Cleared Traditional

N-ASSAY TIA ANTITHROMBIN III TEST KIT (K972257) - FDA 510(k) Clearance

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

K972257 · Crestat Diagnostics, Inc. · Hematology device
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Oct 1997
Decision
125d
Days
Class 2
Risk

K972257 is an FDA 510(k) clearance for the N-ASSAY TIA ANTITHROMBIN III TEST KIT. Classified as Antigen, Antiserum, Control, Antithrombin Iii (product code DDQ), Class II - Special Controls.

Submitted by Crestat Diagnostics, Inc. (Weston, US). The FDA issued a Cleared decision on October 20, 1997 after a review of 125 days - within the typical 510(k) review window.

This device falls under the Hematology FDA review panel, regulated under 21 CFR 864.7060 - 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 Crestat Diagnostics, Inc. devices

Submission Details

510(k) Number K972257 FDA.gov
FDA Decision Cleared Substantially Equivalent - Traditional 510(k) (SESE)
Date Received June 17, 1997
Decision Date October 20, 1997
Days to Decision 125 days
Submission Type Traditional
Review Panel Hematology (HE)
Summary Statement
Third-party Review No - reviewed directly by FDA
Regulatory Context
Review time vs. panel average
12d slower than avg
Panel avg: 113d · This submission: 125d
Pathway characteristics
Predicate-based equivalence. No clinical trials required.

Device Classification

Product Code DDQ Antigen, Antiserum, Control, Antithrombin Iii
Device Class Class 2 - Special Controls
CFR Regulation 21 CFR 864.7060
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.