Cleared Traditional

K952666 - CHROM Z-PROTEIN C, CAT. NO. 5243

K952666 is an FDA 510(k) clearance for CHROM Z-PROTEIN C, manufactured by Helena Laboratories. The device is a Class 2 Hematology device with product code GGP cleared through the Traditional 510(k) pathway after a 232-day FDA review.

K952666 · Helena Laboratories · Hematology device
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Jan 1996
Decision
232d
Days
Class 2
Risk

K952666 is an FDA 510(k) clearance for the CHROM Z-PROTEIN C, CAT. NO. 5243. Classified as Test, Qualitative And Quantitative Factor Deficiency (product code GGP), Class II - Special Controls.

Submitted by Helena Laboratories (Beaumont, US). The FDA issued a Cleared decision on January 30, 1996 after a review of 232 days - an extended review cycle.

This device falls under the Hematology FDA review panel, regulated under 21 CFR 864.7290 - 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 - K952666

510(k) Number K952666 FDA.gov
FDA Decision Cleared Substantially Equivalent - Traditional 510(k) (SESE)
Date Received June 12, 1995
Decision Date January 30, 1996
Days to Decision 232 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
119d slower than avg
Panel avg: 113d · This submission: 232d
Pathway characteristics
Predicate-based equivalence. No clinical trials required.

GGP Device Classification - Class 2, Special Controls

Product Code GGP Test, Qualitative And Quantitative Factor Deficiency
Device Class Class 2 - Special Controls
CFR Regulation 21 CFR 864.7290
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 - GGP Test, Qualitative And Quantitative Factor Deficiency

All 155
Devices cleared under the same product code (GGP) and FDA review panel - the closest regulatory comparables to K952666.
AALTO SCIENTIFIC LIQUID CEREBROSPINAL FLUID CONTROLS LEVELS I AND II
K952126 · Aalto Scientific, Ltd. · Feb 1996
BIOCLOT PROTEIN S
K955738 · Medical Diagnostic Technologies, Inc. · Feb 1996
CHROM Z-F:VIII, CAT. NO. 5241
K952668 · Helena Laboratories · Feb 1996
CHROM Z-PLASMINOGEN, CAT. NO. 5244
K952669 · Helena Laboratories · Dec 1995
ASSERACHROM FREE PROTEIN S KIT
K954017 · American Bioproducts Co. · Nov 1995
ASSERACHROM TOTAL PROTEIN S KIT
K954040 · American Bioproducts Co. · Nov 1995