AMEDICA DRUG SCREEN MDMA-BAR-BZO-MTD-TCA TEST

K031497 · Amedica Biotech, Inc. · DJC · Oct 17, 2003 · Clinical Toxicology

Device Facts

• Record ID: K031497
• Device Name: AMEDICA DRUG SCREEN MDMA-BAR-BZO-MTD-TCA TEST
• Applicant: Amedica Biotech, Inc.
• Product Code: DJC · Clinical Toxicology
• Decision Date: Oct 17, 2003
• Decision: SESE
• Submission Type: Traditional
• Regulation: 21 CFR 862.3610
• Device Class: Class 2

Intended Use

The Amedica Drug Screen MDMA-BAR-BZO-MTD-TCA Test is an in vitro diagnostic test for the rapid detection of 3,4 methylenedioxymethamphetamine, secobarbital, oxazepam, methadone and nortriptyline in human urine at the following cut-off concentration: MDMA 3,4 methylenedioxymethamphetamine 500 ng/ml; BAR secobarbital 300 ng/ml; BZO oxazepam 300 ng/ml; MTD methadone 300 ng/ml; TCA nortriptyline 1000 ng/ml. This test kit is used to obtain a visual, qualitative result and is intended for professional use. It is not intended for over the counter sale.

Device Story

Lateral flow immunochromatographic assay for qualitative drug detection in human urine. Available as dipstick or cassette format. Operator dips strip or adds urine drops to sample well; sample migrates through test strip. Visual readout of test lines indicates presence or absence of specific drugs at defined cutoffs. Intended for professional use in clinical laboratories; not for point-of-care. Results are preliminary; requires GC/MS confirmation. Assists healthcare providers in identifying potential drug use; clinical judgment required for interpretation.

Clinical Evidence

Performance evaluated via correlation study using blind-labeled specimens compared against GC/MS. Study demonstrated >94% agreement with GC/MS results. Clinical site study performed at a certified laboratory confirmed professional utility for visual, qualitative drug detection.

Technological Characteristics

Membrane-based lateral flow competitive immunoassay; utilizes colloidal gold for visual detection. Employs specific antibody-antigen reactions. Standalone test kit; no electronic components or software.

Indications for Use

Indicated for professional use in clinical settings for the rapid, qualitative detection of MDMA, secobarbital, oxazepam, methadone, and nortriptyline in human urine. Not for point-of-care or over-the-counter use. Provides preliminary analytical results; requires confirmation by GC/MS.

Regulatory Classification

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.

Special Controls

*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).

Predicate Devices

• Instant-View MDMA Test (K022501)
• Instant-View Barbiturate Test (K010125)
• Instant-View Benzodiazepine Test (K003879)
• Instant-View Methadone Test (K010014)
• Instant-View TCA Test (K022693)

Submission Summary (Full Text)

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OCT 17 2003

K031497

## Summary of Safety and Effectiveness ( As required by 21CFR 807.92(c))

Device name: Amedica Drug Screen MDMA-BAR-BZO-MTD-TCA Test

Design and Materials: Membrane based one-step, lateral flow, competitive immunoassay use colloidal gold for visual detection of 3,4 methylenedioxymethamphetamine, secobarbital, oxazepam, methadone and nortriptyline.

Intended Use: The Amedica Drug Screen MDMA-BAR-BZO-MTD-TCA Test is a immunochromatographic assay for the rapid detection of of 3,4 methylenedioxymethamphetamine, secobarbital, oxazepam, methadone and nortriptyline in human urine at the following cutoff concentration:

| MDMA | 3,4 methylenedioxymethamphetamine | 500 ng/ml |
|------|-----------------------------------|------------|
| BAR | Secobarbital | 300 ng/ml |
| BZO | Oxazepam | 300 ng/ml |
| MTD | Methadone | 300 ng/ml |
| TCA | Nortriptyline | 1000 ng/ml |

This test kit is used to obtain a visual, qualitative result and is intended for professional use.

Test Principle and Description: The Amedica Drug Screen MDMA-BAR-BZO-MTD-TCA Test is based on the principle of highly specific competitive immunochemical reactions between antigens and antibodies for the analysis of specific substances in urine. During testing, a urine specimen moves along membrane on the strip by capillary action. When drugs concentrations in the urine are below cutoff, they are not enough to saturate all of the binding sites of the antibodycoated colored particles in the test strip. The unsaturated antibody-coated particles will then be captured by drug-protein conjugates immobilized on the strip and colored lines will appear in the test region. The test result is negative. If the drugs levels are above cutoff, they are sufficient to occupy all of the binding sites on the antibody-coated particles. The saturated antibody-coated particles will not be captured by drug-protein conjugate coated on the strip. The colored lines will not form in the test region. The test result is positive. The device also provides a built-in control with a different antibody reaction at the control region. This control line should always appear whether or not the drugs or metabolites are present. If the control line does not appear the test result is invalid. This means that negative urine will produce colored bands in test and control region, while positive urine will produce only colored bands in the control region.

Performance: The product performance was evaluated by correlation study using blind-labeled specimens that have been measured by GC/MS. This study produced > 94% agreement with GC/MS results. In addition, clinical site study was performed at a certified laboratorie and demonstrated that Amedica Biotech Drug Screen MDMA-BAR-BZO-MTD-TCA Test can be use by professionals to obtain a visual, qualitative detection of drugs of abuse. The results of these studies and comparison with predict devices demonstrated that Amedica Biotech Drug

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K 031497 page 2 of 2

Benzodiazepine, Methadone, TCA Test

Screen MDMA-BAR-BZO-MTD-TCA Test is substantially equivalent to the legally marketed devices.

Amedica Biotech, Inc. Manufacturer: 28301 Industrial Blvd. Suite K Hayward, CA 94545 Phone: [phone] Fax: [phone] Instant-View Drug Screen MDMA, Barbiturate, Predicate kits:

.

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Image /page/2/Picture/1 description: The image is a black and white logo for the Department of Health & Human Services USA. The logo consists of a circular arrangement of text that reads "DEPARTMENT OF HEALTH & HUMAN SERVICES • USA". Inside the circle is a stylized symbol that resembles three human profiles facing to the right, with flowing lines connecting them. The symbol is meant to represent health and human services.

OCT 17 2003

Food and Drug Administration 2098 Gaither Road Rockville MD 20850

Mr. Jeff Chen President Amedica Biotech, Inc. 28301 Industrial Blvd - Suite K Hayward, CA 94545

k031497 Re:

> Trade/Device Name: Amedica Drug Screen MDMA-BAR-BZO-MTD-TCA Test Regulation Number: 21 CFR 862.3610 Regulation Name: Methamphetamine test system Regulatory Class: Class II Product Code: DJC; DIS; JXM; DJR; MLK Dated: July 29, 2003 Received: July 31, 2003

Dear Mr. Chen:

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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## Page 2 -

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 Sutman

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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Page of

510(k) Number (if known):

K031497

## Device Name: Amedica Drug Screen MDMA-BAR-BZO-MTD-TCA Test

Indications For Use:

The Amedica Drug Screen MDMA-BAR-BZO-MTD-TCA Test is an in vitro diagnostic test for the rapid detection of 3,4 methylenedioxymethamphetamine, secobarbital, oxazepam, methadone and nortriptyline in human urine at the following cut-off concentration.

| MDMA | 3,4 methylenedioxymethamphetamine | 500 ng/ml |
|------|-----------------------------------|------------|
| BAR | secobarbital | 300 ng/ml |
| BZO | oxazepam | 300 ng/ml |
| MTD | methadone | 300 ng/ml |
| TCA | nortriptyline | 1000 ng/ml |

This test kit is used to obtain a visual, qualitative result and is intended for professional use. It is not intended for over the counter sale.

intended for over-the counter sale

Division Sign-Off

Office of In Vitro Diagnostic Device Evaluation and Safety

510(k) K031497

(PLEASE DO NOT WRITE BELOW THIS LINE-CONTINUE ON ANOTHER PAGE IF NEEDED)

Concurrence of CDRH, Office of Device Evaluation (ODE)

| Prescription Use | |
|----------------------|--|
| (Per 21 CFR 801.109) | |

OR

Over-The-Counter Use

(Optional Format 1-2-96)