Cleared Traditional

K831608 - FIAX IGM TEST KIT

K831608 is the FDA 510(k) clearance for FIAX IGM TEST KIT by Intl. Diagnostic Technology. It is a Class 2 Immunology device (product code DFT) cleared through the Traditional 510(k) pathway after a 35-day FDA review.

K831608 · Intl. Diagnostic Technology · Immunology device
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Jun 1983
Decision
35d
Days
Class 2
Risk

K831608 is an FDA 510(k) clearance for the FIAX IGM TEST KIT. Classified as Igm, Antigen, Antiserum, Control (product code DFT), Class II - Special Controls.

Submitted by Intl. Diagnostic Technology (Mchenry, US). The FDA issued a Cleared decision on June 22, 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 866.5550 - 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 Intl. Diagnostic Technology devices

Submission Details

510(k) Number K831608 FDA.gov
FDA Decision Cleared Substantially Equivalent - Traditional 510(k) (SESE)
Date Received May 18, 1983
Decision Date June 22, 1983
Days to Decision 35 days
Submission Type Traditional
Review Panel Immunology (IM)
Summary -
Third-party Review No - reviewed directly by FDA
Regulatory Context
Review time vs. panel average
69d faster than avg
Panel avg: 104d · This submission: 35d
Pathway characteristics
Predicate-based equivalence. No clinical trials required.

Device Classification

Product Code DFT Igm, Antigen, Antiserum, Control
Device Class Class 2 - Special Controls
CFR Regulation 21 CFR 866.5550
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 - DFT Igm, Antigen, Antiserum, Control

All 23
Devices cleared under the same product code (DFT) and FDA review panel - the closest regulatory comparables to K831608.
QUANTIMETRIC PLUS IGM REAGENT KIT
K855010 · Kallestad Laboratories, Inc. · Feb 1986
AMER. HISTO-ID SYS PRIMARY IGM S7920-31
K842327 · Bartels Immunodiagnostic Supplies, Inc. · Aug 1984
OPTIMATE IGM TEST
K841814 · Miles Laboratories, Inc. · Jun 1984
QUIK-SEP IGM ISOLATION SYSTEM
K830606 · Isolab, Inc. · Mar 1983
ACA IMMUNOGLOBIN M TEST PACK
K812632 · E.I. Dupont DE Nemours & Co., Inc. · Sep 1981
AIM SYSTEM (FOR IGM)
K811124 · Icl Scientific · May 1981