Cleared Traditional

K010001 - LIVESURE THC SCREEN TEST

K010001 is an FDA 510(k) clearance for LIVESURE THC SCREEN TEST, manufactured by Pan Probe Biotech, Inc.. The device is a Class 2 Toxicology device with product code LDJ cleared through the Traditional 510(k) pathway after a 34-day FDA review.

K010001 · Pan Probe Biotech, Inc. · Toxicology device
Download Printable Device Report (PDF) Official FDA 510(k) Summary (PDF)
Optimized for regulatory review, auditing and printing
Feb 2001
Decision
34d
Days
Class 2
Risk

K010001 is an FDA 510(k) clearance for the LIVESURE THC SCREEN TEST. Classified as Enzyme Immunoassay, Cannabinoids (product code LDJ), Class II - Special Controls.

Submitted by Pan Probe Biotech, Inc. (San Diego, US). The FDA issued a Cleared decision on February 5, 2001 after a review of 34 days - a notably fast clearance cycle.

This device falls under the Toxicology FDA review panel, regulated under 21 CFR 862.3870 - 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 - K010001

510(k) Number K010001 FDA.gov
FDA Decision Cleared Substantially Equivalent - Traditional 510(k) (SESE)
Date Received January 02, 2001
Decision Date February 05, 2001
Days to Decision 34 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
53d faster than avg
Panel avg: 87d · This submission: 34d
Pathway characteristics
Predicate-based equivalence. No clinical trials required. Third-party reviewed.

LDJ Device Classification - Class 2, Special Controls

Product Code LDJ Enzyme Immunoassay, Cannabinoids
Device Class Class 2 - Special Controls
CFR Regulation 21 CFR 862.3870
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
JAMES M BARQUEST

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 - LDJ Enzyme Immunoassay, Cannabinoids

All 149
Devices cleared under the same product code (LDJ) and FDA review panel - the closest regulatory comparables to K010001.
EMIT II PLUS CANNABINOID ASSAY, MODEL OSR9N229
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K010138 · Medtox Diagnostics, Inc. · Feb 2001
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K002375 · OraSure Technologies, Inc. · Jan 2001
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K002263 · Branan Medical Corp. · Nov 2000
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K001126 · Alatex Scientific, Inc. · Aug 2000
K010001 · LIVESURE THC SCREEN TEST
Download PDF FDA Summary Pan Probe Biotech, In…