Cleared Traditional

K874406 - IGE ENZYME IMMUNOASSAY TEST KIT NO. MB-...

K874406 is the FDA 510(k) clearance for IGE ENZYME IMMUNOASSAY TEST KIT NO. MB-... by Medix Biotech, Inc.. It is a Class 2 Immunology device (product code DGC) cleared through the Traditional 510(k) pathway after a 28-day FDA review.

K874406 · Medix Biotech, Inc. · Immunology device
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Nov 1987
Decision
28d
Days
Class 2
Risk

K874406 is an FDA 510(k) clearance for the IGE ENZYME IMMUNOASSAY TEST KIT NO. MB-1064. Classified as Ige, Antigen, Antiserum, Control (product code DGC), Class II - Special Controls.

Submitted by Medix Biotech, Inc. (Foster City, US). The FDA issued a Cleared decision on November 25, 1987 after a review of 28 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 Medix Biotech, Inc. devices

Submission Details

510(k) Number K874406 FDA.gov
FDA Decision Cleared Substantially Equivalent - Traditional 510(k) (SESE)
Date Received October 28, 1987
Decision Date November 25, 1987
Days to Decision 28 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
76d faster than avg
Panel avg: 104d · This submission: 28d
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 83
Devices cleared under the same product code (DGC) and FDA review panel - the closest regulatory comparables to K874406.
PHARMACIA IGE EIA ULTRA
K882626 · Pharmacia, Inc. · Aug 1988
PHARMACIA IGE RIACT
K881892 · Pharmacia, Inc. · Jun 1988
RRT TOTAL IGE TEST KIT
K874541 · Incstar Corp. · Feb 1988
ALLEIA TOTAL IGE IRMA W/MONO. ANTI. RKIE 1,2,5
K872913 · Diagnostic Products Corp. · Sep 1987
TANDEM-M IMMUNOENZYMETRIC ASSAY FOR IGE--
K863858 · Hybritech, Inc. · Nov 1986
ENZYMUN-TEST(R) IGE
K863822 · Boehringer Mannheim Corp. · Oct 1986