Cleared Traditional

K792508 - HELENA FACTOR X DEFICIENT SUBSTRATE

K792508 is the FDA 510(k) clearance for HELENA FACTOR X DEFICIENT SUBSTRATE by Helena Laboratories. It is a Class 2 Hematology device (product code GGP) cleared through the Traditional 510(k) pathway after a 27-day FDA review.

K792508 · Helena Laboratories · Hematology device
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Dec 1979
Decision
27d
Days
Class 2
Risk

K792508 is an FDA 510(k) clearance for the HELENA FACTOR X DEFICIENT SUBSTRATE. 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 31, 1979 after a review of 27 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 K792508 FDA.gov
FDA Decision Cleared Substantially Equivalent - Traditional 510(k) (SESE)
Date Received December 04, 1979
Decision Date December 31, 1979
Days to Decision 27 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
86d faster than avg
Panel avg: 113d · This submission: 27d
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 K792508.
HELENA FACTOR IX DEFICIENT SUBSTRATE
K792475 · Helena Laboratories · Dec 1979
HELENA FACTOR XI DEFICIENT SUBSTRATE
K792476 · Helena Laboratories · Dec 1979
HELENA FACTOR V DEFICIENT SUBSTRATE
K792507 · Helena Laboratories · Dec 1979
HELENA FACTOR VII DEFICIENT SUB. PLASMA
K792511 · Helena Laboratories · Dec 1979
HELENA FACTOR II DEFICIENT SUB. PLASMA
K792336 · Helena Laboratories · Dec 1979
HELENA FACTOR VIII DEFICIENT SUB. PLASMA
K792335 · Helena Laboratories · Dec 1979