Cleared Traditional

EMIT QST GENTAMICIN ASSAY (K831304) - FDA 510(k) Clearance

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

K831304 · Syva Co. · Immunology device
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Jun 1983
Decision
42d
Days
Class 2
Risk

K831304 is an FDA 510(k) clearance for the EMIT QST GENTAMICIN ASSAY. Classified as Enzyme Immunoassay, Gentamicin (product code LCD), Class II - Special Controls.

Submitted by Syva Co. (Mchenry, US). The FDA issued a Cleared decision on June 2, 1983 after a review of 42 days - a notably fast clearance cycle.

This device falls under the Immunology FDA review panel, regulated under 21 CFR 862.3450 - the FDA immunology 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 K831304 FDA.gov
FDA Decision Cleared Substantially Equivalent - Traditional 510(k) (SESE)
Date Received April 21, 1983
Decision Date June 02, 1983
Days to Decision 42 days
Submission Type Traditional
Review Panel Immunology (IM)
Summary -
Third-party Review No - reviewed directly by FDA
Combination Product No
PCCP Authorized No
Regulatory Context
Review time vs. panel average
62d faster than avg
Panel avg: 104d · This submission: 42d
Pathway characteristics
Predicate-based equivalence. No clinical trials required.

Device Classification

Product Code LCD Enzyme 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 Immunology devices follow this clearance model.

Regulatory Peers - LCD Enzyme Immunoassay, Gentamicin

All 36
Devices cleared under the same product code (LCD) and FDA review panel - the closest regulatory comparables to K831304.
ARCHITECT iGentamicin
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IMMULITE 2000 GENTAMICIN, MODELS L2KGE2 (200 TESTS), L2KGE6 (600 TESTS)
K012311 · Diagnostic Products Corp. · Aug 2001
IL TEST GENTAMICIN CALIBRATORS
K943982 · Instrumentation Laboratory CO · Jan 1995
DUPONT DIMENSION(R) GENTAMICIN(GENT) METHOD
K904305 · E.I. Dupont DE Nemours & Co., Inc. · Oct 1990