Cleared Traditional

K010079 - INSTANT-VIEW MORPHINE (2000) URINE DIP STRIP TEST

K010079 is an FDA 510(k) clearance for INSTANT-VIEW MORPHINE (2000) URINE DIP ..., manufactured by Alfa Scientific Designs, Inc.. The device is a Class 2 Toxicology device with product code DOE cleared through the Traditional 510(k) pathway after a 139-day FDA review.

K010079 · Alfa Scientific Designs, Inc. · Toxicology device
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May 2001
Decision
139d
Days
Class 2
Risk

K010079 is an FDA 510(k) clearance for the INSTANT-VIEW MORPHINE (2000) URINE DIP STRIP TEST. Classified as Radioimmunoassay, Morphine (125-i), Goat Antibody Ammonium Sulfate Sep. (product code DOE), Class II - Special Controls.

Submitted by Alfa Scientific Designs, Inc. (Poway, US). The FDA issued a Cleared decision on May 29, 2001 after a review of 139 days - within the typical 510(k) review window.

This device falls under the Toxicology FDA review panel, regulated under 21 CFR 862.3640 - 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: Standard predicate-based submission. Standard predicate reliance. This clearance follows a standard predicate-based equivalence path within the Toxicology review framework, consistent with the majority of Class II 510(k) submissions.

View all Alfa Scientific Designs, Inc. devices

FDA 510(k) Submission Details - K010079

510(k) Number K010079 FDA.gov
FDA Decision Cleared Substantially Equivalent - Traditional 510(k) (SESE)
Date Received January 10, 2001
Decision Date May 29, 2001
Days to Decision 139 days
Submission Type Traditional
Review Panel Toxicology (TX)
Summary Summary PDF
Third-party Review No - reviewed directly by FDA
Combination Product No
PCCP Authorized No
Regulatory Context
Review time vs. panel average
52d slower than avg
Panel avg: 87d · This submission: 139d
Pathway characteristics
Predicate-based equivalence. No clinical trials required.

DOE Device Classification - Class 2, Special Controls

Product Code DOE Radioimmunoassay, Morphine (125-i), Goat Antibody Ammonium Sulfate Sep.
Device Class Class 2 - Special Controls
CFR Regulation 21 CFR 862.3640
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 - DOE Radioimmunoassay, Morphine (125-i), Goat Antibody Ammonium Sulfate Sep.

All 8
Devices cleared under the same product code (DOE) and FDA review panel - the closest regulatory comparables to K010079.
INSTANT-VIEW MORPHINE (2000) URINE CASSETTE TEST
K010080 · Alfa Scientific Designs, Inc. · May 2001
ROCHE ABUSCREEN ONLINE FOR OPIATES 1000 TEST KIT-2000 NG/ML CUTOFF OLYMPUS AU800 INSTRUMENT APPLICATION
K951319 · Roche Diagnostic Systems, Inc. · Jun 1995
ROCHE ABUSCREEN RADIOIMMUNOASSAY FOR MORPHINE (HIGH CUT-OFF)
K935055 · Roche Diagnostic Systems, Inc. · Aug 1994
URINE HEROIN/MORPHINE DIRECT RIA KIT (I-125)
K933572 · Immunalysis Corporation · Apr 1994
THE DPC COAT-A-COUNT SERUM MORPHINE RIA KIT
K863913 · Diagnostic Products Corp. · Mar 1987
MORPHINE ROCHE (R) EIA TEST
K864168 · Roche Diagnostic Systems, Inc. · Mar 1987