The Pan Probe Biotech LiveSure™ Methamphetamine Screen Test Card and Test Strip devices are rapid in vitro diagnostic (IVD) qualitative lateral flow immuno-chromatographic competitive urinary assays for the detection of Methamphetamine (MET) and its analogs or metabolites in human urine at the NIDA (National Institute on Drug Abuse) and SAMHSA (Substance Abuse and Mental Health Services Administration) cut-off level of 1,000 ng MET/ml. These tests are intended for visual, qualitative IVD screening, for professional use only, and are not intended for quantitative results, nor for over the counter sales. These screen tests for Methamphetamine, 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 Description

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

AI/ML Overview

The Pan Probe Biotech LiveSure™ Methamphetamine Screen Test Card and Test Strip are in vitro diagnostic devices intended for the qualitative detection of Methamphetamine, its analogs, or metabolites in urine samples.

Here's an analysis of the acceptance criteria and the study proving the device meets them:

1. Table of Acceptance Criteria and Reported Device Performance

The acceptance criteria are not explicitly stated in a quantitative form (e.g., "sensitivity must be >X%"), but rather implied through a comparison with a predicate device (EMIT® II Assay) and a gold standard (GC/MS). The performance is presented as a comparison to these methods.

Metric	Acceptance Criteria (Implied)	LiveSure™ Methamphetamine Test Card Performance	LiveSure™ Methamphetamine Test Strip Performance	EMIT® II Assay Performance
Agreement with GC/MS (quantitative positive results)	100% agreement with positive GC/MS results, and high agreement with negative GC/MS results, with overall accuracy comparable to or superior to predicate.	100%	100%	100%
Agreement with GC/MS (negative results)	High agreement with negative GC/MS results.	98.2%	97.0%	96.4%
Agreement with EMIT® II (positives)	High agreement with EMIT® II positives.	97.8%	99.3%	N/A
Specificity vs. EMIT® II (negatives)	High specificity compared to EMIT® II negatives.	98.2%	98.2%	N/A
False Positives/Negatives (within ±25% of 1000 ng/ml cut-off)	No false positives or false negatives.	0 false positives, 0 false negatives	0 false positives, 0 false negatives	1 false positive (below 750 ng/ml), 3 false negatives (above 1001 ng/ml)
Overall Accuracy vs. GC/MS	Comparable or superior to predicate.	99.0% (297/300)	98.3% (295/300)	97.0% (291/300)
Equivalence to EMIT® II Assay	Data essentially showing equivalency.	Considered equivalent or superior	Considered equivalent or superior	N/A

2. Sample Size Used for the Test Set and the Data Provenance

Sample Size for Test Set: 300 urine samples.
Data Provenance: The data was obtained from "independent clinical testing" conducted at an "external reference laboratory." The country of origin is not explicitly stated, but given the submission is to the U.S. FDA, it is likely that the study was conducted within the United States or at a facility that complies with U.S. regulatory standards. The study appears to be retrospective, as a set of 300 urine samples were tested against the new devices, the predicate, and GC/MS.

3. Number of Experts Used to Establish the Ground Truth for the Test Set and the Qualifications of Those Experts

The ground truth was established by Gas Chromatography/Mass Spectrometry (GC/MS) analysis. GC/MS is a laboratory analytical method and does not involve human experts in the same way as an imaging study. Therefore, the concept of "number of experts" or their "qualifications" for establishing GC/MS ground truth is not applicable. The GC/MS results are considered the definitive, quantitative ground truth.

4. Adjudication Method for the Test Set

Not applicable. The ground truth was established by GC/MS, which is an objective chemical analysis, not a subjective human interpretation requiring adjudication.

5. If a Multi-Reader Multi-Case (MRMC) Comparative Effectiveness Study Was Done, If So, What Was the Effect Size of How Much Human Readers Improve with AI vs Without AI Assistance

Not applicable. This is an in vitro diagnostic device for chemical analysis, not an imaging device or AI-assisted diagnostic tool that involves human readers interpreting results. The device itself provides a qualitative "positive" or "negative" indication.

6. If a Standalone (i.e., algorithm only without human-in-the-loop performance) Was Done

Yes, this study is inherently a standalone performance evaluation. The LiveSure™ Methamphetamine Screen Test Card and Test Strip are designed to provide a direct readout (bands appearing or not appearing), and their performance was assessed directly against reference methods (EMIT® II and GC/MS) without human interpretation affecting the device's output. While a human reads the results from the test strip, the "performance" here refers to the accuracy of the chemical reaction in producing the correct visual outcome.

7. The Type of Ground Truth Used

The primary and most robust ground truth used was Gas Chromatography/Mass Spectrometry (GC/MS) results, which provided quantitative confirmation of Methamphetamine presence and concentration.

8. The Sample Size for the Training Set

The document does not explicitly mention a "training set" in the context of machine learning or algorithm development. This is an immunoassay device, not a software algorithm that undergoes a training phase with a dataset. The development and optimization of the immunoassay reagents and design would have involved internal testing and validation, but this is not typically referred to as a "training set" in the way it is for AI/ML.

9. How the Ground Truth for the Training Set Was Established

As noted above, the concept of a "training set" with established ground truth is not directly applicable to this type of immunoassay device. The device's performance characteristics (e.g., antibody specificity, cut-off levels) would have been established through internal R&D using various methods and known concentrations of analytes and interferents, but not through a formal "training set" in the data science sense.

Summary

{0}------------------------------------------------

K011610

JUN - 8 2001

SUMMARY STATEMENT OF SAFETY AND EFFECTIVENESS

The sponsor, Pan Probe Biotech, Inc., has developed, manufactured, and tested under GMP guidelines, an in vitro diagnostic device for the qualitative testing of une samples for the presence of Methamphetamine, its analogs or metabolites in a screening format.

The trade names of these devices are the Pan Probe Biotech LiveSure™ Methamphetamine Screen Test Card and Test Strip, having a designated common name of Methamphetamine Test Systems and classification as Class II devices as per listing 21 CFR 862.3610. These devices are intended for medical/forensic screening of urines for Methamphetamine.

In-house testing of LiveSure™ Methamphetamine Screen Test Card and 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 300 urine samples against LiveSure™ Methamphetamine 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™ Methamphetamine Test Card gave a 98.2 agreement and the Test Strip gave a 97.0% agreement with GC/MS negative results. whereas EMIT II® yielded only a 96.4% correlation with GC/MS negatives. In comparing the Test Card and Test Strip positives with EMIT® II positives, a 97.8% and a 99.3% respective agreement with EMIT® II was found. Specificity of Test Card and Test Strip negatives with EMIT® II negatives was shown to be 98.2% 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 Methamphetamine, however, the LiveSure™ Methamphetamine Screen Test Card and Strip yielded no false positives or false negative, but EMIT® II resulted in 1 false positives values for urine samples with GC/MS results below 750 ng/ml of Methamphetamine, and 3 false negative values for urine samples with GC/MS results above 1001 ng/ml of Methamphetamine. Finally, the LiveSure™ Methamphetamine Test Card and the Test Strip gave overall accuracy results of 297/300 (99.0%) and 295/300 (98.3%), respectively, versus GC/MS data, whereas 291/300 (97.0%) accuracy was obtained with EMIT®II. Thus, as judged against GC/MS results from an independent laboratory, the LiveSure™ Methamphetamine 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.

{1}------------------------------------------------

DEPARTMENT OF HEALTH & HUMAN SERVICES

Public Health Service

Image /page/1/Picture/2 description: The image shows the logo for the U.S. Department of Health & Human Services. The logo features a stylized eagle head with three curved lines extending upwards, representing the department's mission to promote health and well-being. The words "DEPARTMENT OF HEALTH & HUMAN SERVICES USA" are arranged in a circular pattern around the eagle symbol.

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

Re:

510(k) Number: K011610 STo(K) Name: Pan Probe Biotech LiveSure™ Methamphetamine Screen Tests Regulation Number: 862.3610 Regulatory Class: II Product Code: LAF 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 above and we 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 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 (Premarket Approval), it may be subject to such additional controls. Existing major regulations (1 commiser rippt of the 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 periodio CHIP mith the GMP regulation may result in regulation may result in regulatory action. In addition, FDA may publish further announcements concerning your device in the Federal addition, I Driving protize to your premarket notification submission submission does not affect reason. Flease now might have under sections 531 through 542 of the Act for devices under the any obtigation your and and and 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 his letter will allow you to begill marketing your device to a legally marketed
notification. The FDA finding of substantial equivalence of your device your douges to notification. The FDA inding of substantial equivalise or , .
predicate 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 CFF Part 801 and If you desire specific advice for your do need on our more of the Office of Compliance at additionally 809.10 for in Vitto diagnotions on the promotion and advertising of your device, (301) 594-4588. Additionally, for questions on are p-4639. Also, please note the regulation
please contact the Office of Compliance at (301) 594-4639. And agon and Office entitled, "Misbranding by reference to premarket notification" (21CFR 807.97). Other general entitled, "Misoranding by relection to premier Act may be obtained from the Division of Small
information on your responsibilities under the Act 12011 112 (607) web it information on your responsibilities and its toll-free number (800) 638-2041 or (301) 443-6597 or at its Manufacturers 7135fbailos av a fda.gov/odrh/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}------------------------------------------------

510(k) Number (if known): K011610

Device Name: Pan Probe Biotech LiveSure™ Methamphetamine Screen Tests

INDICATIONS FOR USE STATEMENT:

The Pan Probe Biotech LiveSure™ Methamphetamine Screen Test Card and Test Strip devices are rapid in vitro diagnostic (IVD) qualitative lateral flow immuno-chromatographic competitive urinary assays for viro "diagnolio" (NET) qualifactor "Allin human urine at the at the NiDA (National Institute on Drug Abuse) and SAMHSA (Substance Abuse and Mental Health Services Administration) cut-off level of 1,000 ng MET/ml. These tests are intended for visual, qualitative IVD screening, for professional use only, and are not intended for quantitative results, nor for over the counter sales. These screen tests for Methamphetamine, mendou for qualifikative rocality 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)

Fred Lacy

(Division Sign-Off) Division of Clinical Laboratory Devices K011610 510(k) Number _

Prescription Use:
(Per 21 CFR 801.109) or

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

Regulation Number and Section

§ 862.3610 Methamphetamine test system.

(a)
Identification. A methamphetamine test system is a device intended to measure methamphetamine, a central nervous system stimulating drug, in serum, plasma, and urine. Measurements obtained by this device are used in the diagnosis and treatment of methamphetamine use or overdose.(b)
Classification. Class II (special controls). A methamphetamine 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).