Cleared Traditional

K821963 - EIA-F8 ENZYMEIMMUNOASSAY KIT FOR QUANT.

K821963 is the FDA 510(k) clearance for EIA-F8 ENZYMEIMMUNOASSAY KIT FOR QUANT. by Intl. Immunoassay Laboratories, Inc.. It is a Class 2 Hematology device (product code GGP) cleared through the Traditional 510(k) pathway after a 26-day FDA review.

K821963 · Intl. Immunoassay Laboratories, Inc. · Hematology device
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Jul 1982
Decision
26d
Days
Class 2
Risk

K821963 is an FDA 510(k) clearance for the EIA-F8 ENZYMEIMMUNOASSAY KIT FOR QUANT.. Classified as Test, Qualitative And Quantitative Factor Deficiency (product code GGP), Class II - Special Controls.

Submitted by Intl. Immunoassay Laboratories, Inc. (Mchenry, US). The FDA issued a Cleared decision on July 27, 1982 after a review of 26 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 Intl. Immunoassay Laboratories, Inc. devices

Submission Details

510(k) Number K821963 FDA.gov
FDA Decision Cleared Substantially Equivalent - Traditional 510(k) (SESE)
Date Received July 01, 1982
Decision Date July 27, 1982
Days to Decision 26 days
Submission Type Traditional
Review Panel Hematology (HE)
Summary -
Third-party Review No - reviewed directly by FDA
Regulatory Context
Review time vs. panel average
87d faster than avg
Panel avg: 113d · This submission: 26d
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 127
Devices cleared under the same product code (GGP) and FDA review panel - the closest regulatory comparables to K821963.
FACTOR II DEFICIENT SUBSTRATE PLASMA
K834031 · Helena Laboratories · Dec 1983
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
LANCER COAGENT HUMAN FACTOR 1X PLASMA
K812974 · Sherwood Medical Co. · Nov 1981
LANCER COAGENT HUMAN VACTOR VIII PLASMA
K812975 · Sherwood Medical Co. · Nov 1981