(11 days)
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No
The device description details a standard lateral flow immunoassay based on competitive binding, which is a purely chemical and physical process. There is no mention of any computational analysis, algorithms, or learning processes that would indicate the use of AI or ML. The results are visually interpreted.
No
The device is an in vitro diagnostic (IVD) qualitative lateral flow competitive immuno-chromatographic urinary screening device intended for the detection of Methadone, its analogs and metabolites, which aids in the diagnosis of drug abuse or overuse. It is not intended for treatment or prevention of any disease or condition, which would make it a therapeutic device.
Yes
The "Intended Use / Indications for Use" section explicitly states that the devices are "rapid in vitro diagnostic (IVD) qualitative lateral flow competitive immuno-chromatographic urinary screening devices" intended "to aid in the diagnosis of drug abuse or over use." This phrasing directly indicates their role in the diagnostic process.
No
The device description clearly details a physical, in vitro diagnostic (IVD) immunoassay device (test card and test strip) that uses chemical reactions and visual interpretation. It does not describe any software component as the primary medical device.
Yes, the provided text explicitly states that the device is an IVD (In Vitro Diagnostic).
The "Intended Use / Indications for Use" section begins with: "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..."
N/A
Intended Use / Indications for 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 termed: 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 Methadone Test Card & Test Strip IVD immunoassay devices are designed for visual, qualitative screening, for professional use only, and are not intended for quantitative results, nor for quantitative screening. LiveSure™ Methadone Test Card & Test Strip devices provide only preliminary qualitative (or semi-quantitative) screening data for use to aid in the diagnosis of drug abuse or over use. A confirmatory 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.
Product codes
DJR
Device Description
The Pan Probe Biotech LiveSure™ Methadone Screen Test Card and Test Strip (i.e., LiveSure™ Methadone) 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 conjugate complex for limited specific antibody binding sites. LiveSure™ Methadone devices are 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 action. Antibody-colloidal gold conjugate binds to MED-drug conjugate, forming an antibody-antigen complex. This antibody-MED-drug conjugate appears as a second visible pink colored band and captured reagent at the test region. Any MED present in a sample urine acts as antigens, competing with MED-drug reagent 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 the 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.
Mentions image processing
Not Found
Mentions AI, DNN, or ML
Not Found
Input Imaging Modality
Not Found
Anatomical Site
human urine
Indicated Patient Age Range
Not Found
Intended User / Care Setting
professional use only
Description of the training set, sample size, data source, and annotation protocol
Not Found
Description of the test set, sample size, data source, and annotation protocol
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.
Summary of Performance Studies (study type, sample size, AUC, MRMC, standalone performance, key results)
In-house testing of LiveSure™ Methadone Screen Test Card and Test Strip devices against EMIT® II 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.
Key Metrics (Sensitivity, Specificity, PPV, NPV, etc.)
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. Finally, 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 EMIT®II immunoassay.
Predicate Device(s)
EMIT® II
Reference Device(s)
Not Found
Predetermined Change Control Plan (PCCP) - All Relevant Information
Not Found
§ 862.3620 Methadone test system.
(a)
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.(b)
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).
0
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.
1
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 (301) 594-4588. Additionally, for questions on the promotion and advertising of your device, please contact the Office of Compliance at (301) 594-4639. 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 (800) 638-2041 or (301) 443-6597 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
3
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
/ Prescription Use
Over the Counter Use