AMEDICA DRUG SCREEN TEST CUP

K082898 · Amedica Biotech, Inc. · NGL · Dec 19, 2008 · Clinical Toxicology

Device Facts

• Record ID: K082898
• Device Name: AMEDICA DRUG SCREEN TEST CUP
• Applicant: Amedica Biotech, Inc.
• Product Code: NGL · Clinical Toxicology
• Decision Date: Dec 19, 2008
• Decision: SESE
• Submission Type: Traditional
• Regulation: 21 CFR 862.3650
• Device Class: Class 2

Indications for Use

The Amedica Home Drug Test Cup is an in vitro diagnostic test for the rapid detection of the following drugs in human urine. This test is intended for over-the-counter (OTC) consumer use 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 drugs are ingested, even at or above therapeutic doses. There are no uniformly recognized drug cutoffs for barbiturates, benzodiazepine, and tricyclic antidepressants in urine. The multi-drug 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

Amedica Home Drug Test Cup; lateral flow immunoassay for qualitative detection of 12 drugs/metabolites in human urine. Device consists of a collection cup with integrated reagent strips for each analyte; includes temperature strip for sample validity. Principle: competitive binding; drug in sample competes with immobilized drug-specific conjugate for antibody-coated particles. Presence of drug above cutoff prevents colored line formation at test region; control line indicates proper migration. Intended for OTC consumer use (e.g., parents); provides preliminary results. Positive results require confirmation via GC/MS or HPLC. User reads visual lines on cup; temperature strip verifies sample temperature. Benefits: provides consumers with rapid, preliminary information regarding drug presence; facilitates subsequent professional confirmatory testing.

Clinical Evidence

No clinical data provided; device relies on analytical performance characteristics for drug detection.

Technological Characteristics

Lateral flow immunochromatographic assay; competitive binding principle. Device is a multi-drug collection cup containing specific reagent strips for 12 analytes. Includes integrated temperature strip. No electronic components or software. Visual readout of colored lines.

Indications for Use

Indicated for OTC consumer use for rapid, preliminary detection of THC, Cocaine, Amphetamine, Methamphetamine, Opiates, Opiates300, PCP, Barbiturates, Benzodiazepines, Methadone, Oxycodone, MDMA, and Tricyclic Antidepressants in human urine. Provides preliminary results only; requires confirmatory testing via GC/MS or HPLC.

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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# 510(k) SUBSTANTIAL EQUIVALENCE DETERMINATION DECISION SUMMARY ASSAY ONLY TEMPLATE

A. 510(k) Number:
k082898

B. Purpose for Submission:
This submission is for the addition of an over-the-counter (OTC) claim for previously cleared prescription devices: k040464 (THC, COC, OPI300, OXY, BAR, BZO), k031497 (MDMA, BAR, BZO, MTD, TCA), k023109 (PCP), k023101 (MTH), k023104 (AMP), k023047 (OPI2000), k022954 (COC) and k022955 (THC).

C. Measurand:
Marijuana (THC), Cocaine (COC), Amphetamine (AMP), Methamphetamine (MET), Opiates (OPI), Barbiturates (BAR), Benzodiazepines (BZD), Methadone (MTD), Oxycodone (OXY), MDMA, and Tricyclic Antidepressants (TCA).

D. Type of Test:
Qualitative Lateral Flow Immunoassay

E. Applicant:
Amedica Biotech Inc.

F. Proprietary and Established Names:
Amedica Home Drug Test Cup

G. Regulatory Information:

| Product Code | Classification | Regulation Section | Panel |
| --- | --- | --- | --- |
| NGL | II | 862.3650, Test, Opiates, Over-the-Counter | 91 (Tox) |
| NFT | II | 862.3100, Test, Amphetamine, Over-the-Counter | 91 (Tox) |
| NFY | II | 862.3250, Test, Cocaine and Cocaine Metabolites, Over-the-Counter, | 91 (Tox) |
| NGG | II | 862.3610, Test, | 91 (Tox) |

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| | | Methamphetamine, Over-the-Counter | |
| --- | --- | --- | --- |
| DIS | II | 862.3120, Enzyme immunoassay, Barbiturate | 91 (Tox) |
| NFV | II | 862.3170, Test, Benzodiazepine, over the counter | 91 (Tox) |
| DJR | II | 862.3620, Enzyme Immunoassay, Methadone | 91 (Tox) |
| LCM | Unclassified [510(k) required] | Unclassified - Enzyme immunoassay, phencyclidine | 91 (Tox) |
| LFG | II | 862.3910, Thin layer chromatography, tricyclic antidepressant drugs | 91 (Tox) |
| NFW | II | 862.3870, Test, Cannabinoids, Over-the-Counter | 91 (Tox) |

## H. Intended Use:

1. Intended use(s):

See indications for use section below.

2. Indication(s) for use:

The Amedica Home Drug Test Cup is an *in vitro* diagnostic test for the rapid detection of the following drugs in human urine.

| Drug | Analyte | Cutoff | Device Code |
| --- | --- | --- | --- |
| Marijuana | THC | 50 ng/mL | THC |
| Cocaine | Benzoylecgonine | 300 ng/mL | COC |
| Amphetamine | Amphetamine | 1000 ng/mL | AMP |
| Methamphetamine | Methamphetamine | 1000 ng/mL | MET |
| Opiates | Morphine | 2000 ng/mL | OPI |
| Opiates300 | Morphine | 300 ng/ml | OPI300 |
| Phencyclidine | Phencyclidine | 25 ng/mL | PCP |
| Barbiturates | Secobarbital | 300 ng/mL | BAR |
| Benzodiazepines | Oxazepam | 300 ng/mL | BZD |
| Methadone | Methadone | 300 ng/mL | MTD |
| Oxycodone | Oxycodone | 100 ng/mL | OXY |
| MDMA | MDMA | 500 ng/mL | MDMA |
| Tricyclic Antidepressants | Nortriptyline | 1000 ng/mL | TCA |

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This test is intended for over-the-counter (OTC) consumer use 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 drugs are ingested, even at or above therapeutic doses. There are no uniformly recognized drug cutoffs for barbiturates, benzodiazepine, and tricyclic antidepressants in urine. The multi-drug 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.

3. Special conditions for use statement(s):

This test is intended for over-the-counter (OTC) consumer use 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 drugs are ingested, even at or above therapeutic doses. There are no uniformly recognized drug cutoffs for barbiturates, benzodiazepine, and tricyclic antidepressants in urine. The multi-drug 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.

4. Special instrument requirements:

Not applicable (N/A).

I. Device Description:

The Amedica Home Drug Test Cup is a cup capable of measuring all 12 drugs listed in the intended use. The Amedica Home Drug Test Cup also includes user

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instructions, collection device and mailing information for shipping preliminarily positive urine specimens to the laboratory for confirmation.

## J. Substantial Equivalence Information:

1. Predicate device name(s):

Amedica Drug Screen Test Cup

2. Predicate K number(s):

k063379, k061556, k040464, k031497, k023109, k023101, k023104, k023047, k022954 and k022955

3. Comparison with predicate:

The submission is for identical test strips as the predicate devices. The differences are the target population (OTC vs. prescription use) and the number of drugs detected.

## K. Standard/Guidance Document Referenced (if applicable):

None referenced.

## L. Test Principle:

The Amedica Drug Screen Test Cup employs lateral flow immunochromatographic technology and is based on the principle of competitive binding. Drugs, if present in concentrations below the cutoff level, will not saturate the binding sites of antibody-coated particles in the device. The antibody-coated particles will then be captured by immobilized drug-specific conjugate and a colored line will appear in the test line region. The colored line will not form if the sample contains drug in excess of the cutoff level because the drug will saturate all the binding sites of the drug-specific antibody. There is a specific regent strip for each analyte. Each strip in the device contains a procedural control that appears in the control line region indicating that the sample has migrated properly on the test strip.

## M. Performance Characteristics (if/when applicable):

1. Analytical performance:

This submission is for an OTC claim. Performance characteristics for each of the drugs are found in the following 510(k) numbers:: k040464 (THC, COC, OPI300, OXY, BAR, BZO), k031497 (MDMA, BAR, BZO, MTD, TCA), k023109 (PCP), k023101 (MTH), k023104 (AMP), k023047 (OPI2000), k022954 (COC) and k022955 (THC).

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a. Precision/Reproducibility:

See k040464 (THC, COC, OPI300, OXY, BAR, BZO), k031497 (MDMA, BAR, BZO, MTD, TCA), k023109 (PCP), k023101 (MTH), k023104 (AMP), k023047 (OPI2000), k022954 (COC) and k022955 (THC).

b. Linearity/assay reportable range:

See k040464 (THC, COC, OPI300, OXY, BAR, BZO), k031497 (MDMA, BAR, BZO, MTD, TCA), k023109 (PCP), k023101 (MTH), k023104, (AMP), k023047 (OPI2000), k022954 (COC) and k022955 (THC).

c. Traceability, Stability, Expected values (controls, calibrators, or methods):

This device has internal process controls. Each strip in the device contains a procedural control that appears in the control line region indicating that the sample has migrated properly on the test strip. The sponsor informs the user not to interpret the test if a colored line failed to appear in the control region. External controls are not supplied with this device.

d. Detection limit:

See k040464 (THC, COC, OPI300, OXY, BAR, BZO), k031497 (MDMA, BAR, BZO, MTD, TCA), k023109 (PCP), k023101 (MTH), k023104 (AMP), k023047 (OPI2000), k022954 (COC) and k022955 (THC).

e. Analytical specificity:

See k040464 (THC, COC, OPI300, OXY, BAR, BZO), k031497 (MDMA, BAR, BZO, MTD, TCA), k023109 (PCP), k023101 (MTH), k023104, (AMP), k023047 (OPI2000), k022954 (COC) and k022955 (THC).

f. Assay cut-off:

See k040464 (THC, COC, OPI300, OXY, BAR, BZO), k031497 (MDMA, BAR, BZO, MTD, TCA), k023109 (PCP), k023101 (MTH), k023104 (AMP), k023047 (OPI2000), k022954 (COC) and k022955 (THC).

2. Comparison studies:

a. Method comparison with predicate device:

The sponsor conducted a lay user study with 100 lay persons in three locations: Tennessee, Kentucky and California. Fifty-four females and forty-eight males between 18 and 71 years of age were tested. Fifty-one participants had a high school education or less, forty-eight participants had

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completed college courses. None of the participants had experience with a point of care drug testing product. Each participant was given a pre and post-study questionnaire. The pre-study questionnaire collected personal information about each participant. Test samples were prepared to contain a strong negative (0% of the cutoff), a very weak negative (50% of cutoff), a weak positive (125% of cutoff), a strong positive (150% of cutoff) and a very strong positive (300% of the cutoff) for each drug. The test specimens were prepared at concentrations shown below. Pure drug or metabolite was spiked into drug free human urine. All specimens were verified by GC/MS. 3 users tested six samples, 5 users tested five samples, 92 users tested three samples, one user tested one two samples and one user tested one sample. There were 322 total observations.

| Drug | Cutoff (ng/ml) | Results | Drug Concentration | | | | | | |
| --- | --- | --- | --- | --- | --- | --- | --- | --- | --- |
| | | | Negative | 50% of C/O | 75% of C/O | 125% of C/O | 150% of C/O | 300% of C/O | Total % correct |
| THC | 50 | Negative | 179 | 19 | 12 | 5 | 0 | 0 | 96% |
| | | Positive | 0 | 0 | 5 | 15 | 18 | 20 | |
| | | Total | 179 | 19 | 17 | 20 | 18 | 20 | |
| | | Agreement | 100% | 100% | 72% | 75% | 100% | 100% | |
| MTD | 50 | Negative | 180 | 19 | 11 | 7 | 0 | 0 | 95% |
| | | Positive | 0 | 0 | 7 | 12 | 17 | 20 | |
| | | Total | 180 | 19 | 18 | 19 | 17 | 20 | |
| | | Agreement | 100% | 100% | 63% | 63% | 100% | 100% | |
| COC | 50 | Negative | 180 | 20 | 12 | 5 | 0 | 0 | 96% |
| | | Positive | 0 | 0 | 5 | 14 | 18 | 19 | |
| | | Total | 180 | 20 | 17 | 19 | 18 | 19 | |
| | | Agreement | 100% | 100% | 72% | 74% | 100% | 100% | |
| BZO | 50 | Negative | 178 | 19 | 14 | 8 | 0 | 0 | 95% |
| | | Positive | 0 | 0 | 6 | 12 | 17 | 19 | |
| | | Total | 178 | 19 | 20 | 20 | 17 | 19 | |
| | | Agreement | 100% | 100% | 70% | 60% | 100% | 100% | |
| OPI | 50 | Negative | 167 | 14 | 7 | 1 | 0 | 0 | 98% |
| | | Positive | 0 | 0 | 3 | 8 | 15 | 16 | |
| | | Total | 167 | 14 | 10 | 9 | 15 | 16 | |
| | | Agreement | 100% | 100% | 70% | 89% | 100% | 100% | |

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| OPI300 | 50 | Negative | 25 | 10 | 7 | 3 | 0 | 0 | 93% |
| --- | --- | --- | --- | --- | --- | --- | --- | --- | --- |
| | | Positive | 0 | 0 | 3 | 12 | 15 | 15 | |
| | | Total | 25 | 10 | 10 | 15 | 15 | 15 | |
| | | Agreement | 100% | 100% | 70% | 80% | 100% | 100% | |
| OXY | 50 | Negative | 180 | 19 | 12 | 5 | 0 | 0 | 96% |
| | | Positive | 0 | 0 | 6 | 12 | 20 | 19 | |
| | | Total | 180 | 19 | 18 | 17 | 20 | 19 | |
| | | Agreement | 100% | 100% | 67% | 71% | 100% | 100% | |
| PCP | 50 | Negative | 182 | 19 | 14 | 3 | 0 | 0 | 97% |
| | | Positive | 0 | 0 | 4 | 16 | 18 | 17 | |
| | | Total | 182 | 19 | 18 | 19 | 18 | 17 | |
| | | Agreement | 100% | 100% | 78% | 84% | 100% | 100% | |
| TCA | 50 | Negative | 179 | 19 | 12 | 7 | 0 | 0 | 95% |
| | | Positive | 0 | 0 | 7 | 12 | 18 | 19 | |
| | | Total | 179 | 19 | 19 | 19 | 18 | 19 | |
| | | Agreement | 100% | 100% | 63% | 63% | 100% | 100% | |
| MDMA | 50 | Negative | 176 | 20 | 14 | 5 | 0 | 0 | 96% |
| | | Positive | 0 | 0 | 6 | 14 | 19 | 19 | |
| | | Total | 176 | 20 | 20 | 19 | 19 | 19 | |
| | | Agreement | 100% | 100% | 70% | 74% | 100% | 100% | |
| MET | 50 | Negative | 175 | 20 | 14 | 5 | 0 | 0 | 96% |
| | | Positive | 0 | 0 | 5 | 15 | 20 | 19 | |
| | | Total | 175 | 20 | 19 | 20 | 20 | 19 | |
| | | Agreement | 100% | 100% | 75% | 75% | 100% | 100% | |
| AMP | 50 | Negative | 176 | 20 | 13 | 4 | 0 | 0 | 97% |
| | | Positive | 0 | 0 | 5 | 16 | 19 | 20 | |
| | | Total | 176 | 20 | 18 | 20 | 19 | 20 | |
| | | Agreement | 100% | 100% | 74% | 80% | 100% | 100% | |
| BAR | 50 | Negative | 177 | 20 | 12 | 5 | 0 | 0 | 96% |
| | | Positive | 0 | 0 | 6 | 15 | 18 | 20 | |
| | | Total | 177 | 20 | 18 | 20 | 18 | 20 | |
| | | Agreement | 100% | 100% | 68% | 75% | 100% | 100% | |

A Flesh-Kincaid reading analysis was performed on the package insert and

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the score revealed a reading grade level of 7.4 .

The post-study questionnaire was used to determine if the lay users understood the test instruction and the meaning of the results. Consumers were asked questions about the test, control line and confirmation of results. The results were acceptable. The sponsor conducted a lay-user study to evaluate the temperature strips that are permanently affixed to the Amedica Drug Screen Test Cup. Twenty-one participants between the ages of 18 and 64 years of age tested their own urine samples and recorded what temperature showed up as green on the cup. The participants' results were verified by the professional. All 21 users' results were correct and showed that the users were able to read and understand the affixed temperature strips. Participants were asked questions about how to run the test, ease of use, and how to use the results of the temperature strip. The responses were 100% correct. b.

Matrix comparison:

Not applicable. The assay is intended for urine samples.

3. Clinical studies:

a. Clinical Sensitivity:

Not applicable.

b. Clinical specificity:

Not applicable.

c. Other clinical supportive data (when a. and b. are not applicable):

Not applicable.

4. Clinical cut-off:

Not applicable.

5. Expected values/Reference range:

Not applicable.

N. Proposed Labeling:

The labeling is sufficient and it satisfies the requirements of 21 CFR Part 809.10.

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O. Conclusion:

The submitted information in this premarket notification is complete and supports a substantial equivalence decision.

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