Cleared Traditional

K944279 - AT-III CALIBRATOR

K944279 is an FDA 510(k) clearance for AT-III CALIBRATOR, manufactured by American Bioproducts Co.. The device is a Class 2 Hematology device with product code JBQ cleared through the Traditional 510(k) pathway after a 220-day FDA review.

K944279 · American Bioproducts Co. · Hematology device
Download Printable Device Report (PDF)
Optimized for regulatory review, auditing and printing
Apr 1995
Decision
220d
Days
Class 2
Risk

K944279 is an FDA 510(k) clearance for the AT-III CALIBRATOR. Classified as Antithrombin Iii Quantitation (product code JBQ), Class II - Special Controls.

Submitted by American Bioproducts Co. (Parisppany, US). The FDA issued a Cleared decision on April 7, 1995 after a review of 220 days - an extended review cycle.

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 American Bioproducts Co. devices

FDA 510(k) Submission Details - K944279

510(k) Number K944279 FDA.gov
FDA Decision Cleared Substantially Equivalent - Traditional 510(k) (SESE)
Date Received August 30, 1994
Decision Date April 07, 1995
Days to Decision 220 days
Submission Type Traditional
Review Panel Hematology (HE)
Summary Summary PDF
Third-party Review No - reviewed directly by FDA
Combination Product No
PCCP Authorized No
Regulatory Context
Review time vs. panel average
107d slower than avg
Panel avg: 113d · This submission: 220d
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 K944279.
SPECTROLYSE ANTITHROMBIN III (ANTI-XA)
K960871 · Medical Diagnostic Technologies, Inc. · Aug 1996
COACUTE ANTITHROMBIN R CHROMOGENIC ASSAY
K952515 · Chromogenix AB · Jan 1996
CHROM Z CHROMOGENIC ASSAYS
K951943 · Helena Laboratories · Nov 1995
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