Cleared Traditional

K050878 - ON CALL MULTI-DRUG HOME TEST CUP

K050878 is an FDA 510(k) clearance for ON CALL MULTI-DRUG HOME TEST CUP, manufactured by ACON Laboratories, Inc.. The device is a Class 2 Chemistry device with product code LDJ cleared through the Traditional 510(k) pathway after a 63-day FDA review.

K050878 · ACON Laboratories, Inc. · Chemistry device
Download Printable Device Report (PDF) Official FDA 510(k) Summary (PDF)
Optimized for regulatory review, auditing and printing
Jun 2005
Decision
63d
Days
Class 2
Risk

K050878 is an FDA 510(k) clearance for the ON CALL MULTI-DRUG HOME TEST CUP. 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 June 8, 2005 after a review of 63 days - a notably fast clearance cycle.

This device falls under the Chemistry FDA review panel, regulated under 21 CFR 862.3870 - the FDA in vitro diagnostics and chemistry 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 - K050878

510(k) Number K050878 FDA.gov
FDA Decision Cleared Substantially Equivalent - Traditional 510(k) (SESE)
Date Received April 06, 2005
Decision Date June 08, 2005
Days to Decision 63 days
Submission Type Traditional
Review Panel Chemistry (CH)
Summary Summary PDF
Third-party Review No - reviewed directly by FDA
Combination Product No
PCCP Authorized No
Regulatory Context
Review time vs. panel average
26d faster than avg
Panel avg: 89d · This submission: 63d
Pathway characteristics
Predicate-based equivalence. No clinical trials required.

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 Chemistry devices follow this clearance model.

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 K050878.
AMEDICA DRUG SCREEN THC, COC,OPI,AMP,MET,PCP,MDMA,BAR,BZO,
K061556 · Amedica Biotech, Inc. · Jul 2006
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ON CALL HOME DRUG TEST FOR MARIJUANA AND ON CALL HOME DRUG TEST FOR MARIJUANA AND COCAINE
K050936 · ACON Laboratories, Inc. · Jun 2005
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K050594 · Nano-Ditech Co. · May 2005
ON CALL MULTI-DRUG HOME TEST
K050050 · ACON Laboratories, Inc. · Mar 2005
RANDOX CANNABINOIDS ASSSAY
K041142 · Randox Laboratories, Ltd. · Nov 2004
K050878 · ON CALL MULTI-DRUG HOME TEST CUP
Download PDF FDA Summary ACON Laboratories, In…