Cleared Traditional

K913240 - DIGITOXIN (FPIA) KIT

K913240 is an FDA 510(k) clearance for DIGITOXIN (FPIA) KIT, manufactured by Tudor Laboratories, Inc.. The device is a Class 2 Toxicology device with product code LFM cleared through the Traditional 510(k) pathway after a 46-day FDA review.

K913240 · Tudor Laboratories, Inc. · Toxicology device
Download Printable Device Report (PDF)
Optimized for regulatory review, auditing and printing
Sep 1991
Decision
46d
Days
Class 2
Risk

K913240 is an FDA 510(k) clearance for the DIGITOXIN (FPIA) KIT. Classified as Enzyme Immunoassay, Digitoxin (product code LFM), Class II - Special Controls.

Submitted by Tudor Laboratories, Inc. (Dallas, US). The FDA issued a Cleared decision on September 6, 1991 after a review of 46 days - a notably fast clearance cycle.

This device falls under the Toxicology FDA review panel, regulated under 21 CFR 862.3300 - 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 Tudor Laboratories, Inc. devices

FDA 510(k) Submission Details - K913240

510(k) Number K913240 FDA.gov
FDA Decision Cleared Substantially Equivalent - Traditional 510(k) (SESE)
Date Received July 22, 1991
Decision Date September 06, 1991
Days to Decision 46 days
Submission Type Traditional
Review Panel Toxicology (TX)
Summary Summary PDF
Third-party Review No - reviewed directly by FDA
Regulatory Context
Review time vs. panel average
41d faster than avg
Panel avg: 87d · This submission: 46d
Pathway characteristics
Predicate-based equivalence. No clinical trials required.

LFM Device Classification - Class 2, Special Controls

Product Code LFM Enzyme Immunoassay, Digitoxin
Device Class Class 2 - Special Controls
CFR Regulation 21 CFR 862.3300
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 - LFM Enzyme Immunoassay, Digitoxin

All 18
Devices cleared under the same product code (LFM) and FDA review panel - the closest regulatory comparables to K913240.
KODAK EXTACHEM CLINICAL CHEMISTRY SLIDE DIGOXIN (DGXN)
K942610 · Eastman Kodak Company · Oct 1994
EMIT 2000 DIGOXIN ASSAY/CALIBRATORS
K942619 · Syva Co. · Sep 1994
DIGITOXIN FPIA REAGENT SET
K915465 · Sigma Diagnostics, Inc. · Jan 1992
MILENIA (TM) DIGITOXIN
K900013 · Diagnostic Products Corp. · Mar 1990
CEDIA DIGITOXIN ASSAY
K896021 · Microgenics Corp. · Nov 1989
ACA(R) DIGITOXIN (DGTX) METHOD
K891094 · E.I. Dupont DE Nemours & Co., Inc. · Apr 1989