ACCU-STAT HOME DRUG TEST CUP FOR MAIJUANNA (THC), COCAINE (COC), AMPHETAMINE (AMP), METHAMPHETAMINE (MAMP), ECSTASY

K041221 · Accu-Stat Diagnostics, Inc. · LDJ · Jul 13, 2004 · Clinical Toxicology

Device Facts

• Record ID: K041221
• Device Name: ACCU-STAT HOME DRUG TEST CUP FOR MAIJUANNA (THC), COCAINE (COC), AMPHETAMINE (AMP), METHAMPHETAMINE (MAMP), ECSTASY
• Applicant: Accu-Stat Diagnostics, Inc.
• Product Code: LDJ · Clinical Toxicology
• Decision Date: Jul 13, 2004
• Decision: SESE
• Submission Type: Traditional
• Regulation: 21 CFR 862.3870
• Device Class: Class 2

Indications for Use

The Accu-Stat™ Drugs of Abuse Home Test Cup for Marijuana (THC), Cocaine (COC), Amphetamine (AMP), Methamphetamine (mAMP), Ecstasy (MDMA), Opiates (OPI), and Phencyclidine (PCP), is a screening test for the rapid detection of three to seven of the above listed drugs in a variety of combinations human urine. The designated cut-off concentrations for these drugs are as follows: Marijuana at 50 ng/ml, Cocaine at 300 ng/ml, Amphetamine at 1000 ng/ml, Methamphetamine at 1000 ng/ml, Ecstasy at 500 ng/ml, Opiates at 2000 ng/ml, and Phencyclidine at 25 ng/ml. The tests are intended for over-the-counter (OTC) consumer use as the first step in a two-step process to provide consumers with information concerning the presence of the above stated drugs or their metabolites in a urine sample. Information, along with the materials for shipping a portion of the urine specimen to the laboratory for confirmation testing of a preliminary positive result, the second step in the process, is provided.

Device Story

Two-chamber plastic test cup; contains 3-5 lateral flow immunochromatographic test strips in isolated chamber. User introduces urine via plastic key; majority of specimen remains in main chamber for potential laboratory confirmation. Visually read by consumer; colored line indicates presence/absence of drug based on competitive binding principle. Procedural control line confirms proper sample volume and wicking. Intended for OTC home use as preliminary screen; includes materials for shipping urine to lab for confirmatory testing. Provides rapid detection of drugs at specified cut-off concentrations; clinical judgment required for interpretation of preliminary positive results.

Clinical Evidence

Consumer study performed with 619 unique tests using spiked urine samples (0%, 50%, 75%, 125%, 150%, 200% of target concentrations). Correct interpretation rates ranged from 97% to 99.5% across all drug types. Incorrect interpretations were primarily associated with samples near the cutoff (±25%).

Technological Characteristics

One-step rapid chromatographic immunoassay; competitive binding principle. Device consists of antibody-coated particles and immobilized drug conjugates. Form factor is an integrated test cup. No external energy source required; relies on capillary action. Qualitative visual readout.

Indications for Use

Indicated for OTC consumer use for rapid qualitative screening of 2-6 drugs (THC, COC, AMP, mAMP, MDMA, OPI, PCP) in human urine. Preliminary positive results require confirmatory testing via alternative chemical methods (e.g., GC/MS).

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).

Predicate Devices

• Phamatech At Home™ Drug Test Cup
• First Check® Home Drug Tests
• ACON Laboratories One Step Multi-Drug Multi-Line Screen Test Card with Integrated Cup (K031759)
• Advantage Diagnostics Home Drug Tests

Submission Summary (Full Text)

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

A. 510(k) Number:
K041221

B. Purpose for Submission:
New product

C. Analyte:
Marijuana (THC), Cocaine (COC), Amphetamine (AMP), Methamphetamine (mAMP), Ecstasy (MDMA), Opiates (OPI), and Phencyclidine (PCP)

D. Type of Test:
Qualitative immunoassay

E. Applicant:
Accu-Stat Diagnostics

F. Proprietary and Established Names:
Accu-Stat™ Drugs of Abuse Home Test Cup for Marijuana, Cocaine, Amphetamine, Methamphetamine, Ecstasy, Opiates, and Phencyclidine

G. Regulatory Information:
1. Regulation section:
Unclassified, Test Kit, Multiple Drugs of Abuse, Over the Counter
862.3870, Enzyme Immunoassay, Cannabinoids
862.3250, Enzyme Immunoassay, Cocaine and Cocaine Metabolites
862.3100, Enzyme Immunoassay, Amphetamine
862.3610, Enzyme Immunoassay, Methamphetamine, MDMA (Ecstasy)
862.3650, Enzyme Immunoassay, Opiates
Unclassified, Enzyme Immunoassay, Phencyclidine
2. Classification:
Class II
3. Product Code:
MVO, LDJ, DIO, DKZ, LAF, DJG, and LCM respectively
4. Panel:
Toxicology (91)

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## H. Intended Use:

1. Intended use(s):
See H.2 below.

2. Indication(s) for use:
"The Accu-Stat™ Drugs of Abuse Home Test Cup for Marijuana (THC), Cocaine (COC), Amphetamine (AMP), Methamphetamine (mAMP), Ecstasy (MDMA), Opiates (OPI), and Phencyclidine (PCP) is a single-unit screening test for the rapid detection of two to six of the above drugs in human urine. The designated cut-off concentrations for these drugs are as follows: Marijuana at 50 ng/ml, Cocaine at 300 ng/ml, Amphetamine at 1000 ng/ml, Methamphetamine at 1000 ng/ml, Ecstasy at 500 ng/ml, Opiates at 2000 ng/ml, and Phencyclidine at 25 ng/ml. The tests are intended for over-the-counter (OTC) consumer use as the first step in a two step process that includes confirmatory testing of preliminary positive results. Information, along with the materials for shipping a portion of the urine specimen to the laboratory is provided."

3. Special condition for use statement(s):
This device only provides a preliminary analytical test result. A more specific alternative chemical method must be used to obtain confirmed analytical results. Gas chromatography/mass spectroscopy is the preferred confirmatory method but other chemical confirmation methods are available. Clinical consideration and professional judgment should be applied to any drug of abuse test, particularly when preliminary positive results are used.

The assay is for OTC use.

The materials necessary for confirmation testing are provided with the screening device. Materials, as well as confirmation testing, are provided to the consumer at no additional cost. The consumer pays for shipment of the sample to the laboratory.

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

## I. Device Description:

The device is a two chamber test cup which is a plastic housing with cap that contains three to five test strips (depending on the number of target drugs) in an isolated chamber. A plastic "key" is used to introduce a portion of the urine into the isolated test chamber to begin the test. The majority of the specimen stays in the main chamber uncontaminated by the test strip reagents and can be used for confirmation testing. The product also includes an instruction booklet, the key described above, a numbered sticker for confidential confirmation testing, a transportation pouch with an absorbent strip, and a pre-addressed mailing box.

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## J. Substantial Equivalence Information:

1. Predicate device name(s)
Acon Spectrum Multi-Drug Multi-Line Drug Screen Test Card with Integrated E-Z Split Key Cup

2. Predicate K number(s):
K031759

3. Comparison with predicate:
Both devices are identical in product design, performance characteristics, materials, manufacturing, matrix used, and are intended for use as an initial screening method subject to confirmation. The proposed device is intended to be sold over the counter (OTC) while the predicate is for prescription use only.

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

The sponsor did not reference any standards or guidance documents in the pre-market notification.

## L. Test Principle:

The device 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. Each strip in the device contains a procedural control that appears in the control line region indicating that the proper volume of urine has been added and membrane wicking has occurred.

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

1. Analytical performance:

a. Precision/Reproducibility:

The accuracy and precision of the test was demonstrated in a consumer study. 619 unique tests were performed by consumers using drug-free urine that had been spiked with various concentrations and combinations of drugs. Each drug was tested at 0%, 50%, 75%, 125%, 150%, and 200% of the target concentration. Some samples contained as many as three drugs; there were combinations that contained no drugs at all. At least 20 but not more than 43 tests were performed for each combination. Drug concentrations were confirmed by GC/MS; recovery ranged between 78 to 116% of the target concentration. Approximately 11% of the consumers had used a home drug kit before. 98% reported that they were high-school graduates and the ratio of female to male was

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roughly 1:1. The study took place in four geographic regions, some with several locations, but the settings were not specified.

The results of the study are summarized in the table below:

| Drug | Cutoff Concentration (ng/ml) | Number of Studies | Correctly Interpreted | Incorrectly Interpreted* |
| --- | --- | --- | --- | --- |
| THC | 50 | 191 | 189 | 2 |
| COC | 300 | 190 | 187 | 3 |
| AMP | 1000 | 167 | 165 | 2 |
| mAMP | 1000 | 183 | 181 | 2 |
| MDMA | 500 | 164 | 162 | 2 |
| OPI | 2000 | 183 | 182 | 1 |
| PCP | 25 | 170 | 168 | 2 |

* All incorrectly interpreted samples, except one, were ±25% of the cutoff value (75% or 125% of target).

A consumer questionnaire was administered to evaluate labeling effectiveness. It asked only one question: "Was the test easy to interpret?" Thus it did not determine whether the labeling adequately alerted users to the limitations of home use testing devices. Only one participant of 619 responded that the test was not easy to interpret.

**b. Linearity/assay reportable range:**
Not applicable for a qualitative assay.

**c. Traceability, Stability, Expected values (controls, calibrators, or method):**
The device has an internal process control. Users are informed that the control indicates that sufficient urine was added to the test. This is typical of OTC tests. Users are also informed not to interpret the test if the control line does not form.

**d. Detection limit:**
Issues were addressed in the predicate submission.

**e. Analytical specificity:**
Issues were addressed in the predicate submission.

**f. Assay cut-off:**
The identified cutoff concentrations are those recommended by the Substance Abuse and Mental Health Services Administration (SAMHSA) for all drugs except MDMA. Analytical performance of the device around the cutoff is described in the precision section above.

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2. Comparison studies:
a. Method comparison with predicate device:
Not applicable.
b. Matrix comparison:
Not applicable as the device is only intended for use with urine.

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):
Not applicable; clinical studies are not typically submitted for this device type.

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.