Cleared Traditional

K972257 - N-ASSAY TIA ANTITHROMBIN III TEST KIT

K972257 is an FDA 510(k) clearance for N-ASSAY TIA ANTITHROMBIN III TEST KIT, manufactured by Crestat Diagnostics, Inc.. The device is a Class 2 Hematology device with product code DDQ cleared through the Traditional 510(k) pathway after a 125-day FDA review.

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

FDA 510(k) Submission Details - K972257

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
Combination Product No
PCCP Authorized No
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.

DDQ Device Classification - Class 2, Special Controls

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.