AMEDICA DRUG TEST THC, COC, OPI, AMP, MET, PCP, BAR, BZO, MDMA, OXY, TCA

K100108 · Amedica Biotech, Inc. · NGL · Apr 14, 2010 · Clinical Toxicology

Device Facts

• Record ID: K100108
• Device Name: AMEDICA DRUG TEST THC, COC, OPI, AMP, MET, PCP, BAR, BZO, MDMA, OXY, TCA
• Applicant: Amedica Biotech, Inc.
• Product Code: NGL · Clinical Toxicology
• Decision Date: Apr 14, 2010
• Decision: SESE
• Submission Type: Special
• Regulation: 21 CFR 862.3650
• Device Class: Class 2

Indications for Use

The Amedica Drug Screen Test THC/COC/OPI/AMP/MET/PCP/MDMA/BAR/BZO/MTD/TCA/OXY is an in vitro diagnostic test for the rapid detection of the following drugs in human urine THC 11-nor-Δ -Tetrahydrocannabinol-9-carboxylic 50 ng/ml COC Benzoylecgonine 300 ng/ml OPI Morphine 300 ng/ml OPI Morphine 2000 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 OXY Oxycodone 300 ng/ml This test is intended for use by over-the-counter (OTC) consumers as the first step in a two step process to provide consumers, including but not limited to concerned parents, with information concerning the presence or absence of the above stated drugs or their metabolites in a urine sample. Information regarding confirmatory testing- the second step in the process, is provided in the package labeling. Tests for prescription drugs will yield preliminary positive results when prescription I one 10. Pressed, even at or above therapeutic doses. There are no uniformly recognized drug cutoffs for barbiturates, benzodiazepine, tricyclic antidepressant in urine. The multidrug of abuse urine test device shows the drug was or was not present at the cutoff level. This test provides only a preliminary result. A more specific alternate chemical method must be used in order to obtain a confirmed analytical result. Gas Chromatography / Mass Spectrometry (GC/MS) or High Performance Liquid Chromatography (HPLC) 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 obtained.

Device Story

Drug screen test card; test strips inserted into plastic holder for simultaneous multi-drug testing; integrated into test cup. Used for qualitative drug detection in urine. Modification involves physical integration of test strips into a cup format. Fundamental scientific technology remains unchanged from predicate.

Clinical Evidence

No clinical data provided; device relies on analytical performance characteristics (bench testing) to demonstrate substantial equivalence for qualitative drug detection.

Technological Characteristics

Lateral flow immunoassay; qualitative visual readout; urine specimen; multi-panel test cup format. No electronic components, software, or external energy sources.

Indications for Use

Indicated for the qualitative detection of drugs of abuse in human urine.

Regulatory Classification

Identification

An opiate test system is a device intended to measure any of the addictive narcotic pain-relieving opiate drugs in blood, serum, urine, gastric contents, and saliva. An opiate is any natural or synthetic drug that has morphine-like pharmocological actions. The opiates include drugs such as morphine, morphine glucoronide, heroin, codeine, nalorphine, and meperedine. Measurements obtained by this device are used in the diagnosis and treatment of opiate use or overdose and in monitoring the levels of opiate administration to ensure appropriate therapy.

Special Controls

*Classification.* Class II (special controls). An opiate 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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SPECIAL 510(k): Device Modification

OIVD Review Memorandum (Decision Making Document is Attached)

To: THE FILE

RE: DOCUMENT NUMBER K100108

This 510(k) submission contains information/data on modifications made to the SUBMITTER'S own Class II, Class III or Class I devices requiring 510(k). The following items are present and acceptable (delete/add items as necessary):

1. The name and 510(k) number of the SUBMITTER'S previously cleared device. (For a preamendments device, a statement to this effect has been provided.) k082898 Amedica Home Drug Test Cup
2. Submitter's statement that the INDICATION/INTENDED USE of the modified device as described in its labeling HAS NOT CHANGED along with the proposed labeling which includes instructions for use, package labeling, and, if available, advertisements or promotional materials (labeling changes are permitted as long as they do not affect the intended use).
3. A description of the device MODIFICATION(S), including clearly labeled diagrams, engineering drawings, photographs, user's and/or service manuals in sufficient detail to demonstrate that the FUNDAMENTAL SCIENTIFIC TECHNOLOGY of the modified device has not changed.

This change was for an Amedica drug screen test card where test strips are inserted into a plastic holder so that multiple tests can be performed simultaneously, and the test card is integrated into the test cup.

4. Comparison Information (similarities and differences) to applicant's legally marketed predicate device including, labeling, intended use, and physical characteristics.

5. A Design Control Activities Summary which includes:

a) Identification of Risk Analysis method(s) used to assess the impact of the modification on the device and its components, and the results of the analysis
b) Based on the Risk Analysis, an identification of the verification and/or validation activities required, including methods or tests used and acceptance criteria to be applied
c) A declaration of conformity with design controls. The declaration of conformity should include:

i) A statement signed by the individual responsible, that, as required by the risk analysis, all verification and validation activities were performed by the designated individual(s) and the results demonstrated that the predetermined acceptance criteria were met, and
ii) A statement signed by the individual responsible, that the manufacturing facility is in conformance with design control procedure requirements as specified in 21 CFR 820.30 and the records are available for review.

6. A Truthful and Accurate Statement, a 510(k) Summary or Statement and the Indications for Use Enclosure (and Class III Summary for Class III devices).

The labeling for this modified subject device has been reviewed to verify that the indication/intended use for the device is unaffected by the modification. In addition, the submitter's description of the particular modification(s) and the comparative information between the modified and unmodified devices demonstrate that the fundamental scientific technology has not changed. The submitter has provided the design control information as specified in The New 510(k) Paradigm and on this basis, I recommend the device be determined substantially equivalent to the previously cleared (or their preamendment) device.