Cleared Traditional

K812488 - IMMUNOGL. FRCT. OF RABBIT ANTISER.-IGA

K812488 is the FDA 510(k) clearance for IMMUNOGL. FRCT. OF RABBIT ANTISER.-IGA by Dako Corp.. It is a Class 2 Immunology device (product code CZP) cleared through the Traditional 510(k) pathway after a 23-day FDA review.

K812488 · Dako Corp. · Immunology device
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Sep 1981
Decision
23d
Days
Class 2
Risk

K812488 is an FDA 510(k) clearance for the IMMUNOGL. FRCT. OF RABBIT ANTISER.-IGA. Classified as Iga, Antigen, Antiserum, Control (product code CZP), Class II - Special Controls.

Submitted by Dako Corp. (Mchenry, US). The FDA issued a Cleared decision on September 23, 1981 after a review of 23 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 Dako Corp. devices

Submission Details

510(k) Number K812488 FDA.gov
FDA Decision Cleared Substantially Equivalent - Traditional 510(k) (SESE)
Date Received August 31, 1981
Decision Date September 23, 1981
Days to Decision 23 days
Submission Type Traditional
Review Panel Immunology (IM)
Summary -
Third-party Review No - reviewed directly by FDA
Combination Product No
PCCP Authorized No
Regulatory Context
Review time vs. panel average
81d faster than avg
Panel avg: 104d · This submission: 23d
Pathway characteristics
Predicate-based equivalence. No clinical trials required.

Device Classification

Product Code CZP Iga, 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 - CZP Iga, Antigen, Antiserum, Control

All 42
Devices cleared under the same product code (CZP) and FDA review panel - the closest regulatory comparables to K812488.
IMMUNO DIAGNOSTICS ASSAY
K822026 · Helena Laboratories · Aug 1982
ACA IMMUNOGLOBIN A TEST PACK
K812631 · E.I. Dupont DE Nemours & Co., Inc. · Sep 1981
ACA IMMUNOGLOBULIN A/M CALIBRATORS
K812633 · E.I. Dupont DE Nemours & Co., Inc. · Sep 1981
AIM SYSTEM (FOR IGA)
K811125 · Icl Scientific · May 1981
AUTOMATED IMMUNOPRECIPITIN METHOD/IGA
K803274 · Icl Scientific · Jan 1981
J.T. BAKER IMMUNO. A NEPHELOMETRIC ASSAY
K801283 · J.T. Baker Chemical Co. · Jun 1980