Cleared Traditional

SYVA ADVANCE SYST. EMIT-AMD GENT. ASSAY (K820285) - FDA 510(k) Clearance

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

K820285 · Syva Co. · Toxicology device
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Feb 1982
Decision
16d
Days
Class 2
Risk

K820285 is an FDA 510(k) clearance for the SYVA ADVANCE SYST. EMIT-AMD GENT. ASSAY. Classified as Fluorescent Immunoassay Gentamicin (product code LCQ), Class II - Special Controls.

Submitted by Syva Co. (Mchenry, US). The FDA issued a Cleared decision on February 18, 1982 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 Syva Co. devices

Submission Details

510(k) Number K820285 FDA.gov
FDA Decision Cleared Substantially Equivalent - Traditional 510(k) (SESE)
Date Received February 02, 1982
Decision Date February 18, 1982
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.

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.

Regulatory Peers - LCQ Fluorescent Immunoassay Gentamicin

All 18
Devices cleared under the same product code (LCQ) and FDA review panel - the closest regulatory comparables to K820285.
VARIANT EXPRESS GLYCOHEMOGLOBIN PROGRAM
K972609 · Bio-Rad · Aug 1997
COBAS(R)-FP REAGENTS FOR GENTAMICIN AND COBAS(R)-FP GENTAMICIN CALIBRATORS
K945523 · Roche Diagnostic Systems, Inc. · Mar 1995
'TDXFLX ANALYZER
K904226 · Abbott Laboratories · Oct 1990
COBAS REAGENTS FOR GENTAMICIN & CALIBRAT
K843827 · Roche Diagnostic Systems, Inc. · Feb 1985
CYBREX GENTAMICIN
K801084 · Abbott Laboratories · May 1980