Cleared Traditional

K831906 - RABBIT ANTISERUM TO HUMAN C4

K831906 is an FDA 510(k) clearance for RABBIT ANTISERUM TO HUMAN C4, manufactured by Dako Corp.. The device is a Class 2 Immunology device with product code DBI cleared through the Traditional 510(k) pathway after a 35-day FDA review.

K831906 · Dako Corp. · Immunology device
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Jul 1983
Decision
35d
Days
Class 2
Risk

K831906 is an FDA 510(k) clearance for the RABBIT ANTISERUM TO HUMAN C4. Classified as Complement C4, Antigen, Antiserum, Control (product code DBI), Class II - Special Controls.

Submitted by Dako Corp. (Mchenry, US). The FDA issued a Cleared decision on July 19, 1983 after a review of 35 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 Dako Corp. devices

FDA 510(k) Submission Details - K831906

510(k) Number K831906 FDA.gov
FDA Decision Cleared Substantially Equivalent - Traditional 510(k) (SESE)
Date Received June 14, 1983
Decision Date July 19, 1983
Days to Decision 35 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
70d faster than avg
Panel avg: 105d · This submission: 35d
Pathway characteristics
Predicate-based equivalence. No clinical trials required.

DBI Device Classification - Class 2, Special Controls

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 27
Devices cleared under the same product code (DBI) and FDA review panel - the closest regulatory comparables to K831906.
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
FIAX COMPLEMENT C4 TEST KIT
K830669 · Intl. Diagnostic Technology · Apr 1983
IMMUNOGL. FRCT. OF RABBIT ANTISER.-C4
K812490 · Dako Corp. · Sep 1981
COMPLEMENT C4 NEPHELOMETRIC ASSAY
K801361 · J.T. Baker Chemical Co. · Jun 1980