Cleared Traditional

K820085 - DADE FACTOR ASSAY REFERENCE PLASMA

K820085 is an FDA 510(k) clearance for DADE FACTOR ASSAY REFERENCE PLASMA, manufactured by American Dade. The device is a Class 2 Hematology device with product code GGP cleared through the Traditional 510(k) pathway after a 42-day FDA review.

K820085 · American Dade · Hematology device
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Feb 1982
Decision
42d
Days
Class 2
Risk

K820085 is an FDA 510(k) clearance for the DADE FACTOR ASSAY REFERENCE PLASMA. Classified as Test, Qualitative And Quantitative Factor Deficiency (product code GGP), Class II - Special Controls.

Submitted by American Dade (Mchenry, US). The FDA issued a Cleared decision on February 23, 1982 after a review of 42 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 American Dade devices

FDA 510(k) Submission Details - K820085

510(k) Number K820085 FDA.gov
FDA Decision Cleared Substantially Equivalent - Traditional 510(k) (SESE)
Date Received January 12, 1982
Decision Date February 23, 1982
Days to Decision 42 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
71d faster than avg
Panel avg: 113d · This submission: 42d
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 K820085.
VON WILLEBRAND FACTOR ASSAY
K823453 · General Diagnostics · Jan 1983
FACTOR VIII RELATED ANTIGEN ROCKET EID
K823267 · Helena Laboratories · Dec 1982
EIA-F8 ENZYMEIMMUNOASSAY KIT FOR QUANT.
K821963 · Intl. Immunoassay Laboratories, Inc. · Jul 1982
LANCER COAGENT HUMAN FACTOR 1X PLASMA
K812974 · Sherwood Medical Co. · Nov 1981
LANCER COAGENT HUMAN VACTOR VIII PLASMA
K812975 · Sherwood Medical Co. · Nov 1981
FACTOR VIII DEFICIENT PLASMA #B8D
K812431 · Sigma Chemical Co. · Sep 1981