The Amedica Drug Screen Cocaine Test is an in vitro diagnostic test for the rapid detection of benzoylecgonine in human urine at a cutoff of 300 ng/m1. 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 Description

Membrane based one-step, lateral flow, competitive immunoassay use colloidal gold for visual detection. The test cutoff is 300 ng/ml.

AI/ML Overview

Acceptance Criteria and Study for Amedica Drug Screen Cocaine Test

The provided document describes the Amedica Drug Screen Cocaine Test, an immunochromatographic assay for the rapid detection of benzoylecgonine in human urine. The test has a cutoff concentration of 300 ng/ml.

1. Table of Acceptance Criteria and Reported Device Performance

The document does not explicitly state formal "acceptance criteria" with specific thresholds for performance metrics. However, it implicitly defines success through its claim of "substantial equivalence" to a predicate device and a ">%96 agreement with GC/MS results."

Performance Metric	Acceptance Criteria (Implied)	Reported Device Performance
Agreement with GC/MS	High agreement (implicitly >96% to establish substantial equivalence)	>96% agreement with GC/MS results
Substantial Equivalence	Demonstrated substantial equivalence to the predicate kit (Rapid Cocaine Test)	Demonstrated substantial equivalence to the Rapid Diagnostics Cocaine Test
Intended Use Validation	Usable by healthcare professionals for visual, qualitative detection of drugs of abuse	Clinical site study at two certified laboratories demonstrated use by professionals to obtain visual, qualitative detection

2. Sample Size and Data Provenance

Test Set Sample Size: The document does not specify the exact number of clinical specimens used in the "correlation study" or the "clinical site study."
Data Provenance: The studies were conducted using "blind-labeled clinical specimens" and "at two certified laboratories." The country of origin is not explicitly stated but can be inferred to be the USA, given the manufacturer's address (Hayward, CA) and the FDA submission. The studies were retrospective as they used existing clinical specimens that had already been measured by GC/MS.

3. Number of Experts and Qualifications for Ground Truth

The document does not specify the number of experts or their qualifications used to establish the ground truth for the test set.
However, the ground truth was established by Gas Chromatography/Mass Spectrometry (GC/MS), which is considered a highly accurate and definitive method for drug detection. The "experts" in this context would be the technicians or analysts performing and interpreting the GC/MS results, who are typically highly trained in analytical chemistry.

4. Adjudication Method

The document does not describe an adjudication method for the test set. The comparison was primarily against GC/MS results.

5. Multi-Reader Multi-Case (MRMC) Comparative Effectiveness Study

No MRMC comparative effectiveness study was done as described in the provided text. The study involved comparing the device's results with GC/MS and a predicate device, not measuring improvements in human reader performance with or without AI assistance. This device is a rapid diagnostic test, not an AI-assisted diagnostic tool.

6. Standalone Performance Study

Yes, a standalone performance study was done. The "correlation study using blind-labeled clinical specimens that have been measured by GC/MS" evaluated the Amedica Drug Screen Cocaine Test's performance (specifically, its agreement with GC/MS) independently. The "clinical site study" also demonstrated the device's ability to be used by professionals for detection, indicating its standalone functionality. The "Amedica Drug Screen Cocaine Test can be use by professionals to obtain a visual, qualitative detection of drugs of abuse" indicates that the test itself provides a result without requiring human interpretation beyond reading the visual bands.

7. Type of Ground Truth Used

The primary ground truth used was Gas Chromatography/Mass Spectrometry (GC/MS) results. This is a highly accurate and analytical chemical method considered the gold standard for confirming the presence and concentration of drugs and their metabolites.

8. Sample Size for the Training Set

The document does not specify a training set sample size. This type of rapid diagnostic test typically does not involve a "training set" in the context of machine learning algorithms. The development involves optimizing the biochemical reactions and components rather than training an algorithm.

9. How the Ground Truth for the Training Set Was Established

Since there's no mention of a "training set" in the machine learning sense, this question is not directly applicable. If considering the "development" or "optimization" phase of the test, the ground truth for fine-tuning the assay's chemical parameters would likely involve a combination of spiked samples with known concentrations of benzoylecgonine and possibly preliminary testing with clinically characterized urine samples analyzed by methods like GC/MS to ensure the assay performs as expected for the target cutoff.

Summary

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6 2002 NOV

16022954

2. Summary of Safetv and Effectiveness ( As required bv 21CFR 807.92(c))

Device name: Amedica Drug Screen Cocaine Test

Design and Materials: Membrane based one-step, lateral flow, competitive immunoassay use colloidal gold for visual detection. The test cutoff is 300 ng/ml.

Intended Use: The Amedica Drug Screen Cocaine Test is a immunochromatographic assay for the rapid detection of benzoylecgonine in human urine at a cutoff concentration of 300 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 Cocaine 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 benzoylecgonine concentration in the urine is below 300 ng/ml, it is 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 benzoylecgonine conjugates immobilized on the strip and a colored line will appear in the test region. The test result is negative. If the benzoylecgonine level is above 300 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 benzoylecgonine 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 > 96% agreement with GC/MS results. In addition, clinical site study was performed at two certified laboratories and demonstrated that Amedica Biotech Drug Screen Cocaine 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 Cocaine test demonstrated that Amedica Biotech Drug Screen Cocaine Test is substantially equivalent to the predicate kit.

Manufacturer:	Amedica Biotech, Inc.
	28301 Industrial Blvd. Suite K
	Hayward, CA 94545
	Phone: (510) 785-5980
	Fax: (510) 785-5973
Predicate kit:	Rapid Cocaine Test
	Rapid Diagnostics, Inc.

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DEPARTMENT OF HEALTH & HUMAN SERVICES

Image /page/1/Picture/1 description: The image shows the logo for the Department of Health & Human Services USA. The logo consists of a circle with the text "DEPARTMENT OF HEALTH & HUMAN SERVICES USA" around the perimeter. Inside the circle is a stylized image of three human profiles facing to the right, stacked on top of each other. The profiles are represented by thick, curved lines.

Food and Drug Administratio 2098 Gaither Road Rockville MD 20850

NOV

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

K022954 Trade/Device Name: Amedica Drug Screen Cocaine Test Regulation Number: 21 CFR 862.3250 Regulation Name: Cocaine and cocaine metabolite test system Regulatory Class: Class II Product Code: DIO Dated: September 3, 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 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 (301) 594-4588. Additionally, for questions on the promotion and advertising of your device, please contact the Office of Compliance at (301) 594-4639. 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 (800) 638-2041 or (301) 443-6597 or at its internet address "http://www.fda.gov/cdrh/dsma/dsmamain.html".

Sincerely yours,

Steven Butman

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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1
	1

KO22 510(k) Number (if known):

Device Name: Amedica Drug Screen Cocaine Test

Indications For Use:

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

(Division Sign-Off)
Division of Clinical Laboratory Devices
510(k) Number. K022954

(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)

Over-The-Counter Use

(Optional Format 1-2-96)

Regulation Number and Section

§ 862.3250 Cocaine and cocaine metabolite test system.

(a)
Identification. A cocaine and cocaine metabolite test system is a device intended to measure cocaine and a cocaine metabolite (benzoylecgonine) in serum, plasma, and urine. Measurements obtained by this device are used in the diagnosis and treatment of cocaine use or overdose.(b)
Classification. Class II (special controls). A cocaine and cocaine metabolite 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).