Cleared Traditional

K834605 - C4 ANTIGEN ANTIBODY CONTROL

K834605 is an FDA 510(k) clearance for C4 ANTIGEN ANTIBODY CONTROL, manufactured by Technicon Instruments Corp.. The device is a Class 2 Immunology device with product code DBI cleared through the Traditional 510(k) pathway after a 116-day FDA review.

K834605 · Technicon Instruments Corp. · Immunology device
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Jan 1984
Decision
116d
Days
Class 2
Risk

K834605 is an FDA 510(k) clearance for the C4 ANTIGEN ANTIBODY CONTROL. Classified as Complement C4, Antigen, Antiserum, Control (product code DBI), Class II - Special Controls.

Submitted by Technicon Instruments Corp. (Mchenry, US). The FDA issued a Cleared decision on January 24, 1984 after a review of 116 days - within the typical 510(k) review window.

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: Standard predicate-based submission. Standard predicate reliance. This clearance follows a standard predicate-based equivalence path within the Immunology review framework, consistent with the majority of Class II 510(k) submissions.

View all Technicon Instruments Corp. devices

FDA 510(k) Submission Details - K834605

510(k) Number K834605 FDA.gov
FDA Decision Cleared Substantially Equivalent - Traditional 510(k) (SESE)
Date Received September 30, 1983
Decision Date January 24, 1984
Days to Decision 116 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
11d slower than avg
Panel avg: 105d · This submission: 116d
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 K834605.
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
RABBIT ANTISERUM TO HUMAN C4
K831906 · Dako Corp. · Jul 1983
FIAX COMPLEMENT C4 TEST KIT
K830669 · Intl. Diagnostic Technology · Apr 1983
IMMUNOGL. FRCT. OF RABBIT ANTISER.-C4
K812490 · Dako Corp. · Sep 1981