MICROMEDIC DRUGS OF ABUSE PANEL TEST (9), CATALOG NUMBER 07RD-7062

K033566 · Rapid Diagnostics, Inc. · DKZ · May 17, 2004 · Clinical Toxicology

Device Facts

• Record ID: K033566
• Device Name: MICROMEDIC DRUGS OF ABUSE PANEL TEST (9), CATALOG NUMBER 07RD-7062
• Applicant: Rapid Diagnostics, Inc.
• Product Code: DKZ · Clinical Toxicology
• Decision Date: May 17, 2004
• Decision: SESE
• Submission Type: Traditional
• Regulation: 21 CFR 862.3100
• Device Class: Class 2

Indications for Use

The MICROMEDIC® Drugs of Abuse Panel Test is an immunochromatographic one-step in-vitro test intended for the qualitative determination of up to nine different drug substances in human urine at the following cut-off levels (amphetamine, 1000 ng/ml; barbiturate [secobarbital], 300 ng/ml; benzodiazepine [oxazepam], 300 ng/ml; cocaine, 300 ng/ml; methadone, 300 ng/ml; methamphetamine, 1000 ng/ml; opiates, 2000 ng/ml; phencyclidine, 25 ng/ml; and cannabinoid, 50 ng/ml). The MICROMEDIC® Drugs of Abuse Panel Test is intended for use in a point-ofcare (POC) setting to include emergency hospitals and medical care facilities (i.e., emergency rooms, ambulances, etc.), as well as the workplace, criminal justice and transportation arenas, and walk-in, or mobile drug testing facilities. The MICROMEDIC® Drugs of Abuse Panel Test will provide a preliminary analytical test result. A more specific alternative chemical method must be used in order to obtain a confirmed analytical result. Gas chromatography/ mass spectrometry (GC/MS) has been established as the preferred confirmatory method by the Substance Abuse Mental Health Services Administration (SAMHSA). Clinical consideration and professional judgment should be applied to any drug of abuse test result, particularly when preliminary positive results are indicated. It is the responsibility of those organizations required to follow Department of Transportation (DOT) or the Substance Abuse and Mental Health Administration (SAMHSA) Workplace Drug Testing Guidelines to determine that use of this product satisfics the criteria for workplace testing established under DOT and SAMHSA.

Device Story

Single-use dip-and-read test card; lateral flow immunochromatographic assay. Input: human urine sample. Principle: competitive binding between drug in sample and drug conjugate for limited antibody-dye conjugate. Output: visual colored bands on test strip; absence of band at test line indicates positive result; presence of band at control line indicates valid test. Used in point-of-care settings (hospitals, workplace, criminal justice) by POC staff. Provides preliminary analytical results; requires GC/MS confirmation for clinical decision-making. Benefits: rapid, on-site screening for drug presence.

Clinical Evidence

No clinical studies performed. Performance evaluated via analytical bench testing (precision/reproducibility) and method comparison studies. Precision study used spiked urine controls across three POC sites. Method comparison evaluated accuracy against GC/MS using naturalistic and spiked samples; results demonstrated agreement with original in-house performance data.

Technological Characteristics

Lateral flow immunochromatographic assay. Components: mouse monoclonal anti-drug antibody, goat anti-mouse IgG control line. Form factor: single-use dip-and-read test card. Qualitative visual readout. No instrumentation required. No specific materials or standards referenced.

Indications for Use

Indicated for qualitative detection of amphetamine, barbiturates, benzodiazepines, cocaine, methadone, methamphetamine, opiates, phencyclidine, and cannabinoids in human urine at specified cut-off levels. Intended for point-of-care use in emergency medical facilities, workplace, criminal justice, and transportation settings. Prescription use only.

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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510(k) SUBSTANTIAL EQUIVALENCE DETERMINATION
DECISION SUMMARY
DEVICE ONLY TEMPLATE

A. 510(k) Number:
K033566

B. Purpose of the Submission:
This is a new 510(k). The sponsor is expanding the claim for previously cleared test strips to point-of-care settings, including workplace.

C. Analyte:
amphetamine, barbiturates, benzodiazepines, cocaine, methadone, methamphetamine, opiates, phencyclidine, and cannabinoid

D. Type of Test:
Qualitative immunochromatographic assay

E. Applicant:
Rapid Diagnostics (a division of MP Biomedicals, Inc.)

F. Proprietary and Established Names:
Micromedic Drugs of Abuse Panel Test (AMP, BAR, BZO, COC, MTD, MET, OPI, PCP, THC)

G. Regulatory Information:

1. Regulation section:
862.3100, Enzyme Immunoassay, Amphetamine
862.3150, Enzyme Immunoassay, Barbiturate
862.3170, Enzyme Immunoassay, Benzodiazepine
862.3870, Enzyme Immunoassay, Cannabinoids
862.3250, Enzyme Immunoassay, Cocaine and Cocaine Metabolites
862.3620, Enzyme Immunoassay, Methadone
862.3610, Thin Layer Chromatography, Metamphetamine
862.3650, Enzyme Immunoassay, Opiates
Unclassified, Enzyme Immunoassay, Phencyclidine

2. Classification:
II

3. Product Code:
DKZ, DIS, JXM, LDJ, DIO, DJR, DJC, DJG, LCM, respectively

4. Panel:
Toxicology (91)

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# H. Intended Use:

1. Intended use(s):
Refer to Indications for use.

2. Indication(s) for use:
The MICROMEDIC® Drugs of Abuse Panel Test is an immunochromatographic one-step in-vitro test intended for the qualitative determination of up to nine different drug substances in human urine at the following cut-off levels (amphetamine, 1000 ng/ml; barbiturate [secobarbital], 300 ng/ml; benzodiazepine [oxazepam], 300 ng/ml; cocaine, 300 ng/ml; methadone, 300 ng/ml; methamphetamine, 1000 ng/ml; opiates, 2000 ng/ml; phencyclidine, 25 ng/ml; and cannabinoid, 50 ng/ml).

The MICROMEDIC® Drugs of Abuse Panel Test is intended for use in a point-of-care (POC) setting to include emergency hospitals and medical care facilities (i.e., emergency rooms, ambulances, etc.), as well as the workplace, criminal justice and transportation arenas, and walk-in, or mobile drug testing facilities.

The MICROMEDIC® Drugs of Abuse Panel Test will provide a preliminary analytical test result. A more specific alternative chemical method must be used in order to obtain a confirmed analytical result. Gas chromatography/ mass spectrometry (GC/MS) has been established as the preferred confirmatory method by the Substance Abuse Mental Health Services Administration (SAMHSA). Clinical consideration and professional judgment should be applied to any drug of abuse test result, particularly when preliminary positive results are indicated.

It is the responsibility of those organizations required to follow Department of Transportation (DOT) or the Substance Abuse and Mental Health Administration (SAMHSA) Workplace Drug Testing Guidelines to determine that use of this product satisfies the criteria for workplace testing established under DOT and SAMHSA.

3. Special condition for use statement(s):
The device is for in vitro diagnostic use.
The device is for prescription use.
The assay is intended for use in point-of-care settings.

4. Special instrument Requirements:
Not applicable. The device is a visually read single-use device.

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I. Device Description:
The product is a single-use dip-and-read test card. Operators dip the test strip into the urine and the reaction is initiated by movement of the sample through the test strip.

J. Substantial Equivalence Information:
1. Predicate device name(s):
The predicates are all Rapid Diagnostic previously cleared Rx test strips.
2. Predicate K number(s):
The 510(k) numbers belonging to the sponsor’s earlier cleared strips are K003809 for amphetamine, benzodiazepine, cocaine, methamphetamine, PCP, and THC. K030211 for barbiturates. K023252 for methadone. K020716 for opiates.
3. Comparison with predicate:
Devices are all the same as the originally cleared products. The configurations (or combinations) may vary in the marketed versions from the originally cleared configuration.

K. Standard/Guidance Document Referenced (if applicable):
The sponsor did not reference any standards in their submission.

L. Test Principle:
The test employs lateral flow immunochromatographic technology.

Each component strip of the MICROMEDIC® Drugs of Abuse Panel Test is based on the principle of specific immunochemical reaction between antibodies and antigen to analyze particular compound in human urine specimen. The assay relies on the competition for binding antibody. When drug is present in the urine specimen, it competes with drug conjugate for the limited amount of antibody-dye conjugate. When the amount of drug is equal or more than the cut-off, it will prevent the binding of drug conjugate to the antibody. Therefore, a positive urine specimen will not show a colored band on the test line zone, indicating a positive result, while the presence of a colored band indicates a negative result.

A control line is present in the test window to work as procedural control. This colored band should always appear on the control line to indicate that an adequate volume of sample was added and that the membrane strip is intact.

Description of the test antibody: mouse monoclonal anti-drug antibody
Description of the control line antibody: goat anti-mouse IgG

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

1. Analytical performance:

a. Precision/Reproducibility:

Reproducibility was evaluated to support the expanded POC claim.

Specimen description: spiked control samples

Lots of product used: not specified

Number of operators: three

Operator: POC staff

Testing Facility: POC sites

Urine control material was evaluated. Controls were purchased from Biochemical Diagnostics and were verified by GC/MS. A total of 20 samples for each of the seven testing levels were analyzed for each of the nine drugs. Results of the study are presented below:

PRECISION STUDY RESULTS

| DRUG | CONTROL. ng/ml | #NO | # + Site 1 | # +/- Site 1 | # - Site 1 | # + Site 2 | # +/- Site 2 | # - Site 2 | # + Site 3 | # +/- Site 3 | # - Site 3 |
| --- | --- | --- | --- | --- | --- | --- | --- | --- | --- | --- | --- |
| AMP (1000 ng/ml) | 0 | | | | 20 | | | 20 | | | 20 |
| | 500 ng/ml | 20 | | | 20 | | | 20 | | 20 | |
| | 750 ng/ml | 20 | | | 20 | | | 20 | | 20 | |
| | 1000 ng/ml | 20 | 20 | | | 20 | | | 20 | | |
| | 1250 ng/ml | 20 | 20 | | | 20 | | | 20 | | |
| | 1500 ng/ml | 20 | 20 | | | 20 | | | 20 | | |
| | 3000 ng/ml | 20 | 20 | | | 20 | | | 20 | | |
| BAR (300 ng/ml) | 0 | | | | 20 | | | 20 | | | 20 |
| | 150 ng/ml | 20 | | | 20 | | | 20 | | 20 | |
| | 225 ng/ml | 20 | | | 20 | | | 20 | | 20 | |
| | 300 ng/ml | 20 | 20 | | | 20 | | | 20 | | |
| | 375 ng/ml | 20 | 20 | | | 20 | | | 20 | | |
| | 450 ng/ml | 20 | 20 | | | 20 | | | 20 | | |
| | 900 ng/ml | 20 | 20 | | | 20 | | | 20 | | |
| BZO (300 ng/ml) | 0 | | | | 20 | | | 20 | | | 20 |
| | 150 ng/ml | 20 | | | 20 | | | 20 | | 20 | |
| | 225 ng/ml | 20 | | | 20 | | | 20 | | 20 | |
| | 300 ng/ml | 20 | 20 | | | 20 | | | 20 | | |
| | 375 ng/ml | 20 | 20 | | | 20 | | | 20 | | |
| | 450 ng/ml | 20 | 20 | | | 20 | | | 20 | | |
| | 900 ng/ml | 20 | 20 | | | 20 | | | 20 | | |
| COC (300 ng/ml) | 0 | | | | | | | 20 | | | 20 |
| | 150 ng/ml | 20 | | | 20 | | | 20 | | 20 | |
| | 225 ng/ml | 20 | | | 20 | | | 20 | | 20 | |
| | 300 ng/ml | 20 | 20 | | | 20 | | | 20 | | |
| | 375 ng/ml | 20 | 20 | | | 20 | | | 20 | | |
| | 450 ng/ml | 20 | 20 | | | 20 | | | 20 | | |
| | 900 ng/ml | 20 | 20 | | | 20 | | | 20 | | |

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| DRUG | CONTROL ng/ml | #NO | # + Site 1 | # +/- Site 1 | # - Site 1 | # + Site 2 | # +/- Site 2 | # - Site 2 | # + Site 3 | # +/- Site 3 | # - Site 3 |
| --- | --- | --- | --- | --- | --- | --- | --- | --- | --- | --- | --- |
| MTD (300 ng/ml) | 0 ng/ml | | | | 20 | | | 20 | | | 20 |
| | 150 ng/ml | 20 | | | 20 | | | 20 | | 20 | |
| | 225 ng/ml | 20 | | | 20 | | | 20 | | 20 | |
| | 300 ng/ml | 20 | 20 | | | 20 | | | 20 | | |
| | 375 ng/ml | 20 | 20 | | | 20 | | | 20 | | |
| | 450 ng/ml | 20 | 20 | | | 20 | | | 20 | | |
| | 900 ng/ml | 20 | 20 | | | 20 | | | 20 | | |
| MET (1000 ng/ml) | 0 | 20 | | | 20 | | | 20 | | | 20 |
| | 500 ng/ml | 20 | | | 20 | | | 20 | | 20 | |
| | 750 ng/ml | 20 | | | 20 | | | 20 | | 20 | |
| | 1000 ng/ml | 20 | 20 | | | 18 | | 2 | 20 | | |
| | 1250 ng/ml | 20 | 20 | | | 20 | | | 20 | | |
| | 1500 ng/ml | 20 | 20 | | | 20 | | | 20 | | |
| | 3000 ng/ml | 20 | 20 | | | 20 | | | 20 | | |
| OPI (2000 ng/ml) | 0 | | | | 20 | | | 20 | | | 20 |
| | 1000 ng/ml | 20 | | | 20 | | | 20 | | 20 | |
| | 1500 ng/ml | 20 | | | 20 | | | 20 | | 20 | |
| | 2000 ng/ml | 20 | 20 | | | 20 | | | 20 | | |
| | 2500 ng/ml | 20 | 20 | | | 20 | | | 20 | | |
| | 3000 ng/ml | 20 | 20 | | | 20 | | | 20 | | |
| | 6000 ng/ml | 20 | 20 | | | 20 | | | 20 | | |
| PCP (25 ng/ml) | 0 | | | | 20 | | | 20 | | | 20 |
| | 12.5 ng/ml | 20 | | | 20 | | | 20 | | 20 | |
| | 18.8 ng/ml | 20 | | | 20 | | | 20 | | 20 | |
| | 25 ng/ml | 20 | 20 | | | 20 | | | 20 | | |
| | 31.3 ng/ml | 20 | 20 | | | 20 | | | 20 | | |
| | 37.5 ng/ml | 20 | 20 | | | 20 | | | 20 | | |
| | 75 ng/ml | 20 | 20 | | | 20 | | | 20 | | |
| THC (50 ng/ml) | 0 | | | | 20 | | | 20 | | | 20 |
| | 25 ng/ml | 20 | | | 20 | | | 20 | | 20 | |
| | 37.5 ng/ml | 20 | | | 20 | | | 20 | | 20 | |
| | 50 ng/ml | 20 | 20 | | | 17 | | 3 | 20 | | |
| | 62.5 ng/ml | 20 | 20 | | | 20 | | | 20 | | |
| | 75 ng/ml | 20 | 20 | | | 20 | | | 20 | | |
| | 150 ng/ml | 20 | 20 | | | 20 | | | 20 | | |

Study results appear adequate to support the claim and are consistent with earlier in-house study results.

b. Linearity/assay reportable range:

Not applicable. The assay is intended for qualitative use.

c. Traceability (controls, calibrators, or method):

Control materials are required but are not specifically identified in the labeling. Users are instructed to follow federal, state, and local guidelines when determining when to run external controls.

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The device has an internal process control which indicates whether an adequate volume of sample was added and whether the membrane strip is intact.

# d. Detection limit:

The sponsor indicates that this information was taken from the original $510(\mathrm{k})$ and the labeling has not changed. Therefore the raw data to support these conclusions was not reviewed. It is summarized below:

Cutoff validation and sensitivity were evaluated in-house. The manufacturer analyzed 175 devices of each of the nine analytes individually in strip format at the following concentrations: 0, $50\%$ , $75\%$ , $100\%$ , $125\%$ , $150\%$ and $300\%$ of cut-off level of the assay.

Table 1 Amphetamine (AMP)

| AMP (ng/ml) | # Tested | # Negative | # Borderline | # Positive |
| --- | --- | --- | --- | --- |
| 0 | 25 | 25 | 0 | 0 |
| 500 ng/ml | 25 | 25 | 0 | 0 |
| 750 ng/ml | 25 | 0 | 24 | 1 |
| 1000 ng/ml | 25 | 0 | 0 | 25 |
| 1250 ng/ml | 25 | 0 | 0 | 25 |
| 1500 ng/ml | 25 | 0 | 0 | 25 |
| 3000 ng/ml | 25 | 0 | 0 | 25 |

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Table 2 Barbiturate (BAR)

| BAR (ng/ml) | # Tested | # Negative | # Borderline | # Positive |
| --- | --- | --- | --- | --- |
| 0 | 25 | 25 | 0 | 0 |
| 150 ng/ml | 25 | 25 | 0 | 0 |
| 225 ng/ml | 25 | 10 | 15 | 0 |
| 300 ng/ml | 25 | 0 | 10 | 15 |
| 375 ng/ml | 25 | 0 | 0 | 25 |
| 450 ng/ml | 25 | 0 | 0 | 25 |
| 900 ng/ml | 25 | 0 | 0 | 25 |

Table 3 Benzodiazepine (BZO)

| BZO (ng/ml) | # Tested | # Negative | # Borderline | # Positive |
| --- | --- | --- | --- | --- |
| 0 | 25 | 25 | 0 | 0 |
| 150 ng/ml | 25 | 25 | 0 | 0 |
| 225 ng/ml | 25 | 21 | 4 | 0 |
| 300 ng/ml | 25 | 0 | 6 | 19 |
| 375 ng/ml | 25 | 0 | 0 | 25 |
| 450 ng/ml | 25 | 0 | 0 | 25 |
| 900 ng/ml | 25 | 0 | 0 | 25 |

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Table 4 Cocaine (COC)

| COC (ng/ml) | # Tested | # Negative | # Borderline | # Positive |
| --- | --- | --- | --- | --- |
| 0 | 25 | 25 | 0 | 0 |
| 150 ng/ml | 25 | 25 | 0 | 0 |
| 225 ng/ml | 25 | 16 | 9 | 0 |
| 300 ng/ml | 25 | 0 | 20 | 5 |
| 375 ng/ml | 25 | 0 | 2 | 23 |
| 450 ng/ml | 25 | 0 | 0 | 25 |
| 900 ng/ml | 25 | 0 | 0 | 25 |

Table 5 Methadone (MTD)

| MTD (ng/ml) | # Tested | # Negative | # Borderline | # Positive |
| --- | --- | --- | --- | --- |
| 0 | 25 | 25 | 0 | 0 |
| 150 ng/ml | 25 | 25 | 0 | 0 |
| 225 ng/ml | 25 | 10 | 15 | 0 |
| 300 ng/ml | 25 | 0 | 10 | 15 |
| 375 ng/ml | 25 | 0 | 0 | 25 |
| 450 ng/ml | 25 | 0 | 0 | 25 |
| 900 ng/ml | 25 | 0 | 0 | 25 |

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Table 6 Methamphetamine (MET)

| MET (ng/ml) | # Tested | # Negative | # Borderline | # Positive |
| --- | --- | --- | --- | --- |
| 0 | 25 | 25 | 0 | 0 |
| 500 ng/ml | 25 | 25 | 0 | 0 |
| 750 ng/ml | 25 | 25 | 0 | 0 |
| 1000 ng/ml | 25 | 0 | 18 | 7 |
| 1250 ng/ml | 25 | 0 | 23 | 2 |
| 1500 ng/ml | 25 | 0 | 3 | 22 |
| 3000 ng/ml | 25 | 0 | 0 | 25 |

Table 7 Opiate (OPI)

| OPI (ng/ml) | # Tested | # Negative | # Borderline | # Positive |
| --- | --- | --- | --- | --- |
| 0 | 25 | 25 | 0 | 0 |
| 1000 ng/ml | 25 | 25 | 0 | 0 |
| 1500 ng/ml | 25 | 25 | 0 | 0 |
| 2000 ng/ml | 25 | 0 | 12 | 13 |
| 2500 ng/ml | 25 | 0 | 0 | 25 |
| 3000 ng/ml | 25 | 0 | 0 | 25 |
| 6000 ng/ml | 25 | 0 | 0 | 25 |

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Table 8 Phencyclidine (PCP)

| PCP (ng/ml) | # Tested | # Negative | # Borderline | # Positive |
| --- | --- | --- | --- | --- |
| 0 | 25 | 25 | 0 | 0 |
| 12.5 ng/ml | 25 | 25 | 0 | 0 |
| 18.8 ng/ml | 25 | 25 | 0 | 0 |
| 25 ng/ml | 25 | 3 | 21 | 1 |
| 31.3 ng/ml | 25 | 0 | 25 | 0 |
| 37.5 ng/ml | 25 | 0 | 18 | 7 |
| 75 ng/ml | 25 | 0 | 0 | 25 |

Table 9 Cannabinoid (THC)

| THC (ng/ml) | # Tested | # Negative | # Borderline | # Positive |
| --- | --- | --- | --- | --- |
| 0 | 25 | 25 | 0 | 0 |
| 25 ng/ml | 25 | 25 | 0 | 0 |
| 37.5 ng/ml | 25 | 25 | 0 | 0 |
| 50 ng/ml | 25 | 0 | 3 | 22 |
| 62.5 ng/ml | 25 | 0 | 0 | 25 |
| 75 ng/ml | 25 | 0 | 0 | 25 |
| 150 ng/ml | 25 | 0 | 0 | 25 |

e. Analytical specificity:

The sponsor indicates that this information is taken from the original 510(k). It was not reviewed, but is presented below.

The assays were evaluated with samples prepared with drug at the cut-off concentration. Readings were shown not to be interfered with by pH conditions between 4 and 9 and when the specific gravity varied between 1.005 and 1.035.

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The following substances were tested in negative samples and samples spiked with drugs at the cut-off concentration, and confirmed to not effect test results:

Glucose 2000 mg/dl
Human albumin 2000 mg/dl
Human hemoglobin 10 mg/dl
Urea 4000 mg/dl
Uric acid 10 mg/dl

The following table lists compounds that are detected by DOA panel test which produced positive results when tested at levels equal or greater than the concentrations listed below:

| Test | Compounds | Cut-off (ng/ml) |
| --- | --- | --- |
| Amphetamine | D-Amphetamine | 1,000 |
| | D/L-Amphetamine | 2,000 |
| | (±)3,4Methylenedioxyamphetamine | 2,500 |
| | l-Amphetamine | 30,000 |
| | (+)methamphetamine | >100 μg/ml |
| | (±)3,4Methylenedioxymethamphetamine | >100 μg/ml |

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| Test | Compounds | Cut-off (ng/ml) |
| --- | --- | --- |
| Barbiturate | Alphenal | 100 |
| | Barbital | 150 |
| | Pentobarbital | 150 |
| | Phenobarbital | 150 |
| | Amobarbital | 300 |
| | Secobarbital | 300 |
| | Butalbital | 5,000 |
| Benzodiazepines | Nitrazepam | 100 |
| | Chloradiazepoxide HCI | 300 |
| | Clobazam | 300 |
| | Desmethyldiazepam | 300 |
| | Oxazepam | 300 |
| | Temazepam | 300 |
| | Alprazolam | 1000 |
| | Bromazepam | 1000 |
| | Diazepam | 1000 |
| | Flunitrazepam | 1000 |
| | Lorazepam | 1000 |
| | Clonazepam | 2000 |
| | Flurazepam | 100 |
| Cocaine | Benzoylecgonine | 300 |
| | Cocaine | 30,000 |
| Methadone | Methadone | 300 |
| | Methadol | 300 |
| Methamphetamine | (+)Methamphetamine | 1000 |
| | (±)3,4Methylenedioxymethamphetamine | 1000 |
| | d-Amphetamine | > 100 μg/ml |
| | l-Amphetamine | > 100 μg/ml |
| | (±)3,4Methylenedioxyamphetamine | > 100 μg/ml |
| | Chloroquine | > 100 μg/ml |
| | (-)Ephedrine | > 100 μg/ml |
| | β-Phenylethylamine | > 100 μg/ml |
| | Procaine | > 100 μg/ml |
| | d-Pseudoephedrine | > 100 μg/ml |
| | Ranitidine | > 100 μg/ml |
| Opiate | Ethylmorphine | 1,000 |
| | Morphine | 2,000 |
| | Morphine-3-β-glucuronide | 2,000 |
| | Codeine | 2,000 |
| | 6-Acetylmorphine | 2,000 |
| | Dihydrocodone | 2,000 |
| | Heroin | 5,000 |
| | Hydrocodone | 7,500 |
| | Hydromorphone | 7,500 |
| | Nalorphine | 15,000 |
| | Normorphine | 20,000 |
| | Norcodeine | 100,000 |
| | Naloxone | 100,000 |
| | Oxycodone | 100,000 |
| Phencyclidine | PCP | 25 |
| THC | 11-nor-Δ⁹-THC-9-COOH | 50 |
| | 11-nor-Δ⁸-THC-9-COOH | 37.5 |
| | 11-hydroxy-Δ⁹-THC | 5000 |
| | Δ⁸-Tetrahydrocannabinol | 15000 |
| | Δ⁹-Tetrahydrocannabinol | 25000 |

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The following compounds show no cross-reactivity at concentration up to 100 $\mu \mathrm{g} / \mathrm{ml}$ unless specified. There is a possibility that other substances and/or factors not listed above may interfere with the test and cause false results, e.g., technical or procedural errors.

| 4-Acetamidophenol | Cortisone | Homatropine | Perphenazine |
| --- | --- | --- | --- |
| Acetaminophen | Deoxyephedrine | Hydrochlorothiazide | Phenylethylamine-α |
| Acetylsalicylic acid | Dextromethorphan | Ibuprofen | Phenylpropanolamine |
| Amikacin | Digitoxin | Imipramine | Promethazine |
| Amitriptyline | Digoxin | Isoproterenol | Pseudoephedrine |
| Arterenol | Diphenhydramine | Ketamine | Quinine antidine |
| Ascorbic acid | Ecgonine | Lidocaine | Salicylic acid |
| Aspartame | Ecgonine methyl ester | Meperidine | Tetracycline |
| Atropine | Ephedrine | Methaqualone | Tetrahydrozoline |
| Caffeine | Epinephrine | Methylphenidate | Theophylline |
| Camphor | Gentisic | Neomycin | Thioridazine |
| Chlorpheniramine | Guaiacol glyceric ester | Niacinamide | Trifluoperazine |
| Chloroquine | Histamine | Penicillin G | Tryptophan |
| | | | Tyramine |

f. Assay cut-off:

These have not changed from the originally cleared products.

Characterization of how the device performs analytically around the claimed cutoff concentration appears in the precision and sensitivity sections, above.

2. Comparison studies:

a. Method comparison with predicate device:

The sponsor provided naturalistic samples and prepared spiked samples to a POC employee for analysis. The samples were also analyzed by GC/MS.

Number of study sites: one

Type of study site(s): POC setting

Operator description: POC staff member

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Results of the study appear below:

Accuracy was tested in each component strip and compared to GC/MS method at the following concentrations: d-amphetamine 1000 ng/ml (AMP), secobarbital 300 ng/ml (BAR), oxazepam, 300 ng/ml (BZO), benzoylecgonine 300 ng/ml (COC), methadone 300 ng/ml (MTD), (+)methamphetamine 1000 ng/ml (MET), morphine 2000 ng/ml (OPI), phencyclidine 25 ng/ml (PCP) and 11-nor-Δ⁹-THC-9-COOH 50ng/ml (THC).

The results of each component strip are listed below:

Table 1: Amphetamine (AMP)

The accuracy of the amphetamine test was evaluated in comparison to GC/MS method at a cut-off of 1000 ng/ml. Eighty-one (81) specimens with GC/MS confirmed d-amphetamine concentration were evaluated.

| | (-) | | (+) | | |
| --- | --- | --- | --- | --- | --- |
| Rapid AMP Test | Negative by GC/MS | Near Cutoff NEG (between -25% and C/O) | Near Cutoff POS (between C/O and +25%) | GC/MS POS (greater than +25% C/O) | Percent agreement with GC/MS |
| Positive | 2 | 1 | 8 | 26 | 92% |
| Negative | 43 | 0 | 1 | 0 | 98% |
| Total | 45 | 1 | 9 | 26 | N=81 |

Table 2: Barbiturate (BAR)

The accuracy of the barbiturate test was evaluated in comparison to GC/MS method at a cut-off of 300 ng/ml secobarbital. One-hundred thirteen (113) specimens with GC/MS confirmed barbiturate concentration were evaluated in this study.

| | (-) | | (+) | | |
| --- | --- | --- | --- | --- | --- |
| Rapid BAR Test | Negative by GC/MS | Near Cutoff NEG (between -25% and C/O) | Near Cutoff POS (between C/O and +25%) | GC/MS POS (greater than +25% C/O) | Percent agreement with GC/MS |
| Positive | 0 | 0 | 6 | 58 | 100% |
| Negative | 45 | 4 | 0 | 0 | 100% |
| Total | 45 | 4 | 6 | 58 | N=113 |

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Table 3: Benzodiazipine (BZO)

The accuracy of the benzodiazepine test was evaluated in comparison to GC/MS method at a cut-off of 300 ng/ml oxazepam. Seventy-nine (79) specimens with GC/MS confirmed oxazepam concentration were evaluated.

| | (-) | | (+) | | |
| --- | --- | --- | --- | --- | --- |
| Rapid BZO Test | Negative by GC/MS | Near Cutoff NEG (between -25% and C/O) | Near Cutoff POS (between C/O and +25%) | GC/MS POS (greater than +25% C/O) | Percent agreement with GC/MS |
| Positive | 0 | 1 | 6 | 30 | 97% |
| Negative | 42 | 0 | 0 | 0 | 100% |
| Total | 42 | 1 | 6 | 30 | N=79 |

Table 4: Cocaine (COC)

The accuracy of the cocaine test was evaluated in comparison to GC/MS method at a cut-off of 300 ng/ml benzoylecgonine. Eighty-one (81) specimens with GC/MS confirmed benzoylecgonine concentration were evaluated.

| | (-) | | (+) | | |
| --- | --- | --- | --- | --- | --- |
| Rapid COC Test | Negative by GC/MS | Near Cutoff NEG (between -25% and C/O) | Near Cutoff POS (between C/O and +25%) | GC/MS POS (greater than +25% C/O) | Percent agreement with GC/MS |
| Positive | 0 | 2 | 3 | 31 | 94% |
| Negative | 41 | 4 | 0 | 0 | 100% |
| Total | 41 | 6 | 3 | 31 | N=81 |

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Table 5: Methadone (MTD)
The accuracy of the methadone test was evaluated in comparison to GC/MS method at a cut-off of 300 ng/ml methadone. Ninety-nine (99) specimens with GC/MS confirmed methadone concentration were evaluated.

| | (-) | | (+) | | |
| --- | --- | --- | --- | --- | --- |
| Rapid MTD Test | Negative by GC/MS | Near Cutoff NEG (between -25% and C/O) | Near Cutoff POS (between C/O and +25%) | GC/MS POS (greater than +25% C/O) | Percent agreement with GC/MS |
| Positive | 0 | 0 | 4 | 46 | 100% |
| Negative | 40 | 9 | 0 | 0 | 100% |
| Total | 40 | 9 | 4 | 46 | N=99 |

Table 6: Methamphetamine (MET)
The accuracy of the methamphetamine test was evaluated in comparison to GC/MS method at a cut-off of 1000 ng/ml methamphetamine. Eighty (80) specimens with GC/MS confirmed methamphetamine concentration were evaluated in this study.

| | (-) | | (+) | | |
| --- | --- | --- | --- | --- | --- |
| Rapid MET Test | Negative by GC/MS | Near Cutoff NEG (between -25% and C/O) | Near Cutoff POS (between C/O and +25%) | GC/MS POS (greater than +25% C/O) | Percent agreement with GC/MS |
| Positive | 0 | 2 | 4 | 31 | 95% |
| Negative | 40 | 3 | 0 | 0 | 100% |
| Total | 40 | 5 | 4 | 31 | N=80 |

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# Table 7: Opiates (OPI)

The accuracy of the opiates test was evaluated in comparison to GC/MS method at a cut-off of 2000 ng/ml morphine. Eighty-three (83) specimens with GC/MS confirmed morphine and codeine concentrations were evaluated.

| | (-) | | (+) | | |
| --- | --- | --- | --- | --- | --- |
| Rapid OPI Test | Negative by GC/MS | Near Cutoff NEG (between -25% and C/O) | Near Cutoff POS (between C/O and +25%) | GC/MS POS (greater than +25% C/O) | Percent agreement with GC/MS |
| Positive | 2 | 2 | 8 | 27 | 90% |
| Negative | 44 | 0 | 0 | 0 | 100% |
| Total | 46 | 2 | 8 | 27 | N=83 |

# Table 8: Phencyclidine (PCP)

The accuracy of the phencyclidine test was evaluated in comparison to GC/MS method at a cut-off of 25 ng/ml phencyclidine. Eighty (80) specimens with GC/MS confirmed morphine and codeine concentrations were evaluated.

| | (-) | | (+) | | |
| --- | --- | --- | --- | --- | --- |
| Rapid PCP Test | Negative by GC/MS | Near Cutoff NEG (between -25% and C/O) | Near Cutoff POS (between C/O and +25%) | GC/MS POS (greater than +25% C/O) | Percent agreement with GC/MS |
| Positive | 0 | 1 | 1 | 34 | 97% |
| Negative | 43 | 1 | 0 | 0 | 100% |
| Total | 43 | 2 | 1 | 34 | N=80 |

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The accuracy of the cannabinoid test was evaluated in comparison to GC/MS method at a cut-off of $50\mathrm{ng / ml}$ 11-nor- $\Delta^9$ -THC-9-COOH. Eighty-eight (88) specimens with GC/MS confirmed 11-nor- $\Delta^9$ -THC-9-COOH concentration were evaluated.

Table 9: Cannabinoid (THC)

| | (-) | | (+) | | |
| --- | --- | --- | --- | --- | --- |
| Rapid THC Test | Negative by GC/MS | Near Cutoff NEG (between -25% and C/O) | Near Cutoff POS (between C/O and +25%) | GC/MS POS (greater than +25% C/O) | Percent agreement with GC/MS |
| Positive | 1 | 1 | 3 | 35 | 95% |
| Negative | 44 | 4 | 0 | 0 | 100% |
| Total | 45 | 5 | 3 | 35 | N=88 |

The POC results appear consistent with the performance originally demonstrated in the in-house studies. However, because all of the positive samples for some of the drugs in this study were prepared samples and because of the way the naturalistic samples were selected for inclusion in this study it was decided to limit the presentation of performance to the information from the sponsor's in-house study. This information appearing in the package insert was not reviewed again as the sponsor indicates they have not changed the information from how it was presented at the time of the original prescription clearance.

The sponsor was asked to include only a statement in their package insert indicating that the product was evaluated in a POC setting and results were comparable.

b. Matrix comparison:

Not applicable. The assay is intended for only one sample matrix.

# 3. Clinical studies:

a. Clinical sensitivity:

Not applicable. Clinical studies are not typically submitted for this device type.

b. Clinical specificity:

Not applicable. Clinical studies are not typically submitted for this device type.

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

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4. Clinical cut-off:
Not applicable.

5. Expected values/Reference range:
Not applicable.

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