FIRST SIGN DRUG OF ABUSE URINE SCREENING TEST

K052197 · W.H.P.M., Inc. · DJR · Jun 9, 2006 · Clinical Toxicology

Device Facts

• Record ID: K052197
• Device Name: FIRST SIGN DRUG OF ABUSE URINE SCREENING TEST
• Applicant: W.H.P.M., Inc.
• Product Code: DJR · Clinical Toxicology
• Decision Date: Jun 9, 2006
• Decision: SESE
• Submission Type: Traditional
• Regulation: 21 CFR 862.3620
• Device Class: Class 2

Intended Use

The First Sign Drug of Abuse Tests are rapid, chromatographic immunoassays for the qualitative detection of drugs-of-abuse in human urine. The tests may be run singly of in combinations of up to six drugs simultaneously. The cut-off concentrations and specific analytes tested for are listed below. This assay provides only a preliminary test result. A more specific alternate chemical method must be used to obtain a confirmed analytical result. Gas chromatography/mass spectrometry (GC/MS) is the preferred confirmatory method. Clinical and professional judgment must be applied to any drug of abuse test result, particularly when preliminary positive results are obtained. For Professional Use Only.

Device Story

Rapid chromatographic immunoassay for qualitative detection of drugs of abuse in human urine; detects nortriptyline, secobarbital, MDMA, oxazepam, oxycodone, and methadone. Device used in professional clinical settings; operated by healthcare professionals. Input is human urine sample; principle of operation is immunoassay; output is visual qualitative result. Preliminary results require confirmation via GC/MS or HPLC. Assists clinicians in identifying potential drug use; supports clinical decision-making when combined with professional judgment.

Clinical Evidence

Clinical evaluation compared First Sign test results against GC/MS or HPLC. Sample size not specified. Results: Nortriptyline (97.5% pos agreement, >99% neg agreement), Secobarbital (97.4% pos, 97.6% neg), MDMA (92.5% pos, >99% neg), Oxazepam (95.7% pos, >99% neg), Methadone (93.7% pos, 97.9% neg), Oxycodone (95% pos, >99% neg).

Technological Characteristics

Rapid chromatographic immunoassay; lateral flow format. Qualitative detection based on competitive binding. No electronic components, software, or external energy source required.

Indications for Use

Indicated for professional use for the qualitative detection of drugs of abuse (nortriptyline, secobarbital, MDMA, oxazepam, oxycodone, methadone) in human urine. Provides preliminary results requiring confirmation by GC/MS or HPLC.

Regulatory Classification

Identification

A methadone test system is a device intended to measure methadone, an addictive narcotic pain-relieving drug, in serum and urine. Measurements obtained by this device are used in the diagnosis and treatment of methadone use or overdose and to determine compliance with regulations in methadone maintenance treatment.

Special Controls

*Classification.* Class II (special controls). A methadone 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 BZO One Step Benzodiazepine Test Strip (K012300)
• ACON OXY One Step Oxycodone Test Strip (K043507)
• ACON BAR One Step Barbiturates Test Strip (K050593)
• ACON MTD One Step Methadone test Strip (K012595)
• ACON TCA One Step Tricyclic Antidepressants (K021526)
• ACON MDMA One Step Ecstasy Test Strip (K022589)

Submission Summary (Full Text)

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K052/97

JUN - 9 2006

# 510(k) Summary

Date of Summary: 30 May, 2005

#### Product Name

First Sign™ Drug of Abuse Urine Screening Tests

#### Sponsor and Manufacturer

WHPM, Inc. 9662 Telstar Avenue El Monte, CA 91731

WHPM, Bioresearch and Technology Co. Ltd. 806 Taihong Mansion, No 44 Chongwai Street Chongwai District Beijing, China 100062

Product will be manufactured in both locations and distributed through the California site.

#### Correspondent

Fran White, President MDC Associates, LLC 163 Cabot Street Beverly, MA 01915

# Substantial Equivalency

The First Sign™ Drug of Abuse Urine Screening Test is substantially equivalent to other tests currently on the market.

| First Sign Test Analyte | Predicate Device Name | Predicate Device 510(k) # |
|-------------------------|---------------------------------------------|---------------------------|
| Oxazepam | ACON BZO One Step Benzodiazepine Test Strip | K012300 |
| Oxycodone | ACON OXY One Step Oxycodone Test Strip | K043507 |
| Secobarbital | ACON BAR One Step Barbiturates Test Strip | K050593 |
| Methadone | ACON MTD One Step Methadone test Strip | K012595 |
| Nortriptyline | ACON TCA One Step Tricyclic Antidepressants | K021526 |
| MDMA | ACON MDMA One Step Ecstasy Test Strip | K022589 |

#### Product Description

The First Sign Drug of Abuse Tests are rapid, chromatographic immunoassays for the qualitative detection of drugs-of-abuse in human urine.

# Indications for Use

The First Sign Drug of Abuse Tests are rapid, chromatographic immunoassays for the qualitative detection of drugs-of-abuse in human urine. The tests may be run singly or in combinations of up to six drugs simultaneously. The cut-off concentrations for these drugs are as follows: Nortriptyline 1,000ng/mL, Secobarbital 300ng/mL, MDMA 500ng/mL, Oxazepam 300ng/mL, Methadone 300ng/mL, Oxycodone 100ng/mL. For Professional Use Only.

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# Performance Characteristics

A clinical evaluation compared test results between the First Sign Drugs of Abuse Tests and GC/MS or HPLC results. The results are summarized below.

| First Sign Test | Positive Agreement | Negative Agreement | Overall Agreement |
|-----------------|--------------------|--------------------|-------------------|
| Nortriptyline | 97.5% | >99% | 98.7% |
| Secobarbital | 97.4% | 97.6% | 97.5% |
| MDMA | 92.5% | >99% | 96.2% |
| Oxazepam | 95.7% | >99% | 97.5% |
| Methadone | 93.7% | 97.9% | 96.2% |
| Oxycodone | 95% | >99% | 97.5% |

# Conclusion

Clinical studies demonstrate the substantial equivalence between the First Sign Drugs of Abuse Tests [Nortriptyline, Secobarbital, MDMA, Oxazepam, Methadone, and Oxycodone] and commercially available FDA-cleared drugs of abuse tests. The studies also demonstrated that the First Sign tests are safe and effective in detecting drugs of abuse at or above their stated cut-off concentrations.

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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 stylized eagle with three stripes forming its body and wing. The eagle is positioned to the right of a circular emblem that contains the text "DEPARTMENT OF HEALTH & HUMAN SERVICES - USA" arranged around the perimeter.

Public Health Service

Food and Drug Administration 2098 Gaither Road Rockville MD 20850

JUN - 9 2006

WHPM, Inc c/o Ms. Fran White President MDC Associates, LLC. 163 Cabot Street Beverly, MA 01915

Re: k052197

> Trade/Device Name: First Sign Drug of Abuse Urine Screening Test Regulation Number: 21 CFR 862.3620 Regulation Name: Methadone test system Regulatory Class: Class II Product Code: DJR, LFG, DIS, LAF, JXM, DJG Dated: May 11, 2006 Received: May 12, 2006

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/industry/support/index.html.

Sincerely yours,

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

#### 510(k) Number (if known): K052197

Device Name: First Sign Drug of Abuse Urine Screening Test

Indications For Use:

The First Sign Drug of Abuse Tests are rapid, chromatographic immunoassays for the qualitative detection of drugs-of-abuse in human urine. The tests may be run singly of in combinations of up to six drugs simultaneously. The cut-off concentrations and specific analytes tested for are listed below.

This assay provides only a preliminary test result. A more specific alternate chemical method must be used to obtain a confirmed analytical result. Gas chromatography/mass spectrometry (GC/MS) is the preferred confirmatory method. Clinical and professional judgment must be applied to any drug of abuse test result, particularly when preliminary positive results are obtained.

For Professional Use Only.

| Test Name | Analyte Tested | Cut-off Concentration |
|--------------------------|----------------|-----------------------|
| First Sign Nortriptyline | nortriptyline | 1,000ng/mL |
| First Sign Secobarbital | secobarbital | 300ng/mL |
| First Sign MDMA | mdma | 500ng/mL |
| First Sign Oxazepam | oxazepam | 300ng/mL |
| First Sign Oxycodone | oxycodone | 100ng/mL |
| First Sign Methadone | methadone | 300ng/mL |

Prescription Use X (Part 21 CFR 801 Subpart D)

AND/OR

Over-The-Counter Use (21 CFR 801 Subpart C)

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

Concurrence of CORH. Office of In Vitro Diagnostic Devices (OIVD)

Division Sign-Off

Office of In Vitro Diagnostic Device Evaluation and Safety

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