Cleared Special

K033548 - ROCHE DIAGNOSTICS URISYS 1100 URINE ANALYZER

K033548 is an FDA 510(k) clearance for ROCHE DIAGNOSTICS URISYS 1100 URINE ANA..., manufactured by Roche Diagnostics Corp.. The device is a Class 2 Chemistry device with product code KHE cleared through the Special 510(k) pathway after a 12-day FDA review.

K033548 · Roche Diagnostics Corp. · Chemistry device
Download Printable Device Report (PDF) Official FDA 510(k) Summary (PDF)
Optimized for regulatory review, auditing and printing
Nov 2003
Decision
12d
Days
Class 2
Risk

K033548 is an FDA 510(k) clearance for the ROCHE DIAGNOSTICS URISYS 1100 URINE ANALYZER. Classified as Reagent, Occult Blood (product code KHE), Class II - Special Controls.

Submitted by Roche Diagnostics Corp. (Indianapolis, US). The FDA issued a Cleared decision on November 24, 2003 after a review of 12 days - a notably fast clearance cycle.

This device falls under the Chemistry FDA review panel, regulated under 21 CFR 864.6550 - 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 - K033548

510(k) Number K033548 FDA.gov
FDA Decision Cleared Substantially Equivalent - Traditional 510(k) (SESE)
Date Received November 12, 2003
Decision Date November 24, 2003
Days to Decision 12 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
76d faster than avg
Panel avg: 88d · This submission: 12d
Pathway characteristics
Modification to existing cleared device.

KHE Device Classification - Class 2, Special Controls

Product Code KHE Reagent, Occult Blood
Device Class Class 2 - Special Controls
CFR Regulation 21 CFR 864.6550
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 - KHE Reagent, Occult Blood

All 73
Devices cleared under the same product code (KHE) and FDA review panel - the closest regulatory comparables to K033548.
CARE FECAL OCCULT BLOOD TEST, MODEL KT313
K051806 · Epitope Diagnostics, Inc. · Oct 2005
HEMOSURE ONE-STEP FECAL OCCULT BLOOD TEST
K041202 · W.H.P.M., Inc. · Aug 2004
POLYMEDCO OC LIGHT FOBT TEST
K041297 · Polymedco, Inc. · Aug 2004
HEMAPROMPT GASTRIC
K031356 · Aerscher Diagnostics · Sep 2003
COLONCARE
K030216 · Care Products, Inc. · Apr 2003
LIFEGUARD
K022755 · Medtek, LLC · Sep 2002
K033548 · ROCHE DIAGNOSTICS URISYS 1100 URINE ANALYZER
Download PDF FDA Summary Roche Diagnostics Cor…