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

Intended 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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DEPARTMENT OF HEALTH & HUMAN SERVICES

Image /page/0/Picture/1 description: The image shows the logo for the U.S. Department of Health & Human Services. The logo features a stylized eagle with its wings spread, symbolizing protection and care. The text "DEPARTMENT OF HEALTH & HUMAN SERVICES - USA" is arranged in a circular pattern around the eagle, indicating the department's name and national affiliation. The logo is presented in black and white.

Public Health Service

Food and Drug Administration 2098 Gaither Road Rockville MD 20850

2005 DEC 8

John Wu, Ph.D. Director of Quality Assurance Ameditech, Inc. 10340 Camino Santa Fe, Suite F San Diego, CA 92121

k053175 Re: Trade/Device Name: Ameditech DrugSmartCup™ Regulation Number: 21 CFR 862.3100

Regulation Name: Amphetamine test system Regulatory Class: Class II Regulatory Class. Class II
Product Code: DKZ, DIS, JXM, LDJ, DIO, DJR, DJC, DJG, LFG, LCM Dated: November 10, 2005 Received: November 16, 2005

Dear Dr. Wu:

We have reviewed your Section 510(k) premarket notification of intent to market the device we nave reviewed your Section 310(x) premained is substantially equivalent (for the indications felerenced above and nave determined the actived predicate devices marketed in interstate for use stated in the encrosule) to regally manated profite Amedical Device Amendments, or to commerce prior to May 28, 1776, the enacement auth the provisions of the Federal Food, Drug, devices that have been recalismed in assess approval of a premarket approval application (PMA). and Cosment Act (Act) that do not require subject to the general controls provisions of the Act. The You may, merciole, market the device, soloje requirements for annual registration, listing of general controls provisions of the ree, labeling, and prohibitions against misbranding and adulteration.

If your device is classified (see above) into either class II (Special Controls) or class III (PMA), If your device is classified (360 a00 vo) including major regulations affecting your device It may be subject to Such additions come Regulations (CFR), Parts 800 to 895. In addition, FDA can be found in Thic 21, Cour cannouncements concerning your device in the Federal Register.

Please be advised that FDA's issuance of a substantial equivalence determination does not mean Prease be advised that I DA 3 issuation of a basedianal with other requirements of the Act mat I DA has made a decerminations administered by other Federal agencies. You must of ally it catal statutes and regaranents and limited to: registration and listing (21 Comply with an the Tree Frequirents, one of and 809); and good manufacturing practice and 800) CTN Part 807), laoemig as set forth in the quality systems (QS) regulation (21 CFR Part 820).

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This letter will allow you to begin marketing your device as described in your Section 510(k) I his icher will anow you to oegin maxicang your device of your device to a legally premarket notification: "The PDT interly on for your device and thus, permits your device to proceed to the market.

If you desire specific information about the application of labeling requirements to your device, If you desire specific infortion and advertising of your device, please contact the Office of In of quotions on the promotion and Safety at [phone]. Also, please note the viro Diaghebited "Misbranding by reference to premarket notification" (21CFR Part 807.97). You may obtain other general information on your responsibilities under the Act from the I ou may obtain other generational and Consumer Assistance at its toll-free number [phone] or [phone] or at its Internet address http://www.fda.gov/cdrh/industry/support/index.html.

Sincerely vours,

Alberto G

Alberto Gutierrez, Ph.D. Director Division of Chemistry and Toxicology Office of In Vitro Diagnostic Device Evaluation and Safety Center for Devices and Radiological Health

Enclosure

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## Indications for Use

Indications for 350 Koss 3175
510(k) Number (if known): K053175
-

Device Name: Ameditech DrugSmartCup™

Indications For Use:

The Ameditech DrugSmartCup™ is an In Vitro screen test device for the qualitative The Amedited Drugs in human urine. The cutoff concentrations for this test are as follows.

| Test | Calibrator | Cutoff<br>(ng/ml) |
|--------------------------------------------|----------------------------------|-------------------|
| Amphetamine (AMP) | Amphetamine | 1000 |
| Barbiturates (BAR) | Secobarbital | 300 |
| Cocaine metabolite (COC) | Benzoylecgonine | 300 |
| Benzodiazepines (BZO) | Oxazepam | 300 |
| 3,4methylenedioxymethamphetamine<br>(MDMA) | 3,4methylenedioxymethamphetamine | 500 |
| Methamphetamine (MET) | Methamphetamine | 1000 |
| Methadone (MTD) | Methadone | 300 |
| Opiates (OPI300) | Morphine | 300 |
| Opiates (OPI2000) | Morphine | 2000 |
| Oxycodone (OXY) | Oxycodone | 100 |
| Phencyclidine (PCP) | Phencyclidine | 25 |
| Tricyclic Antidepressants (TCA) | Nortriptyline | 1000 |
| Tetrahydrocannabinol (THC) | 11-nor- $\Delta^9$ -THC-9-COOH | 50 |

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 I his ussay provides only drug of abuse test result, particularly in evaluating a juaghen mast ve uppersult. In order to obtain a confirmed analytical result, a more precific alternate chemical method is needed. Gas Chromatography/Mass Spectroscopy (GC/MS) is the preferred confirmation method.

Over-The-Counter Use AND/OR Prescription Use _ (21 CFR 807 Subpart C) (Part 21 CFR 801 Subpart D)

(PLEASE DO NOT WRITE BELOW THIS LINE-CONTINUE ON ANOTHER PAGE IF NEEDED)

Concurrence of CDRH, Office of In Vitro Diagnostic Devices (OIVD)

Carol C Bernoon

Division Sign-Off

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Office of In Vitro Diagnostic Device Evaluation and Safety

C9(k) K053175