ADVANTAGE MULTIPLE DRUGS OF ABUSE TEST by ADVANTAGE DIAGNOSTICS CORP

The Advantage Multiple Drugs of Abuse Test is a qualitative, one step, immunochromatographic competitive assay used to screen human urine for the presence of one to five of the following Drugs of Abuse at the indicated cut off: THC 50ng/mL, Phencyclidine (PCP) 25ng/mL, Opiates 2000 ng/mL, Cocaine 300ng/mL, Amphetamine 1,000ng/mL and Methamphetamine 1,000ng/mL. The tests are formatted in multiple plastic test cards, which hold up to 5 drug test strips, and single plastic test cards which hold one drug test strip. The test is qualitative and provides only a preliminary analytical result, which must be confirmed by an alternate methodology preferably, GC/MS. The test is for professional use.

Device Description

The Advantage Multiple Drugs of Abuse Test is an immunochromatographic based one step in vitro test. The tests are formatted in a multiple plastic card, which holds up to 5 drug test strips, and a single plastic test card, which holds a single drug test strip.

AI/ML Overview

Here's a breakdown of the acceptance criteria and study information for the Advantage Multiple Drugs of Abuse Test, based on the provided 510(k) summary:

1. Table of Acceptance Criteria and Reported Device Performance:

Drug Tested	Cut-off Concentration (ng/mL)	Acceptance Criteria (Correlation)	Reported Device Performance (Correlation)
THC	50	Not explicitly stated as a number, but implied by "substantially equivalent"	90-96% (vs. GC/MS), >99% (vs. EMIT in drug-free urine)
Benzoylecgonine/Cocaine	300	Not explicitly stated as a number, but implied by "substantially equivalent"	90-96% (vs. GC/MS), >99% (vs. EMIT in drug-free urine)
Opiates	2,000	Not explicitly stated as a number, but implied by "substantially equivalent"	90-96% (vs. GC/MS), >99% (vs. EMIT in drug-free urine)
Methamphetamine	1,000	Not explicitly stated as a number, but implied by "substantially equivalent"	90-96% (vs. GC/MS), >99% (vs. EMIT in drug-free urine)
Amphetamine	1,000	Not explicitly stated as a number, but implied by "substantially equivalent"	90-96% (vs. GC/MS), >99% (vs. EMIT in drug-free urine)
PCP	25	Not explicitly stated as a number, but implied by "substantially equivalent"	90-96% (vs. GC/MS), >99% (vs. EMIT in drug-free urine)

Note: The acceptance criteria are not explicitly numerical targets in the summary but are represented by the claim of "substantial equivalence" to GC/MS and EMIT testing, with the provided correlation percentages demonstrating this equivalence.

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

Sample Size: Not explicitly stated in the provided document. The summary only mentions "individual Advantage drug tests" were evaluated.
Data Provenance: Not specified. It's likely the testing was conducted in a laboratory setting, but the country of origin or whether the samples were retrospective or prospective is not mentioned.

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

This information is not applicable and not provided. The ground truth was established by laboratory reference methods (GC/MS and EMIT), not by human expert opinion.

4. Adjudication Method for the Test Set:

Not applicable. Adjudication methods are typically used when subjective human interpretation is involved. For a diagnostic test compared to objective lab measurements like GC/MS and EMIT, adjudication is not relevant.

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 device is an in-vitro diagnostic test for drugs of abuse; it is not an AI-assisted diagnostic tool that would involve human readers or MRMC studies.

6. If a Standalone (i.e. algorithm only without human-in-the-loop performance) was done:

Yes, implicitly. The performance data (correlations) are for the device itself as a standalone diagnostic tool, comparing its results directly against reference methods (GC/MS and EMIT). There is no "human-in-the-loop" component described for interpreting the primary device result. Although a human reads the test result, the performance metrics are for the device's accuracy in producing that result.

7. The type of ground truth used:

Laboratory Reference Standards:
- GC/MS (Gas Chromatography/Mass Spectrometry): Considered a "gold standard" for drug testing, providing definitive identification and quantification of substances.
- EMIT (Enzyme Multiplied Immunoassay Technique): Another immunoassay method for screening drugs, specifically used for comparison in "drug-free urine."

8. The sample size for the training set:

Not applicable and not provided. This device is an immunochromatographic test, not a machine learning or AI algorithm that requires a "training set" in the conventional sense. The test's design is based on chemical and biological principles rather than data-driven learning.

9. How the ground truth for the training set was established:

Not applicable. As noted above, there is no "training set" for this type of device. The accuracy of the device is assessed against established laboratory reference methods using test samples.

Summary

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JAN 31 2003

510(k) Summary

This summary of 510(k) safety and effectiveness information is being submitted in accordance with the requirements of the SMDA 1990 and 21 CFR Part 807.92.

The assigned 510(k) number is:_K033712-

Date of summary: October 30, 2002

1. Submitted by: Advantage Diagnostics Corporation 764 San Aleso Avenue Sunnyvale, CA 94085
  Advantage Multiple Drugs of Abuse Test. 3. Device Name:

Device Classification: CFR 21 862.3870. 862.3250. 8610.3610. Class II. Panel 91 Toxicology
Device description: The Advantage Multiple Drugs of Abuse Test is an immunochromatographic based one step in vitro test.
Intended Use: The Advantage Multiple Drugs of Abuse Test is a qualitative, one step immunochromatographic competitive assay used to screen human urine for the presence of the six commonly abused drugs at cut off concentrations of 50 ng/mL THC. 300ng/mL benzoylecgonine/cocaine, 2,000ng/mL opiates, 1,000ng/mL methamphetamine 1,000ng/mL amphetamine and 25ng/mLPCP. The tests are formatted in a multiple plastic card, which holds up to 5 drug test strips, and a single plastic test card, which holds a single drug test strip. The test is qualitative and provides only a preliminary analytical result, which must be confirmed by an alternate methodology preferably. GC/MS.
Substantial Equivalence: The Advantage Multible Drugs of Abuse Test was found substantially equivalent to GC/MS and EMIT testing. The individual Advantage drug tests demonstrated correlations between 90-96% as compared to GC/MS and >99% in drug free urine as compared to EMIT testing.

Conclusion:

The Advantage Multiple Drugs of Abuse Test is substantially equivalent in performance characteristics to GC/MS testing and EMIT testing.

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Food and Drug Administration 2098 Gaither Road Rockville MD 20850

Ms. Janis Freestone Director. Regulatory Affairs Advantage Diagnostics Corporation 764 San Aleso Avenue Sunnyvale, CA 94085

JAN 31 2003

K023712 Trade/Device Name: Advantage Multiple Drugs of Abuse Test Regulation Number: 21 CFR 862.3100 Regulation Name: Amphetamine test system Regulatory Class: Class II Product Code: DKZ; LDJ; DIO; DJC; DJG; LCM Dated: January 7, 2003 Received: January 9, 2003

Dear Ms. Freestone:

Re:

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 Title 21, Code of Federal Regulations (CFR), Parts 800 to 895. 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 Parts 801 and 809); and good manufacturing practice requirements as set forth in the quality systems (QS) regulation (21 CFR Part 820).

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This letter will allow you to begin marketing your device as described in your Section 510(k) premarket notification. The FDA finding of substantial equivalence of your device to a legally marketed predicate device results in a classification for your device and thus, permits your device to proceed to the market.

If you desire specific information about the application of labeling requirements to your device, or questions on the promotion and advertising of your device, please contact the Office of In Vitro Diagnostic Device Evaluation and Safety at (301) 594-3084. Also, please note the regulation entitled, "Misbranding by reference to premarket notification" (21CFR Part 807.97). You may obtain other general information on your responsibilities under the Act 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/cdrh/dsma/dsmamain.html.

Sincerely yours,

Steven Dutman

Steven I. Gutman, M.D., M.B.A. Director Office of In Vitro Diagnostic Device Evaluation and Safety Center for Devices and Radiological Health

Enclosure

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510k Number:

Device Name: Advantage Multiple Drugs of Abuse Test

Indications for Use:

Sean Cooper

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

Concurrence of CDRH, Office of Device Evaluation (ODE)

Prescription Use
(Per 21 CFR 801.109)

Over the counter use

Regulation Number and Section

§ 862.3100 Amphetamine test system.

(a)
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.(b)
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).