Cleared Traditional

K831607 - FIAX IGA TEST KIT

K831607 is an FDA 510(k) clearance for FIAX IGA TEST KIT, manufactured by Intl. Diagnostic Technology. The device is a Class 2 Immunology device with product code CZN cleared through the Traditional 510(k) pathway after a 35-day FDA review.

K831607 · Intl. Diagnostic Technology · Immunology device
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Jun 1983
Decision
35d
Days
Class 2
Risk

K831607 is an FDA 510(k) clearance for the FIAX IGA TEST KIT. Classified as Iga, Fitc, Antigen, Antiserum, Control (product code CZN), 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 866.5510 - 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 Intl. Diagnostic Technology devices

FDA 510(k) Submission Details - K831607

510(k) Number K831607 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
Combination Product No
PCCP Authorized No
Regulatory Context
Review time vs. panel average
70d faster than avg
Panel avg: 105d · This submission: 35d
Pathway characteristics
Predicate-based equivalence. No clinical trials required.

CZN Device Classification - Class 2, Special Controls

Product Code CZN Iga, Fitc, 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.