Cleared Traditional

K840404 - DIFFU-GEN HAPTOGLOBIN RADIAL IMMUNO

K840404 is the FDA 510(k) clearance for DIFFU-GEN HAPTOGLOBIN RADIAL IMMUNO by Tago, Inc.. It is a Class 2 Immunology device (product code DAD) cleared through the Traditional 510(k) pathway after a 38-day FDA review.

K840404 · Tago, Inc. · Immunology device
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Mar 1984
Decision
38d
Days
Class 2
Risk

K840404 is an FDA 510(k) clearance for the DIFFU-GEN HAPTOGLOBIN RADIAL IMMUNO. Classified as Haptoglobin, Antigen, Antiserum, Control (product code DAD), Class II - Special Controls.

Submitted by Tago, Inc. (Mchenry, US). The FDA issued a Cleared decision on March 9, 1984 after a review of 38 days - a notably fast clearance cycle.

This device falls under the Immunology FDA review panel, regulated under 21 CFR 866.5460 - 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 Tago, Inc. devices

Submission Details

510(k) Number K840404 FDA.gov
FDA Decision Cleared Substantially Equivalent - Traditional 510(k) (SESE)
Date Received January 31, 1984
Decision Date March 09, 1984
Days to Decision 38 days
Submission Type Traditional
Review Panel Immunology (IM)
Summary -
Third-party Review No - reviewed directly by FDA
Regulatory Context
Review time vs. panel average
66d faster than avg
Panel avg: 104d · This submission: 38d
Pathway characteristics
Predicate-based equivalence. No clinical trials required.

Device Classification

Product Code DAD Haptoglobin, Antigen, Antiserum, Control
Device Class Class 2 - Special Controls
CFR Regulation 21 CFR 866.5460
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 - DAD Haptoglobin, Antigen, Antiserum, Control

All 13
Devices cleared under the same product code (DAD) and FDA review panel - the closest regulatory comparables to K840404.
RAICHEM(TM) SPIA(TM) HAPTOGLOBIN REAGENT
K911898 · Reagents Applications, Inc. · May 1991
HAPTOGLOBIN
K873866 · Unipath , Ltd. · Oct 1987
QM300 HAPTOGLOBIN ANTIBODY PACK
K872717 · Kallestad Diag, A Div. of Erbamont, Inc. · Jul 1987
DETERM. SIZE 72 RADIAL HUMAN HAPTOGLOB
K831957 · Kent Laboratories, Inc. · Jul 1983
IMMUNOGL. FRCT. OF RABBIT ANTISER.-HAPTO
K812494 · Dako Corp. · Sep 1981
HAPTOGLOBIN NEPHELOMETRIC ASSAY
K801433 · J.T. Baker Chemical Co. · Jul 1980