Cleared Traditional

K901577 - MILENIA(TM) OPIATES

K901577 is the FDA 510(k) clearance for MILENIA(TM) OPIATES by Diagnostic Products Corp.. It is a Class 2 Toxicology device (product code DJG) cleared through the Traditional 510(k) pathway after a 43-day FDA review.

K901577 · Diagnostic Products Corp. · Toxicology device
Download Printable Device Report (PDF)
Optimized for regulatory review, auditing and printing
May 1990
Decision
43d
Days
Class 2
Risk

K901577 is an FDA 510(k) clearance for the MILENIA(TM) OPIATES. Classified as Enzyme Immunoassay, Opiates (product code DJG), Class II - Special Controls.

Submitted by Diagnostic Products Corp. (Los Angeles, US). The FDA issued a Cleared decision on May 17, 1990 after a review of 43 days - a notably fast clearance cycle.

This device falls under the Toxicology FDA review panel, regulated under 21 CFR 862.3650 - 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 K901577 FDA.gov
FDA Decision Cleared Substantially Equivalent - Traditional 510(k) (SESE)
Date Received April 04, 1990
Decision Date May 17, 1990
Days to Decision 43 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
44d faster than avg
Panel avg: 87d · This submission: 43d
Pathway characteristics
Predicate-based equivalence. No clinical trials required.

Device Classification

Product Code DJG Enzyme Immunoassay, Opiates
Device Class Class 2 - Special Controls
CFR Regulation 21 CFR 862.3650
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 - DJG Enzyme Immunoassay, Opiates

All 126
Devices cleared under the same product code (DJG) and FDA review panel - the closest regulatory comparables to K901577.
ABUSCREEN ONLINE TM FOR OPIATES
K904997 · Roche Diagnostic Systems, Inc. · Dec 1990
BIOSITE DIAGNOSTICS OPIATE SCREENING TEST
K902924 · Biosite Incorporated · Sep 1990
EMIT(R) II OPIATE ASSAY
K902577 · Syva Co. · Jul 1990
HYCOR ACCUPINCH MORPHINE TEST
K900173 · Hycor Biomedical, Inc. · Mar 1990
COAT-A-COUNT(TM) FENTANYL (TKFN1)
K891605 · Diagnostic Products Corp. · Sep 1989
ABUSCREEN FP FOR MORPHINE
K890888 · Roche Diagnostic Systems, Inc. · Mar 1989