Cleared Traditional

K853465 - GILFORD IMMUNOGLOBULIN G REAGENT

K853465 is the FDA 510(k) clearance for GILFORD IMMUNOGLOBULIN G REAGENT by Gilford. It is a Class 2 Immunology device (product code DEW) cleared through the Traditional 510(k) pathway after a 28-day FDA review.

K853465 · Gilford · Immunology device
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Sep 1985
Decision
28d
Days
Class 2
Risk

K853465 is an FDA 510(k) clearance for the GILFORD IMMUNOGLOBULIN G REAGENT. Classified as Igg, Antigen, Antiserum, Control (product code DEW), 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 866.5510 - 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 Gilford devices

Submission Details

510(k) Number K853465 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 DEW Igg, 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 - DEW Igg, Antigen, Antiserum, Control

All 55
Devices cleared under the same product code (DEW) and FDA review panel - the closest regulatory comparables to K853465.
PENTAVALENT ANTISERUM TO HUMAN IMMUNOGLOBULINS
K871352 · Helena Laboratories · Apr 1987
TINA-QUANT(R) IGG
K862764 · Boehringer Mannheim Corp. · Sep 1986
DAKO ITA SYSTEM
K861059 · Dako Corp. · Aug 1986
DART IMMUNOGLOBULINS REAGENT SYSTEM
K851541 · Coulter Electronics, Inc. · Jul 1985
TDX IMMUNOGLOBULIN G DIAGNOSTIC KIT
K852589 · Abbott Laboratories · Jul 1985
AMER. HISTO-ID SYS PRIMARY IGG S7920-11
K842329 · Bartels Immunodiagnostic Supplies, Inc. · Aug 1984