Cleared Traditional

K200811 - cobas u 701 microscopy analyzer (FDA 510(k) Clearance)

Class II Hematology device cleared through predicate-based substantial equivalence - typically does not require clinical trials.

K200811 · Roche Diagnostics · Hematology device
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Nov 2020
Decision
224d
Days
Class 2
Risk

K200811 is an FDA 510(k) clearance for the cobas u 701 microscopy analyzer. Classified as Counter, Urine Particle (product code LKM), Class II - Special Controls.

Submitted by Roche Diagnostics (Indianapolis, US). The FDA issued a Cleared decision on November 6, 2020 after a review of 224 days - an extended review cycle.

This device falls under the Hematology FDA review panel, regulated under 21 CFR 864.5200 - the FDA hematology device framework. The Traditional 510(k) pathway establishes clearance through substantial equivalence to a legally marketed predicate device, without requiring clinical trial data.

Device pattern: Standard predicate-based submission. Standard predicate reliance. This clearance follows a standard predicate-based equivalence path within the Hematology review framework, consistent with the majority of Class II 510(k) submissions.

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Submission Details

510(k) Number K200811 FDA.gov
FDA Decision Cleared Substantially Equivalent - Traditional 510(k) (SESE)
Date Received March 27, 2020
Decision Date November 06, 2020
Days to Decision 224 days
Submission Type Traditional
Review Panel Hematology (HE)
Summary Summary PDF
Third-party Review No - reviewed directly by FDA
Combination Product No
PCCP Authorized No
Regulatory Context
Review time vs. panel average
111d slower than avg
Panel avg: 113d · This submission: 224d
Pathway characteristics
Predicate-based equivalence. No clinical trials required.

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 Hematology 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 K200811.
iQ200 Series
K252580 · Beckman Coulter, Inc. · Sep 2025
AUTION EYE AI-4510 Urine Particle Analysis System
K232416 · Arkray, Inc. · May 2024
iQ200 System, iChemVELOCITY Automated Urine Chemistry System
K210127 · Beckman Coulter, Inc. · Jul 2021
Sysmex UF-5000 Fully Automated Urine Particle Analyzer
K171883 · Sysmex America, Inc. · Apr 2018