Cleared Traditional

K840928 - FACTOR DEFICIENT SUBSTRATE PLASMA VIII

K840928 is an FDA 510(k) clearance for FACTOR DEFICIENT SUBSTRATE PLASMA VIII, manufactured by Diatech, Inc.. The device is a Class 2 Hematology device with product code GGP cleared through the Traditional 510(k) pathway after a 59-day FDA review.

K840928 · Diatech, Inc. · Hematology device
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Apr 1984
Decision
59d
Days
Class 2
Risk

K840928 is an FDA 510(k) clearance for the FACTOR DEFICIENT SUBSTRATE PLASMA VIII. Classified as Test, Qualitative And Quantitative Factor Deficiency (product code GGP), Class II - Special Controls.

Submitted by Diatech, Inc. (Mchenry, US). The FDA issued a Cleared decision on April 30, 1984 after a review of 59 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 Diatech, Inc. devices

FDA 510(k) Submission Details - K840928

510(k) Number K840928 FDA.gov
FDA Decision Cleared Substantially Equivalent - Traditional 510(k) (SESE)
Date Received March 02, 1984
Decision Date April 30, 1984
Days to Decision 59 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
54d faster than avg
Panel avg: 113d · This submission: 59d
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 156
Devices cleared under the same product code (GGP) and FDA review panel - the closest regulatory comparables to K840928.
VONWILLEBRAND FACTOR ANTIGEN SEMI-QUANT
K842617 · American Dade · Oct 1984
COAGULATION CONTROL PLASMA LEVEL 1/2/3
K841461 · Diatech, Inc. · May 1984
FACTOR DEFICIENT SUBSTRATE PLASMA II
K840927 · Diatech, Inc. · Apr 1984
COAGULATION FACTOR V DEFICIENT SUBSTR
K841364 · American Dade · Apr 1984
RISTOCETIN COFACTOR ASSAY
K840329 · Helena Laboratories · Apr 1984
PROTOPATH FACTOR IX ASSAY
K834050 · American Dade · Feb 1984