Cleared Traditional

K953448 - ROCHE COBAS MICROS HEMATOLOGY ANALYZER

K953448 is an FDA 510(k) clearance for ROCHE COBAS MICROS HEMATOLOGY ANALYZER, manufactured by Roche Diagnostic Systems, Inc.. The device is a Class 2 Hematology device with product code GKZ cleared through the Traditional 510(k) pathway after a 88-day FDA review.

K953448 · Roche Diagnostic Systems, Inc. · Hematology device
Download Printable Device Report (PDF)
Optimized for regulatory review, auditing and printing
Oct 1995
Decision
88d
Days
Class 2
Risk

K953448 is an FDA 510(k) clearance for the ROCHE COBAS MICROS HEMATOLOGY ANALYZER. Classified as Counter, Differential Cell (product code GKZ), Class II - Special Controls.

Submitted by Roche Diagnostic Systems, Inc. (Branchburg, US). The FDA issued a Cleared decision on October 13, 1995 after a review of 88 days - a notably fast clearance 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: Fast-track predicate clearance. Standard predicate reliance. The short review cycle indicates strong predicate alignment - the FDA found sufficient equivalence without extended technical review.

View all Roche Diagnostic Systems, Inc. devices

FDA 510(k) Submission Details - K953448

510(k) Number K953448 FDA.gov
FDA Decision Cleared Substantially Equivalent - Traditional 510(k) (SESE)
Date Received July 17, 1995
Decision Date October 13, 1995
Days to Decision 88 days
Submission Type Traditional
Review Panel Hematology (HE)
Summary Summary PDF
Third-party Review No - reviewed directly by FDA
Regulatory Context
Review time vs. panel average
25d faster than avg
Panel avg: 113d · This submission: 88d
Pathway characteristics
Predicate-based equivalence. No clinical trials required.

GKZ Device Classification - Class 2, Special Controls

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 288
Devices cleared under the same product code (GKZ) and FDA review panel - the closest regulatory comparables to K953448.
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CELL-DYN 3500 MULTI-PARAMETER AUTOMATED HEMATOLOGY ANALYZER
K951496 · Abbott Laboratories · Oct 1995
CYTO-STAT/COULTER CLONE CD3-ECD/T4-RD1/T8-FITC MONOCLONAL ANTIBOEY REAGENT
K950742 · Coulter Corp. · Aug 1995
TRITEST CONTROL REAGENT IGG1 FITC/IGFG1 PE/CD45 PERCP
K950057 · Becton Dickinson Immunocytometry Systems · Aug 1995
OPTICLONE CD4FITC/CD8 PE MONOCLONAL ANTIBODIES
K952789 · Immunotech Corp. · Aug 1995