AMEDITECH DRUGSMARTCUP

K053175 · Ameditech, Inc. · DKZ · Dec 8, 2005 · Clinical Toxicology

Device Facts

• Record ID: K053175
• Device Name: AMEDITECH DRUGSMARTCUP
• Applicant: Ameditech, Inc.
• Product Code: DKZ · Clinical Toxicology
• Decision Date: Dec 8, 2005
• Decision: SESE
• Submission Type: Special
• Regulation: 21 CFR 862.3100
• Device Class: Class 2

Indications for Use

The Ameditech DrugSmartCup™ is an In Vitro screen test device for the qualitative detection of drugs in human urine. The cutoff concentrations for this test are as follows. [Table of analytes: AMP 1000, BAR 300, COC 300, BZO 300, MDMA 500, MET 1000, MTD 300, OPI300 300, OPI2000 2000, OXY 100, PCP 25, TCA 1000, THC 50 ng/ml]. This test is used to obtain a visual, qualitative result and is intended for professional use. This assay provides only a preliminary result. Clinical consideration and professional judgment must be used with any drug of abuse test result, particularly in evaluating a preliminary positive result. In order to obtain a confirmed analytical result, a more specific alternate chemical method is needed. Gas Chromatography/Mass Spectroscopy (GC/MS) is the preferred confirmation method.

Device Story

Ameditech DrugSmartCup™ is a lateral flow immunoassay device for qualitative detection of drugs of abuse in human urine. Device consists of a cup integrated with test strips; user collects urine sample directly into cup. Principle of operation is competitive binding immunoassay; drug in urine competes with drug conjugate for limited antibody binding sites. Visual qualitative results appear as colored lines on test strips. Intended for professional use in clinical settings to provide preliminary screening results. Positive results require confirmation via more specific analytical methods, preferably GC/MS. Device aids healthcare providers in rapid drug screening; clinical judgment required for interpretation.

Clinical Evidence

No clinical data provided; device relies on analytical performance characteristics typical of lateral flow immunoassay drug screening tests.

Technological Characteristics

Lateral flow immunoassay; competitive binding principle. Integrated cup form factor. Visual readout. No electronic components, software, or external energy source required.

Indications for Use

Indicated for professional use as an in vitro qualitative screening test for drugs of abuse in human urine. Detects Amphetamine, Barbiturates, Cocaine metabolite, Benzodiazepines, MDMA, Methamphetamine, Methadone, Opiates, Oxycodone, Phencyclidine, Tricyclic Antidepressants, and THC at specified cutoff concentrations.

Regulatory Classification

Identification

An amphetamine test system is a device intended to measure amphetamine, a central nervous system stimulating drug, in plasma and urine. Measurements obtained by this device are used in the diagnosis and treatment of amphetamine use or overdose and in monitoring levels of amphetamine to ensure appropriate therapy.

Special Controls

*Classification.* Class II (special controls). An amphetamine test system is not exempt if it is intended for any use other than employment or insurance testing or is intended for Federal drug testing programs. The device is exempt from the premarket notification procedures in subpart E of part 807 of this chapter subject to the limitations in § 862.9, provided the test system is intended for employment and insurance testing and includes a statement in the labeling that the device is intended solely for use in employment and insurance testing, and does not include devices intended for Federal drug testing programs (*e.g.,* programs run by the Substance Abuse and Mental Health Services Administration (SAMHSA), the Department of Transportation (DOT), and the U.S. military).

Submission Summary (Full Text)

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SPECIAL 510(k): Device Modification

ODE Review Memorandum (Decision Making Document is Attached)

To: THE FILE

RE: DOCUMENT NUMBER K 053175

This 510(k) submission contains information/data on modifications made to the SUBMITTER'S own Class II, Class III or Class I devices requiring 510(k). The following items are present and acceptable (delete/add items as necessary):

1. The name and 510(k) number of the SUBMITTER'S previously cleared device. (For a preamendments device, a statement to this effect has been provided.) k040092, k042975, k050186
2. Submitter's statement that the INDICATION/INTENDED USE of the modified device as described in its labeling HAS NOT CHANGED along with the proposed labeling which includes instructions for use, package labeling, and, if available, advertisements or promotional materials (labeling changes are permitted as long as they do not affect the intended use).
3. A description of the device MODIFICATION(S), including clearly labeled diagrams, engineering drawings, photographs, user's and/or service manuals in sufficient detail to demonstrate that the FUNDAMENTAL SCIENTIFIC TECHNOLOGY of the modified device has not changed.

This change is for addition of the Ameditech DrugSmartCup Product line which is modifying the predicate device. The modification is that the test strips are now placed in a plastic strip holder that is located inside the cup as opposed to inside the lid of the cup.

4. Comparison Information (similarities and differences) to applicant's legally marketed predicate device including, labeling, intended use, physical characteristics, shelf-life, assay principles and cut-off concentrations.
5. A Design Control Activities Summary which includes:

a) Identification of Risk Analysis method(s) used to assess the impact of the modification on the device and its components, and the results of the analysis
b) Based on the Risk Analysis, an identification of the verification and/or validation activities required, including methods or tests used and acceptance criteria to be applied
c) A declaration of conformity with design controls. The declaration of conformity should include:

i) A statement signed by the individual responsible, that, as required by the risk analysis, all verification and validation activities were performed by the designated individual(s) and the results demonstrated that the predetermined acceptance criteria were met, and
ii) A statement signed by the individual responsible, that the manufacturing facility is in conformance with design control procedure requirements as specified in 21 CFR 820.30 and the records are available for review.

6. A Truthful and Accurate Statement, a 510(k) Summary or Statement and the Indications for Use Enclosure (and Class III Summary for Class III devices).

The labeling for this modified subject device has been reviewed to verify that the indication/intended use for the device is unaffected by the modification. In addition, the submitter's description of the particular modification(s) and the comparative information between the modified and unmodified devices demonstrate that the fundamental scientific technology has not changed. The submitter has provided the design control information as specified in The New 510(k) Paradigm and on this basis, I recommend the device be determined substantially equivalent to the previously cleared (or their preamendment) device.