Cleared Traditional

K952669 - CHROM Z-PLASMINOGEN, CAT. NO. 5244

K952669 is an FDA 510(k) clearance for CHROM Z-PLASMINOGEN, 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 178-day FDA review.

K952669 · Helena Laboratories · Hematology device
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Dec 1995
Decision
178d
Days
Class 2
Risk

K952669 is an FDA 510(k) clearance for the CHROM Z-PLASMINOGEN, CAT. NO. 5244. Classified as Test, Qualitative And Quantitative Factor Deficiency (product code GGP), Class II - Special Controls.

Submitted by Helena Laboratories (Frankst, US). The FDA issued a Cleared decision on December 7, 1995 after a review of 178 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 - K952669

510(k) Number K952669 FDA.gov
FDA Decision Cleared Substantially Equivalent - Traditional 510(k) (SESE)
Date Received June 12, 1995
Decision Date December 07, 1995
Days to Decision 178 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
65d slower than avg
Panel avg: 113d · This submission: 178d
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 K952669.
BIOCLOT PROTEIN S
K955738 · Medical Diagnostic Technologies, Inc. · Feb 1996
CHROM Z-F:VIII, CAT. NO. 5241
K952668 · Helena Laboratories · Feb 1996
CHROM Z-PROTEIN C, CAT. NO. 5243
K952666 · Helena Laboratories · Jan 1996
ASSERACHROM FREE PROTEIN S KIT
K954017 · American Bioproducts Co. · Nov 1995
ASSERACHROM TOTAL PROTEIN S KIT
K954040 · American Bioproducts Co. · Nov 1995
PROTEIN C REAGENT, COAGULOMETRIC
K924425 · Behring Diagnostics, Inc. · Jan 1995