Cleared Special

K050026 - PRECINORM PROTEINS IN URINE/CSF (PUC) AND PRECIPATH PUC

K050026 is an FDA 510(k) clearance for PRECINORM PROTEINS IN URINE/CSF (PUC) A..., manufactured by Roche Diagnostics. The device is a Class 2 Chemistry device with product code JIX cleared through the Special 510(k) pathway after a 25-day FDA review.

K050026 · Roche Diagnostics · Chemistry device
Download Printable Device Report (PDF) Official FDA 510(k) Summary (PDF)
Optimized for regulatory review, auditing and printing
Jan 2005
Decision
25d
Days
Class 2
Risk

K050026 is an FDA 510(k) clearance for the PRECINORM PROTEINS IN URINE/CSF (PUC) AND PRECIPATH PUC. Classified as Calibrator, Multi-analyte Mixture (product code JIX), Class II - Special Controls.

Submitted by Roche Diagnostics (Indianapolis, US). The FDA issued a Cleared decision on January 31, 2005 after a review of 25 days - a notably fast clearance cycle.

This device falls under the Chemistry FDA review panel, regulated under 21 CFR 862.1150 - 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 - K050026

510(k) Number K050026 FDA.gov
FDA Decision Cleared Substantially Equivalent - Traditional 510(k) (SESE)
Date Received January 06, 2005
Decision Date January 31, 2005
Days to Decision 25 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
64d faster than avg
Panel avg: 89d · This submission: 25d
Pathway characteristics
Modification to existing cleared device.

JIX Device Classification - Class 2, Special Controls

Product Code JIX Calibrator, Multi-analyte Mixture
Device Class Class 2 - Special Controls
CFR Regulation 21 CFR 862.1150
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 - JIX Calibrator, Multi-analyte Mixture

All 301
Devices cleared under the same product code (JIX) and FDA review panel - the closest regulatory comparables to K050026.
LIPOPROTEIN FOR MULTIPLE ANALYTES
K051619 · Bayer Healthcare, LLC · Aug 2005
SENTINEL PLASMAPROTEINS CAL 3X
K051457 · Sentinel Ch. Srl · Jul 2005
OLYMPUS LYOPHILIZED CHEMISTRY CALIBRATORS DR0070 AND DR0071
K043460 · Olympus America, Inc. · Jan 2005
HDL/LDL-ADVANCE CALIBRATOR, CAT. NO. SE-278
K041926 · Diagnostic Chemicals , Ltd. · Nov 2004
MULTI-CHEM CALIBRATOR A
K042551 · Wako Chemicals USA, Inc. · Nov 2004
MULTI CHEM CAL B
K042549 · Wako Chemicals USA, Inc. · Nov 2004
K050026 · PRECINORM PROTEINS IN URINE/CSF (PUC) AND PRECIPATH PUC
Download PDF FDA Summary Roche Diagnostics