Cleared Traditional

K801019 - 125I-IGE RADIOIMMUNOASSAY KIT

K801019 is the FDA 510(k) clearance for 125I-IGE RADIOIMMUNOASSAY KIT by Bio-Ria. It is a Class 2 Immunology device (product code DGC) cleared through the Traditional 510(k) pathway after a 20-day FDA review.

K801019 · Bio-Ria · Immunology device
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May 1980
Decision
20d
Days
Class 2
Risk

K801019 is an FDA 510(k) clearance for the 125I-IGE RADIOIMMUNOASSAY KIT. Classified as Ige, Antigen, Antiserum, Control (product code DGC), Class II - Special Controls.

Submitted by Bio-Ria (Mchenry, US). The FDA issued a Cleared decision on May 20, 1980 after a review of 20 days - a notably fast clearance cycle.

This device falls under the Immunology FDA review panel, regulated under 21 CFR 866.5510 - the FDA immunology 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 Bio-Ria devices

Submission Details

510(k) Number K801019 FDA.gov
FDA Decision Cleared Substantially Equivalent - Traditional 510(k) (SESE)
Date Received April 30, 1980
Decision Date May 20, 1980
Days to Decision 20 days
Submission Type Traditional
Review Panel Immunology (IM)
Summary -
Third-party Review No - reviewed directly by FDA
Regulatory Context
Review time vs. panel average
84d faster than avg
Panel avg: 104d · This submission: 20d
Pathway characteristics
Predicate-based equivalence. No clinical trials required.

Device Classification

Product Code DGC Ige, Antigen, Antiserum, Control
Device Class Class 2 - Special Controls
CFR Regulation 21 CFR 866.5510
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 Immunology devices follow this clearance model.

Regulatory Peers - DGC Ige, Antigen, Antiserum, Control

All 85
Devices cleared under the same product code (DGC) and FDA review panel - the closest regulatory comparables to K801019.
KALLESTAD QUANTITOPE LOW LEVEL IGE REAG
K811545 · Kallestad Laboratories, Inc. · Jun 1981
TAN DEM* - IGE KIT
K802913 · Hybritech, Inc. · May 1981
PHADEZYM IGE PRIST TEST
K810507 · Pharmacia, Inc. · Mar 1981
RIA KIT, QUANTITOPE IGE
K781904 · Kallestad Laboratories, Inc. · Feb 1979
LAS-R HUMAN IGE TEST
K780753 · Hyland Therapeutic Div., Travenol Laboratories · Jun 1978
RID PLATES & INTENSI. FOR HUMAN IGE ETC
K771238 · G.D. Searle and Co. · Jul 1977