Cleared Traditional

CHROM Z CHROMOGENIC ASSAYS (K951943) - FDA 510(k) Clearance

Class II Hematology device cleared through predicate-based substantial equivalence - typically does not require clinical trials.

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

Submission Details

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.

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 55
Devices cleared under the same product code (JBQ) and FDA review panel - the closest regulatory comparables to K951943.
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COAMATIC LR ANTITHROMBIN, NOTE: LR=LIQUID REAGENTS
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COAMATIC AT-400
K022195 · Instrumentation Laboratory CO · Aug 2002