Cleared Traditional

HEALTHTEST HEPARIN/PLATELET FACTOR 4 ANTIBODY ASSAY (K040293) - FDA 510(k) Clearance

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

K040293 · Akers Laboratories, Inc. · Hematology device
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May 2004
Decision
112d
Days
Class 2
Risk

K040293 is an FDA 510(k) clearance for the HEALTHTEST HEPARIN/PLATELET FACTOR 4 ANTIBODY ASSAY. Classified as Platelet Factor 4 Radioimmunoassay (product code LCO), Class II - Special Controls.

Submitted by Akers Laboratories, Inc. (Thorofare, US). The FDA issued a Cleared decision on May 28, 2004 after a review of 112 days - within the typical 510(k) review window.

This device falls under the Hematology FDA review panel, regulated under 21 CFR 864.7695 - 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 Akers Laboratories, Inc. devices

Submission Details

510(k) Number K040293 FDA.gov
FDA Decision Cleared Substantially Equivalent - Traditional 510(k) (SESE)
Date Received February 06, 2004
Decision Date May 28, 2004
Days to Decision 112 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
1d faster than avg
Panel avg: 113d · This submission: 112d
Pathway characteristics
Predicate-based equivalence. No clinical trials required.

Device Classification

Product Code LCO Platelet Factor 4 Radioimmunoassay
Device Class Class 2 - Special Controls
CFR Regulation 21 CFR 864.7695
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 - LCO Platelet Factor 4 Radioimmunoassay

All 12
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