Cleared Traditional

K011011 - LIVESURE MORPHINE SCREEN TEST

K011011 is an FDA 510(k) clearance for LIVESURE MORPHINE SCREEN TEST, manufactured by Pan Probe Biotech, Inc.. The device is a Class 2 Toxicology device with product code DOE cleared through the Traditional 510(k) pathway after a 9-day FDA review.

K011011 · Pan Probe Biotech, Inc. · Toxicology device
Download Printable Device Report (PDF) Official FDA 510(k) Summary (PDF)
Optimized for regulatory review, auditing and printing
Apr 2001
Decision
9d
Days
Class 2
Risk

K011011 is an FDA 510(k) clearance for the LIVESURE MORPHINE SCREEN TEST. Classified as Radioimmunoassay, Morphine (125-i), Goat Antibody Ammonium Sulfate Sep. (product code DOE), Class II - Special Controls.

Submitted by Pan Probe Biotech, Inc. (San Diego, US). The FDA issued a Cleared decision on April 13, 2001 after a review of 9 days - a notably fast clearance cycle.

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: Fast-track predicate clearance. Standard predicate reliance. The short review cycle indicates strong predicate alignment - the FDA found sufficient equivalence without extended technical review.

FDA 510(k) Submission Details - K011011

510(k) Number K011011 FDA.gov
FDA Decision Cleared Substantially Equivalent - Traditional 510(k) (SESE)
Date Received April 04, 2001
Decision Date April 13, 2001
Days to Decision 9 days
Submission Type Traditional
Review Panel Toxicology (TX)
Summary Summary PDF
Third-party Review Yes - reviewed by an FDA-accredited third party
Combination Product No
PCCP Authorized No
Regulatory Context
Review time vs. panel average
78d faster than avg
Panel avg: 87d · This submission: 9d
Pathway characteristics
Predicate-based equivalence. No clinical trials required. Third-party reviewed.

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 Consultant

California Department of Health Services

The regulatory consultant manages the 510(k) submission process on behalf of the applicant - coordinating technical documentation, predicate strategy and FDA communications. Identifying the consultant behind a submission is a key signal for competitive regulatory intelligence.

Regulatory Peers - DOE Radioimmunoassay, Morphine (125-i), Goat Antibody Ammonium Sulfate Sep.

All 11
Devices cleared under the same product code (DOE) and FDA review panel - the closest regulatory comparables to K011011.
INSTANT-VIEW MORPHINE (2000) URINE DIP STRIP TEST
K010079 · Alfa Scientific Designs, Inc. · May 2001
INSTANT-VIEW MORPHINE (2000) URINE CASSETTE TEST
K010080 · Alfa Scientific Designs, Inc. · May 2001
BRANAN MEDICAL CORPORATION MONITECT MORPHINE 300 DRUG SCREEN TEST, MODEL 133C AND 133D
K002418 · Branan Medical Corporation · Nov 2000
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
K011011 · LIVESURE MORPHINE SCREEN TEST
Download PDF FDA Summary Pan Probe Biotech, In…