Cleared Traditional

K831304 - EMIT QST GENTAMICIN ASSAY

K831304 is the FDA 510(k) clearance for EMIT QST GENTAMICIN ASSAY by Syva Co.. It is a Class 2 Immunology device (product code LCD) cleared through the Traditional 510(k) pathway after a 42-day FDA review.

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 30
Devices cleared under the same product code (LCD) and FDA review panel - the closest regulatory comparables to K831304.
STRATUS GENTAMICIN FLUOROMETRIC ENZYM
K832445 · American Dade · Aug 1983
EMIT AMD GENTAMICIN ASSAY
K832056 · Syva Co. · Aug 1983
EMIT QST TOBRAMYCIN ASSAY
K831416 · Syva Co. · Jun 1983
SOPHEIA GENTAMICIN EIA KIT
K823387 · Diagnostic Products Corp. · Dec 1982
GENTAMICIN REAGENT TEST KIT
K811692 · Beckman Instruments, Inc. · Jul 1981
VIRGO IPA FOR DETECTION OF GENTAMICIN
K811744 · Electro-Nucleonics Laboratories, Inc. · Jul 1981