LIVESURE AMPHETAMINE SCREEN TEST

K011609 · Pan Probe Biotech, Inc. · DKZ · Jun 8, 2001 · Clinical Toxicology

Device Facts

• Record ID: K011609
• Device Name: LIVESURE AMPHETAMINE SCREEN TEST
• Applicant: Pan Probe Biotech, Inc.
• Product Code: DKZ · Clinical Toxicology
• Decision Date: Jun 8, 2001
• Decision: SESE
• Submission Type: Traditional
• Regulation: 21 CFR 862.3100
• Device Class: Class 2
• Attributes: 3rd-Party Reviewed

Intended Use

The Pan Probe Biotech LiveSure™ Amphetamine Screen Test Card and Test Strip devices are rapid in vitro diagnostic (IVD) qualitative lateral flow immuno-chromatographic urinary assays for detection of D-Amphetamine (AMP) in human urine at the NIDA (National Institute on Drug Abuse) and SAMHSA (Substance Abuse and Mental Health Services Administration) cut-off level of 1000 ng AMP/ml. These tests are intended for visual, qualitative screening, and professional use only, and are not intended for quantitative results, nor for over the counter use. These screen tests for Amphetamine, analogs and metabolites 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 recommend gas chromatography/mass spectrometry (GCMS) as the preferred 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 chromatographic immunoassay for qualitative detection of Amphetamine in human urine. Device consists of test card or strip containing membrane pre-coated with AMP drug conjugate and control band; anti-AMP monoclonal antibody-colloidal gold conjugate pad. Principle: competitive immunoassay; drug in sample competes with pre-coated AMP conjugate for limited antibody binding sites. Negative sample: pink band at test region and control region. Positive sample: pink band only at control region. Used in clinical/forensic settings by professionals. Provides preliminary qualitative screening results; requires confirmation by GC/MS. Benefits patient/clinician by enabling rapid, point-of-care identification of potential Amphetamine presence.

Clinical Evidence

Clinical study of 257 urine samples compared the device against GC/MS and the EMIT® II Assay. Results showed 100% agreement with GC/MS positive results and 98.8% agreement with GC/MS negative results. Overall accuracy was 99.2% (255/257) compared to GC/MS. Specificity of negatives was 100% relative to EMIT® II. No false positives were observed at or below the 1000 ng/ml cut-off.

Technological Characteristics

Lateral flow chromatographic immunoassay. Components: membrane pre-coated with AMP drug conjugate and control band; anti-AMP monoclonal antibody-colloidal gold conjugate pad. Qualitative visual readout. Standalone device (test card or strip).

Indications for Use

Indicated for professional, qualitative screening of human urine for D-Amphetamine, its analogs, or metabolites at a 1000 ng/ml cut-off. Not for over-the-counter use or quantitative analysis.

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

• EMIT® II Assay

Submission Summary (Full Text)

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K011609

### SUMMARY STATEMENT OF SAFETY AND EFFECTIVENESS

The sponsor, Pan Probe Biotech, Inc., has developed, manufactured, and tested under Good Laboratory Practices quidelines, an in vitro diagnostic device for the qualitative testing of urine samples for the presence of Amphetamine , its analogs or metabolites in a screening format.

The trade names of these devices are the Pan Probe Biotech LiveSure™ Amphetamine Screen Test Card and Test Strip, having a designated common name of Amphetamine Test Systems and classification as Class II devices as per listing 21 CFR 862.3100. These devices are intended for medical/forensic screening of urines for Amphetamine.

The Pan Probe Biotech LiveSure™ Amphetamine Screen Test Card and Test Strip (i.e., LiveSure™ Amphetamine Tests) are rapid qualitative chromatographic immunoassays in which a chemically labeled drug conjugate competes with Amphetamine (AMP) drug, analogs or metabolites that may be present in test urinary samples for limited specific antibody binding sites. LiveSure™ Amphetamine devices contain a unique membrane that has been pre-coated both with AMP drug conjugate at the test band, and have a built-in reference band with second antibody as a system control band. A pink colored anti-AMP monoclonal antibody-colloidal gold conjugate pad is placed on the test strip. In the absence of AMP drug, analogs or metabolites in the test urine, the pink colored antibody-colloidal gold conjugate moves chromatographically along with the unnary sample on the capillary action. The antibody-colloidal gold conjugate binds to drug conjugate, forming an antibody-antigen complex. This complex binds to drug conjugate as a captured reagent at the test region and produces a visible pink colored band. When AMP is present in a test urine, that drug, analog or metabolite antigen competes with AMP conjugate at the test band region for the limited antibody sites on the antibody-colloidal gold conjugate. When a sufficient concentration of urinary AMP drug, analogs or metabolites is present, it blocks limited antibody binding sites. This blockage-binding prevents attachment of pink colored antibody-colloidal gold conjugate to the Amphetamine drug conjugate zone located at the LiveSure™ Amphetamine test band region. To serve as a procedural control, a pink colored band in a control region will always appear regardless of presence of AMP in samples. Thus, negative urine samples produces two pink colored bands, while positive urine samples produce only one pink colored band.

In-house testing of LiveSure™ Amphetamine Screen Test Strip devices against EMIT® II Assay as a predicate provided data essentially showing equivalency between these devices and the predicate EMIT® II Assay. Additionally, independent clinical testing of 257 urine samples against LiveSure™ Amphetamine Screen Test Card and Test Strip devices, as well as EMIT® II Assay at an external reference laboratory resulted in a 100% percent agreement with all GC/MS quantitative positive results. Moreover, LiveSure™ Amphetamine Test Card or Strip gave both 98.8% agreement with GC/MS negative results, whereas EMIT II® yielded only a 97.6% correlation with GC/MS negatives. In comparing the Test Card and Test Strip positives with EMIT® II positives, both 98.0% respective agreement with EMIT® II was found. Specificity of Test Card and Test Strip negatives with EMIT® II negatives was shown to be 100% of both. In terms of overall accuracy of values at and below the ±25% range of the NIDA/SAMHSA cut-off of 1000 ng/ml of Amphetamine, however, the LiveSure™ Amphetamine Screen Test Card and Strip yielded no false positives or FP, but EMIT® II resulted in 1 FP values for urine samples with GC/MS results below 750 ng/ml of Amphetamine. Finally, the LiveSure™ Amphetamine Test Card and the Test Strip gave overall accuracy results of 255/257 (99.2%), respectively, versus GC/MS data, whereas 253/255 (98.4%) accuracy was obtained with EMIT®II. Thus, as judged against GCMS results from an independent laboratory, the LiveSure™ Amphetamine Test Card and Test Strip were determined to be equivalent in performance to each other and somewhat superior in capability versus assays with EMIT®II.

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

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DEPARTMENT OF HEALTH & HUMAN SERVICES

Image /page/1/Picture/1 description: The image is a black and white logo for the U.S. Department of Health & Human Services. The logo features a stylized depiction of an eagle or bird with outstretched wings, rendered in a simple, flowing line drawing. The bird is positioned within a circular border, and the text "DEPARTMENT OF HEALTH & HUMAN SERVICES USA" is arranged around the upper portion of the circle.

Public Health Service

JUN - 8 2001

Food and Drug Administration 2098 Gaither Road Rockville MD 20850

James M. Barquest, Ph. D. Acting Chief Pan Probe Biotech, Inc. c/o California Department of Health Food & Drug Branch P.O. Box 942732 (MS-357) Sacramento, CA 94234

510(k) Number: K011609 Re: 510(K) Number. RUT1007
Trade/Device Name: Pan Probe Biotech LiveSure™ Amphetamine Screen Tests Regulation Number: 862.3100 Regulatory Class: II Product Code: DKZ Dated: May 21, 2001 Received: May 25, 2001

Dear Dr. Barquest:

We have reviewed your Section 510(k) notification of intent to market the device referenced in we have reviewed your Section 910(t). It is substantially equivalent to devices marketed in interstate commerce prior to May 28, 1976, the enactment date of the Medical Device interstate comments, or to devices that have been reclassified in accordance with the provisions of the skeries, subject to Amendments, or to devices mat liave book rockessince your recefere, market the device, subject to Federal Food, Drug, and Cosmono Act. The general controls provisions of the Actinelude the general controls provisions of the Fict. "The gollering practice, labeling, and prohibitions against misbranding and adulteration.

If your device is classified (see above) into either class II (Special Controls) or class III If your device is classifica (sec above) into such additional controls. Existing major regulations (Premarket Approval), it may of subject to sueral Regulations, Title 21, Parts 800 to 895.
affecting your device can be found in the Code of Federal Regulations, Title 21, Ma allecting your device can be round in the essumes compliance with the Good Manufacturing A substantially equivalient acterimidator assumments (21 CFR Part 820) and that, through Practice for Mcdical Devioles: "Sensial (Drug Administration (FDA) will verify such periodic Olvir inspections, the I ood alla Dring regulation may result in regulatory action. In the closed assumptions. Transic to compty was and seeming your device in the Federal addition, FDA may publish furtion anno anno are market notification submission does not affect Register. Flease note: this responder sections 531 through 542 of the Act for devices under the ally obligation you inight have andel provisions, or other Federal laws or regulations.

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This letter will allow you to begin marketing your device as described in your 510(k) prematket This letter will allow you to begin marketing your device to a legally marketed
notification. The FDA finding of substantial equivalence of your device to notification. The FDA finding of substantal equivalence of 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 CFF Part 801 and If you desire specific advice for your device devices), please contact the Office of Compliance at
additionally 809.10 for in vitro diagnostic devices), please contact the Of additionally 809.10 for in yife diagnostic as nothe promotion advertising of your device,
[phone]. Additionally, for questions on the promotion advertising of your de [phone]. Additionally, for questions on and promoted. A hiso, please note the regulation please contact the Office of Compliance at (30) - 1101 (CFR 807.97). Other general
entitled, "Misbranding by reference to premarket notification" (21CFR 807.97). Other genera entitled, "Misbranding by reference oplemans. Included from the Division of Small
information on your responsibilities under the Act may be obtained from the Division of Smal information on your responsibilities under [phone] or [phone] or at its
Manufacturers Assistance at its toll-free number [phone] or [phone] or at Manufacturers Assistance at its ton-free nation (or the )
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 Office of Devices and Radiological Health

Enclosure

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### 510(k) Number (if known): K011609

# 5 f0(k) Namber (if mire - Pan Probe Biotech LiveSure™ Amphetamine Screen Tests

## INDICATIONS FOR USE STATEMENT:

INDICATIONS FOR USE ON And Test Card and Test Card and Test Strip devices are
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rapid in vitro diagnostic (IVD) qualitative lateral flow immuno-chromative urinary rapid in vitro diagnostic (IVD) qualifative lateral nov innune at the NID &(National linstitute
assays for detection of D-Amphetamine (AMP) in human urine at the NICA (Nation assays for detection of D-Amphetamine (AMP) in numan unte at the Rich (microsis in the mineralian) cuton Drug Abuse) and SAMHSA (Substance Abuse and Mental Health Services and SAMHSA (Substance Abuse and Mehilar inealir ocliniose Non Roman, Marina, Inc.
off level of 1000 ng AMP/ml. These tests are intended for visual, qualitative (VD screening, off level of 1000 g AMP/ml. These test are intended for quantialive results, nor for over the counter and professional use only, and are not intended for quantalites provide only pliminary qualitative
These screen tests for Amphetamine, analogs and method must be used in order to These screen tests for Amphetanine, analogs and metabol must be used in order to obtain a
analytical data. A more specific quantitative alternative method must be used in ord analytical data. A more specific quantitative niemod intost or chromatographic mass
confirmed analytical result NIDA and SAMHSA confirmed analytical result. NIDA and SAMHSA method. Clinical Considerations and spectrometry (GCMS) as the preferred committed onlined belined believe test result, particularly when
professional judgment should be applied to any drug of abuse test result professional Judge results are indicated.

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

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(Division Sign-Off) Division of Clinical Laboratory Devices K011609 510(k) Number.

Prescription Use:
(Per 21 CFR 801.109) or

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