ADVANTAGE MULTIPLE DRUGS OF ABUSE TEST

• K Number: K023712
• Device Name: ADVANTAGE MULTIPLE DRUGS OF ABUSE TEST
• Manufacturer: ADVANTAGE DIAGNOSTICS CORP
• Date Cleared: 2003-01-31 ( 88 days)
• Product Code: DKZ DIO DJC DJG LCM LDJ
• Regulation Number: 862.3100

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 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.

Predicate Devices

DKZ, LDJ, DIO, DJC, DJG, LCM

Reference Devices

Not Found

AI/ML (Artificial Intelligence / Machine Learning)

No
The description details a standard immunochromatographic assay for drug screening, with no mention of AI or ML technologies.

Therapeutic

No
The device is an in-vitro diagnostic test used to screen for drugs of abuse in urine; it does not treat or diagnose a disease.

Diagnostic

Yes

The device screens human urine for the presence of drugs of abuse, which is a diagnostic purpose. Although it provides a preliminary result, it is still used in the process of making a diagnosis regarding drug presence.

SaMD (Software as a Medical Device)

No

The device description explicitly states it is an "immunochromatographic based one step in vitro test" formatted in "multiple plastic test cards" and "single plastic test cards," indicating it is a physical test kit, not software.

IVD (In Vitro Diagnostic)

Yes, this device is an IVD (In Vitro Diagnostic).

Here's why:

• Intended Use: The "Intended Use / Indications for Use" section explicitly states that the test is used to "screen human urine for the presence of one to five of the following Drugs of Abuse". This indicates that the test is performed on a sample taken from the human body (urine) to provide information about a person's health status (presence of drugs).
• Device Description: The "Device Description" section describes the test as an "immunochromatographic based one step in vitro test". The term "in vitro" directly means "in glass" or "in the lab," referring to tests performed outside of the living organism.
• Sample Type: The test uses "human urine," which is a biological sample taken from a patient.
• Purpose: The purpose is to detect the presence of substances (drugs of abuse) in the sample, which is a diagnostic activity.

These points align with the definition of an In Vitro Diagnostic device, which is a medical device intended for use in vitro for the examination of specimens derived from the human body solely or principally for the purpose of providing information concerning a physiological or pathological state, or concerning a congenital abnormality, or to monitor therapeutic measures.

PCCP (Predetermined Change Control Plan) Authorized

N/A

Overview

Intended Use / Indications for 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 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.

Product codes

DKZ, LDJ, DIO, DJC, DJG, LCM

Device Description

The Advantage Multiple Drugs of Abuse Test is an immunochromatographic based one step in vitro test.

Format: 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.

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

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

Not Found

Summary of Performance Studies

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.

Key Metrics

Not Found

Predicate Device(s)

Not Found

Reference Device(s)

Not Found

Predetermined Change Control Plan (PCCP) - All Relevant Information

Not Found

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).

Summary

0

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-

1. Date of summary: October 30, 2002

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

4. Device Classification: CFR 21 862.3870. 862.3250. 8610.3610. Class II. Panel 91 Toxicology

5. Device description: The Advantage Multiple Drugs of Abuse Test is an immunochromatographic based one step in vitro test.

6. 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.

7. 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 [phone]. 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 [phone] or [phone] 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:

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.

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)

OR

Over the counter use