Cleared Traditional

K853469 - GILFORD IMMUNOGLOBULIN M REAGENT

K853469 is the FDA 510(k) clearance for GILFORD IMMUNOGLOBULIN M REAGENT by Gilford. It is a Class 2 Immunology device (product code DFT) cleared through the Traditional 510(k) pathway after a 28-day FDA review.

K853469 · Gilford · Immunology device
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Sep 1985
Decision
28d
Days
Class 2
Risk

K853469 is an FDA 510(k) clearance for the GILFORD IMMUNOGLOBULIN M REAGENT. Classified as Igm, Antigen, Antiserum, Control (product code DFT), Class II - Special Controls.

Submitted by Gilford (Oberlin, US). The FDA issued a Cleared decision on September 16, 1985 after a review of 28 days - a notably fast clearance cycle.

This device falls under the Immunology FDA review panel, regulated under 21 CFR 866.5550 - 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 Gilford devices

Submission Details

510(k) Number K853469 FDA.gov
FDA Decision Cleared Substantially Equivalent - Traditional 510(k) (SESE)
Date Received August 19, 1985
Decision Date September 16, 1985
Days to Decision 28 days
Submission Type Traditional
Review Panel Immunology (IM)
Summary -
Third-party Review No - reviewed directly by FDA
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 DFT Igm, Antigen, Antiserum, Control
Device Class Class 2 - Special Controls
CFR Regulation 21 CFR 866.5550
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 - DFT Igm, Antigen, Antiserum, Control

All 23
Devices cleared under the same product code (DFT) and FDA review panel - the closest regulatory comparables to K853469.
TITAN GEL IMMUNOFIX CONTROLS
K871498 · Helena Laboratories · Apr 1987
TINA-QUANT(R) IGM
K862762 · Boehringer Mannheim Corp. · Sep 1986
QUANTIMETRIC PLUS IGM REAGENT KIT
K855010 · Kallestad Laboratories, Inc. · Feb 1986
AMER. HISTO-ID SYS PRIMARY IGM S7920-31
K842327 · Bartels Immunodiagnostic Supplies, Inc. · Aug 1984
OPTIMATE IGM TEST
K841814 · Miles Laboratories, Inc. · Jun 1984
QUIK-SEP IGM ISOLATION SYSTEM
K830606 · Isolab, Inc. · Mar 1983