AMEDICA DRUG SCREEN THC/COC, OP1300, PPX, OXY, BAR/BZO TEST

K040464 · Amedica Biotech, Inc. · LDJ · May 17, 2004 · Clinical Toxicology

Device Facts

• Record ID: K040464
• Device Name: AMEDICA DRUG SCREEN THC/COC, OP1300, PPX, OXY, BAR/BZO TEST
• Applicant: Amedica Biotech, Inc.
• Product Code: LDJ · Clinical Toxicology
• Decision Date: May 17, 2004
• Decision: SESE
• Submission Type: Traditional
• Regulation: 21 CFR 862.3870
• Device Class: Class 2

Intended Use

The Amedica Drug Screen THC/COC, OPI300, PPX, OXY, BAR/BZO Test is an in vitro diagnostic test for the rapid detection of THC, benzoylecgonine, morphine, propoxyphene, oxycodone, secobarbital and oxazepam in human urine at the following cut-off concentration THC 11-nor-Δ⁹-THC-9-COOH 50 ng/ml COC benzoylecgonine 300 ng/ml OPI morphine 300 ng/ml PPY propoxyphene 300 ng/ml OXY oxycodone 100 ng/ml BAR secobarbital 300 ng/ml BZO oxazepam 300 ng/ml This test kit is used to obtain a visual, qualitative result and is intended for use in laboratories and workplaces by trained users. It is not intended for over the counter sale. For in vitro diagnostic use Minimum training for operators is defined as those individuals who have received instructions for drugs of abuse testing from a physician or medical review officer. Operators may be lay users with no prior experience in running laboratory tests, but who are expected to perform at least 5 tests per week. Training should cover a variety of topics such as the value of confirmation testing, how to obtain confirmation testing, false positive results, false negative results, and quality control procedures. The sponsor recommends that operators take a written and practical exam before performing any testing and that employers keep documentation of the testing.

Device Story

Lateral flow immunochromatographic assay; detects seven drugs of abuse in human urine. Input: urine sample applied to dipstick, cassette, or cup format. Principle: competitive binding between drug in sample and drug-labeled conjugate for antibody binding sites on nitrocellulose strip. Output: visual presence or absence of colored test line; internal process control line confirms sample volume and strip integrity. Used in laboratories and workplaces; operated by trained personnel. Results are preliminary; require confirmation via GC/MS. Affects clinical/workplace decision-making by identifying potential drug presence; benefits patient/employer by providing rapid screening.

Clinical Evidence

No clinical studies performed. Evidence consists of analytical performance data: precision/reproducibility studies (n=180 per concentration), analytical sensitivity (detection limits validated at cutoff), and method comparison studies against GC/MS and predicate devices. Method comparison included 74-115 samples per analyte group, showing high agreement (90-100%) with GC/MS and predicate results.

Technological Characteristics

Lateral flow immunochromatographic assay. Nitrocellulose strip in dipstick, cassette, or cup formats. Sensing principle: competitive antibody-antigen binding. Internal process control: goat anti-rabbit antibodies/rabbit antibody gold complex. Visual readout. No external energy source required. Single-use.

Indications for Use

Indicated for rapid, qualitative detection of THC, benzoylecgonine, morphine, propoxyphene, oxycodone, secobarbital, and oxazepam in human urine. Intended for use in laboratory and workplace settings by trained personnel. Not for OTC 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).

Submission Summary (Full Text)

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Image /page/0/Picture/1 description: The image shows the logo for the U.S. Department of Health & Human Services. The logo consists of a stylized caduceus, which is a symbol of medicine, with three horizontal lines representing the branches of government. The logo is surrounded by a circular border with the text "DEPARTMENT OF HEALTH & HUMAN SERVICES • USA" written around it.

Food and Drug Administration 2098 Gaither Road Rockville MD 20850

MAY 1 7 2004

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

k040464 Re:

K040-01-12-2014 Name: Amedica Drug Screen THC/COC, OP1300, PPX, OXY, BAR/BZO Test

Regulation Number: 21 CFR 862.3870 Regulation Name: Cannabinoid test system Regulatory Class: Class II Product Code: LDJ, DIO, DJG, JXN, DIS, JXM Dated: February 12, 2004 Received: February 23, 2004

Dear Mr. Chen:

We have reviewed your Section 510(k) premarket notification of intent to market the device we nave reviewed your betermined the device is substantially equivalent (for the indications for use stated in the enclosure) to legally marketed predicate devices marketed in interstate for use stated in the encreated 776, the enactment date of the Medical Device Amendments, or to conniered processified 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). and Connetter for ( roy ) . roy ( reserve subject to the general controls provisions of the Act. The I ou mayy atests 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 ean be found further announcements concerning your device in the Federal Register.

Please be advised that I·DA's issuance of a substantial equivalence determination does not mean r touse to actived a determination that your device complies with other requirements of the Act that 1171 has matures and regulations administered by other Federal agencies. You must or any I vatuall the Act's requirements, including, but not limited to: registration and listing (21 CHR 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,

Seain M. Cooper, US, DVM.

Jean M. Cooper, MS, D.V.M. Director Division of Chemistry and Toxicology Office of In Vitro Diagnostic Device Evaluation and Safety Center for Devices and Radiological Health

Enclosure

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## Indications for Use

## 510(k) Number (if known): k040464

Device Name: Amedica Drug Screen THC/COC, OP1300, PPX, OXY, BAR/BZO Test

Indications For Use:

The Amedica Drug Screen THC/COC, OPI300, PPX, OXY, BAR/BZO Test is an in vitro diagnostic test for the rapid detection of THC, benzoylecgonine, morphine, oxycodone, secobarbital and oxazepam in human urine at the following cut-off concentration

| THC | 11-nor-Δ⁹-THC-9-COOH | 50 ng/ml |
|-----|----------------------|-----------|
| COC | benzoylecgonine | 300 ng/ml |
| OPI | morphine | 300 ng/ml |
| PPY | propoxyphene | 300 ng/ml |
| OXY | oxycodone | 100 ng/ml |
| BAR | secobarbital | 300 ng/ml |
| BZO | oxazepam | 300 ng/ml |

This test kit is used to obtain a visual, qualitative result and is intended for use in laboratories and workplaces by trained users. It is not intended for over the counter sale. For in vitro diagnostic use

Minimum training for operators is defined as those individuals who have received instructions for drugs of abuse testing from a physician or medical review officer. Operators may be lay users with no prior experience in running laboratory tests, but who are expected to perform at least 5 tests per week. Training should cover a variety of topics such as the value of confirmation testing, how to obtain confirmation testing, false positive results, false negative results, and quality control procedures. We recommend that operators take a written and practical exam before performing any testing and that employers keep documentation of the training.

This assay provides only a preliminary result. Clinical consideration and professional judgment should be applied to any drug of abuse test result, particularly in evaluating a preliminary positive result. To obtain a confirmed analytical result, a more specific alternate chemical method is needed Gas chromatography/mass spectroscopy (GC/MS) is the recommended confirmatory method.

Prescription Use V (Part 21 CFR 801 Subpart D) AND/OR

Over-The-Counter Use (21 CFR 807 Subpart C)

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Office of In Vitro Diagnostic Device Evaluation and of CDRH, Office of In Vitro Diagnostic Devices (OIVD)

510(k) K040464

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