AT HOME DRUG TEST MODELS, 9308T AND 9308X

K070009 · Phamatech, Inc. · DIS · Dec 7, 2007 · Clinical Toxicology

Device Facts

• Record ID: K070009
• Device Name: AT HOME DRUG TEST MODELS, 9308T AND 9308X
• Applicant: Phamatech, Inc.
• Product Code: DIS · Clinical Toxicology
• Decision Date: Dec 7, 2007
• Decision: SESE
• Submission Type: Traditional
• Regulation: 21 CFR 862.3150
• Device Class: Class 2

Indications for Use

The Phamatech At Home 12 Drug Test: Models 9308T and 9308Z for amphetamines (AMP), barbiturates (BAR), benzodiazepines (BZD), cocaine (COC), ecstasy (MDMA), methadone (MTD), methamphetamine (MET), opiates (OPI), oxycodone (OXY), phencyclidine (PCP) and marijuana (THC) is a screening test for the rapid detection of the drugs listed above in urine. The cut-off concentrations (ng/ml) for these drugs are as follows: amphetamines (1000), barbiturates (200), benzodiazepines (200), cocaine (300), ecstasy (500), methadone (300), methamphetamine (500), opiates (300), oxycodone (100), phencyclidine (25) and marijuana (50). The BAR, BZD and OXY assay will yield preliminary positive results when these drugs are ingested at or above therapeutic doses. There are no uniformly recognized drug levels for barbiturates, benzodiazepines or oxycodone in urine. This test only identifies the presence of these drugs when present at or above the stated cut-off concentration. This assay provides only a preliminary test result. A more specific alternate analytical method must be used in order to obtain a confirmed analytical result. Gas chromatography / Mass spectrometry (GC/MS) is the preferred confirmatory test method. Clinical consideration and professional judgment should be applied to any drug of abuse test result, particularly when preliminary positive results are indicated. This device is not for professional or workplace testing. It is intended for Home Use. This device is 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 or absence of the above stated drugs / drug metabolites in urine. Information regarding confirmation testing – the second step in the process, along with materials for shipping urine samples to the laboratory, are included.

Device Story

Single-use lateral flow immunoassay for qualitative detection of drugs of abuse in urine. Device formats include a collection cup (9308Z) or dip card (9308T). User collects urine; sample migrates through test strips via capillary action. Competitive binding between drug in sample and drug-labeled conjugate occurs at antibody sites. Absence of line in test area indicates presumptive positive; presence of line indicates negative. Control line confirms proper sample volume and migration. Intended for home use by consumers as a preliminary screening step; positive results require confirmatory testing via GC/MS. Kit includes collection materials and mailer for laboratory confirmation. Provides consumers with information on drug presence to facilitate clinical decision-making or professional consultation.

Clinical Evidence

Three consumer studies (n=180 participants) evaluated untrained user performance. Participants interpreted 1,874 tests; 98.4% (1,844/1,874) were interpreted correctly. Studies used spiked urine samples at 0%, 50%, 75%, 125%, and 150% of target cut-off concentrations. Results confirmed high accuracy across all analytes near cut-off levels. No clinical sensitivity/specificity data provided as this is a qualitative screening assay; performance relies on analytical validation and consumer comprehension of instructions.

Technological Characteristics

Lateral flow immunochromatographic assay; competitive binding principle. Formats: urine collection cup or dip card. Internal control line confirms sample migration and volume. No external instrumentation required. Materials include plastic cup/card, absorbent pads, and test strips.

Indications for Use

Indicated for OTC consumer use for rapid qualitative screening of 12 drugs of abuse (AMP, BAR, BZD, COC, MDMA, MTD, MET, OPI, OXY, PCP, THC) in human urine. Intended for home use; not for professional or workplace testing. Provides preliminary results; requires GC/MS confirmation.

Regulatory Classification

Identification

A barbiturate test system is a device intended to measure barbiturates, a class of hypnotic and sedative drugs, in serum, urine, and gastric contents. Measurements obtained by this device are used in the diagnosis and treatment of barbiturate use or overdose and in monitoring levels of barbiturate to ensure appropriate therapy.

Special Controls

*Classification.* Class II (special controls). A barbiturate 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

• Quick Screen Pro Multi Drug Screening Test, Model 9153T (k000131)
• Quick Screen Benzodiazepine (Models 9025, 9026, 9027T, 9153 and 9195X) (k043167)
• Quick Screen Pro Drug Cup, Model 9195X (k001397)
• Quick Screen Oxycodone, Model 9120X (k043051)

Submission Summary (Full Text)

{0}

1

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

A. 510(k) Number:
k070009

B. Purpose for Submission:
This submission is for the addition of four new analytes intended for over-the-counter (OTC) use; these devices have been previously cleared for prescription use.

C. Measurand:
Benzodiazepines, Barbiturates, Methadone and Oxycodone

D. Type of Test:
Qualitative Lateral Flow Immunoassay

E. Applicant:
Phamatech, Inc.

F. Proprietary and Established Names:
At Home Drug Test 12: Models 9308T and 9308Z

G. Regulatory Information:
1. Regulation section:
21 CFR 862.3150, Enzyme Immunoassay, Barbiturate
21 CFR 862.3170, Enzyme Immunoassay, Benzodiazepine
21 CFR 862.3620, Enzyme Immunoassay, Methadone
21 CFR 862.3650, Enzyme Immunoassay, Opiates
2. Classification:
Class II
3. Product Codes:
DIS, JXM, DJR, and DJG
4. Panel:
Toxicology (91)

H. Intended Use:
1. Intended use(s):
Refer to the Indications for use below.

2. Indication(s) for use:
The Phamatech At Home 12 Drug Test: Models 9308T and 9308Z for amphetamines (AMP), barbiturates (BAR), benzodiazepines (BZD), cocaine (COC), ecstasy (MDMA), methadone (MTD), methamphetamine (MET), opiates (OPI), oxycodone (OXY), phencyclidine (PCP) and marijuana (THC) is a screening test for the rapid detection of the drugs listed above in urine. The cut-

{1}

off concentrations (ng/ml) for these drugs are as follows: amphetamines (1000), barbiturates (200), benzodiazepines (200), cocaine (300), ecstasy (500), methadone (300), methamphetamine (500), opiates (300), oxycodone (100), phencyclidine (25) and marijuana (50).

The BAR, BZD and OXY assay will yield preliminary positive results when these drugs are ingested at or above therapeutic doses. There are no uniformly recognized drug levels for barbiturates, benzodiazepines or oxycodone in urine.

This test only identifies the presence of these drugs when present at or above the stated cut-off concentration.

This assay provides only a preliminary test result. A more specific alternate analytical method must be used in order to obtain a confirmed analytical result. Gas chromatography / Mass spectrometry (GC/MS) is the preferred confirmatory test method. Clinical consideration and professional judgment should be applied to any drug of abuse test result, particularly when preliminary positive results are indicated.

This device is not for professional or workplace testing. It is intended for Home Use.

This device is 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 or absence of the above stated drugs / drug metabolites in urine. Information regarding confirmation testing – the second step in the process, along with materials for shipping urine samples to the laboratory, are included.

3. Special conditions for use statement(s):

The BAR, BZD and OXY assay will yield preliminary positive results when these drugs are ingested at or above therapeutic doses. There are no uniformly recognized drug levels for barbiturates, benzodiazepines or oxycodone in urine. This test only identifies the presence of these drugs when present at or above the stated cut-off concentration.

This assay provides only a preliminary test result. A more specific alternate analytical method must be used in order to obtain a confirmed analytical result. Gas chromatography / Mass spectrometry (GC/MS) is the preferred confirmatory test method. Clinical consideration and professional judgment should be applied to any drug of abuse test result, particularly when preliminary positive results are indicated.

This device is not for professional or workplace testing. It is intended for Home Use.

This device is intended for over-the-counter (OTC) consumer use as the first step

2

{2}

in a two step process to provide consumers with information concerning the presence or absence of the above stated drugs / drug metabolites in urine. Information regarding confirmation testing – the second step in the process, along with materials for shipping urine samples to the laboratory, are included.

4. Special instrument requirements: Not applicable.

I. Device Description:

The At Home Drug Test 12 Model 9308Z is a single use device utilizing a cup format. The user collects urine in the cup to the recommended volume and fills the labeled vial to two-thirds full. The reaction is initiated by movement of the sample through the test strip. Test strips are incorporated into the sides of a sample cup. The kit includes the following materials: 1 instructional booklet, 1 urine collection cup, 1 labeled vial, 1 plastic pouch with absorbent pad, 1 pre-addressed mailer box and 1 personal identification label.

The At Home Drug Test 12 Model 9308T is a single use dip card device. The user inserts the absorbent end of the device in the urine sample to the maximum level indicated by the line on the device label. The test reaction is initiated by movement of the sample through the test strip. The kit includes the following materials: 1 instructional booklet, 1 urine collection cup, 1 labeled vial, 1 plastic pouch with absorbent pad, 1 pre-addressed mailer box and 1 personal identification label.

The At Home Drug Test 12 devices detect up to twelve drugs of abuse. The table presented below lists the drugs of abuse that were previously cleared for OTC use, the 510(k) number they were cleared under and the device format (card or cup).

| 510(k) # | Device Name | Device Format | Analytes |
| --- | --- | --- | --- |
| k030447 | At Home Drug Test Model 9150X | Cup | cocaine, THC, opiates, amphetamine/MDA, methamphetamine/MDMA |
| k010655 | At Home Drug Test Model 9150T | Card | cocaine, THC, opiates, amphetamine/MDA, methamphetamine/MDMA |
| k010651 | At Home Drug Test Model 9133T | Card | PCP |

J. Substantial Equivalence Information:

1. Predicate device name(s):

Quick Screen Pro Multi Drug Screening Test, Model 9153T

Quick Screen Benzodiazepine (Models 9025, 9026, 9027T, 9153 and 9195X)

Quick Screen Pro Drug Cup, Model 9195X

Quick Screen Oxycodone, Model 9120X

{3}

2. Predicate K number(s):
k000131
k043167
k001397
k043051

3. Comparison with predicate:

| Similarities | | |
| --- | --- | --- |
| Item | Device | Predicate |
| Intended Use | For the qualitative detection of drugs of abuse | Same |
| Specimen Type | Urine | Same |
| Principle | Immunochromatographic Lateral Flow Immunoassay | Same |
| Format | Cup and Card | Same |
| Differences | | |
| --- | --- | --- |
| Item | Device | Predicate |
| Analytes, OTC | Barbiturates, benzodiazepine, oxycodone, methadone, cocaine, THC, opiates, amphetamine/MDA, methamphetamine/MDMA, and PCP | Cocaine, THC, opiates, amphetamine/MDA, methamphetamine/MDMA, and PCP |

K. Standard/Guidance Document Referenced (if applicable):
None referenced.

L. Test Principle:
The tests employ lateral flow immunochromatographic technology, which involves the recognition and formation of a specific antibody/target drug complex. Drug in the sample and drug-labeled conjugate compete for antibody binding sites. Absence of a line in the test area is a presumptive positive result, and the presence of a line in the test area is a negative result. The control line (C) serves as an internal quality control to ensure proper sample volume has been added to the test and that the sample has correctly migrated up the test strip.

M. Performance Characteristics (if/when applicable):
1. Analytical performance:
a. Precision/Reproducibility:
See Clinical Studies section 3c. below for performance data around the cutoffs.
b. Linearity/assay reportable range:
Not applicable.
c. Traceability, Stability, Expected values (controls, calibrators, or methods):
This device has internal process controls. A colored line appearing in the

{4}

control region confirms that sufficient sample volume has been applied and that the sample has migrated correctly on the test strip. Users are informed 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:
Performance characteristics have been addressed in k000131 (Phamatech QuickScreen Pro Multi Drug Screening Test), k043167 Phamatech QuickScreen Benzodiazepines Test), k001397 (Phamatech QuickScreen Pro Drug Cup) and k043051 (Phamatech QuickScreen Oxycodone Test).

e. Analytical Specificity:
Performance characteristics have been addressed in k000131, k043167, k001397 and k043051.

f. Assay cut-off:
Performance characteristics have been addressed in k000131, k043167, k001397 and k043051.

2. Comparison studies:
a. Method comparison with predicate device:
Performance characteristics have been addressed in k000131, k043167, k001397 and k043051.
b. Matrix comparison:
Not applicable.

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):
Three consumer studies were conducted to determine the device's performance when used by untrained users following the instructions in the labeling. Note: Study number three was performed only with sample solutions containing oxycodone at two concentrations: approximately 67 ng/mL and approximately 109 ng/mL. A questionnaire was used to determine if the untrained users understood the test instructions and the meaning of the results. Consumers were asked if they understood the best time to collect a sample, the directions for collecting a urine sample, performing the test and interpreting the test result. 180 consumers interpreted a total of 1,874 tests and 98% (1,844 of 1,874) were interpreted correctly. Approximately 50% of the participants were female and 50% were male ranging in age from 18 to >60 years of age. Approximately 25 of 180 had less than 12 years of education, approximately 42 of 180 were high school graduates, and approximately 109 of 180 had attended college or graduated from college. There was no

5

{5}

information on the educational background of approximately four consumers.

## Study #1

109 consumers performed the tests using high clinical samples diluted in normal drug-free urine. Some samples contained as many as ten drugs; there were combinations that contained no drugs at all. Drug concentrations were confirmed by GC/MS. Consumers tested even numbered samples on the test cup device and odd numbered samples on the test card device. Each of the new drugs intended for OTC use, barbiturates, benzodiazepines, methadone and oxycodone, were tested at 0%, 50%, 75%, 125%, and 150% of the target concentration. The drugs previously cleared for OTC use, amphetamines, cocaine, methamphetamines, opiates, PCP, and THC were tested at various cutoff concentrations ranging from 0% to 150% of the target concentrations.

1,073 of 1,081 interpretations made by lay users were correct (99%). At 75% of the cutoff, 99 of the 100 test interpretations were scored as correct. There was one false positive for amphetamines. At ≤50% of the cutoff, 884 of the 891 test interpretations were scored as correct. There was 1 false positive for benzodiazepine and THC, 2 false positives for opiates and 3 false positives for PCP.

## Study #2

760 unique tests with sample solutions containing amphetamines, methamphetamines, cocaine, benzodiazepine, barbiturates, oxycodone, methadone, opiates, THC and PCP were performed by 38 consumers using drug-free urine that had been spiked with various concentrations and combinations of drugs. Participants tested random coded samples with various combinations of drugs at 75%, 125% and 150% of the target concentrations. Drug concentrations were confirmed by GC/MS. Consumers performed the assays using the test card format.

750 of 760 interpretations (98%) made by lay users were correct. At 75% of cut-off, 229 of 235 interpretations were scored as correct results. There were 6 false positives for oxycodone; 1 false positive for benzodiazepines and 1 false positive for cocaine. At 125% of cut-off 268 of 270 interpretations were scored as correct results. There were 2 Invalid test results; i.e., control and/or test line did not develop. At 150% of cut-off 253 of 255 interpretations were scored as correct results. There was 1 false negative for PCP and 1 false negative for THC.

## Study #3

Sample solutions containing oxycodone were performed by thirty-three consumers at two Phamatech locations. Thirty of the samples were clinical samples diluted in drug-free urine to an approximate concentration of 67 ng/mL. Three positive samples were Oxycodone 200 ng/ml control diluted to an approximate concentration of 109 ng/mL. Of the total thirty-three

6

{6}

interpretations made by lay users a total of 33 test results were correct. Consumers performed the assays using the test card format.

A total of 1,874 tests were interpreted by lay users and 1,844 tests were interpreted correctly. The sponsor pooled the results obtained by the test cup and test card formats because these formats were demonstrated to be equivalent in $510(\mathrm{k})\mathrm{s}$ previously cleared for these analytes. The summary of the results for Studies 1, 2 and 3 is presented in the tables below:

| Drug | Candidate Device Results | Less than half the cutoff concentration by GC/MS analysis | Near Cutoff Negative (Between 50% below the cutoff and the cutoff concentration) | Near Cutoff Positive (Between the cutoff and 50% above the cutoff concentration) | High Positive (greater than 50% above the cutoff concentration) |
| --- | --- | --- | --- | --- | --- |
| Amphetamine | Positive | 0 | 1 | 27 | 31 |
| | Negative | 93 | 35 | 0 | 0 |
| Methamphetamine | Positive | 0 | 0 | 27 | 33 |
| | Negative | 93 | 34 | 0 | 0 |
| Cocaine | Positive | 0 | 4 | 27 | 33 |
| | Negative | 93 | 30 | 0 | 0 |
| Benzodiazepine | Positive | 1 | 1 | 27 | 30 |
| | Negative | 92 | 33 | 0 | 0 |
| Barbiturate | Positive | 0 | 0 | 36 | 32 |
| | Negative | 85 | 34 | 0 | 0 |
| Oxycodone | Positive | 0 | 6 | 30 | 36 |
| | Negative | 89 | 57 | 0 | 0 |
| Drug | Candidate Device Results | Less than half the cutoff concentration by GC/MS analysis | Near Cutoff Negative (Between 50% below the cutoff and the cutoff concentration) | Near Cutoff Positive (Between the cutoff and 50% above the cutoff concentration) | High Positive (greater than 50% above the cutoff concentration) |
| --- | --- | --- | --- | --- | --- |
| Methadone | Positive | 0 | 0 | 39 | 41 |
| | Negative | 68 | 34 | 0 | 0 |
| Opiates | Positive | 2 | 0 | 27 | 33 |
| | Negative | 90 | 33 | 0 | 0 |
| THC | Positive | 1 | 0 | 27 | 31 |
| | Negative | 92 | 23 | 0 | 1 |
| PCP | Positive | 3 | 0 | 27 | 25 |
| | Negative | 90 | 34 | 0 | 1 |

{7}

The results of the post-survey questionnaire are presented below:

| Question: | Easy to Understand | Somewhat Difficult | Difficult |
| --- | --- | --- | --- |
| The section “What is the At Home Drug Test” instruction was | 169/180 | 10/180 | 1/180 |
| When is the best time to collect a sample was | 174/180 | 4/180 | 2/180 |
| Direction for collecting the urine and performing the test were | 161/180 | 16/180 | 3/180 |
| The “Interpretation of Your Test Result” section was | 163/180 | 14/180 | 3/180 |
| Actually reading the test result was | 156/180 | 20/180 | 4/180 |
| I found the test device format was | 173/180 | 6/180 | 1/180 |
| The Question and Answer section was | 177/180 | 2/180 | 1/180 |

The reading level of the package inserts (less than 8th grade) was determined on MS Word.

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.

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