FIRST SIGN DRUG OF ABUSE SCREENING TEST

K032575 · W.H.P.M., Inc. · DKZ · May 19, 2004 · Clinical Toxicology

Device Facts

• Record ID: K032575
• Device Name: FIRST SIGN DRUG OF ABUSE SCREENING TEST
• Applicant: W.H.P.M., Inc.
• Product Code: DKZ · Clinical Toxicology
• Decision Date: May 19, 2004
• Decision: SESE
• Submission Type: Traditional
• Regulation: 21 CFR 862.3100
• Device Class: Class 2

Intended Use

First Sign™ Drugs of Abuse Screening Test are one-step lateral flow immunoassays intended for the detection of drug analytes in urine. First Sign™ Drug of Abuse Screening Test are 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 Methamphetamine ((+)methamphetamine HC1) METH 1000 ng/ml Opiates 2000 (morphine-3-P-D glucuronide) OPI 2000 ng/ml Opiates 300 (morphine-3-P-D glucuronide) OPI 300 ng/ml Cocaine (Benzoylecgonine) COC 300 ng/ml Cannabinoids (11-nor-A9-THC-9-carboxylic-acid) THC 50 ng/ml Phencyclidine (phencyclidine HC1) PCP 25 ng/ml First Sign™ 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 urine; detects AMP, METH, OPI, COC, THC, and PCP at specified cutoff levels. Device used by professionals in clinical settings; provides preliminary results. Requires confirmation via GC/MS for clinical decision-making. Benefits include rapid screening for substance abuse.

Clinical Evidence

No clinical trials performed. Evidence consists of analytical performance studies including precision/reproducibility (n=40 per concentration), cutoff verification (n=10 per concentration), and analytical specificity/cross-reactivity. Method comparison studies were conducted using clinical and spiked urine samples compared against GC/MS and predicate devices, showing high agreement (>94% across all analytes).

Technological Characteristics

Lateral flow immunochromatographic assay. Components: dye pad with colloidal gold particles coated with mouse monoclonal antibody; test line with drug-protein conjugates; control line with goat polyclonal antibody. Visual readout. Single-use, standalone device. No electronic components or software.

Indications for Use

Indicated for professional use in the qualitative detection of drugs of abuse (Amphetamine, Methamphetamine, Opiates, Cocaine, Cannabinoids, Phencyclidine) in human urine at SAMHSA-recommended cutoff levels.

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

• Acon Rapid Drug Screens

Submission Summary (Full Text)

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K032575

MAY 1 9 2004

Page 33 of 38

# 510 (K) SUMMARY

Date of Summary: 8-18-03

Product Name:

First Sign Drug of Abuse Assays Sponsor: WHPM 9440 Telstar Ave. Unit I : 上 El Monte, CA 91731

# Correspondent:

Fran White MDC Associates 163 Cabot Street Beverly, MA 01915 Substantially Equivalent Devices:

> Product: Acon Rapid Drug Screens Manufactured by: Acon Laboratories

## PRODUCT DESCRIPTION:

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

## INTENDED USE:

First Sign™ Drugs of Abuse Screening Test are one-step lateral flow immunoassays intended for the detection of drug analytes in urine. First Sign™ Drug of Abuse Screening Test are 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 |
| Methamphetamine ((+)methamphetamine HC1) | METH | 1000 ng/ml |
| Opiates 2000 (morphine-3-P-D glucuronide) | OPI | 2000 ng/ml |
| Opiates 300 (morphine-3-P-D glucuronide) | OPI | 300 ng/ml |
| Cocaine (Benzoylecgonine) | COC | 300 ng/ml |
| Cannabinoids (11-nor-A9-THC-9-carboxylic-acid) | THC | 50 ng/ml |
| Phencyclidine (phencyclidine HC1) | PCP | 25 ng/ml |

First Sign™ 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

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# 510k Submission WHPM, Inc.

# preferred confirmatory method. Apply clinical and professional judgment to any drug of abuse test result, particularly when preliminary positive results are obtained.

# PERFORMANCE CHARACTERISTICS:

First Sign™ drugs of abuse screening test detects drugs in human urine at the levels indicated.

First Sign™ is substantial equivalent to Acon Rapid One Step Immunoassay Tests manufactured Acon Laboratories.

Product performance was compared Acon Rapid Assays manufactured by Acon Laboratories rapid tests manufactured by Acon Rapid Assays. 60 Positive and 60 negative samples were tested against each drug. All results were confirmed by GC/MS.

The First Sign™ Drugs of Abuse Screening Test was compared to a FDA substantially equivalent approved device. First Sign™ demonstrated performance of >97% for all drugs when performance was compared to a legally marketed device and GC/MS.

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 First Sign™ Drugs of Abuse Screening Test.

## CONCLUSION:

First Sign™ Drug of Abuse Screening Test is substantially equivalent to Acon Laboratories drug of Abuse Screening Test.

:

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DEPARTMENT OF HEALTH & HUMAN SERVICES

Image /page/2/Picture/1 description: The image shows the logo for the U.S. Department of Health & Human Services. The logo consists of a circular seal with the text "DEPARTMENT OF HEALTH & HUMAN SERVICES - USA" arranged around the perimeter. Inside the circle is a stylized image of three human profiles facing to the right, stacked on top of each other.

MAY 1 9 2004

Food and Drug Administration 2098 Gaither Road Rockville MD 20850

W.H.P.M., Inc. Ms. Fran White Regulatory Consultant MDC Associates 163 Cabot Street Beverly, MA 01915

Re: k032575

Trade/Device Name: First Sign Drug of Abuse Screening Test Regulation Number: 21 CFR 862.3100 Regulation Name: Amphetamine test system Regulatory Class: Class II Product Code: DKZ, DJC, DJG, DIO, DKE, LCM Dated: February 23, 2004 Received: February 24, 2004

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 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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### Page 2

This letter will allow you to begin marketing your device as described in your Section 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 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 Vitro Diagnostic Device Evaluation and Safety at [phone]. Also, please note the regulation entitled, "Misbranding by reference to premarket notification" (21CFR Part 807.97). You may obtain other general information on your responsibilities under the Act 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.

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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# 510(k) Number: K03 2515 Device Name: First Sign Drug of Abuse Screening Test

#### Indication for Use:

First Sign™ Drugs of Abuse Screening Test are one-step lateral flow immunoassays intended for the detection of drug analytes in urine. First Sign™ Drug of Abuse Screening Test are 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 |
| Methamphetamine ((+)methamphetamine HC1) | METH | 1000 ng/ml |
| Opiates 2000 (morphine-3-P-D glucuronide) | OPI | 2000 ng/ml |
| Opiates 300 (morphine-3-P-D glucuronide) | OPI | 300 ng/ml |
| Cocaine (Benzoylecgonine) | COC | 300 ng/ml |
| Cannabinoids (11-nor-A9-THC-9-carboxylic-acid) | THC | 50 ng/ml |
| Phencyclidine (phencyclidine HC1) | PCP | 25 ng/ml |

First Sign™ 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.

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For professional use only.

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

| Prescription Use | OR | Over The Counter Use |
|-------------------------------------------------------|-----------------------------------------|--------------------------|
| (Per 21 CFR 801.109) | | (Optional Format 1-2-96) |
| <div><img alt="Checkmark" src="checkmark.png"/></div> | | |
| | (Division Sign-Off) | |
| | Division of Clinical Laboratory Devices | |
| | 510(k) Number | K032575 |