Cleared Traditional

K050758 - CHEMPAQ XBC ANALYZER

K050758 is the FDA 510(k) clearance for CHEMPAQ XBC ANALYZER by Chempaq A/S. It is a Class 2 Hematology device (product code GKZ) cleared through the Traditional 510(k) pathway after a 274-day FDA review.

K050758 · Chempaq A/S · Hematology device
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Dec 2005
Decision
274d
Days
Class 2
Risk

K050758 is an FDA 510(k) clearance for the CHEMPAQ XBC ANALYZER. Classified as Counter, Differential Cell (product code GKZ), Class II - Special Controls.

Submitted by Chempaq A/S (Washington, US). The FDA issued a Cleared decision on December 22, 2005 after a review of 274 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 Chempaq A/S devices

Submission Details

510(k) Number K050758 FDA.gov
FDA Decision Cleared Substantially Equivalent - Traditional 510(k) (SESE)
Date Received March 23, 2005
Decision Date December 22, 2005
Days to Decision 274 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
161d slower than avg
Panel avg: 113d · This submission: 274d
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 194
Devices cleared under the same product code (GKZ) and FDA review panel - the closest regulatory comparables to K050758.
COULTER LH 780 HEMATOLOGY ANALYZER
K061616 · Beckman Coulter, Inc. · Oct 2006
COULTER LH 750 HEMATOLOGY ANALYZER, MODEL 6605632
K061574 · Beckman Coulter, Inc. · Jul 2006
CELL-DYN RUBY SYSTEM
K061667 · Abbott Laboratories · Jul 2006
MODIFICATION TO COULTER LH 750 HEMATOLOGY ANALYZER
K052905 · Beckman Coulter, Inc. · Nov 2005
ITAG MHC TETRAMER CMV ASSAY
K051122 · Beckman Coulter, Inc. · Aug 2005
CELL-DYN SAPPHIRE SYSTEM
K051215 · Abbott Laboratories · Jul 2005