AMEDICA DRUG SCREEN THC, COC, OPI, AMP, MET, PCP, MDMA, BAR, BZO, M, MODELS C1210, C1220

K063379 · Amedica Biotech, Inc. · DKZ · Dec 11, 2006 · Clinical Toxicology

Device Facts

• Record ID: K063379
• Device Name: AMEDICA DRUG SCREEN THC, COC, OPI, AMP, MET, PCP, MDMA, BAR, BZO, M, MODELS C1210, C1220
• Applicant: Amedica Biotech, Inc.
• Product Code: DKZ · Clinical Toxicology
• Decision Date: Dec 11, 2006
• Decision: SESE
• Submission Type: Special
• Regulation: 21 CFR 862.3100
• Device Class: Class 2

Intended Use

The Amedica Drug Screen Test Cup II THC/COC/OPI/AMP/MET/PCP/MDMA/BAR/BZO/MTD/TCA/PPX/OXY test is intended for the qualitative detection of drug metabolites in human urine. The test is intended for professional use only.

Device Story

Drug screen test cup; collects human urine; detects up to 12 drug metabolites; utilizes permanent test strips; features tamper-proof design preventing access to strips; two cup configurations (A and B) with varying drug panels; professional use only; provides qualitative results; aids in clinical drug screening.

Clinical Evidence

No clinical data provided. Device performance is established through analytical bench testing, including sensitivity, specificity, and cutoff verification for each drug analyte.

Technological Characteristics

Lateral flow immunoassay; qualitative visual readout; urine specimen; multi-panel test cup format. Detects drugs at specific ng/mL cutoffs (e.g., THC 50, COC 300, OPI 300/2000, AMP 1000, MET 1000, PCP 25, MDMA 500, BAR 300, BZO 300, MTD 300, TCA 1000, PPX 300, OXY 300).

Indications for Use

Indicated for professional use in the qualitative detection of drug metabolites (THC, COC, OPI, AMP, MET, PCP, MDMA, BAR, BZO, MTD, TCA, PPX, OXY) in human urine samples.

Regulatory Classification

Identification

An amphetamine test system is a device intended to measure amphetamine, a central nervous system stimulating drug, in plasma and urine. Measurements obtained by this device are used in the diagnosis and treatment of amphetamine use or overdose and in monitoring levels of amphetamine to ensure appropriate therapy.

Special Controls

*Classification.* Class II (special controls). An amphetamine 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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Food and Drug Administration 2098 Gaither Road Rockville MD 20850

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

DEC 1 1 2006

Re: k063379 Trade/Device Name: Amedica Drug Screen Test Cup II Regulation Number: 21 CFR 862.3100 Regulation Name: Amphetamine test system Regulatory Class: Class II Product Code: DKZ, DIS, JXM, LDJ, DIO, DJR, DJC, DJG, LFG, LCM, JXN Dated: October 30, 2006

Received: November 8, 2006

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 (OS) 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/industry/support/index.html.

Sincerely yours,

Alberto Gutierrez, Ph.D.

Alberto Gutierrez, Ph.D. 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: k063379

## Device Name: Amedica Drug Screen Test Cup II THC,COC,OPI,AMP,MET,PCP,MDMA,BAR,BZO,MTD,TCA,PPX,OXY

Indications For Use:

The Amedica Drug Screen Test Cup II THC, COC, OPI, AMP, MET, PCP, MDMA, BAR, BZO, MTD, TCA, PPX, OXY is an in vitro diagnostic test for the rapid detection of THC, benzoylecgonine, morphine, amphetamine, methamphetamine, phencyclidine, MDMA, barbiturates, benzodiazepines, methadone, tricyclic antidepressants, propoxyphene and oxycodone in human urine at the following cutoff concentration:

| THC | 11-nor-Δ9-Tetrahydrocannabinol-9-carboxylic | 50 ng,ml |
|------|---------------------------------------------|------------|
| COC | Benzoylecgonine | 300 ng,ml |
| OPI | Morphine | 2000 ng,ml |
| OPI | Morphine | 300 ng,ml |
| AMP | Amphetamine | 1000 ng,ml |
| MET | Methamphetamine | 1000 ng,ml |
| PCP | Phencyclidine | 25 ng,ml |
| 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 |
| PPX | Propoxyphene | 300 ng/ml |
| OXY | Oxycodone | 300 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 must be used in order to obtain a confirmed analytical result. Gas chromatography/mass spectrometry (GC/MS) is the preferred confirmatory method. Clinical consideration and professional judgment should be applied to any drug of abuse test result, particularly when preliminary positive results are used.

Prescription Use X (Part 21 CFR 801 Subpart D)

AND/OR

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

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

Concurrence of CDRH, Office of In Vitro Diagnostic Devices (OIVD)

Division Sign Off

Office of In Vitro Diagnostic Device
Evaluation and Safety

510(k) k063379