Cleared Traditional

K833402 - TECH. RA-1000SYS-ANALYTES IMMUNOGLOBULIN

K833402 is the FDA 510(k) clearance for TECH. RA-1000SYS-ANALYTES IMMUNOGLOBULIN by Technicon Instruments Corp.. It is a Class 2 Chemistry device (product code DEW) cleared through the Traditional 510(k) pathway after a 116-day FDA review.

K833402 · Technicon Instruments Corp. · Chemistry device
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Jan 1984
Decision
116d
Days
Class 2
Risk

K833402 is an FDA 510(k) clearance for the TECH. RA-1000SYS-ANALYTES IMMUNOGLOBULIN. Classified as Igg, Antigen, Antiserum, Control (product code DEW), Class II - Special Controls.

Submitted by Technicon Instruments Corp. (Walker, 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 Chemistry FDA review panel, regulated under 21 CFR 866.5510 - the FDA in vitro diagnostics and chemistry 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 Chemistry review framework, consistent with the majority of Class II 510(k) submissions.

View all Technicon Instruments Corp. devices

Submission Details

510(k) Number K833402 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 Chemistry (CH)
Summary -
Third-party Review No - reviewed directly by FDA
Combination Product No
PCCP Authorized No
Regulatory Context
Review time vs. panel average
28d slower than avg
Panel avg: 88d · This submission: 116d
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 Chemistry devices follow this clearance model.

Regulatory Peers - DEW Igg, Antigen, Antiserum, Control

All 54
Devices cleared under the same product code (DEW) and FDA review panel - the closest regulatory comparables to K833402.
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
OPTIMATE IGG TEST
K841816 · Miles Laboratories, Inc. · Jun 1984
TITAN IMMUNO-FIX
K830594 · Helena Laboratories · Mar 1983
DAKO PAP KIT K505
K812484 · Dako Corp. · Feb 1982
ACA IMMUNOGLOBULIN G ANALYTICAL TEST
K812664 · E.I. Dupont DE Nemours & Co., Inc. · Oct 1981