Cleared Traditional

K050050 - ON CALL MULTI-DRUG HOME TEST

K050050 is the FDA 510(k) clearance for ON CALL MULTI-DRUG HOME TEST by ACON Laboratories, Inc.. It is a Class 2 Toxicology device (product code LDJ) cleared through the Traditional 510(k) pathway after a 60-day FDA review.

K050050 · ACON Laboratories, Inc. · Toxicology device
Download Printable Device Report (PDF)
Optimized for regulatory review, auditing and printing
Mar 2005
Decision
60d
Days
Class 2
Risk

K050050 is an FDA 510(k) clearance for the ON CALL MULTI-DRUG HOME TEST. Classified as Enzyme Immunoassay, Cannabinoids (product code LDJ), Class II - Special Controls.

Submitted by ACON Laboratories, Inc. (San Diego, US). The FDA issued a Cleared decision on March 11, 2005 after a review of 60 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.

View all ACON Laboratories, Inc. devices

Submission Details

510(k) Number K050050 FDA.gov
FDA Decision Cleared Substantially Equivalent - Traditional 510(k) (SESE)
Date Received January 10, 2005
Decision Date March 11, 2005
Days to Decision 60 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
27d faster than avg
Panel avg: 87d · This submission: 60d
Pathway characteristics
Predicate-based equivalence. No clinical trials required.

Device Classification

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 Peers - LDJ Enzyme Immunoassay, Cannabinoids

All 85
Devices cleared under the same product code (LDJ) and FDA review panel - the closest regulatory comparables to K050050.
VITROS CHEMISTRY PRODUCTS THC REAGENT, CALIBRATOR KIT 30, FS CALIBRATOR 1, AND DAT PERFORMANCE VERIFIERS I, II, III, IV
K063164 · Ortho-Clinical Diagnostics, Inc. · Dec 2006
ON CALL HOME DRUG TEST FOR MARIJUANA AND ON CALL HOME DRUG TEST FOR MARIJUANA AND COCAINE
K050936 · ACON Laboratories, Inc. · Jun 2005
ON CALL MULTI-DRUG HOME TEST CUP
K050878 · ACON Laboratories, Inc. · Jun 2005
RANDOX CANNABINOIDS ASSSAY
K041142 · Randox Laboratories, Ltd. · Nov 2004
ONLINE DAT II CANNABINOIDS II
K030213 · Roche Diagnostics Corp. · Apr 2003
CANNABINOID ENZYME IMMUNOASSAY, CATALOG 0070, 0071
K021887 · Lin-Zhi International, Inc. · Aug 2002