QUICKSCREEN ONE STEP PCP SCREENING TEST

K974582 · Phamatech · LCM · Feb 4, 1998 · TX

Device Facts

• Record ID: K974582
• Device Name: QUICKSCREEN ONE STEP PCP SCREENING TEST
• Applicant: Phamatech
• Product Code: LCM · TX
• Decision Date: Feb 4, 1998
• Decision: SESE
• Submission Type: Traditional
• Device Class: Class U

Intended Use

A drug of abuse assay intended for use in clinical toxicology laboratories, physicians' offices, drug-of-abuse clinics and law enforcement agencies is an in-vitro diagnostic test for the qualitative identification of phencyclidine in urine. Measurements that are obtained by this device are used in the diagnosis and treatment of PCP use or overdose

Device Story

QuickScreen One Step PCP Screening Test is an in-vitro diagnostic immunoassay for qualitative detection of phencyclidine (PCP) in urine. Device utilizes colloidal gold-labeled antibodies in a one-step sandwich immunoassay format. Sample (urine) migrates across a test strip; if PCP is present, it forms specific antibody-PCP-antibody complexes, resulting in a visual color change. Used in clinical toxicology labs, physicians' offices, clinics, and law enforcement settings by professional technicians. Output is a qualitative visual result indicating presence or absence of PCP. Results assist healthcare providers in diagnosing and managing PCP use or overdose.

Clinical Evidence

Clinical performance evaluated via sample correlation study and blind labeled PCP study. Compared against Syva EMIT II. Results demonstrated sensitivity >99%, specificity >99%, and accuracy >99%. Studies conducted by two independent clinical laboratories confirmed performance in the hands of professional laboratory technicians.

Technological Characteristics

Qualitative lateral flow immunoassay. Uses colloidal gold as a label. Principle of operation is immunochemical sandwich assay (antibody/PCP/antibody complex formation). Visual readout. No electronic components or software.

Indications for Use

Indicated for the qualitative identification of phencyclidine (PCP) in urine for use in clinical toxicology labs, physicians' offices, drug-of-abuse clinics, and law enforcement agencies. Used for the diagnosis and treatment of PCP use or overdose.

Predicate Devices

• ABI SureStep
• Syntron Bioresearch PCP Test

Reference Devices

• Syva EMIT II

Submission Summary (Full Text)

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974582

#### 1 1998 FEB

### SUMMARY

OuickScreenTM One Step PCP Screening Test (9130) Identification:

Immunoassay for the Qualitative Detection of Phencyclidine in Urine Description:

## US FDA 510(k) Number:

# Establishment Registration Number: 2030941

Name Of Manufacturer:

Phamatech 9265 Activity Road #112 / 113 San Diego, California 92126, USA

Intended Use: A drug of abuse assay intended for use in clinical toxicology laboratories, physicians' offices, drug-of-abuse clinics and law enforcement agencies is an in-vitro diagnostic test for the qualitative identification of phencyclidine in urine. Measurements that are obtained by this device are used in the diagnosis and treatment of PCP use or overdose

The QuickScreen TM One Step PCP Screening Test utilizes colloidal gold as Technology: the label like other commercially available immunoassays for drug of abuse test kits, to qualitatively measure for the presence of PCP by visual color sandwich one step immunoassay technology. Examples of such predicate devices include the ABI SureStep (San Diego, CA 92121)and the Syntron Bioresearch PCP Test (Vista, CA 92083). All of the above devices rely on the basic immunochemical sandwich assay principle of recognition and formation of specific antibody / PCP / antibody / complexes.

The product performance characteristics of the QuickScreenTM One Step Performance: PCP Screening Test was evaluated in a clinical sample correlation study and a blind labeled PCP study. The results of these studies demonstrate the Phamatech QuickScreenTM One Step PCP Screening Test to be substantially equivalent to the reported performance characteristics of other commercially available tests for the qualitative detection of Cocaine in urine.

Correlation studies, using clinical specimens, produced a sensitivity of greater than 99%, a specificity of greater than 99% and accuracy greater than 99% when compared to the Syva EMIT II (San Jose, CA 95161).

Two independent clinical laboratories conducted studies which demonstrated the Phamatech OuickScreen™ exhibited excellent performance in the hands of professional laboratory technicians.

Conclusion: For the reasons mentioned above, it may be concluded that the Phamatech QuickScreenTM One Step PCP ScreeningTest is substantially equivalent to a variety of qualitative PCP screening tests currently in commercial distribution.

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Food and Drug Administration 2098 Gaither Road Rockville MD 20850

FEB 4 1998

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

Re : K974582 QuickScreen™ One Step PCP Screening Test Requlatory Class: Unclassified Product Code: LCM December 5, 1997 Dated: Received: December 8, 1997

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 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 (Premarket Approval), it may be subject to such additional controls. Existing major regulations affecting your device can be found in the Code of Federal Requlations, Title 21, Parts 800 to 895. ਸ 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.

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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 requlation (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

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### INDICATIONS FOR USE

Applicant: Phamatech

510(k) Number (if known): ____________________________________________________________________________________________________________________________________________________

Device Name: QuickScreen TM One Step PCP Screening Test

Indications for Use:

A drug of abuse assay intended for use in clinical toxicology laboratories, > physicians' offices, drug-of-abuse clinics and law enforcement agencies is an invitro diagnostic test for the qualitative identification of phencyclidine (PCP), a hallucinogenic compound in urine. Measurements that are obtained by this device are used in the diagnosis and treatment of phencyclidine (PCP) use.

PLEASE DO NOT WRITE BELOW THIS LINE

Concurrence of CDRH Office of Device Evaluation (ODE)

y

Division Sign-Off) Division of Clinical Laborato 510(k) Number

Division Sign-Off Division of Clinical Laboratory Devices 510(k) Number:

Prescription Use: Per 21 CFR 801.109

OR Over the Counter