Cleared Traditional

K913667 - ANTITHROMBIN III IMMUNOLOGICAL NL TEST KIT

K913667 is an FDA 510(k) clearance for ANTITHROMBIN III IMMUNOLOGICAL NL TEST KIT, manufactured by The Binding Site, Ltd.. The device is a Class 2 Hematology device with product code JBQ cleared through the Traditional 510(k) pathway after a 137-day FDA review.

K913667 · The Binding Site, Ltd. · Hematology device
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Jan 1992
Decision
137d
Days
Class 2
Risk

K913667 is an FDA 510(k) clearance for the ANTITHROMBIN III IMMUNOLOGICAL NL TEST KIT. Classified as Antithrombin Iii Quantitation (product code JBQ), Class II - Special Controls.

Submitted by The Binding Site, Ltd. (Los Angeles, US). The FDA issued a Cleared decision on January 3, 1992 after a review of 137 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 The Binding Site, Ltd. devices

FDA 510(k) Submission Details - K913667

510(k) Number K913667 FDA.gov
FDA Decision Cleared Substantially Equivalent - Traditional 510(k) (SESE)
Date Received August 19, 1991
Decision Date January 03, 1992
Days to Decision 137 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
24d slower than avg
Panel avg: 113d · This submission: 137d
Pathway characteristics
Predicate-based equivalence. No clinical trials required.

JBQ Device Classification - Class 2, Special Controls

Product Code JBQ Antithrombin Iii Quantitation
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.

Regulatory Peers - JBQ Antithrombin Iii Quantitation

All 47
Devices cleared under the same product code (JBQ) and FDA review panel - the closest regulatory comparables to K913667.
BIOMERIEUX HEMOLAB AT III
K934156 · Biomerieux Vitek, Inc. · Dec 1994
ACCUCOLOR(TM) ANTITHROMBIN III CHROMOGENIC ASSAY
K935308 · Sigma Diagnostics, Inc. · May 1994
ANTITHROMBIN III CHROMOGENIC ASSAY
K936196 · Baxter Diagnostics, Inc. · May 1994
LIATEST(R) AT III TEST KIT
K905110 · American Bioproducts Co. · Jan 1991
BECKMAN ANTITHROMBIN III REAGENT KIT
K901977 · Beckman Instruments, Inc. · Aug 1990
ORTHOKROME* ANTITHROMBIN
K900400 · Ortho Diagnostic Systems, Inc. · Mar 1990