFR Regulation 21 CFR 862.1645
What this classification means

Class I devices are subject to general controls only and most are exempt from 510(k) premarket notification. They represent the lowest regulatory burden in the FDA device framework.

Regulatory Peers - JIQ Turbidimetric Method, Protein Or Albumin (urinary, Non-quant.)

All 10
Devices cleared under the same product code (JIQ) and FDA review panel - the closest regulatory comparables to K141925.
ENZIP IMMUNOTURBIDIMETRIC MICROALBUMIN ASSAY KIT
K971458 · Diagnostic Specialties · Sep 1997
IMMAGE IMMUNOCHEMISTRY SYSTEM MICROALBUMIN (MA) REAGENT
K965035 · Beckman Instruments, Inc. · Apr 1997
WAKO MICRO-ALBUMIN B/WAKO MICRO ALBUMIN CALIBRATOR
K944664 · Wako Chemicals USA, Inc. · Feb 1995
URINARY ALBUMIN TEST PACK
K936202 · Dupont Medical Products · May 1994
SYNERMED IR 500 CHEMISTRY ANALYZER
K935662 · Synermed, Inc. · Apr 1994
RAICHEM(TM) SPIA(TM) MICROALBULMIN REAGENT
K903123 · Reagents Applications, Inc. · Sep 1990