Cleared Traditional

K952515 - COACUTE ANTITHROMBIN R CHROMOGENIC ASSAY

K952515 is the FDA 510(k) clearance for COACUTE ANTITHROMBIN R CHROMOGENIC ASSAY by Chromogenix AB. It is a Class 2 Hematology device (product code JBQ) cleared through the Traditional 510(k) pathway after a 237-day FDA review.

K952515 · Chromogenix AB · Hematology device
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Jan 1996
Decision
237d
Days
Class 2
Risk

K952515 is an FDA 510(k) clearance for the COACUTE ANTITHROMBIN R CHROMOGENIC ASSAY. Classified as Antithrombin Iii Quantitation (product code JBQ), Class II - Special Controls.

Submitted by Chromogenix AB (Franklin, US). The FDA issued a Cleared decision on January 23, 1996 after a review of 237 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 Chromogenix AB devices

Submission Details

510(k) Number K952515 FDA.gov
FDA Decision Cleared Substantially Equivalent - Traditional 510(k) (SESE)
Date Received May 31, 1995
Decision Date January 23, 1996
Days to Decision 237 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
124d slower than avg
Panel avg: 113d · This submission: 237d
Pathway characteristics
Predicate-based equivalence. No clinical trials required.

Device Classification

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 40
Devices cleared under the same product code (JBQ) and FDA review panel - the closest regulatory comparables to K952515.
IMMAGE IMMUNOCHEMISTRY SYSTEM ANTITHROMBIN III (AT3) REAGENT
K974110 · Beckman Instruments, Inc. · Dec 1997
SIGMA DIAGNOSTICS ACCUCOLOR ANTITHROMBIN III
K972144 · Sigma Diagnostics, Inc. · Jul 1997
SPECTROLYSE ANTITHROMBIN III (ANTI-XA)
K960871 · Medical Diagnostic Technologies, Inc. · Aug 1996
CHROM Z CHROMOGENIC ASSAYS
K951943 · Helena Laboratories · Nov 1995
AT-III CALIBRATOR
K944279 · American Bioproducts Co. · Apr 1995
BIOMERIEUX HEMOLAB AT III
K934156 · Biomerieux Vitek, Inc. · Dec 1994