Cleared Traditional

K782025 - GENTAMICIN FLUROIMMUNASSAY KIT

K782025 is the FDA 510(k) clearance for GENTAMICIN FLUROIMMUNASSAY KIT by Technia Diagnostics , Ltd.. It is a Class 2 Toxicology device (product code LCQ) cleared through the Traditional 510(k) pathway after a 52-day FDA review.

K782025 · Technia Diagnostics , Ltd. · Toxicology device
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Jan 1979
Decision
52d
Days
Class 2
Risk

K782025 is an FDA 510(k) clearance for the GENTAMICIN FLUROIMMUNASSAY KIT. Classified as Fluorescent Immunoassay Gentamicin (product code LCQ), Class II - Special Controls.

Submitted by Technia Diagnostics , Ltd. (Mchenry, US). The FDA issued a Cleared decision on January 26, 1979 after a review of 52 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 Technia Diagnostics , Ltd. devices

Submission Details

510(k) Number K782025 FDA.gov
FDA Decision Cleared Substantially Equivalent - Traditional 510(k) (SESE)
Date Received December 05, 1978
Decision Date January 26, 1979
Days to Decision 52 days
Submission Type Traditional
Review Panel Toxicology (TX)
Summary -
Third-party Review No - reviewed directly by FDA
Regulatory Context
Review time vs. panel average
35d faster than avg
Panel avg: 87d · This submission: 52d
Pathway characteristics
Predicate-based equivalence. No clinical trials required.

Device Classification

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.