Cleared Traditional

K010080 - INSTANT-VIEW MORPHINE (2000) URINE CASS...

K010080 is the FDA 510(k) clearance for INSTANT-VIEW MORPHINE (2000) URINE CASS... by Alfa Scientific Designs, Inc.. It is a Class 2 Toxicology device (product code DOE) cleared through the Traditional 510(k) pathway after a 139-day FDA review.

K010080 · Alfa Scientific Designs, Inc. · Toxicology device
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May 2001
Decision
139d
Days
Class 2
Risk

K010080 is an FDA 510(k) clearance for the INSTANT-VIEW MORPHINE (2000) URINE CASSETTE 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

Submission Details

510(k) Number K010080 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.

Device Classification

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 K010080.
INSTANT-VIEW MORPHINE (2000) URINE DIP STRIP TEST
K010079 · 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