Cleared Special

SYSMEX UF-1000I, AUTOMATED URINE PARTICLE ANALYZER WITH URINALYSIS WAM SOFTWARE (K080887) - FDA 510(k) Clearance

Class II Pathology device cleared through the Special 510(k) pathway - typically does not require clinical trials.

K080887 · Sysmex America, Inc. · Pathology device
Download Printable Device Report (PDF)
Optimized for regulatory review, auditing and printing
May 2008
Decision
32d
Days
Class 2
Risk

K080887 is an FDA 510(k) clearance for the SYSMEX UF-1000I, AUTOMATED URINE PARTICLE ANALYZER WITH URINALYSIS WAM SOFTWARE. Classified as Counter, Urine Particle (product code LKM), Class II - Special Controls.

Submitted by Sysmex America, Inc. (Mundelein, US). The FDA issued a Cleared decision on May 2, 2008 after a review of 32 days - a notably fast clearance cycle.

This device falls under the Pathology FDA review panel, regulated under 21 CFR 864.5200 - the FDA pathology device 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.

View all Sysmex America, Inc. devices

Submission Details

510(k) Number K080887 FDA.gov
FDA Decision Cleared Substantially Equivalent - Traditional 510(k) (SESE)
Date Received March 31, 2008
Decision Date May 02, 2008
Days to Decision 32 days
Submission Type Special
Review Panel Pathology (PA)
Summary Summary PDF
Third-party Review No - reviewed directly by FDA
Regulatory Context
Review time vs. panel average
45d faster than avg
Panel avg: 77d · This submission: 32d
Pathway characteristics
Modification to existing cleared device.

Device Classification

Product Code LKM Counter, Urine Particle
Device Class Class 2 - Special Controls
CFR Regulation 21 CFR 864.5200
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 Pathology devices follow this clearance model.

Regulatory Peers - LKM Counter, Urine Particle

All 14
Devices cleared under the same product code (LKM) and FDA review panel - the closest regulatory comparables to K080887.
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K200811 · Roche Diagnostics · Nov 2020
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K171883 · Sysmex America, Inc. · Apr 2018