AMEDICHECK DRUG SCREEN THC, COC, OPI, AMP, MET, PCP, MDMA,BAR, BZ

K080872 · Amedica Biotech, Inc. · LDJ · Aug 19, 2008 · Clinical Toxicology

Device Facts

• Record ID: K080872
• Device Name: AMEDICHECK DRUG SCREEN THC, COC, OPI, AMP, MET, PCP, MDMA,BAR, BZ
• Applicant: Amedica Biotech, Inc.
• Product Code: LDJ · Clinical Toxicology
• Decision Date: Aug 19, 2008
• Decision: SESE
• Submission Type: Special
• Regulation: 21 CFR 862.3870
• Device Class: Class 2

Indications for Use

The AmediCheck Drug Screen Test THC/COC/OPVAMP/MET/PCP/BAR/BZQ/MDMA/OXY/MTD/ PPX/TCA is an in vitro diagnostic test for the rapid detection of THC, benzoylecgonine, morphine, amphetamine, methamphetamine, phencyclidine, barbiturates, benzodiazepines, MDMA, oxycodone, methadone, propoxyphene and tricyclic antidepressants in human urine at the following cutoff concentration: [Table of cutoffs provided]. 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 spectrometers (GCMS) 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.

Device Story

Integrated drug screening device; combines specimen collection cup with lateral flow test strips. Input: human urine specimen. Operation: specimen collected in cup; test strips activated immediately upon contact with specimen. Output: visual qualitative results on test strips indicating presence or absence of specific drugs. Used in clinical settings by healthcare professionals. Modification from predicate: addition of clear plastic collection cup for integrated collection/testing; reduction of required test strip saturation time from 15 seconds to immediate activation. Benefit: streamlined workflow for specimen collection and drug testing.

Clinical Evidence

No clinical data provided. Bench testing only.

Technological Characteristics

Lateral flow immunoassay; qualitative visual readout; urine specimen; multi-panel test format for simultaneous detection of THC, COC, OPI, AMP, MET, PCP, BAR, BZO, MDMA, OXY, MTD, PPX, and TCA at specified ng/mL cutoff concentrations.

Indications for Use

Indicated for the qualitative detection of drugs of abuse in human urine specimens. Intended for use by healthcare professionals and in clinical settings for the screening of drug 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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SPECIAL 510(k): Device Modification

ODE Review Memorandum (Decision Making Document is Attached)

To: THE FILE

RE: DOCUMENT NUMBER k080872

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.) k022955 Amedica Drug Screen THC Test, k022954 Amedica Drug Screen Cocaine Test, k023047 Amedica Drug Screen Opiate Test, k023104 Amedica Drug Screen Amphetamine Test, k023101 Amedica Drug Screen Methamphetamine Test, k023109 Amedica Drug Screen Phencyclidine Test, k031497 Amedica Drug Screen MDMA, BAR, BZO, MTD, TCA Test, k040464 Amedica Drug Screen THC, COC, OPI300, PPX, OXY, BAR, BZO Test

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 the addition of a clear plastic collection cup to the device to create an integrated test device. The integrated test device can be used for collecting the specimen and performing the tests at the same time. In addition, the previously cleared device required a holding time of 15 seconds to allow the test strips to be saturated with specimen, while the modified device can be activated immediately.

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