Cleared Traditional

K811692 - GENTAMICIN REAGENT TEST KIT

K811692 is an FDA 510(k) clearance for GENTAMICIN REAGENT TEST KIT, manufactured by Beckman Instruments, Inc.. The device is a Class 2 Toxicology device with product code LCD cleared through the Traditional 510(k) pathway after a 30-day FDA review.

K811692 · Beckman Instruments, Inc. · Toxicology device
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Jul 1981
Decision
30d
Days
Class 2
Risk

K811692 is an FDA 510(k) clearance for the GENTAMICIN REAGENT TEST KIT. Classified as Enzyme Immunoassay, Gentamicin (product code LCD), Class II - Special Controls.

Submitted by Beckman Instruments, Inc. (Mchenry, US). The FDA issued a Cleared decision on July 15, 1981 after a review of 30 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 Beckman Instruments, Inc. devices

FDA 510(k) Submission Details - K811692

510(k) Number K811692 FDA.gov
FDA Decision Cleared Substantially Equivalent - Traditional 510(k) (SESE)
Date Received June 15, 1981
Decision Date July 15, 1981
Days to Decision 30 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
57d faster than avg
Panel avg: 87d · This submission: 30d
Pathway characteristics
Predicate-based equivalence. No clinical trials required.

LCD Device Classification - Class 2, Special Controls

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 Toxicology devices follow this clearance model.

Regulatory Peers - LCD Enzyme Immunoassay, Gentamicin

All 34
Devices cleared under the same product code (LCD) and FDA review panel - the closest regulatory comparables to K811692.
EMIT QST TOBRAMYCIN ASSAY
K831416 · Syva Co. · Jun 1983
EMIT QST GENTAMICIN ASSAY
K831304 · Syva Co. · Jun 1983
SOPHEIA GENTAMICIN EIA KIT
K823387 · Diagnostic Products Corp. · Dec 1982
VIRGO IPA FOR DETECTION OF GENTAMICIN
K811744 · Electro-Nucleonics Laboratories, Inc. · Jul 1981
EMIT TOBRAMYCIN ASSAY
K800150 · Syva Co. · Feb 1980