LIVESURE METHADONE SCREEN TESTS

K013796 · Pan Probe Biotech, Inc. · DJR · Nov 26, 2001 · Clinical Toxicology

Device Facts

• Record ID: K013796
• Device Name: LIVESURE METHADONE SCREEN TESTS
• Applicant: Pan Probe Biotech, Inc.
• Product Code: DJR · Clinical Toxicology
• Decision Date: Nov 26, 2001
• Decision: SESE
• Submission Type: Traditional
• Regulation: 21 CFR 862.3620
• Device Class: Class 2
• Attributes: 3rd-Party Reviewed

Intended Use

The Pan Probe Biotech (PPB), Inc LiveSure™ Methadone Screen Test Card & Test Strip devices are rapid in vitro diagnostic (IVD) qualitative lateral flow competitive immuno-chromatographic urinary screening devices intended for detection of Methadone, its analogs and metabolites (collectively screening at the NIDA (National Institute on Drug Abuse) and SAMHSA (Substance Abuse and Health Services Administration) cut-off level of 300 ng MED/ml of human urine. These PPB Mcharl Featur bervices Hand & Test Strip IVD immunoassay devices are designed for visual, qualitative screening, for professional use only, and are not intended for quantitative results, nor for quanuative berealling) for presentativeSure™ Methadone Test Card & Test Strip devices provide only ovel ate commal (or o) creening data for use to aid in the diagnosis of drug abuse or over use. A premium y 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 result. NDTT and of micel 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 competitive immuno-chromatographic test card/strip; detects Methadone, analogs, and metabolites in human urine. Principle: drug in sample competes with pre-coated Methadone-drug conjugate for limited antibody binding sites on colloidal gold conjugate. Absence of drug: pink band forms at test region (negative). Presence of drug: blocks binding, preventing test band formation (positive). Control band always appears. Used in professional clinical settings; interpreted visually by healthcare providers. Provides preliminary screening data; requires confirmation by GC/MS. Benefits: rapid, qualitative assessment for drug abuse diagnosis.

Clinical Evidence

Clinical study of 301 urine samples compared the device against GC/MS (gold standard) and EMIT® II. Results: 100% agreement with GC/MS positive results; 99.0% agreement with GC/MS negative results. Overall accuracy was 99.3% (299/301) versus GC/MS. Specificity against EMIT® II negatives was 99.4%. The device yielded zero false positives and zero false negatives compared to GC/MS, whereas the predicate EMIT® II showed 1 false positive and 1 false negative.

Technological Characteristics

Lateral flow competitive immuno-chromatographic assay. Components: test strip with Methadone-drug conjugate test band, control band, and anti-MED monoclonal antibody-colloidal gold conjugate pad. Visual readout. Professional use only. No external energy source required. Standalone diagnostic device.

Indications for Use

Indicated for professional qualitative screening of human urine for Methadone, its analogs, and metabolites at a 300 ng/ml cut-off level to aid in the diagnosis of drug abuse.

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

• EMIT® II Methadone immunoassay

Submission Summary (Full Text)

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Pan Probe Biotech LiveSure™ Methadone Screen Test Card & Test Strip

Pan Probe Biotech, Inc.

NOV 2 6 2001

( 0 13796 Revision B, October 22, 2001

## SUMMARY STATEMENT OF SAFETY AND EFFECTIVENESS

The sponsor, Probe Biotech, Inc., has developed, manufactured, and tested under Good Laboratory Practices guidelines, in vitro diagnostic (IVD) devices for qualitative testing of urine samples for the presence of guidemics) in "The Canglessia (State (States) in an IVD screening format. The trade name of the devices are the Pan Methadone, 16 thatogo, and news on and Test Strip, having TDA assigned name: Methadone I love Diotech Livesure - Mediatone of Select I device per 21 CFR 862.3260, with product code: DJR. These IVD I est youth a casomethon as a caso eening of urines for Methadone, its analogs, and metabolites.

The Pan Probe Biotech LiveSure™ Methadone Screen Test Card and Test Strip (i.e., LiveSure™ Methadone) I which are rapid qualitative chromatographic IVD immunoassays, in which chemically labeled drug conjugate competes with any Methadone (MED) drugs, analogs or metabolites that may be in the conjugure comples for limited specific antibody binding sites. LiveSure™ Methadone devices prescient in test annual bas been pre-coated both with a Methadone (MED-)drug conjugate at the test band, and is followed by a built-in reference band with a second antibody as a system control band. A test colored anti-MED monoclonal antibody-colloidal gold conjugate pad is placed to the right of a test strip. In the absence of MED drugs, analogs or metabolites in urine, pink colored antibody-colloidal gold conjugates move chromatographically along with the urinary samples on the membrane by capillary ection. Antibody-colloidal gold conjugate binds to MED-drug conjugate, forming an antibody-antigen complex. This antibody-MED-drug conjugate appears as second visible pink colored band and captured reagent at the test region. Any MED present in a sample urine act as antigens, competing with MED-drug reagon at the test band region for limited MED-antibody binding sites on antibody-colloidal gold conjugate. When a sufficient concentration of urinary MED drugs, analogs or metabolites are present, these analytes block the limited antibody binding sites. This blockage-binding process prevents attachment of anial colored antibody-colloidal gold conjugate at the MED-drug conjugate zone located at the test band region. To serve as a procedural control, a pink colored band in a control region will always appear, regardless of the presence of MED in urine samples. Thus, negative urine samples produce two pink colored bands, while positive urine samples produce only one pink colored band.

In-house testing of LiveSure™ Methadone Screen Test Card and Test Strip devices against EMIT® II In house to as a predicate device provided data essentially showing equivalency between the Card and Strip devices, and to the predicate EMIT® II Assay. Additionally, independent clinical testing of 301 urine samples against LiveSure™ Methadone 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™ Methadone Test Card or Strip gave both 99.0% agreement with GC/MS negative results. In comparing the Test Card and Test Strip positives with EMIT® II positives, both gave 98.4% respective agreement with EMIT® II positives. Specificity of Test Card and Test Strip negatives with EMIT® II negatives was shown to be 99.4% for both. In terms of overall accuracy of values at and below the ±25% range of the NIDA/SAMHSA cut-off of 300 ng Methadone/ml, however, the LiveSure™ Methadone Screen Test Card and Strip yielded no false positives (FP), whereas EMIT®II resulted in 1 FP value for urine samples with GC/MS results below 225 ng/ml. Also EMIT® II apparently had 1 false negative (1FN), while Test Card & Test Strip gave zero FN results vs. GC/MS. Finaly, the LiveSure™ Methadone Test Card and the Test Strip gave overall accuracy results of 299/301 (99.3%) for both versus GC/MS data, whereas 296/301 (98.3%) accuracy was obtained with EMTT®II immunoassay. Thus, the LiveSure™ Methadone Test Card and Test Strip devices were determined to be substantially equivalent in performance to the approved predicate EMTT® II Methadone immunoassay device, and the LiveSure™ Methadone Test Card and Test Strip devices were shown to be substantially equivalent to each other in performance, each versus the external GC/MS Methadone laboratory results.

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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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 abstract design, resembling a bird or a flowing shape, with three curved lines. The text "DEPARTMENT OF HEALTH & HUMAN SERVICES - USA" is arranged in a circular fashion around the design.

Food and Drug Administration 2098 Gaither Road Rockville MD 20850

NOV 2 6 2001

Pan Probe Biotech, Inc. c/o Raymond Wilson, Pharm. D. California Department of Health Services Food and Drug Branch 714/744 P Street P.O. Box 942732 (MS-357) Sacramento, CA 94234-7320

k013796 Re:

Trade/Device Name: PanProbe Biotech, Inc. LiveSure™ Methadone Screen Test Card & Test Strip

Regulation Number: 21 CFR 862.3620 Regulation Name: Methadone test system Regulatory Class: Class II Product Code: DJR Dated: November 2, 2001 Received: November 15, 2001

Dear Dr. Wilson:

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 the Code of Federal Regulations, Title 21, Parts 800 to 898. 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 Part 801); good manufacturing practice requirements as set forth in the quality systems (QS) regulation (21 CFR Part 820); and if applicable, the electronic product radiation control provisions (Sections 531-542 of the Act); 21 CFR 1000-1050.

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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 nredicate 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 1 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" (21CFR 807.97). Other general information on your responsibilities under the Act may be obtained 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/cdrb/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 Pan Probe Biotech LiveSure™ Methadone Screen Test Card & Test Strip 19 Revision B, October 22, 2001 Proprietary Information Pan Probe Biotech, Inc.

510(k) Regulatory No. (if known): 21 CFR 862.3620; Product Code: DJR

# DEVICE NAME: Pan Probe Biotech, Inc. LiveSure™ Methadone Screen Test Card & Test Strip

## INDICATIONS FOR USE STATEMENT

The Pan Probe Biotech (PPB), Inc LiveSure™ Methadone Screen Test Card & Test Strip devices are rapid in vitro diagnostic (IVD) qualitative lateral flow competitive immuno-chromatographic urinary screening devices intended for detection of Methadone, its analogs and metabolites (collectively screening at the NIDA (National Institute on Drug Abuse) and SAMHSA (Substance Abuse and termed: Health Services Administration) cut-off level of 300 ng MED/ml of human urine. These PPB Mcharl Featur bervices Hand & Test Strip IVD immunoassay devices are designed for visual, qualitative screening, for professional use only, and are not intended for quantitative results, nor for quanuative berealling) for presentativeSure™ Methadone Test Card & Test Strip devices provide only ovel ate commal (or o) creening data for use to aid in the diagnosis of drug abuse or over use. A premium y 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 result. NDTT and of micel 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)

Thomas C. Durto

(Division Sign-Off) Division of Clinical Laboratory Devices Kor3196 510(k) Number

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