Cleared Traditional

K833715 - EMIT NETILMICIN ASSAY

K833715 is the FDA 510(k) clearance for EMIT NETILMICIN ASSAY by Syva Co.. It is a Class 2 Toxicology device (product code LCE) cleared through the Traditional 510(k) pathway after a 67-day FDA review.

K833715 · Syva Co. · Toxicology device
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Dec 1983
Decision
67d
Days
Class 2
Risk

K833715 is an FDA 510(k) clearance for the EMIT NETILMICIN ASSAY. Classified as Radioimmunoassay, Netilmicin (i-125) (product code LCE), Class II - Special Controls.

Submitted by Syva Co. (Mchenry, US). The FDA issued a Cleared decision on December 27, 1983 after a review of 67 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 Syva Co. devices

Submission Details

510(k) Number K833715 FDA.gov
FDA Decision Cleared Substantially Equivalent - Traditional 510(k) (SESE)
Date Received October 21, 1983
Decision Date December 27, 1983
Days to Decision 67 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
20d faster than avg
Panel avg: 87d · This submission: 67d
Pathway characteristics
Predicate-based equivalence. No clinical trials required.

Device Classification

Product Code LCE Radioimmunoassay, Netilmicin (i-125)
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.

Regulatory Peers - LCE Radioimmunoassay, Netilmicin (i-125)

Devices cleared under the same product code (LCE) and FDA review panel - the closest regulatory comparables to K833715.
AMES TDA NETILMICIN TEST & SERUM
K832088 · Miles Laboratories, Inc. · Oct 1983
NETILMICIN FLUORESCENT IMMUNOASSAY
K822941 · American Diagnostic Corp. · Oct 1982
TDX NETILMICIN
K821698 · Abbott Laboratories · Jun 1982
MACRO-VUE CARD TEST, NETILMICIN
K821399 · Bd Becton Dickinson Vacutainer Systems Preanalytic · May 1982
EMIT AND NETILMICIN ASSAY
K820324 · Syva Co. · Feb 1982