AMEDICA DRUG SCREEN THC TEST

K022955 · Amedica Biotech, Inc. · LDJ · Nov 6, 2002 · Clinical Toxicology

Device Facts

• Record ID: K022955
• Device Name: AMEDICA DRUG SCREEN THC TEST
• Applicant: Amedica Biotech, Inc.
• Product Code: LDJ · Clinical Toxicology
• Decision Date: Nov 6, 2002
• Decision: SESE
• Submission Type: Traditional
• Regulation: 21 CFR 862.3870
• Device Class: Class 2

Intended Use

The Amedica Drug Screen THC Test is an in vitro diagnostic test for the rapid detection of THC in human urine at a cutoff of 50 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. This assay provides only a preliminary result. A more specific alternative chemical method is needed to obtain a confirmed result.

Device Story

Amedica Drug Screen THC Test is a lateral flow, competitive immunoassay for qualitative THC detection in human urine. Input: urine specimen; Principle: capillary action moves specimen along membrane; competitive immunochemical reaction between THC and antibody-coated colored particles. If THC < 50 ng/ml, unsaturated antibody-coated particles bind to immobilized THC conjugates, forming a visible test line (negative result). If THC > 50 ng/ml, binding sites are saturated, preventing test line formation (positive result). Built-in control line confirms test validity. Used by healthcare professionals in clinical settings; provides preliminary results requiring confirmation by alternative chemical methods (e.g., GC/MS). Benefits include rapid, visual screening for drugs of abuse.

Clinical Evidence

Performance evaluated via correlation study using blind-labeled clinical specimens compared against GC/MS. Study demonstrated >96% agreement with GC/MS results. Clinical site study performed at two certified laboratories confirmed the device's utility for professional, visual, qualitative detection of drugs of abuse.

Technological Characteristics

Membrane-based lateral flow, competitive immunoassay. Uses colloidal gold for visual detection. Cutoff concentration: 50 ng/ml. Built-in control line for procedural validity. Manual, qualitative, visual readout. No electronic components or software.

Indications for Use

Indicated for professional use for the rapid, qualitative detection of THC in human urine at a 50 ng/ml cutoff. Not for over-the-counter use.

Regulatory Classification

Identification

A cannabinoid test system is a device intended to measure any of the cannabinoids, hallucinogenic compounds endogenous to marihuana, in serum, plasma, saliva, and urine. Cannabinoid compounds include delta-9-tetrahydrocannabinol, cannabidiol, cannabinol, and cannabichromene. Measurements obtained by this device are used in the diagnosis and treatment of cannabinoid use or abuse and in monitoring levels of cannabinoids during clinical investigational use.

Special Controls

*Classification.* Class II (special controls). A cannabinoid 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

• Rapid THC Test (Rapid Diagnostics, Inc.)

Submission Summary (Full Text)

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NOV 6 2002

KO 22955

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

Device name: Amedica Drug Screen THC Test

Design and Materials: Membrane based one-step, lateral flow, competitive immunoassay use colloidal gold for visual detection. The test cutoff is 50 ng/ml.

Intended Use: The Amedica Drug Screen THC Test is a immunochromatographic assay for the rapid detection of THC in human urine at a cutoff concentration of 50 ng/ml. This assay has not been evaluated at point-of-care locations and is intended for use by healthcare professionals. This assay provides only a preliminary result. A more specific alternative chemical method is needed to obtain a confirmed result.

Test Principle and Description: The Amedica Drug Screen THC Test is based on the principle of highly specific competitive immunochemical reactions between 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 THC concentration in the urine is below 50 ng/ml, it is not enough to saturate all of the binding sites of the antibody-coated colored particles in the test strip. The unsaturated antibody-coated particles will then be captured by THC conjugates immobilized on the strip and a colored line will appear in the test region. The test result is negative. If the THC level is above 50 ng/ml, it is sufficient to occupy all of the binding sites on the antibody-coated particles. The saturated antibody-coated particles will not be captured by THC conjugate coated on the strip. The colored line will not form in the test region. The test result is positive. The device also provides a built-in control with a different antigen/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 two colored bands, and positive urine will produce only one band at control region.

Performance: The product performance was evaluated by correlation study using blind-labeled clinical specimens that have been measured by GC/MS. This study produced > 96% agreement with GC/MS results. In addition, clinical site study was performed at two certified laboratories and demonstrated that Amedica Biotech Drug Screen THC Test can be use by professionals to obtain a visual, qualitative detection of drugs of abuse. The results of these study and comparison with Rapid Diagnostics THC test demonstrated that Amedica Biotech Drug Screen THC Test is substantially equivalent to the predicate kit.

| Manufacturer: | Amedica Biotech, Inc.<br>28301 Industrial Blvd. Suite K<br>Hayward, CA 94545<br>Phone: [phone]<br>Fax: [phone] |
|----------------|------------------------------------------------------------------------------------------------------------------------------|
| Predicate kit: | Rapid THC Test<br>Rapid Diagnostics, Inc. |

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## DEPARTMENT OF HEALTH & HUMAN SERVICES

Image /page/1/Picture/1 description: The image shows the seal for the Department of Health & Human Services - USA. The seal is circular, with the text "DEPARTMENT OF HEALTH & HUMAN SERVICES - USA" arranged around the perimeter. Inside the circle is an abstract symbol that resembles an eagle or a bird in flight, composed of three curved lines.

ood and Drug Administration 198 Gaither Road Rockville MD 20850

## 6 2002 NOV

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

> k022955 Trade/Device Name: Amedica Drug Screen THC Test Regulation Number: 21 CFR 862.3870 Regulation Name: Cannabinoid test system Regulatory Class: Class II Product Code: LDJ Dated: August 30, 2002 Received: September 5, 2002

Dear Mr. Chen:

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 the Code of Federal Regulations, Title 21, Parts 800 to 898. 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 Part 801); good manufacturing practice requirements as set forth in the quality systems (QS) regulation (21 CFR Part 820); and if applicable, the electronic product radiation control provisions (Sections 531-542 of the Act); 21 CFR 1000-1050.

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This letter will allow you to begin marketing your device as described in your 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 g 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 [phone]. Additionally, for questions on the promotion and advertising of your device, please contact the Office of Compliance at [phone]. 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 Manufacturers International and Consumer Assistance at its toll-free number [phone] or [phone] or at its internet address "http://www.fda.gov/odrh/dsma/dsmamain.html".

Sincerely yours,

Steven Putman

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

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510(k) Number (if known):

Device Name: Amedica Drug Screen THC Test

Indications For Use:

The Amedica Drug Screen THC Test is an in vitro diagnostic test for the rapid detection of THC in human urine at a cutoff of 50 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.

This assay provides only a preliminary result. A more specific alternative chemical method is needed to obtain a confirmed result.

Jean Leogn

(Division Sign-Off)

Division of Clinical Laboratory Device.

510(k) Number: K022955

(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

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