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) Official FDA 510(k) Summary (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.

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
Combination Product No
PCCP Authorized No
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 12
Devices cleared under the same product code (JIQ) and FDA review panel - the closest regulatory comparables to K141925.
AUSAM TOTAL ALBUMIN ASSAY
K013643 · Ausam Biotecthnologies, Inc. · Aug 2003
HEMOCHEK URINE COLLECTION KIT
K991800 · Osborn Group, Inc. · Sep 1999
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
K141925 · TOTAL PROTEIN URINE/CSF GEN.3
Download PDF FDA Summary Roche Diagnostics Ope…