Cleared Traditional

MILENIA (TM) DIGITOXIN (K900013) - FDA 510(k) Clearance

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

K900013 · Diagnostic Products Corp. · Toxicology device
Download Printable Device Report (PDF)
Optimized for regulatory review, auditing and printing
Mar 1990
Decision
66d
Days
Class 2
Risk

K900013 is an FDA 510(k) clearance for the MILENIA (TM) DIGITOXIN. Classified as Enzyme Immunoassay, Digitoxin (product code LFM), Class II - Special Controls.

Submitted by Diagnostic Products Corp. (Los Angeles, US). The FDA issued a Cleared decision on March 9, 1990 after a review of 66 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 Diagnostic Products Corp. devices

Submission Details

510(k) Number K900013 FDA.gov
FDA Decision Cleared Substantially Equivalent - Traditional 510(k) (SESE)
Date Received January 02, 1990
Decision Date March 09, 1990
Days to Decision 66 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
21d faster than avg
Panel avg: 87d · This submission: 66d
Pathway characteristics
Predicate-based equivalence. No clinical trials required.

Device Classification

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 19
Devices cleared under the same product code (LFM) and FDA review panel - the closest regulatory comparables to K900013.
DIMENSION VISTA DIGITOXIN, DIGOXIN, GENTAMICIN, N-ACETYLPROCAINAMIDE, PHENYTOIN, THEOPHYLLINE FLEX REAGENT CARTRIDGE
K062024 · Dade Behring, Inc. · Jul 2006
DGTX FLEX REAGENT CARTRIDGE, MODEL DF36
K990251 · Dade Behring, Inc. · Mar 1999
ABBOTT AXSYM DIGITOXIN (MODIFY)
K963158 · Abbott Laboratories · Sep 1996
AXSYM DIGITOXIN
K954420 · Abbott Laboratories · Dec 1995
IMMULITE DIGITOXIN
K943235 · Diagnostic Products Corp. · Oct 1994
EMIT 2000 DIGOXIN ASSAY/CALIBRATORS
K942619 · Syva Co. · Sep 1994