STARTOX DRUG OF ABUSE SCREENING TEST

K021006 · Starplex Scientific, Inc. · DKZ · Jun 10, 2002 · Clinical Toxicology

Device Facts

• Record ID: K021006
• Device Name: STARTOX DRUG OF ABUSE SCREENING TEST
• Applicant: Starplex Scientific, Inc.
• Product Code: DKZ · Clinical Toxicology
• Decision Date: Jun 10, 2002
• Decision: SESE
• Submission Type: Traditional
• Regulation: 21 CFR 862.3100
• Device Class: Class 2

Intended Use

STARTOX™ Drugs of Abuse Screening Test is a one-step lateral flow immunoassay intended for the simultaneous detection of multiple drug analytes in urine. STARTOX™ is intended for use in the qualitative detection of drugs of abuse at the following Substance Abuse Mental Health Services Administration (SAMHSA) recommended levels: Compound Abbreviation Level Amphetamine (d-amphetamine sulfate) AMP 1000 ng/ml Opiates (morphine-3-P-D glucuronide) OPIATES 2000 ng/ml Phencyclidine (phencyclidine HCl) PCP 25 ng/ml Cocaine (benzoylecgonine) COCAINE 300 ng/ml Cannabinoids (11-nor-Δ9-THC-9-carboxylic-acid) THC 50 ng/ml STARTOX™ Drugs of Abuse Screening Test provide only a preliminary qualitative test result. Use a more specific alternate quantitative analytical method to obtain a confirmed analytical result. Gas chromatography/mass spectrometry (GC/MS) is the preferred confirmatory method. Apply clinical and professional judgment to any drug of abuse test result, particularly when preliminary positive results are obtained. For professional use only.

Device Story

Lateral flow immunoassay for qualitative detection of drugs of abuse in human urine; simultaneous multi-analyte screening. Device utilizes immunochemical reaction; visual readout of test results. Intended for professional use in clinical settings. Provides preliminary qualitative results; requires confirmatory testing via GC/MS for clinical decision-making. Benefits include rapid screening for drug presence to guide further diagnostic or clinical management.

Clinical Evidence

Bench testing only. Performance evaluated using 90 urine samples per drug (50 negative, 40 positive). Positive samples confirmed via Emit and GC/MS. Accuracy reported as >99% compared to Medtox Profile II. Reproducibility confirmed using controls above and below cutoff levels.

Technological Characteristics

Lateral flow immunoassay; qualitative visual readout. Detects AMP, OPIATES, PCP, COCAINE, and THC in urine at specified ng/ml concentrations. Standalone test device.

Indications for Use

Indicated for professional use in the qualitative detection of Amphetamine, Opiates, Phencyclidine, Cocaine, and Cannabinoids in human urine at SAMHSA-recommended cutoff levels. Provides preliminary results requiring confirmation by GC/MS.

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).

Predicate Devices

• Rapid Drug Screen - 9 panel (K002447)
• ABMC Rapid Drug Screen multi-drug products (K012159)

Reference Devices

• Medtox Profile II

Submission Summary (Full Text)

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JUN 1 0 2002

# Starplex Scientific Inc. 510k Submission K021006 Additional Information 6/6/02

# 510 (K) SUMMARY

Page 3 of 19

#### Date of Summary

June 4, 2002

Product Name:

STARTOX™

#### Sponsor and Manufacturer:

Starplex Scientific, Inc. 50 Steinway Blvd. Etobicoke, Ontario, Canada M9W 6Y3

#### Correspondent:

Fran White MDC Associates 163 Cabot Street Beverly, MA 01915

#### Substantially Equivalent Device:

Product: Rapid Drug Screen - 9 panel Manufactured by: American BioMedica Corp 510k Number: K002447

#### Product Description:

A lateral flow immunoassay for the detection of drugs of abuse.

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### Starplex Scientific Inc. 510k Submission K021006 Additional Information 6/6/02

### Page 4 of 19

#### INTENDED USE:

STARTOX™ Drugs of Abuse Screening Test is a one-step lateral flow immunoassay intended for the simultaneous detection of multiple drug analytes in urine. STARTOX™ is intended for use in the qualitative detection of drugs of abuse at the following Substance Abuse Mental Health Services Administration (SAMHSA) recommended levels:

| Compound | Abbreviation | Level |
|---------------------------------------------------|--------------|------------|
| Amphetamine (d-amphetamine sulfate) | AMP | 1000 ng/ml |
| Opiates (morphine-3-P-D glucuronide) | OPIATES | 2000 ng/ml |
| Phencyclidine (phencyclidine HCl) | PCP | 25 ng/ml |
| Cocaine (benzoylecgonine) | COCAINE | 300 ng/ml |
| Cannabinoids<br>(11-nor-Δ9-THC-9-carboxylic-acid) | THC | 50 ng/ml |

STARTOX™ Drugs of Abuse Screening Test provide only a preliminary qualitative test result. Use a more specific alternate quantitative analytical method to obtain a confirmed analytical result. Gas chromatography/mass spectrometry (GC/MS) is the preferred confirmatory method. Apply clinical and professional judgment to any drug of abuse test result, particularly when preliminary positive results are obtained.

### PERFORMANCE CHARACTERISTICS:

STARTOX™ drugs of abuse screening test detects 5 drugs in human urine at the levels indicated.

STARTOX™ is substantial equivalent to Rapid Drug Screen 9 panel manufactured by American BioMedica Corporation 510k number K002447.

Product performance was compared Medtox Profile II manufactured by Medtox Diagnostics. Ninety (90) samples were tested against each drug, 50 negative which were confirmed to be drug free and 40 positive specimens for each drug were screened as positive by Emit, confirmed and quantified by GC/MS.

The STARTOX™ Drugs of Abuse Screening Test was compared to a FDA substantially equivalent approved device, Medtox Profile II. STARTOX™ demonstrated greater than 99% accuracy with when compared to a legally marketed device.

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# Starplex Scientific Inc. 510k Submission K021006 Additional Information 6/6/02

Page 5 of 19

Reproducibility was evaluated using control urines containing drug concentrations above and below the stated cut-off. Negative controls were also tested. The results confirmed the reproducibility of the STARTOXTM Drugs of Abuse Screening Test.

### CONCLUSION:

STARTOX™ Drug of Abuse Screening Test is substantially equivalent to ABMC Rapid Drug Screen multi-drug products (K012159, K002447) previously cleared for market as demonstrated by the results obtained in the studies.

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Image /page/3/Picture/1 description: The image shows the logo for the U.S. Department of Health & Human Services. The logo features a stylized eagle with three horizontal lines forming its body and wings. The words "DEPARTMENT OF HEALTH & HUMAN SERVICES USA" are arranged in a circular pattern around the eagle.

Food and Drug Administration 2098 Gaither Road Rockville MD 20850

# JUN 1 0 2002

Starplex Scientific, Inc. c/o Ms. Fran White Regulatory Consultant MDC Associates 163 Cabot Street Beverly, MA 01915

Re: k021006

Trade/Device Name: Startox™ Drug of Abuse Screening Test Regulation Number: 21 CFR 862.3100 Regulation Name: Amphetamine test system Regulatory Class: Class II Product Code: DKZ; DJG; LCM; DIO; LDJ Dated: March 27, 2002 Received: March 28, 2002

Dear Ms. White:

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 the Code of Federal Regulations, Title 21, Parts 800 to 898. 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 Part 801); good manufacturing practice requirements as set forth in the quality systems (OS) regulation (21 CFR Part 820); and if applicable, the electronic product radiation control provisions (Sections 531-542 of the Act); 21 CFR 1000-1050.

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Page 2 -

This letter will allow you to begin marketing your device as described in your 510(k) premarket notification. The FDA finding of substantial equivalence of your device to a legally marketed predicate device results in a classification for your device and thus, permits your device to proceed to the market.

If you desire specific advice for your device on our labeling regulation (21 CFR Part 801 and additionally 809.10 for in vitro diagnostic devices), please contact the Office of Compliance at [phone]. Additionally, for questions on the promotion and advertising of your device, please contact the Office of Compliance at [phone]. Also, please note the regulation entitled, "Misbranding by reference to premarket notification" (21CFR 807.97). Other general information on your responsibilities under the Act may be obtained from the Division of Small Manufacturers International and Consumer Assistance at its toll-free number [phone] or [phone] or at its internet address "http://www.fda.gov/cdrh/dsma/dsmamain.html".

Sincerely yours.

Steven Butman

Steven I. Gutman, M.D., M.B.A. Director Division of Clinical Laboratory-Devices Office of Device Evaluation Center for Devices and Radiological Health

Enclosure

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### Starplex Scientific Inc. 510k Submission K021006 Additional Information 6/6/02

Page 6 of 19

510(k) Number: Device Name: STARTOXTM Drug of Abuse Screening Test

#### Indication for Use:

STARTOX™ Drugs of Abuse Screening Test is a one-step lateral flow immunoassay intended for the simultaneous detection of multiple drug analytes in urine. STARTOX™ is intended for use in the qualitative detection of drugs of abuse at the following Substance Abuse Mental Health Services Administration (SAMHSA) recommended levels:

| Compound | Abbreviation | Level |
|---------------------------------------------------|--------------|------------|
| Amphetamine (d-amphetamine sulfate) | AMP | 1000 ng/ml |
| Opiates (morphine-3-P-D glucuronide) | OPIATES | 2000 ng/ml |
| Phencyclidine (phencyclidine HCl) | PCP | 25 ng/ml |
| Cocaine (benzoylecgonine) | COCAINE | 300 ng/ml |
| Cannabinoids<br>(11-nor-Δ9-THC-9-carboxylic-acid) | THC | 50 ng/ml |

STARTOX™ Drugs of Abuse Screening Test provide only a preliminary qualitative test result. Use a more specific alternate quantitative analytical method to obtain a confirmed analytical result. Gas chromatography/mass spectrometry (GC/MS) is the preferred confirmatory method. Apply clinical and professional judgment to any drug of abuse test result, particularly when preliminary positive results are obtained.

For professional use only.

Cooger
(Division -Off)
Division o Clinical Laboratory Devices
510(k) Numes: K221006

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

### Concurrence of CDRH, Office of Device Evaluation (ODE)

Prescription Use (Per 21 CFR 801.109)

OR

Over the Counter Use (Optional Format 1-2-96)