AMEDITECH IMMUTEST MULTI-DRUG SCREEN PANEL III

K050186 · Ameditech, Inc. · DKZ · Mar 4, 2005 · Clinical Toxicology

Device Facts

• Record ID: K050186
• Device Name: AMEDITECH IMMUTEST MULTI-DRUG SCREEN PANEL III
• Applicant: Ameditech, Inc.
• Product Code: DKZ · Clinical Toxicology
• Decision Date: Mar 4, 2005
• Decision: SESE
• Submission Type: Traditional
• Regulation: 21 CFR 862.3100
• Device Class: Class 2

Intended Use

The Ameditech ImmuTest Multi-Drug Screen Panel III is an In Vitro screen test device for the qualitative detection of multi-drugs in human urine. The cutoff concentrations for this panel test are as follows. [Table of cutoffs omitted for brevity]. This test uses multiple test strips in card format (test strips are placed in a card strip holder), cassette format (test strips are placed in a cassette strip holder), and cup format (test strips are placed in a lid strip holder). 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 applied to 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

In vitro diagnostic device for qualitative detection of 12 drugs in human urine; utilizes lateral flow immunochromatographic technology based on competitive binding. Device formats include card, cassette, and cup; contains drug-specific test strips. Urine sample application initiates test; drug presence below cutoff allows antibody-coated particles to bind to immobilized conjugate, forming colored line (negative result). Drug presence above cutoff saturates binding sites, preventing line formation (positive result). Intended for professional use in point-of-care settings. Results are read visually by operator. Preliminary results require confirmation via GC/MS or other specific chemical methods. Benefits include rapid, multi-drug screening capability for clinical decision-making.

Clinical Evidence

No clinical studies performed. Evidence consists of analytical bench testing, including precision/reproducibility studies (n=540 per drug), analytical sensitivity (cutoff validation), cross-reactivity, and interference studies (pH, specific gravity, common compounds). Method comparison study performed against GC/MS and predicate devices using 1641 clinical samples, showing high percent agreement.

Technological Characteristics

Lateral flow immunochromatographic assay; competitive binding principle. Formats: card, cassette, cup. Test strips (50-59 mm). Visual readout. No instrumentation required. Internal process controls (control line) included. No external controls supplied.

Indications for Use

Indicated for the qualitative detection of drugs of abuse (COC, THC, MET, OPI, PCP, AMP, BAR, BZO, MTD, TCA, OXY, MDMA) in human urine for professional use. Provides preliminary analytical test results.

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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Food and Drug Administration 2098 Gaither Road Rockville MD 20850

MAR 4 - 2005

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

Re: k050186

> Trade/Device Name: Ameditech ImmuTest Multi-Drug Screen Panel III Regulation Number: 21 CFR 862.3100 Regulation Name: Amphetamine test system Regulatory Class: Class II Product Code: DKZ, DIS, JXM, LDJ, DIO, DJR, DJC, DJG, LFG, LCM Dated: January 21, 2005 Reccived: January 28, 2005

Dear Dr. Wu:

We have reviewed your Section 510(k) premarket notification of intent to market the device referenced above and have determined the device is substantially equivalent (for the indications for use stated in the enclosure) to legally marketed predicate devices marketed in interstate commerce prior to May 28, 1976, the enactment date of the Medical Device Amendments, or to devices that have been reclassified in accordance with the provisions of the Federal Food, Drug, and Cosmetic Act (Act) that do not require approval of a premarket approval application (PMA). You may, therefore, market the device, subject to the general controls provisions of the Act. The general controls provisions of the Act include requirements for annual registration, listing of devices, good manufacturing practice, labeling, and prohibitions against misbranding and adulteration.

If your device is classified (see above) into either class II (Special Controls) or class III (PMA), it may be subject to such additional controls. Existing major regulations affecting your device can be found in Title 21, Code of Federal Regulations (CFR), Parts 800 to 895. In addition, FDA may publish further announcements concerning your device in the Federal Register.

Please be advised that FDA's issuance of a substantial equivalence determination does not mean that FDA has made a determination that your device complies with other requirements of the Act or any Federal statutes and regulations administered by other Federal agencies. You must comply with all the Act's requirements, including, but not limited to: registration and listing (21 CFR Part 807); labeling (21 CFR Parts 801 and 809); and good manufacturing practice requirements 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) This letter will anow you to oogin maneting of substantial equivalence of your device to a legally premarket notification: "The PDs in a classification 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, or questions on the promotion and advertising of your device, please contact the Office of In or quottons on the promie Evaluation and Safety at [phone]. Also, please note the regulation entitled, "Misbranding by reference to premarket notification" (21CFR Part 807.97). Tegulation other general information on your responsibilities under the Act from the I bu may oount oner getierers, International 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 yours,

Jean M. Cooper, MS, DVM

Jean M. Cooper, MS, D.V.M. 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

510(k) Number (if known):

Device Name: Ameditech ImmuTest Multi-Drug Screen Panel III

Indications For Use:

The Ameditech ImmuTest Multi-Drug Screen Panel III is an In Vitro screen test device for the qualitative detection of multi-drugs in human urine. The cutoff concentrations for this panel test are as follows.

| Test | Calibrator | · Cutoff<br>(ng/ml) |
|--------------------------------------------|----------------------------------|---------------------|
| Cocaine metabolite (COC) | Benzoylecgonine | 300 |
| Tetrahydrocannabinol (THC) | 11-nor-Δ9-THC-9-COOH | 50 |
| Methamphetamine (MET1000) | Methamphetamine | 1000 |
| Opiates (OPI) | Morphine | 2000 |
| Phencyclidine (PCP) | Phencyclidine | 25 |
| Amphetamine (AMP) | Amphetamine | 1000 |
| Barbiturates (BAR) | Secobarbital | 300 |
| Benzodiazepines (BZO) | Oxazepam | 300 |
| Methadone (MTD) | Methadone | 300 |
| Tricyclic Antidepressants (TCA) | Nortriptyline | 1000 |
| Oxycodone (OXY) | Oxycodone | 100 |
| 3,4methylenedioxymethamphetamine<br>(MDMA) | 3,4methylenedioxymethamphetamine | 500 |

This test uses multiple test strips in card format (test strips are placed in a card strip holder), cassette format (test strips are placed in a cassette strip holder), and cup format (test strips are placed in a lid strip holder).

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 applied to 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.

Prescription Use (Part 21 CFR 801 Subpart D) AND/OR

Over-The-Counter Use (21 CFR 807 Subpart C)

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