Cleared Abbreviated

CDS HEMATOLOGY CALIBRATOR (CDS CAL) (K041130) - FDA 510(k) Clearance

Class II Hematology device cleared through the Abbreviated 510(k) pathway - typically does not require clinical trials.

K041130 · Clinical Diagnostic Solutions, Inc. · Hematology device
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Jun 2004
Decision
41d
Days
Class 2
Risk

K041130 is an FDA 510(k) clearance for the CDS HEMATOLOGY CALIBRATOR (CDS CAL). Classified as Calibrator For Hemoglobin And Hematocrit Measurement (product code KRZ), Class II - Special Controls.

Submitted by Clinical Diagnostic Solutions, Inc. (Plantation, US). The FDA issued a Cleared decision on June 10, 2004 after a review of 41 days - a notably fast clearance cycle.

This device falls under the Hematology FDA review panel, regulated under 21 CFR 864.8165 - 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 Clinical Diagnostic Solutions, Inc. devices

Submission Details

510(k) Number K041130 FDA.gov
FDA Decision Cleared Substantially Equivalent - Traditional 510(k) (SESE)
Date Received April 30, 2004
Decision Date June 10, 2004
Days to Decision 41 days
Submission Type Abbreviated
Review Panel Hematology (HE)
Summary Statement
Third-party Review No - reviewed directly by FDA
Regulatory Context
Review time vs. panel average
72d faster than avg
Panel avg: 113d · This submission: 41d
Pathway characteristics
Standards-based clearance path.

Device Classification

Product Code KRZ Calibrator For Hemoglobin And Hematocrit Measurement
Device Class Class 2 - Special Controls
CFR Regulation 21 CFR 864.8165
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.