Cleared Traditional

K951943 - CHROM Z CHROMOGENIC ASSAYS

K951943 is an FDA 510(k) clearance for CHROM Z CHROMOGENIC ASSAYS, manufactured by Helena Laboratories. The device is a Class 2 Hematology device with product code JBQ cleared through the Traditional 510(k) pathway after a 201-day FDA review.

K951943 · Helena Laboratories · Hematology device
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Nov 1995
Decision
201d
Days
Class 2
Risk

K951943 is an FDA 510(k) clearance for the CHROM Z CHROMOGENIC ASSAYS. Classified as Antithrombin Iii Quantitation (product code JBQ), Class II - Special Controls.

Submitted by Helena Laboratories (Beaumont, US). The FDA issued a Cleared decision on November 13, 1995 after a review of 201 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 Helena Laboratories devices

FDA 510(k) Submission Details - K951943

510(k) Number K951943 FDA.gov
FDA Decision Cleared Substantially Equivalent - Traditional 510(k) (SESE)
Date Received April 26, 1995
Decision Date November 13, 1995
Days to Decision 201 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
88d slower than avg
Panel avg: 113d · This submission: 201d
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 K951943.
SIGMA DIAGNOSTICS ACCUCOLOR ANTITHROMBIN III
K972144 · Sigma Diagnostics, Inc. · Jul 1997
SPECTROLYSE ANTITHROMBIN III (ANTI-XA)
K960871 · Medical Diagnostic Technologies, Inc. · Aug 1996
COACUTE ANTITHROMBIN R CHROMOGENIC ASSAY
K952515 · Chromogenix AB · Jan 1996
AT-III CALIBRATOR
K944279 · American Bioproducts Co. · Apr 1995
BIOMERIEUX HEMOLAB AT III
K934156 · Biomerieux Vitek, Inc. · Dec 1994
ACCUCOLOR(TM) ANTITHROMBIN III CHROMOGENIC ASSAY
K935308 · Sigma Diagnostics, Inc. · May 1994