Cleared Traditional

K171655 - cobas m 511 integrated hematology analyzer

K171655 is the FDA 510(k) clearance for cobas m 511 integrated hematology analyzer by Roche Diagnostics Hematology, Inc.. It is a Class 2 Hematology device (product code GKZ) cleared through the Traditional 510(k) pathway after a 270-day FDA review.

K171655 · Roche Diagnostics Hematology, Inc. · Hematology device
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Mar 2018
Decision
270d
Days
Class 2
Risk

K171655 is an FDA 510(k) clearance for the cobas m 511 integrated hematology analyzer. Classified as Counter, Differential Cell (product code GKZ), Class II - Special Controls.

Submitted by Roche Diagnostics Hematology, Inc. (Westborough, US). The FDA issued a Cleared decision on March 2, 2018 after a review of 270 days - an extended review cycle.

This device falls under the Hematology FDA review panel, regulated under 21 CFR 864.5220 - 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.

View all Roche Diagnostics Hematology, Inc. devices

Submission Details

510(k) Number K171655 FDA.gov
FDA Decision Cleared Substantially Equivalent - Traditional 510(k) (SESE)
Date Received June 05, 2017
Decision Date March 02, 2018
Days to Decision 270 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
157d slower than avg
Panel avg: 113d · This submission: 270d
Pathway characteristics
Predicate-based equivalence. No clinical trials required.

Device Classification

Product Code GKZ Counter, Differential Cell
Device Class Class 2 - Special Controls
CFR Regulation 21 CFR 864.5220
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 - GKZ Counter, Differential Cell

All 193
Devices cleared under the same product code (GKZ) and FDA review panel - the closest regulatory comparables to K171655.
Sysmex XN-L Automated Hematology Analyzer
K182389 · Sysmex America, Inc. · Jan 2019
Athelas One
K181288 · Athelas, Inc. · Nov 2018
HemoScreen Hematology Analyzer
K180020 · Pixcell Medical Technologies, Ltd. · Oct 2018
XW-100 Automated Hematology Analyzer for CLIA Waived Use
K172604 · Sysmex America, Inc. · Nov 2017
ADVIA 2120i, ADVIA 2120
K162977 · Siemens Healthcare Diagnostics · Aug 2017
Sysmex XN-L Automated Hematology Analyzer
K160538 · Sysmex America, Inc. · Dec 2016