Cleared Traditional

VITAL SCIENTIFIC APTT, APTT & QUIKCOAG APTT (K022021) - FDA 510(k) Clearance

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

K022021 · Vital Scientific N.V. · Hematology device
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Nov 2002
Decision
134d
Days
Class 2
Risk

K022021 is an FDA 510(k) clearance for the VITAL SCIENTIFIC APTT, APTT & QUIKCOAG APTT. Classified as Activated Partial Thromboplastin (product code GFO), Class II - Special Controls.

Submitted by Vital Scientific N.V. (Newton, US). The FDA issued a Cleared decision on November 1, 2002 after a review of 134 days - within the typical 510(k) review window.

This device falls under the Hematology FDA review panel, regulated under 21 CFR 864.7925 - 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 Vital Scientific N.V. devices

Submission Details

510(k) Number K022021 FDA.gov
FDA Decision Cleared Substantially Equivalent - Traditional 510(k) (SESE)
Date Received June 20, 2002
Decision Date November 01, 2002
Days to Decision 134 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
21d slower than avg
Panel avg: 113d · This submission: 134d
Pathway characteristics
Predicate-based equivalence. No clinical trials required.

Device Classification

Product Code GFO Activated Partial Thromboplastin
Device Class Class 2 - Special Controls
CFR Regulation 21 CFR 864.7925
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 - GFO Activated Partial Thromboplastin

All 51
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