Cleared Traditional

K813542 - TOBRAMYCIN FLUORESCENT IMMUNOASSAY

K813542 is an FDA 510(k) clearance for TOBRAMYCIN FLUORESCENT IMMUNOASSAY, manufactured by American Diagnostic Corp.. The device is a Class 2 Toxicology device with product code LCR cleared through the Traditional 510(k) pathway after a 22-day FDA review.

K813542 · American Diagnostic Corp. · Toxicology device
Download Printable Device Report (PDF)
Optimized for regulatory review, auditing and printing
Jan 1982
Decision
22d
Days
Class 2
Risk

K813542 is an FDA 510(k) clearance for the TOBRAMYCIN FLUORESCENT IMMUNOASSAY. Classified as Fluorescent Immunoassay, Tobramycin (product code LCR), Class II - Special Controls.

Submitted by American Diagnostic Corp. (Walker, US). The FDA issued a Cleared decision on January 12, 1982 after a review of 22 days - a notably fast clearance cycle.

This device falls under the Toxicology FDA review panel, regulated under 21 CFR 862.3900 - 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 American Diagnostic Corp. devices

FDA 510(k) Submission Details - K813542

510(k) Number K813542 FDA.gov
FDA Decision Cleared Substantially Equivalent - Traditional 510(k) (SESE)
Date Received December 21, 1981
Decision Date January 12, 1982
Days to Decision 22 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
65d faster than avg
Panel avg: 87d · This submission: 22d
Pathway characteristics
Predicate-based equivalence. No clinical trials required.

LCR Device Classification - Class 2, Special Controls

Product Code LCR Fluorescent Immunoassay, Tobramycin
Device Class Class 2 - Special Controls
CFR Regulation 21 CFR 862.3900
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 - LCR Fluorescent Immunoassay, Tobramycin

All 15
Devices cleared under the same product code (LCR) and FDA review panel - the closest regulatory comparables to K813542.
NEEDLE HOLDERS
K822197 · Kelleher Corp. · Aug 1982
VIRGO IMMUNO-PRECIPITATION ASSAY TOBRA
K821542 · Electro-Nucleonics Laboratories, Inc. · Jun 1982
ADVANCE SYSTEM EMIT-AMD TOBRAMYCIN ASSAY
K820130 · Syva Co. · Feb 1982
AMES TDA TOBRAMYCIN TEST
K810941 · Miles Laboratories, Inc. · Apr 1981
CYBREX TOBRAMYCIN
K802668 · Abbott Laboratories · Nov 1980
FIAX TEST KIT FOR TOBRAMYCIN QUANTITA
K801308 · Intl. Diagnostic Technology · Jun 1980