LIVESURE PHENECYCLINE (PCP) SCREEN TESTS

K012107 · Pan Probe Biotech, Inc. · LCM · Jul 20, 2001 · TX

Device Facts

• Record ID: K012107
• Device Name: LIVESURE PHENECYCLINE (PCP) SCREEN TESTS
• Applicant: Pan Probe Biotech, Inc.
• Product Code: LCM · TX
• Decision Date: Jul 20, 2001
• Decision: SESE
• Submission Type: Traditional
• Device Class: Class U
• Attributes: 3rd-Party Reviewed

Intended Use

The Pan Probe Biotech LiveSure™ Phencyclidine Screen Test Card and Test Strip devices are rapid in vitro diagnostic (IVD) qualitative lateral flow immuno-chromatographic competitive urinary rapid in Thiro didinestion of Phencyclidine, analogs and metabolites (collectively: PCP) in human urine at the NIDA (National Institute on Drug Abuse) and SAMHSA (Substance Abuse and Mental at the Nizes (national motified of 25 ng PCP/ml. These IVD tests are intended for visual, qualitative screening, for professional use only, and are not intended for quantitative visual, qualifative Screening, Tor prorocolonial ass "Chily" and PCP Screen Tests for PCP provide only preliminary qualitative analytical data. A more specific quantitative alternative method must be used in order to obtain a confirmed analytical result. NIDA and SAMHSA have established gas chromatographic/mass spectrometry (GC/MS) as the preferred confirmatory method. Clinical considerations and professional judgment should be applied to any drug of abuse test result, particularly when preliminary positive results are indicated.

Device Story

Lateral flow immuno-chromatographic test card or strip; detects PCP, analogs, and metabolites in human urine. Principle: competitive immunoassay using membrane pre-coated with PCP-conjugate and gold-labeled anti-PCP monoclonal antibody. In absence of PCP, antibody-gold conjugate binds to PCP-conjugate on membrane, forming visible pink test band. In presence of PCP, analytes compete for limited antibody binding sites, preventing test band formation. Procedural control band always appears. Used by professionals in clinical settings for preliminary screening. Results interpreted visually; positive results require GC/MS confirmation for clinical decision-making.

Clinical Evidence

Clinical evaluation of 297 urine samples compared against GC/MS quantitative results. Study demonstrated 100% agreement with GC/MS positive results. Negative agreement was 97.2%. Overall accuracy was 98.0% (291/297). Comparison with EMIT® II showed 100% agreement for positives and 99.0% specificity for negatives.

Technological Characteristics

Lateral flow immuno-chromatographic assay. Components: membrane absorbent pad, gold-probe-PCP conjugate, anti-PCP monoclonal antibody (mouse), capture reagent (goat). Visual readout via pink colored bands. Qualitative, standalone device. No external energy source required. Manual operation.

Indications for Use

Indicated for professional, qualitative screening of human urine for Phencyclidine (PCP), its analogs, and metabolites at a cutoff concentration of 25 ng/mL. Not for quantitative use. Preliminary results require confirmation by GC/MS.

Predicate Devices

• EMIT® II Assay

Submission Summary (Full Text)

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#### 510k Submission for

K012107

## LiveSure™ PHENECYCLINE (PCP) SCREEN TESTS

Pan Probe Biotech, Inc.

Revision E, July 16, 2001

## SUMMARY STATEMENT OF SAFETY AND EFFECTIVENESS

The sponsor, Pan Probe Biotech, Inc., has developed, manufactured, and testing of urine The Spollson, Practices guidelines, in vitro diagnostic (IVD) devices for qualitative testing of the Laboratory Tractices 'guidelinos, in 'thiro' and metabolites in an IVD screening format.

The trade names for the devices are the Pan Probe Biotech LiveSure™ Phencycliding Screen Test The trade names for the donooo are the Promoted name of Phencyclidine Test Systems. These Class II Card and Test stip, having a FDA dolgnatod harme of There a product code: LCM. These devices, as yet, do hot have a 21 on forensic screening of urine for Phencyclidine.

The Pan Probe Biotech LiveSure™ Phencyclidine Screen Test Card and Test Streen TM The Fall Trobe Blotoon Live competitive competitive chromatographic IVD immunoassays, in r hencyclidine rest) devices are rapia qualican with any Phencyclidine (PCP) drug, analogs or which a chemically labord drug obligate comples for limited specific antibody binding sites. LiveSure™ PCP devices have a unique membrane pre-coated with a gold conjugate immunoassay indicator that is used is pre-labeled with specific monoclonal antibody from mouse directed against Indicator that is used to pro labora will opists of a membrane absorbent pad having a gold-probe-POr . Each rest othp and Toot ours control ontibody from mouse that is directed against PCP, Conjugate pre labolou with openits monecoated with a chemically modified PCP-conjugate as a and a chromatographio mombrare pro oats device has been layered with PCP-conjugate as a 11 capture reagent, while the Process Control region has been pre-coated with a first molledge and capture Teagent derived from goat. A pink colored anti-PCP monoclonal antibody-colloidal gold anabody reagent derivou from goal. A phe test strip. In the absence of PCP drug, analogs or conjugate paa is placed to sample, the pink colored antibody-colloidal gold conjugate moves chromatographically along with the urinary sample on the membrane by capillary action. Antibodycolloidal gold conjugate binds to PCP-drug conjugate, forming an antibody-antigen complex. This collondar gold conjugate appears as second visible pink colored band and captured reagent at the test region. Any PCP drug, analogs or metabolites that are present in sample urine act as the test region. Any PCP-drug conjugate at the test band region for limited PCP-antibody amigone, oomponing min-reloidal gold conjugate. When a sufficient concentration of urinary PCP blog, analogs or metabolites are present, these analytes block the limited antibody binding sites. This andy, and oge of measons of pink colored antibody-colloidal gold conjugate to the PCPblookugo binding provents d at the test band region. To serve as a procedural control, a pink colored arag control region will always appear regardless of the presence of PCP in urinary samples. band in a ountrol rogion will amays appear of an and while positive urine samples produce only one pink colored band.

In-house testing of LiveSure™ Phencyclidine Screen Test Card and Test Strip devices against In Node toomig er a predicate device provided data essentially showing equivalency between these devices and the predicate EMIT® II Assay. Additionally, independent clinical testing of 297 urine samples against LiveSure™ Phencyclidine Screen Test Card and Test Strip devices, as well as Sumplos agains E.V.Our - nefference laboratory resulted in a 100% percent agreement with all GC/MS quantitative positive results. Moreover, LiveSure™ Phencyclidine Test Strip gave 97.2% of both agreement with GC/MS negative results, whereas EMIT II® yielded a 98.1% gave of .E % or both agrooming the Test Card and Test Strip positives with EMIT® II positives, 100% agreement with EMIT® II was found, respectively. Specificity of Test Card and Test Strip negatives with EMIT® II negatives was shown to be 99.0%, respectively. Finally, the LiveSure™ Phencyclidine Test Card and the Test Strip gave overall accuracy results of 291/297 (98.0%), versus r noneyellains roor as 295/297 (99.3%) accuracy was obtained with EMIT®II, respectively. Thus, as judged against GC/MS results from an independent laboratory, the LiveSure™ Phencyclidine Test Card and Test Strip were determined to be equivalent in performance to each other and similarity in capability versus assays with EMIT®II Phencyclidine Assay.

Additional information on this submission may be obtained by contacting Alice Yu, Vice President, Pan Probe Biotech, Inc. at: 1-858-689-9936 or by fax at 1-858-689-6896.

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DEPARTMENT OF HEALTH & HUMAN SERVICES

Image /page/1/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 stripes extending from its head, representing health, services, and people. The words "DEPARTMENT OF HEALTH & HUMAN SERVICES (USA)" are arranged in a circular pattern around the eagle.

Public Health Service

Food and Drug Administration 2098 Gaither Road Rockville MD 20850

### (JUL 2 0 ZUUI

Pan Probe Biotech, Inc. c/o James M. Barquest, Ph.D. California Department of Health Services Food and Drug Branch PO Box 942732 601 North Seventh Street (MS 357) Sacramento, CA 94234-7320

510(k) Number: K012107 Re: STO(K) Namo: Roteror
Trade/Device Name: Pan Probe Biotech LiveSure™ Phencyclidine (PCP) Screen Tests Regulatory Class: II Product Code: LCM Dated: July 3, 2001 Received: July 5, 2001

Dear Dr.Barquest:

We have reviewed your Section 510(k) notification of intent to market the device referenced n o have love have determined the device is substantially equivalent to devices marketed in interstate commerce prior to May 28, 1976, the enactment date of the Medical Device mendments, 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 the general of 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 Regulations, Title 21, Parts 800 to 895. A substantially equivalent determination assumes compliance with the Good Manufacturing Practice for Medical Devices: General (GMP) regulation (21 CFR Part 820) and that, through periodic GMP 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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Page 2

This letter will allow you to begin marketing your device as described in your 510(k) premarket I hill lotter will and to your ding of substantial equivalence of your device to a legally marketed noutheation. The I Dr I intently sification 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, (301) 59 +12t 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 mionination on your responsive at its toll-free number [phone] or [phone] or at its internet address "http://www.fda.gov/cdrh/dsma/dsmamain.html".

Sincerely yours,

Steven Sutman

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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510k Submission for

LiveSure™ PHENECYCLINE (PCP) SCREEN TESTS

Pan Probe Biotech, Inc.

Revision E, July 16, 2001

### 510(k) Number (if known): Not yet assigned

# Device Name: Pan Probe Biotech LiveSure™ Phencyclidine (PCP) Screen Tests

## INDICATIONS FOR USE STATEMENT:

The Pan Probe Biotech LiveSure™ Phencyclidine Screen Test Card and Test Strip devices are rapid in vitro diagnostic (IVD) qualitative lateral flow immuno-chromatographic competitive urinary rapid in Thiro didinestion of Phencyclidine, analogs and metabolites (collectively: PCP) in human urine at the NIDA (National Institute on Drug Abuse) and SAMHSA (Substance Abuse and Mental at the Nizes (national motified of 25 ng PCP/ml. These IVD tests are intended for visual, qualitative screening, for professional use only, and are not intended for quantitative visual, qualifative Screening, Tor prorocolonial ass "Chily" and PCP Screen Tests for PCP provide only preliminary qualitative analytical data. A more specific quantitative alternative method must be used in order to obtain a confirmed analytical result. NIDA and SAMHSA have established gas chromatographic/mass spectrometry (GC/MS) as the preferred confirmatory method. Clinical considerations and professional judgment should be applied to any drug of abuse test result, particularly when preliminary positive results are indicated.

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

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

can Cooper

(Division Sign-Off)
Division of Clinical Laboratory Devices
510(k) Number K012107

or

Prescription Use:
(Per 21 CFR 801.109)

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