Cleared Traditional

K830594 - TITAN IMMUNO-FIX

K830594 is the FDA 510(k) clearance for TITAN IMMUNO-FIX by Helena Laboratories. It is a Class 2 Immunology device (product code DEW) cleared through the Traditional 510(k) pathway after a 28-day FDA review.

K830594 · Helena Laboratories · Immunology device
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Mar 1983
Decision
28d
Days
Class 2
Risk

K830594 is an FDA 510(k) clearance for the TITAN IMMUNO-FIX. Classified as Igg, Antigen, Antiserum, Control (product code DEW), Class II - Special Controls.

Submitted by Helena Laboratories (Mchenry, US). The FDA issued a Cleared decision on March 24, 1983 after a review of 28 days - a notably fast clearance cycle.

This device falls under the Immunology FDA review panel, regulated under 21 CFR 866.5510 - 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 Helena Laboratories devices

Submission Details

510(k) Number K830594 FDA.gov
FDA Decision Cleared Substantially Equivalent - Traditional 510(k) (SESE)
Date Received February 24, 1983
Decision Date March 24, 1983
Days to Decision 28 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
76d faster than avg
Panel avg: 104d · This submission: 28d
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 Immunology 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 K830594.
AMER. HISTO-ID SYS PRIMARY IGG S7920-11
K842329 · Bartels Immunodiagnostic Supplies, Inc. · Aug 1984
OPTIMATE IGG TEST
K841816 · Miles Laboratories, Inc. · Jun 1984
TECH. RA-1000SYS-ANALYTES IMMUNOGLOBULIN
K833402 · Technicon Instruments Corp. · Jan 1984
DAKO PAP KIT K505
K812484 · Dako Corp. · Feb 1982
ACA IMMUNOGLOBULIN G ANALYTICAL TEST
K812664 · E.I. Dupont DE Nemours & Co., Inc. · Oct 1981
ACA IMMUNOGLOBULIN G CALIBRATOR
K812630 · E.I. Dupont DE Nemours & Co., Inc. · Sep 1981