Cleared Traditional

K852372 - CELL-DYN BRAND HEMATOLOGY REAGENTS (FDA 510(k) Clearance)

Class II Hematology device cleared through predicate-based substantial equivalence - typically does not require clinical trials.

K852372 · Abbott Diagnostics · Hematology device
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Sep 1985
Decision
91d
Days
Class 2
Risk

K852372 is an FDA 510(k) clearance for the CELL-DYN BRAND HEMATOLOGY REAGENTS. Classified as Mixture, Hematology Quality Control (product code JPK), Class II - Special Controls.

Submitted by Abbott Diagnostics (Mountain View, US). The FDA issued a Cleared decision on September 3, 1985 after a review of 91 days - within the typical 510(k) review window.

This device falls under the Hematology FDA review panel, regulated under 21 CFR 864.8625 - 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.

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Submission Details

510(k) Number K852372 FDA.gov
FDA Decision Cleared Substantially Equivalent - Traditional 510(k) (SESE)
Date Received June 04, 1985
Decision Date September 03, 1985
Days to Decision 91 days
Submission Type Traditional
Review Panel Hematology (HE)
Summary -
Third-party Review No - reviewed directly by FDA
Regulatory Context
Review time vs. panel average
22d faster than avg
Panel avg: 113d · This submission: 91d
Pathway characteristics
Predicate-based equivalence. No clinical trials required.

Device Classification

Product Code JPK Mixture, Hematology Quality Control
Device Class Class 2 - Special Controls
CFR Regulation 21 CFR 864.8625
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.