Cleared Traditional

K800032 - FIAX TEST KIT FOR GENTAMICIN QUAN.

K800032 is an FDA 510(k) clearance for FIAX TEST KIT FOR GENTAMICIN QUAN., manufactured by Intl. Diagnostic Technology. The device is a Class 2 Toxicology device with product code LCQ cleared through the Traditional 510(k) pathway after a 16-day FDA review.

K800032 · Intl. Diagnostic Technology · Toxicology device
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Jan 1980
Decision
16d
Days
Class 2
Risk

K800032 is an FDA 510(k) clearance for the FIAX TEST KIT FOR GENTAMICIN QUAN.. Classified as Fluorescent Immunoassay Gentamicin (product code LCQ), Class II - Special Controls.

Submitted by Intl. Diagnostic Technology (Mchenry, US). The FDA issued a Cleared decision on January 23, 1980 after a review of 16 days - a notably fast clearance cycle.

This device falls under the Toxicology FDA review panel, regulated under 21 CFR 862.3450 - the FDA toxicology 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 - K800032

510(k) Number K800032 FDA.gov
FDA Decision Cleared Substantially Equivalent - Traditional 510(k) (SESE)
Date Received January 07, 1980
Decision Date January 23, 1980
Days to Decision 16 days
Submission Type Traditional
Review Panel Toxicology (TX)
Summary -
Third-party Review No - reviewed directly by FDA
Combination Product No
PCCP Authorized No
Regulatory Context
Review time vs. panel average
71d faster than avg
Panel avg: 87d · This submission: 16d
Pathway characteristics
Predicate-based equivalence. No clinical trials required.

LCQ Device Classification - Class 2, Special Controls

Product Code LCQ Fluorescent Immunoassay Gentamicin
Device Class Class 2 - Special Controls
CFR Regulation 21 CFR 862.3450
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 Toxicology devices follow this clearance model.