QUICKSCREEN BENZODIAZEPINES SCREENING TEST MODEL NUMBERS 9025,9026 AND QUICKSCREEN PRO MULTI DRUG SCREENING TEST MODEL 1

K981687 · Phamatech · JXM · Jun 3, 1998 · Clinical Toxicology

Device Facts

• Record ID: K981687
• Device Name: QUICKSCREEN BENZODIAZEPINES SCREENING TEST MODEL NUMBERS 9025,9026 AND QUICKSCREEN PRO MULTI DRUG SCREENING TEST MODEL 1
• Applicant: Phamatech
• Product Code: JXM · Clinical Toxicology
• Decision Date: Jun 3, 1998
• Decision: SESE
• Submission Type: Traditional
• Regulation: 21 CFR 862.3170
• Device Class: Class 2

Intended Use

The QuickScreen™ One Step Benzodiazepines Screening Test is a rapid, qualitative immunoassay for the detection of benzodiazepines compounds in urine. The cut-off concentration for this test is 200 ng/mL. This assay is intended for use in clinical toxicology laboratories, physicians' offices and drug of abuse clinics. Benzodiazepines form one of the largest classes of abused pharmaceuticals. These products are sedative and hypnotics, tranquilizers and anti-anxiety drugs which produce a calming effect, thus they are often prescribed as tranquilizers.

Device Story

QuickScreen™ Benzodiazepines Screening Test is a rapid, qualitative, one-step immunoassay for detecting benzodiazepines in urine. Device utilizes visual color sandwich immunochemical technology; relies on specific antibody-benzodiazepine-antibody complex formation. Cut-off concentration is 200 ng/mL. Used in clinical toxicology laboratories, physicians' offices, and drug abuse clinics by professional users. Provides visual qualitative results to healthcare providers to assist in diagnosing and treating drug abuse.

Clinical Evidence

Clinical performance evaluated via clinical sample correlation study and blind labeled spiked study. Compared against ABI SureStep and EMIT II tests. Results demonstrated >99% correlation. Clinical laboratory study reported sensitivity, specificity, and accuracy all >99% in the hands of professional users.

Technological Characteristics

Visual color sandwich immunoassay. Qualitative detection of benzodiazepines in urine. Cut-off concentration 200 ng/mL. Manual test format.

Indications for Use

Indicated for the qualitative identification of benzodiazepines in urine for the diagnosis and treatment of drug abuse in clinical settings.

Regulatory Classification

Identification

A benzodiazepine test system is a device intended to measure any of the benzodiazepine compounds, sedative and hypnotic drugs, in blood, plasma, and urine. The benzodiazepine compounds include chlordiazepoxide, diazepam, oxazepam, chlorzepate, flurazepam, and nitrazepam. Measurements obtained by this device are used in the diagnosis and treatment of benzodiazepine use or overdose and in monitoring levels of benzodiazepines to ensure appropriate therapy.

Special Controls

*Classification.* Class II (special controls). A benzodiazepine 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

• ABMC (Ancramdale, NY)
• Applied Biotech SureStep Test (San Diego, CA 92121)

Reference Devices

• EMIT II Test (San Jose, CA)

Submission Summary (Full Text)

{0}------------------------------------------------

K981687

JUN 3 1998

## 510 (k) SUMMARY AS REQUIRED BY SECTION 807.92(C)

QuickScreen™ Benzodiazepines Screening Test (9025/9026) ldentification:

Description: Immunoassay for the qualitative detection of benzodiazepines in Urine

Name Of Manufacturer: Phamatech 9265 Activity Road #112 San Diego, California 92126, USA

Intended Use: The QuickScreen™ One Step Benzodiazepines Screening Test is a rapid, qualitative immunoassay for the detection of benzodiazepines compounds in urine. The cut-off concentration for this test is 200 ng/mL. This assay is intended for use in clinical toxicology laboratories, physicians' offices and drug of abuse clinics. Benzodiazepines form one of the largest classes of abused pharmaceuticals. These products are sedative and hypnotics, tranquilizers and anti-anxiety drugs which produce a calming effect, thus they are often prescribed as tranquilizers.

The QuickScreen™ Test, like many commercially available drug Technology: screening test kits, qualitatively measures the presence of benzodiazepines by visual color sandwich one step immunoassay technology. Examples of such predicate devices include the ABMC (Ancramdale, NY) and the Applied Biotech SureStep Test (San Diego, CA 92121). All of the above devices rely on the basic immunochemical sandwich assay principle of recognition and formation of specific antibody / benzodiazepines / antibody / complexes.

Performance: The product performance characteristics of the QuickScreen™ Benzodiazepines Screening Test were evaluated in a clinical sample correlation study and a blind labeled spiked study. The results of these studies demonstrate the Phamatech QuickScreen™ Test to be substantially equivalent to the reported performance characteristics of other commercially available tests for the qualitative detection of benzodiazepines in urine. Correlations studies, using clinical specimens, produced a >99% correlation when compared to the ABI SureStep (San Diego, CA 92121) and the EMIT II Test (San Jose, CA ). A clinical laboratory study was also performed, the Phamatech QuickScreen™ exhibited excellent sensitivity (>99%), specificity (>99%), and accuracy (>99%) in the hands of professional users.

Conclusion: For the reasons mentioned above, it may be concluded that the Phamatech QuickScreen™ Benzodiazepines Screening Test is substantially equivalent to a variety of benzodiazepines detection tests currently in commercial distribution.

FDA/CDRH/ODE/DMO

13 May 98 10 42

RECEIVED

{1}------------------------------------------------

Image /page/1/Picture/1 description: The image shows the logo for the Department of Health & Human Services - USA. The logo features a stylized eagle with its wings spread, along with the text "DEPARTMENT OF HEALTH & HUMAN SERVICES - USA" arranged in a circular pattern around the eagle. The text is in all caps and appears to be in a sans-serif font. The logo is black and white.

Food and Drug Administration 2098 Gaither Road Rockville MD 20850

## 3 1998 JUN

Carl Mongiovi . Director of Operations Phamatech 9265 Activity Road #112 San Diego, California 92126

K981687 Re : QuickScreen™ Benzodiazepines Screening Test (Models 9025, 9026) QuickScreen™ Pro Multi Drug Screening Test (Model 9151) II Regulatory Class: Product Code: JXM May 8, 1998 Dated: Received: May 13, 1998

Dear Mr. Mongiovi:

We have reviewed your Section 510(k) notification of intent to market the device referenced above and we have determined the device is substantially equivalent (for the indications for use stated in the enclosure) to 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). You may, therefore, market the device, subject to the general controls provisions The general controls provisions of the Act of the Act. include requirements for annual registration, listing of devices, qood 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 (Premarket Approval), it may be subject to such additional controls. Existing major requlations affecting your device can be found in the Code of Federal Regulations, Title 21, Parts 800 to 895. A substantially equivalent determination assumes compliance with the Current Good Manufacturing Practice requirements, as set forth in the Quality System Regulation (QS) for Medical Devices: General regulation (21 CFR Part 820) and that, through periodic QS inspections, the Food and Drug Administration (FDA) will verify such assumptions. Failure to comply with the GMP regulation may result in regulatory action. In addition, FDA may publish further announcements concerning your device in the Federal Register. Please note: this response to your premarket notification submission does not affect any obligation you might have under sections 531 through 542 of the Act for devices under the Electronic Product Radiation Control provisions, or other Federal laws or regulations.

{2}------------------------------------------------

Page 2

Under the Clinical Laboratory Improvement Amendments of 1988 (CLIA-88), this device may require a CLIA complexity categorization. To determine if it does, you should contact the Centers for Disease Control and Prevention (CDC) at [phone].

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" (21 CFR 807.97). Other general information on your responsibilities under the Act may be obtained from the Division of Small Manufacturers Assistance at its toll-free number [phone] or [phone] or at its internet address "http://www.fda.gov/cdrh/dsmamain.html".

Sincerely yours,
Steven Litman

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

{3}------------------------------------------------

## INDICATIONS FOR USE

Applicant: Phamatech

510 (k) Number (if known): k981/687

Device Name: QuickScreen™ Benzodiazepines Screening Test

Indications for Use:

An in vitro diagnostic test for the qualitative identification of benzodiazepines in urine. Measurements obtained by this device are used in the diagnosis and treatment of drug abuse.

## PLEASE DO NOT WRITE BELOW THIS LINE

Concurrence of the CDRH Office of Device Evaluation (ODE)

Division Sign-off Division of Clinical Laboratory Devices 510 (k) Number: K 9816 87

Prescription Use: Per 21 CFR 801.109 OR

Over the Counter: ____________________________________________________________________________________________________________________________________________________________

(Division Sign-Off)
Division of Clinical Laboratory Devices
510(k) Number. K98/687