AMEDICA DRUG SCREEN PHENCYCLIDINE TEST

K023109 · Amedica Biotech, Inc. · LCM · Dec 16, 2002 · TX

Device Facts

• Record ID: K023109
• Device Name: AMEDICA DRUG SCREEN PHENCYCLIDINE TEST
• Applicant: Amedica Biotech, Inc.
• Product Code: LCM · TX
• Decision Date: Dec 16, 2002
• Decision: SESE
• Submission Type: Traditional
• Device Class: Class U

Intended Use

The Amedica Drug Screen Phencyclidine Test is an in vitro diagnostic test for the rapid detection of Phencyclidine in human urine at a cutoff of 25 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

The Amedica Drug Screen Phencyclidine Test is a lateral flow, competitive immunoassay for detecting Phencyclidine in human urine. The device uses colloidal gold-labeled antibodies on a membrane strip. Urine samples migrate via capillary action; if Phencyclidine concentration is below 25 ng/ml, unsaturated antibody-coated particles bind to immobilized Phencyclidine conjugates, forming a visible colored line (negative result). If concentration exceeds 25 ng/ml, binding sites are saturated, preventing line formation (positive result). A built-in control line confirms test validity. The device is intended for use by healthcare professionals in clinical laboratory settings to provide preliminary qualitative results. Results require confirmation by a more specific alternative chemical method. The test aids in the rapid identification of drug presence, supporting clinical decision-making regarding substance use.

Clinical Evidence

Performance evaluated via correlation study using blind-labeled clinical specimens compared against GC/MS. Study demonstrated >93% agreement with GC/MS results. Clinical site study performed at two certified laboratories confirmed the device provides visual, qualitative detection of drugs of abuse for professional use.

Technological Characteristics

Membrane-based one-step lateral flow competitive immunoassay. Uses colloidal gold for visual detection. Cutoff concentration: 25 ng/ml. Built-in control line for procedural validity. Manual, non-instrumented visual readout.

Indications for Use

Indicated for professional use for the rapid, qualitative detection of Phencyclidine in human urine at a 25 ng/ml cutoff. Not for over-the-counter sale.

Predicate Devices

• Rapid Phencyclidine Test (Rapid Diagnostics, Inc.)

Submission Summary (Full Text)

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K023109

## 3. Summary of Safety and Effectiveness ( As required bv 21CFR 807.92(c))

DEC 1 6 2002

Device name: Amedica Drug Screen Phencyclidine Test

Design and Materials: Membrane based one-step, lateral flow, competitive immunoassay use colloidal gold for visual detection. The test cutoff is 25 ng/ml.

Intended Use: The Amedica Drug Screen Phencyclidine Test is a immunochromatographic assay for the rapid detection of Phencyclidine in human urine at a cutoff concentration of 25 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 Phencyclidine 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 Phencyclidine concentration in the urine is below 25 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 Phencyclidinc conjugates immobilized on the strip and a colored line will appear in the test region. The test result is negative. If the Phencyclidine level is above 25 ng/m], 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 Phencyclidine 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 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 > 93% agreement with GC/MS results. In addition, clinical site study was performed at two certified laboratories and demonstrated that Amedica Biotech Drug Screen Phencyclidine 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 Phencyclidine test demonstrated that Amedica Biotech Drug Screen Phencyclidine Test is substantially equivalent to the predicate kit.

## Manufacturer:

Amedica Biotech, Inc. 28301 Industrial Blvd. Suite K Hayward, CA 94545 Phone: [phone] Fax: [phone]

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Predicate kit:

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Rapid Phencyclidine Test
Rapid Diagnostics, Inc.

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Image /page/2/Picture/0 description: The image is a black and white 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. In the center of the seal is a stylized image of three overlapping human figures.

## DEPARTMENT OF HEALTH & HUMAN SERVICES

Food and Drug Administration 2098 Gaither Road Rockville MD 20850

EC 1 6 2002

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

Re: k023109 Trade/Device Name: Amedica Drug Screen Phencyclidine Test Regulation Name: Phencyclidine test system Regulatory Class: Class II Product Code: LCM Dated: November 12, 2002 Received: November 19, 2002

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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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). 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/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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| 510(k) Number (if known): | K023108 |
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Device Name: Amedica Drug Screen Phencyclidine Test

Indications For Use:

The Amedica Drug Screen Phencyclidine Test is an in vitro diagnostic test for the rapid detection of Phencyclidine in human urine at a cutoff of 25 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.

Jian Lopez
(Division Sign-Off)
Clinical Laboratoi
K023109

(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)