Cleared Traditional

K833402 - TECH. RA-1000SYS-ANALYTES IMMUNOGLOBULIN

K833402 is an FDA 510(k) clearance for TECH. RA-1000SYS-ANALYTES IMMUNOGLOBULIN, manufactured by Technicon Instruments Corp.. The device is a Class 2 Chemistry device with 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

FDA 510(k) Submission Details - K833402

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.

DEW Device Classification - Class 2, Special Controls

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 57
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
TIA-IGG REAGENT & CALIBRATOR SETS
K831101 · Worthington Diagnostic Systems · Apr 1983
TITAN IMMUNO-FIX
K830594 · Helena Laboratories · Mar 1983
DAKO PAP KIT K505
K812484 · Dako Corp. · Feb 1982