Cleared Traditional

EMIT-AMD AMIKACIN CONTR. (ENZYME IMMUNO (K820440) - FDA 510(k) Clearance

Class II Toxicology device cleared through predicate-based substantial equivalence - typically does not require clinical trials.

K820440 · Syva Co. · Toxicology device
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Mar 1982
Decision
26d
Days
Class 2
Risk

K820440 is an FDA 510(k) clearance for the EMIT-AMD AMIKACIN CONTR. (ENZYME IMMUNO. Classified as Enzymatic Radiochemical Assay, Amikacin (product code LDN), Class II - Special Controls.

Submitted by Syva Co. (Mchenry, US). The FDA issued a Cleared decision on March 15, 1982 after a review of 26 days - a notably fast clearance cycle.

This device falls under the Toxicology FDA review panel, regulated under 21 CFR 862.3035 - 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 Syva Co. devices

Submission Details

510(k) Number K820440 FDA.gov
FDA Decision Cleared Substantially Equivalent - Traditional 510(k) (SESE)
Date Received February 17, 1982
Decision Date March 15, 1982
Days to Decision 26 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
61d faster than avg
Panel avg: 87d · This submission: 26d
Pathway characteristics
Predicate-based equivalence. No clinical trials required.

Device Classification

Product Code LDN Enzymatic Radiochemical Assay, Amikacin
Device Class Class 2 - Special Controls
CFR Regulation 21 CFR 862.3035
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.