Cleared Traditional

K853468 - GILFORD C4 COMPLEMENT REAGENT

K853468 is the FDA 510(k) clearance for GILFORD C4 COMPLEMENT REAGENT by Gilford. It is a Class 2 Immunology device (product code DBI) cleared through the Traditional 510(k) pathway after a 28-day FDA review.

K853468 · Gilford · Immunology device
Download Printable Device Report (PDF)
Optimized for regulatory review, auditing and printing
Sep 1985
Decision
28d
Days
Class 2
Risk

K853468 is an FDA 510(k) clearance for the GILFORD C4 COMPLEMENT REAGENT. Classified as Complement C4, Antigen, Antiserum, Control (product code DBI), 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 866.5240 - 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 K853468 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 DBI Complement C4, Antigen, Antiserum, Control
Device Class Class 2 - Special Controls
CFR Regulation 21 CFR 866.5240
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 - DBI Complement C4, Antigen, Antiserum, Control

All 24
Devices cleared under the same product code (DBI) and FDA review panel - the closest regulatory comparables to K853468.
PRECIMAT(R) C4
K871023 · Boehringer Mannheim Corp. · May 1987
TINA-QUANT(R) (A) C4
K870931 · Boehringer Mannheim Corp. · Mar 1987
QUANTIMETRIC PLUS C4 REAGENT KIT
K855012 · Kallestad Laboratories, Inc. · Feb 1986
C4 ANTIGEN ANTIBODY CONTROL
K834605 · Technicon Instruments Corp. · Jan 1984
RABBIT ANTISERUM TO HUMAN C4
K831906 · Dako Corp. · Jul 1983
IMMUNOGL. FRCT. OF RABBIT ANTISER.-C4
K812490 · Dako Corp. · Sep 1981