Cleared Abbreviated

K050421 - MS 4/5 HEMATOLOGY ANALYZER

K050421 is an FDA 510(k) clearance for MS 4/5 HEMATOLOGY ANALYZER, manufactured by Melet Schloesing Laboratories USA. The device is a Class 2 Hematology device with product code GKZ cleared through the Abbreviated 510(k) pathway after a 194-day FDA review.

K050421 · Melet Schloesing Laboratories USA · Hematology device
Download Printable Device Report (PDF)
Optimized for regulatory review, auditing and printing
Aug 2005
Decision
194d
Days
Class 2
Risk

K050421 is an FDA 510(k) clearance for the MS 4/5 HEMATOLOGY ANALYZER. Classified as Counter, Differential Cell (product code GKZ), Class II - Special Controls.

Submitted by Melet Schloesing Laboratories USA (El Cajon, US). The FDA issued a Cleared decision on August 31, 2005 after a review of 194 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 Abbreviated 510(k) pathway was used, relying on FDA-recognized standards to demonstrate substantial equivalence.

Device pattern: Standards-based predicate clearance. Standards-verified equivalence. The Abbreviated pathway signals strong alignment with FDA-recognized performance standards - typically associated with lower review burden and faster clearance cycles.

View all Melet Schloesing Laboratories USA devices

FDA 510(k) Submission Details - K050421

510(k) Number K050421 FDA.gov
FDA Decision Cleared Substantially Equivalent - Traditional 510(k) (SESE)
Date Received February 18, 2005
Decision Date August 31, 2005
Days to Decision 194 days
Submission Type Abbreviated
Review Panel Hematology (HE)
Summary Statement
Third-party Review No - reviewed directly by FDA
Combination Product No
PCCP Authorized No
Regulatory Context
Review time vs. panel average
81d slower than avg
Panel avg: 113d · This submission: 194d
Pathway characteristics
Standards-based clearance path.

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 295
Devices cleared under the same product code (GKZ) and FDA review panel - the closest regulatory comparables to K050421.
CHEMPAQ XBC ANALYZER
K050758 · Chempaq A/S · Dec 2005
MODIFICATION TO COULTER LH 750 HEMATOLOGY ANALYZER
K052905 · Beckman Coulter, Inc. · Nov 2005
SYSMEX MODEL XE-2100DC AUTOMATED HEMATOLOGY ANALYZER
K051459 · Sysmex America, Inc. · Sep 2005
IPF (IMMATURE PLATELET FRACTION) PARAMETER ON THE SYSMEX MODEL XE-2100 AUTOMATED HEMATOLOGY ANALYZER
K051199 · Sysmex America, Inc. · Aug 2005
ITAG MHC TETRAMER CMV ASSAY
K051122 · Beckman Coulter, Inc. · Aug 2005
MS 9/5 HEMATOLOGY ANALYZER
K050436 · Melet Schloesing Laboratories USA · Jul 2005