Cleared Traditional

K834031 - FACTOR II DEFICIENT SUBSTRATE PLASMA

K834031 is the FDA 510(k) clearance for FACTOR II DEFICIENT SUBSTRATE PLASMA by Helena Laboratories. It is a Class 2 Hematology device (product code GGP) cleared through the Traditional 510(k) pathway after a 24-day FDA review.

K834031 · Helena Laboratories · Hematology device
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Dec 1983
Decision
24d
Days
Class 2
Risk

K834031 is an FDA 510(k) clearance for the FACTOR II DEFICIENT SUBSTRATE PLASMA. Classified as Test, Qualitative And Quantitative Factor Deficiency (product code GGP), Class II - Special Controls.

Submitted by Helena Laboratories (Mchenry, US). The FDA issued a Cleared decision on December 16, 1983 after a review of 24 days - a notably fast clearance 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: Fast-track predicate clearance. Standard predicate reliance. The short review cycle indicates strong predicate alignment - the FDA found sufficient equivalence without extended technical review.

View all Helena Laboratories devices

Submission Details

510(k) Number K834031 FDA.gov
FDA Decision Cleared Substantially Equivalent - Traditional 510(k) (SESE)
Date Received November 22, 1983
Decision Date December 16, 1983
Days to Decision 24 days
Submission Type Traditional
Review Panel Hematology (HE)
Summary -
Third-party Review No - reviewed directly by FDA
Combination Product No
PCCP Authorized No
Regulatory Context
Review time vs. panel average
89d faster than avg
Panel avg: 113d · This submission: 24d
Pathway characteristics
Predicate-based equivalence. No clinical trials required.

Device Classification

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 126
Devices cleared under the same product code (GGP) and FDA review panel - the closest regulatory comparables to K834031.
RISTOCETIN COFACTOR ASSAY
K840329 · Helena Laboratories · Apr 1984
PROTOPATH FACTOR IX ASSAY
K834050 · American Dade · Feb 1984
PROTOPATH FACTOR VIII ASSAY
K834051 · American Dade · Feb 1984
VON WILLEBRAND FACTOR ASSAY
K823453 · General Diagnostics · Jan 1983
FACTOR VIII RELATED ANTIGEN ROCKET EID
K823267 · Helena Laboratories · Dec 1982
DADE FACTOR ASSAY REFERENCE PLASMA
K820085 · American Dade · Feb 1982