(15 days)
Not Found
Not Found
No
The device description and performance studies describe a standard lateral flow immunoassay, which relies on chemical reactions and capillary action for results, not computational algorithms like AI/ML.
No
The device is described as an "in vitro diagnostic (IVD) qualitative lateral flow immuno-chromatographic competitive urinary rapid in detection of Phencyclidine" and is used for screening, not treatment or prevention of a disease.
Yes
The device is described as an "in vitro diagnostic (IVD) qualitative lateral flow immuno-chromatographic competitive urinary rapid test" for the detection of Phencyclidine, analogs and metabolites, which directly indicates its diagnostic purpose.
No
The device is described as a "rapid qualitative competitive chromatographic IVD immunoassay" and involves physical components like a membrane, absorbent pad, and gold conjugate. This indicates a hardware-based diagnostic test, not a software-only device.
Yes, this device is an IVD (In Vitro Diagnostic).
The "Intended Use / Indications for Use" section explicitly states: "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..."
This statement clearly identifies the device as an in vitro diagnostic.
N/A
Intended Use / Indications for 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.
Product codes (comma separated list FDA assigned to the subject device)
LCM
Device Description
The Pan Probe Biotech LiveSure™ Phencyclidine Screen Test Card and Test Strip (PCP Test) devices are rapid qualitative competitive chromatographic IVD immunoassays, in which a chemically labeled drug conjugate competes 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. Antibody-colloidal 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.
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 297 urine samples against LiveSure™ Phencyclidine Screen Test Card and Test Strip devices, as well as Sumplos agains E.V.Our - nefference laboratory, in comparison to GC/MS quantitative positive results.
Summary of Performance Studies (study type, sample size, AUC, MRMC, standalone performance, key results)
In-house testing of LiveSure™ Phencyclidine Screen Test Card and Test Strip devices against a predicate device (EMIT® II Assay) essentially showed equivalency.
Independent clinical testing of 297 urine samples:
- Against GC/MS quantitative positive results: LiveSure™ devices showed 100% agreement.
- Against GC/MS negative results: LiveSure™ Phencyclidine Test Strip showed 97.2% agreement. EMIT II® yielded 98.1% agreement.
- Positive agreement with EMIT® II: Test Card and Test Strip showed 100% agreement.
- Specificity of Test Card and Test Strip negatives with EMIT® II negatives: 99.0% respectively.
- Overall accuracy results:
- LiveSure™ Phencyclidine Test Card: 291/297 (98.0%)
- EMIT®II: 295/297 (99.3%)
The LiveSure™ Phencyclidine Test Card and Test Strip were determined to be equivalent in performance to each other and similar in capability versus assays with EMIT®II Phencyclidine Assay, when judged against GC/MS results from an independent laboratory.
Key Metrics (Sensitivity, Specificity, PPV, NPV, etc.)
- Agreement with GC/MS quantitative positive results: 100%
- Agreement with GC/MS negative results for LiveSure™ Phencyclidine Test Strip: 97.2%
- Agreement with GC/MS negative results for EMIT II®: 98.1%
- Agreement with EMIT® II positives (Test Card and Test Strip): 100%
- Specificity of Test Card and Test Strip negatives with EMIT® II negatives: 99.0%
- Overall accuracy LiveSure™ Phencyclidine Test Card: 98.0% (291/297)
- Overall accuracy EMIT®II: 99.3% (295/297)
Predicate Device(s): If the device was cleared using the 510(k) pathway, identify the Predicate Device(s) K/DEN number used to claim substantial equivalence and list them here in a comma separated list exactly as they appear in the text. List the primary predicate first in the list.
Not Found
Reference Device(s): Identify the Reference Device(s) K/DEN number and list them here in a comma separated list exactly as they appear in the text.
Not Found
Predetermined Change Control Plan (PCCP) - All Relevant Information for the subject device only (e.g. presence / absence, what scope was granted / cleared under the PCCP, any restrictions, etc).
Not Found
N/A
0
510k Submission for
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.
1
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.
2
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 (301) 594-4588. Additionally, for questions on the promotion and advertising of your device, (301) 59 +12t 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 mionination on your responsive at its toll-free number (800) 638-2041 or (301) 443-6597 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
3
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)