(47 days)
First Sign™ Drug of Abuse Tests are immunochromatographic assays for the qualitative determination of Amphetamine (d-amphetamine), Cocaine (Benzoylecgonine), and Marijuana (11-nor-A9-THC-9-COOH ) in human urine at cut-off concentrations of 1000 ng/mL, and 50 ng/mL, respectively. The tests are available in a Cup format and a Dip Card format.
The tests provide only preliminary test results. A more specific alternative chemical method must be used in order to obtain a confirmed analytical result. GC/MS is the preferred confirmatory method. Clinical consideration and professional iudgment should be exercised with any drug of abuse test result, particularly when the preliminary result is possive. For in vitro diagnostic use only. The tests are intended for over-the-counter and for prescription use.
First Sign™ Drug of Abuse Tests are immunochromatographic assays. Each assay test is a lateral flow system for the qualitative detection of cocaine, amphetamine, and marijuana in human urine. The products are single-use in vitro diagnostic devices, which come in the formats of DipCards or Cups. Each test kit contains a Test Device (in one of the two formats), a package insert and a urine cup for sample collection. Each test device is sealed with a desiccant in an aluminum pouch.
This document describes the performance characteristics of the First Sign™ Drug of Abuse Dip Card Test and First Sign™ Drug of Abuse Cup Test for Amphetamine, Cocaine, and Marijuana.
Here's an analysis based on your request:
1. Table of Acceptance Criteria and Reported Device Performance
The document does not explicitly state "acceptance criteria" as a set of predefined thresholds. However, the performance is demonstrated through various studies. The primary measure of performance is the ability of the device to correctly identify positive and negative samples relative to a defined cut-off, as confirmed by GC/MS.
For the precision studies, the acceptance criterion implicitly appears to be 100% agreement for samples significantly below (-50%, -75%, -100% cut-off) and significantly above (+50%, +75%, +100% cut-off) the cut-off. For samples near the cut-off, some discordance is expected.
For the comparison studies (against GC/MS), the performance is presented through the number of correct classifications. For the lay-user study, the performance is given as the "percentage of correct results (%)".
Below is a summary of the reported device performance for samples at the cut-off and at +25% and -25% of the cut-off, as these are the most critical regions for accuracy.
Amphetamine (AMP) - Cut-off: 1000 ng/mL (all values are percentage of samples correctly classified)
| Device Type | Assay | % Correct at -25% Cut-off (750 ng/mL) | % Correct at Cut-off (1000 ng/mL) | % Correct at +25% Cut-off (1250 ng/mL) |
|---|---|---|---|---|
| Dip Card (Precision) | AMP | 100% Negative (150/150) | 94% Positive (140/150) | 100% Positive (150/150) |
| Cup (Precision) | AMP | 100% Negative (150/150) | 96% Positive (144/150) | 100% Positive (150/150) |
| Dip Card (Comparison) | AMP | Varies by viewer (e.g., Viewer A: 19/20 negative) | Varies by viewer (e.g., Viewer A: 4/14 negative, 10/14 positive) | Varies by viewer (e.g., Viewer A: 26/26 positive, 4/4 negative) |
| Cup (Comparison) | AMP | Varies by viewer (e.g., Viewer A: 19/20 negative) | Varies by viewer (e.g., Viewer A: 1/14 negative, 13/14 positive) | Varies by viewer (e.g., Viewer A: 26/26 positive, 1/1 negative) |
| Lay-User (Dip Card) | AMP | 95% Negative (19/20) | Not explicitly reported at cut-off | 90% Positive (18/20) |
| Lay-User (Cup) | AMP | 90% Negative (18/20) | Not explicitly reported at cut-off | 95% Positive (19/20) |
Cocaine (COC) - Cut-off: 300 ng/mL
| Device Type | Assay | % Correct at -25% Cut-off (225 ng/mL) | % Correct at Cut-off (300 ng/mL) | % Correct at +25% Cut-off (375 ng/mL) |
|---|---|---|---|---|
| Dip Card (Precision) | COC | 100% Negative (150/150) | 95% Positive (142/150) | 100% Positive (150/150) |
| Cup (Precision) | COC | 100% Negative (150/150) | 96% Positive (145/150) | 100% Positive (150/150) |
| Dip Card (Comparison) | COC | Varies by viewer (e.g., Viewer A: 19/20 negative) | Varies by viewer (e.g., Viewer A: 4/14 negative, 10/14 positive) | Varies by viewer (e.g., Viewer A: 26/26 positive, 4/4 negative) |
| Cup (Comparison) | COC | Varies by viewer (e.g., Viewer A: 19/20 negative) | Varies by viewer (e.g., Viewer A: 2/14 negative, 12/14 positive) | Varies by viewer (e.g., Viewer A: 26/26 positive, 2/2 negative) |
| Lay-User (Dip Card) | COC | 85% Negative (17/20) | Not explicitly reported at cut-off | 95% Positive (19/20) |
| Lay-User (Cup) | COC | 90% Negative (18/20) | Not explicitly reported at cut-off | 100% Positive (20/20) |
Marijuana (THC) - Cut-off: 50 ng/mL
| Device Type | Assay | % Correct at -25% Cut-off (37.5 ng/mL) | % Correct at Cut-off (50 ng/mL) | % Correct at +25% Cut-off (62.5 ng/mL) |
|---|---|---|---|---|
| Dip Card (Precision) | THC | 100% Negative (150/150) | 95% Positive (144/150) | 100% Positive (150/150) |
| Cup (Precision) | THC | 100% Negative (150/150) | 96% Positive (146/150) | 100% Positive (150/150) |
| Dip Card (Comparison) | THC | Varies by viewer (e.g., Viewer A: 18/20 negative) | Not applicable, samples categorized as "Near Cutoff Positive" | 100% Positive (26/26) |
| Cup (Comparison) | THC | Varies by viewer (e.g., Viewer A: 19/20 negative) | Not applicable, samples categorized as "Near Cutoff Positive" | 100% Positive (26/26) |
| Lay-User (Dip Card) | THC | 95% Negative (19/20) | Not explicitly reported at cut-off | 100% Positive (20/20) |
| Lay-User (Cup) | THC | 95% Negative (19/20) | Not explicitly reported at cut-off | 95% Positive (19/20) |
Note: For the precision and lay-user studies, performance at the exact cut-off received mixed results (some negative, some positive), indicating the inherent variability near the detection limit. For the comparison studies, samples were categorized into "Near Cutoff Negative" (between -50% and cut-off) and "Near Cutoff Positive" (between cut-off and +50%), not specifically at the cut-off. Performance percentages for comparison studies are not directly provided in the text and would require calculation from the tables.
2. Sample Size and Data Provenance for Test Set
-
Precision Studies:
- For each drug (AMP, COC, THC) and each format (Dip Card, Cup), 9 different concentrations were tested: -100%, -75%, -50%, -25%, Cut-off, +25%, +50%, +75%, +100% of the cut-off.
- Each concentration was tested two runs per day for 25 days, using three different lots of the device. This means for each drug/format/concentration, there were 50 tests per lot, totaling 150 tests per concentration. (e.g., 50-/0+ means 50 negative results, 0 positive results).
- Total tests for precision: 3 drugs * 2 formats * 9 concentrations * 150 tests/concentration = 8100 tests.
- Data Provenance: "Samples were prepared by spiking drug in negative samples." "Each drug concentration was confirmed by GC/MS." This suggests prospective, laboratory-controlled data using spiked urine samples. The country of origin is not specified but implied to be the location of the manufacturing company (W.H.P.M., Inc., Irwindale, CA).
-
Cut-off Verification Study:
- A total of 150 samples equally distributed at -50% cut-off; -25% cut-off; cut-off; +25% cut-off; +50% cut-off were tested.
- This implies 5 concentrations * 30 samples/concentration = 150 samples.
- Data Provenance: Not explicitly stated but likely lab-prepared spiked samples similar to precision studies.
-
Comparison Studies (Method Comparison):
- 80 clinical samples (40 negative and 40 positive) were used for each drug (AMP, COC, THC) and each format (Cup, Dip Card).
- Total samples for comparison studies: 3 drugs * 2 formats * 80 samples/drug/format = 480 clinical samples.
- Data Provenance: "Un-altered clinical samples." This suggests retrospective or prospectively collected clinical samples, but without further detail on how they were collected. The country of origin is not specified but implied to be the location of the study (in-house).
-
Lay-user Study:
- 280 lay persons tested the Amphetamine devices.
- 280 lay persons tested the Cocaine devices.
- 280 lay persons tested the Marijuana devices.
- Each participant was given 1 blind labeled sample. These samples were prepared at 7 different concentrations: negative, +/-25%, +/-50%, +/-75%, +/-100% of the cut-off. This suggests that for each drug, 7 concentrations * 20 samples/concentration = 140 samples were prepared. Given 280 lay persons, it implies each person tested one sample, and samples were duplicated for the number of participants.
- Data Provenance: "Urine samples were prepared at the following concentrations; negative, +/-75%, +/-25% of the cutoff by spiking drugs into drug free-pooled urine specimens. The concentrations of the samples were confirmed by GC/MS." This is prospective, laboratory-prepared spiked urine samples, presented as blind-labeled to the lay users. Country of origin not specified, but study performed "at three intended user sites".
3. Number of Experts and Qualifications for Ground Truth
- Precision, Cut-off, Interference, Specificity, and Effect of Urine Specific Gravity and pH Studies: The ground truth was established by GC/MS (Gas Chromatography/Mass Spectrometry). GC/MS is a laboratory analytical method and does not involve human experts in establishing the "ground truth" concentration of the drugs. These studies were performed by laboratory personnel.
- Comparison Studies (Method Comparison): The ground truth for the 480 clinical samples was also established by GC/MS. These were "compared to GC/MS results," meaning GC/MS served as the reference method (ground truth). The tests themselves were run by "three different laboratory assistants." Their qualifications beyond being "laboratory assistants" are not specified.
- Lay-user Study: The ground truth for the spiked samples was established by GC/MS.
4. Adjudication Method for the Test Set
- Precision, Cut-off, Interference, Specificity, and Effect of Urine Specific Gravity and pH Studies: The data presented are direct results from the devices (negative/positive) for specific concentrations as confirmed by GC/MS. There is no mention of an adjudication method as the results are quantitative and compared against a defined cut-off.
- Comparison Studies: The tests were run by "three different laboratory assistants" (Viewers A, B, C). Each viewer independently provided results (Positive/Negative). The tables present results for each viewer separately. There is no explicit adjudication method (like rule-based consensus, e.g., 2+1, 3+1). Discordant results are noted for individual viewers without a resolution process described for a single, unified "device result."
- Lay-user Study: Each lay person provided individual results. The data aggregates these individual results. There is no adjudication method described for resolving differences between lay users.
5. Multi Reader Multi Case (MRMC) Comparative Effectiveness Study
No. The document presents neither an MRMC study design nor a comparative effectiveness study evaluating human readers with and without AI assistance. The studies involve (1) laboratory personnel interpreting the device, and (2) lay users interpreting the device. There is no AI component mentioned.
6. Standalone (Algorithm Only) Performance
Yes, in essence, the "Analytical Performance" section (Precision, Interference, Specificity, Cut-off, Stability, Effect of Urine Specific Gravity and pH) and the "Comparison Studies" with laboratory assistants can be considered standalone performance of the device without explicit human-in-the-loop assistance influencing the device's detection capabilities. The human element here is about reading and interpreting the visual line on the test, not assisting an underlying algorithm. The device itself is an immunochromatographic assay, which is a chemical/biological-based test, not an AI algorithm.
7. Type of Ground Truth Used
The type of ground truth used across all reported studies (Precision, Cut-off, Comparison, Lay-user) is GC/MS (Gas Chromatography/Mass Spectrometry). This is a laboratory-based, highly accurate chemical method considered the gold standard for drug confirmation in urine. All samples (spiked or clinical) had their drug concentrations confirmed using GC/MS.
8. Sample Size for the Training Set
This document describes a medical device which is an immunochromatographic assay, not an AI/ML-based device. Therefore, there is no "training set" in the context of machine learning algorithms. The performance is based on the chemical reactions and design of the lateral flow assay.
9. How the Ground Truth for the Training Set Was Established
As there is no "training set" for an AI/ML algorithm mentioned, this question is not applicable. The device operates based on antigen-antibody immunochemistry, not learned patterns from data.
{0}------------------------------------------------
Image /page/0/Picture/1 description: The image shows the logo for the U.S. Department of Health & Human Services. The logo consists of a circular border with the text "DEPARTMENT OF HEALTH & HUMAN SERVICES - USA" arranged around the perimeter. Inside the circle is a stylized image of three human profiles facing to the right, with the profiles overlapping to create a sense of depth and connection.
Food and Drug Administration 10903 New Hampshire Avenue Document Control Center - WO66-G609 Silver Spring, MD 20993-0002
October 7, 2014
WHPM, INC. C/O JOE SHIA LSI INTERNATIONAL INC. 504 EAST DIAMOND AVE. SUITE F GAITHERSBURG, MD 20877
Re: K142353 Trade/Device Name: First Sign Drug of Abuse Dip Card Test First Sign Drug of Abuse Cup Test Regulation Number: 21 CFR 862.3250 Regulation Name: Cocaine & Cocaine Metabolite test system Regulatory Class: Class II Product Code: DIO, DKZ and LDJ Dated: August 15, 2014 Received: August 21, 2014
Dear Mr. Joe Shia:
We have reviewed your Section 510(k) premarket notification of intent to market the device referenced above and have determined the device is substantially equivalent (for the indications for use stated in the enclosure) to legally marketed predicate devices marketed in interstate commerce prior to May 28, 1976, the enactment date of the Medical Device Amendments, or to devices that have been reclassified in accordance with the provisions of the Federal Food, Drug, and Cosmetic Act (Act) that do not require approval of a premarket approval application (PMA). You may, therefore, market the device, subject to the general controls provisions of the Act. The general controls provisions of the Act include requirements for annual registration, listing of devices, good manufacturing practice, labeling, and prohibitions against misbranding and adulteration. Please note: CDRH does not evaluate information related to contract liability warranties. We remind you, however, that device labeling must be truthful and not misleading.
If your device is classified (see above) into either class II (Special Controls) or class III (PMA), it may be subject to additional controls. Existing major regulations affecting your device can be found in the Code of Federal Regulations, Title 21, Parts 800 to 898. In addition, FDA may publish further announcements concerning your device in the Federal Register.
Please be advised that FDA's issuance of a substantial equivalence determination does not mean that FDA has made a determination that your device complies with other requirements of the Act or any Federal statutes and regulations administered by other Federal agencies. You must comply with all the Act's requirements, including, but not limited to: registration and listing (21 CFR Part 807); labeling (21 CFR Part 801); medical device reporting (reporting of medical
{1}------------------------------------------------
device-related adverse events) (21 CFR 803); good manufacturing practice requirements as set forth in the quality systems (QS) regulation (21 CFR Part 820); and if applicable, the electronic product radiation control provisions (Sections 531-542 of the Act); 21 CFR 1000-1050.
If you desire specific advice for your device on our labeling regulation (21 CFR Part 801), please contact the Division of Industry and Consumer Education at its toll-free number (800) 638-2041 or (301) 796-7100 or at its Internet address
http://www.fda.gov/MedicalDevices/Resourcesfor You/Industry/default.htm. Also, please note the regulation entitled. "Misbranding by reference to premarket notification" (21CFR Part 807.97). For questions regarding the reporting of adverse events under the MDR regulation (21 CFR Part 803), please go to
http://www.fda.gov/MedicalDevices/Safety/ReportaProblem/default.htm for the CDRH's Office of Surveillance and Biometrics/Division of Postmarket Surveillance.
You may obtain other general information on your responsibilities under the Act from the Division of Industry and Consumer Education at its toll-free number (800) 638-2041 or (301) 796-7100 or at its Internet address
http://www.fda.gov/MedicalDevices/ResourcesforYou/Industry/default.htm.
Sincerely yours,
Courtney
Courtney H. Lias, Ph.D. Director Division of Chemistry and Toxicology Devices Office of In Vitro Diagnostics and Radiological Health Center for Devices and Radiological Health
Enclosure
{2}------------------------------------------------
DEPARTMENT OF HEALTH AND HUMAN SERVICES Food and Drug Administration
Indications for Use
510(k) Number (if known) K142353
Device Name First Sign™ Drug of Abuse Cup Test First Sign™ Drug of Abuse Dip Card Test
Indications for Use (Describe)
Card format.
First Sign™ Drug of Abuse Tests are immunochromatographic assays for the qualitative determination of Amphetamine (d-amphetamine), Cocaine (Benzoylecgonine), and Marijuana (11-nor-A9-THC-9-COOH ) in human urine at cut-off concentrations of 1000 ng/mL, and 50 ng/mL, respectively. The tests are available in a Cup format and a Dip
The tests provide only preliminary test results. A more specific alternative chemical method must be used in order to obtain a confirmed analytical result. GC/MS is the preferred confirmatory method. Clinical consideration and professional iudgment should be exercised with any drug of abuse test result, particularly when the preliminary result is possive. For in vitro diagnostic use only. The tests are intended for over-the-counter and for prescription use.
Type of Use (Select one or both, as applicable)
X Prescription Use (Part 21 CFR 801 Subpart D)
Over-The-Counter Use (21 CFR 801 Subpart C)
CONTINUE ON A SEPARATE PAGE IF NEEDED.
This section applies only to requirements of the Paperwork Reduction Act of 1995.
DO NOT SEND YOUR COMPLETED FORM TO THE PRA STAFF EMAIL ADDRESS BELOW.
The burden time for this collection of information is estimated to average 79 hours per response, including the time to review instructions, search existing data sources, gather and maintain the data needed and complete and review the collection of information. Send comments regarding this burden estimate or any other aspect of this information collection, including suggestions for reducing this burden, to:
Department of Health and Human Services Food and Drug Administration Office of Chief Information Officer Paperwork Reduction Act (PRA) Staff PRAStaff(@fda.hhs.gov
"An agency may not conduct or sponsor, and a person is not required to respond to, a collection of information unless it displays a currently valid OMB number."
{3}------------------------------------------------
510(k) SUMMARY K142353
| 1. Date: | September 22, 2014 |
|---|---|
| 2. Submitter | W.H.P.M., Inc.5358 Irwindale Ave.Irwindale, CA 91706 |
| 3. Contact person: | John WanW.H.P.M., Inc. |
5358 Irwindale Ave. Irwindale, CA 91706 Telephone: 626-443-8480 Fax: 626-443-8065 Email: johnwan@whpm.com
- First Sign™ Drug of Abuse Cup Test 4. Device Name: First Sign™ Drug of Abuse Dip Card Test
Classification: Class II
| ProductCode | CFR # | Panel |
|---|---|---|
| DIO | 21 CFR, 862.3250 Cocaine Test System | Toxicology |
| DKZ | 21 CFR, 862.3100 Amphetamine Test System | Toxicology |
| LDJ | 21 CFR, 862.3870 Cannabinoid Test System | Toxicology |
5. Predicate Devices:
K052115 First Check Multi Drug Cup 12
-
- Intended Use
First Sign™ Drug of Abuse Tests are immunochromatographic assays for the qualitative determination of Amphetamine (d-amphetamine), Cocaine (Benzoylecgonine), and Marijuana (11-nor-Δ9-THC-9-COOH ) in human urine at cut-off concentrations of 1000 ng/mL, 300 ng/mL, and 50 ng/mL, respectively. The tests are available in a Cup format and a Dip Card format.
- Intended Use
The tests provide only preliminary test results. A more specific alternative chemical method must be used in order to obtain a confirmed analytical result. GC/MS is the preferred confirmatory method.
{4}------------------------------------------------
Clinical consideration and professional judgment should be exercised with any drug of abuse test result, particularly when the preliminary result is positive.
For in vitro diagnostic use only. The tests are intended for over-the-counter and for prescription use.
-
- Device Description
First Sign™ Drug of Abuse Tests are immunochromatographic assays. Each assay test is a lateral flow system for the qualitative detection of cocaine, amphetamine, and marijuana in human urine. The products are single-use in vitro diagnostic devices, which come in the formats of DipCards or Cups. Each test kit contains a Test Device (in one of the two formats), a package insert and a urine cup for sample collection. Each test device is sealed with a desiccant in an aluminum pouch.
- Device Description
-
- Substantial Equivalence Information
A summary comparison of features of the First Sign™ Drug of Abuse Test and the predicate device is provided in Table 1, Table 2 & Table 3.
- Substantial Equivalence Information
| Item | Device | Predicate -K052115 |
|---|---|---|
| Indication(s)for Use | For the qualitative determination ofcocaine in human urine. | Same |
| Calibrator | Benzoylecgonine | Same |
| Methodology | Competitive binding, lateral flowimmunochromatographic assays based onthe principle of antigen antibodyimmunochemistry. | Same |
| Specimen Type | Human Urine | Same |
| Cut-Off Values | 300 ng/mL | Same |
| IntendedPopulation | For over-the-counter and prescriptionuses. | Forover-the-counteruse. |
| Configurations | Cup, Dip Card | Cup |
Table 1: Features Comparison of First Sign™ Cocaine Test and the Predicate Device
| Table 2: Features Comparison of First Sign™ Amphetamine Test and the Predicate Device | |||||
|---|---|---|---|---|---|
| -- | -- | -- | -- | -- | --------------------------------------------------------------------------------------- |
| Item | Device | Predicate - K052115 |
|---|---|---|
| Indication(s)for Use | For the qualitative determination ofamphetamine in human urine. | Same |
| Calibrator | D-amphetamine | Same |
| Methodology | Competitive binding, lateral flow | Same |
{5}------------------------------------------------
| Item | Device | Predicate - K052115 |
|---|---|---|
| immunochromatographic assays basedon the principle of antigen antibodyimmunochemistry. | ||
| Specimen Type | Human Urine | Same |
| Cut-Off Values | 1000 ng/mL | Same |
| IntendedPopulation | For over-the-counter and prescriptionuses. | For over-the-counteruse. |
| Configurations | Cup, Dip Card | Cup |
Table 3: Features Comparison of First Sign™ Marijuana Test and the Predicate Device
| Item | Device | Predicate - K052115 |
|---|---|---|
| Indication(s)for Use | For the qualitative determination ofmarijuana in human urine. | Same |
| Calibrator | 11-nor- $\u0394$ 9-THC-9 COOH | Same |
| Methodology | Competitive binding, lateral flowimmunochromatographic assays basedon the principle of antigen antibodyimmunochemistry. | Same |
| Specimen Type | Human Urine | Same |
| Cut-Off Values | 50 ng/mL | Same |
| Intended | For over-the-counter and prescription | For over-the-counter |
| Population | uses. | use. |
| Configurations | Cup, Dip Card | Cup |
9. Test Principle
First Sign™ Drug of Abuse Tests are rapid tests for the qualitative detection of cocaine (benzovlecgonine), amphetamine) and marijuana (11-nor-A9-THC-9 COOH) in urine samples. Each assay test is a lateral flow chromatographic immunoassay. During testing, a urine specimen migrates upward by capillary action. If target drugs are present in the urine specimen below its cut-off concentration. it will not saturate the binding sites of its specific antibody (monoclonal mouse antibody) coated on the particles. The antibody-coated particles will then be captured by immobilized drug-conjugate and a visible colored line will show up in the test line region. The colored line will not form in the test line region if the target drug level exceeds its cut-off concentration because it will saturate all the binding sites of the antibody coated on the particles. A band should form in the control region of the devices regardless of the presence of drug or metabolite in the sample.
{6}------------------------------------------------
10. Performance Characteristics
1. Analytical Performance
a. Precision
Precision studies were carried out for samples with concentrations of -100% cut-off, -50% cut-off, -25% cut-off, at the cut-off, +25% cut-off, +75% cut-off, +75% cut-off and +100% cut-off. These samples were prepared by spiking drug in negative samples. Each drug concentration was confirmed by GC/MS. All sample aliquots were blind-labeled and randomized. For each concentration, tests were performed two runs per day for 25 days. The results obtained are summarized in the following tables:
| Result | -100%Cut-off | -75%Cut-off | -50%Cut-off | -25%Cut-off | Cut-off | +25%Cut-off | +50%Cut-off | +75%Cut-off | +100%Cut-off | |
|---|---|---|---|---|---|---|---|---|---|---|
| Drug | Lot.:I3091168 | 50-/0+ | 50-/0+ | 50-/0+ | 50-/0+ | 4-/46+ | 50+/0- | 50+/0- | 50+/0- | 50+/0- |
| Lot.: I3091170 | 50-/0+ | 50-/0+ | 50-/0+ | 50-/0+ | 3-/47+ | 50+/0- | 50+/0- | 50+/0- | 50+/0- | |
| Lot.: I3091172 | 50-/0+ | 50-/0+ | 50-/0+ | 50-/0+ | 3-/47+ | 50+/0- | 50+/0- | 50+/0- | 50+/0- |
Amphetamine (AMP) Dip Card Format
(AMP) Cup Format
| Result | -100%Cut-off | -75%Cut-off | -50%Cut-off | -25%Cut-off | Cut-off | +25%Cut-off | +50%Cut-off | +75%Cut-off | +100%Cut-off |
|---|---|---|---|---|---|---|---|---|---|
| Drug | |||||||||
| Lot.: I3091169 | 50-/0+ | 50-/0+ | 50-/0+ | 50-/0+ | 2-/48+ | 50+/0- | 50+/0- | 50+/0- | 50+/0- |
| Lot.: I3091171 | 50-/0+ | 50-/0+ | 50-/0+ | 50-/0+ | 3-/47+ | 50+/0- | 50+/0- | 50+/0- | 50+/0- |
| Lot.: I3091173 | 50-/0+ | 50-/0+ | 50-/0+ | 50-/0+ | 1-/49+ | 50+/0- | 50+/0- | 50+/0- | 50+/0- |
Cocaine (COC) Dip Card Format
| Result | -100%Cut-off | -75%Cut-off | -50%Cut-off | -25%Cut-off | Cut-off | +25%Cut-off | +50%Cut-off | +75%Cut-off | +100%Cut-off |
|---|---|---|---|---|---|---|---|---|---|
| Drug | |||||||||
| Lot.:I3091168 | 50-/0+ | 50-/0+ | 50-/0+ | 50-/0+ | 3-/47+ | 50+/0- | 50+/0- | 50+/0- | 50+/0- |
| Lot.: I3091170 | 50-/0+ | 50-/0+ | 50-/0+ | 50-/0+ | 4-/46+ | 50+/0- | 50+/0- | 50+/0- | 50+/0- |
| Lot.: I3091172 | 50-/0+ | 50-/0+ | 50-/0+ | 50-/0+ | 3-/47+ | 50+/0- | 50+/0- | 50+/0- | 50+/0- |
{7}------------------------------------------------
(COC) Cup Format
| Result | -100%Cut-off | -75%Cut-off | -50%Cut-off | -25%Cut-off | Cut-off | +25%Cut-off | +50%Cut-off | +75%Cut-off | +100%Cut-off |
|---|---|---|---|---|---|---|---|---|---|
| Drug | |||||||||
| Lot.: I3091169 | 50-/0+ | 50-/0+ | 50-/0+ | 50-/0+ | 3-/47+ | 50+/0- | 50+/0- | 50+/0- | 50+/0- |
| Lot.: I3091171 | 50-/0+ | 50-/0+ | 50-/0+ | 50-/0+ | 2-/48+ | 50+/0- | 50+/0- | 50+/0- | 50+/0- |
| Lot.: I3091173 | 50-/0+ | 50-/0+ | 50-/0+ | 50-/0+ | 3-/47+ | 50+/0- | 50+/0- | 50+/0- | 50+/0- |
Marijuana (THC) Dip Card Format
| Drug | Result | -100%Cut-off | -75%Cut-off | -50%Cut-off | -25%Cut-off | Cut-off | +25%Cut-off | +50%Cut-off | +75%Cut-off | +100%Cut-off |
|---|---|---|---|---|---|---|---|---|---|---|
| Lot.:I3091168 | 50-/0+ | 50-/0+ | 50-/0+ | 50-/0+ | 4-/46+ | 50+/0- | 50+/0- | 50+/0- | 50+/0- | |
| Lot.: I3091170 | 50-/0+ | 50-/0+ | 50-/0+ | 50-/0+ | 3-/47+ | 50+/0- | 50+/0- | 50+/0- | 50+/0- | |
| Lot.: I3091172 | 50-/0+ | 50-/0+ | 50-/0+ | 50-/0+ | 3-/47+ | 50+/0- | 50+/0- | 50+/0- | 50+/0- | |
| Result | -100%Cut-off | -75%Cut-off | -50%Cut-off | -25%Cut-off | Cut-off | +25%Cut-off | +50%Cut-off | +75%Cut-off | +100%Cut-off | |
| Drug | ||||||||||
| Lot.: I3091169 | 50-/0+ | 50-/0+ | 50-/0+ | 50-/0+ | 2-/48+ | 50+/0- | 50+/0- | 50+/0- | 50+/0- | |
| Lot.: I3091171 | 50-/0+ | 50-/0+ | 50-/0+ | 50-/0+ | 1-/49+ | 50+/0- | 50+/0- | 50+/0- | 50+/0- | |
| Lot.: I3091173 | 50-/0+ | 50-/0+ | 50-/0+ | 50-/0+ | 2-/48+ | 50+/0- | 50+/0- | 50+/0- | 50+/0- |
THC Cup Format
b. Linearity
Not applicable.
c.Stability
The devices are stable at 4-30°C (39-86°F) for 24 months based on the accelerated stability study at 50°C. Control materials are not provided with the device. The labeling provides information on how to obtain control materials.
d. Cut-off
A total of 150 samples equally distributed at concentrations of -50% cut-off; -25% cut-off; cut-off; +25% cut-off; +50% cut-off were tested using three different lots of each device by three different operators. Results were all positive at and above +25% cut-off and all negative at and
{8}------------------------------------------------
below -25% cut-off for Amphetamine, Cocaine and Marijuana. The following cut-off values for the test devices have been verified.
| Test | Calibrator | Cut-off (ng/mL) | |
|---|---|---|---|
| One Step Amphetamine Test | D-amphetamine | 1000 | |
| One Step Cocaine Test | Benzoylecogonine | 300 | |
| One Step Marijuana Test | 11-nor-Δ9-THC-9 COOH | 20 |
e. Interference
Potential interfering substances found in human urine of physiological or pathological conditions were added to drug-free urine and to urine containing target drugs at 25% below and 25% above cut-off levels. These urine samples were tested using three batches of each device for all formats.
Compounds that showed no interference at a concentration of 100µg/mL are summarized in the following tables. There were no differences observed for different formats.
| AMP | ||
|---|---|---|
| 4-Acetamidophenol | L-Ephedrine | Oxycodone |
| Acetophenetidin | (-) Y Ephedrine | Oxymetazoline |
| N-Acetylprocainamide | Erythromycin | Papaverine |
| Acetylsalicylic acid | β-Estradiol | Penicillin-G |
| Aminopyrine | Estrone-3-sulfate | Pentazocaine |
| Amitryptyline | Ethyl-p-aminobenzoate | Pentobarbital |
| Amobarbital | Fenfluramine | Perphenazine |
| Amoxicillin | Fenoprofen | Phencyclidine |
| Ampicillin | Furosemide | Phenelzine |
| Ascorbic acid | Gentisic acid | Phenobarbital |
| Aspartame | Hemoglobin | Phetoin |
| Atropine | Hydralazine | L-Phenylephrine |
| Benzilic acid | Hydrochlorothiazide | Phenylpropanolamine |
| Benzoic acid | Hydrocodone | Prednisolone |
| Benzoylecgonine | Hydrocortisone | Prednisone |
| Bilirubin | O-Hydroxyhippuric acid | Procaine |
| Brompheniramine | 3-Hydroxytyramine | Promazine |
| Caffeine | Ibuprofen | Promethazine |
| Cannabidiol | Imipramine | D,L-Propanolol |
| Cannabinol | (-) Isoproterenol | D-Propoxyphene |
| Chloralhydrate | Isoxsuprine | Quinidine |
| Chloramphenicol | Ketamine | Quinine |
| Chlordiazepoxide | Ketoprofen | Ranitidine |
- AMP
{9}------------------------------------------------
| Chlorothiazide | Labetalol | Salicylic acid |
|---|---|---|
| (±) Chlorpheniramine | Levorphanol | Secobarbital |
| Chlorpromazine | Loperamide | Sulfamethazine |
| Chlorquine | Maprotiline | Sulindac |
| Cholesterol | Meperidine | Temazepam |
| Clomipramine | Meprobamate | Tetracycline |
| Clonidine | Methadone | Tetrahydrocortisone |
| Cocaine hydrochloride | Methylphenidate | Tetrahydrozoline |
| Codeine | Morphine-3-Dglucuronide | A9-THC-COOH |
| Cortisone | Nalidixic acid | Thebaine |
| (-) Cotinine | Naloxone | Thiamine |
| Creatinine | Naltrexone | Thioridazine |
| Deoxycorticosterone | Naproxen | D,L-Thyroxine |
| Dextromethorphan | Niacinamide | Tolbutamine |
| Diazepam | Nifedipine | Triamterene |
| Diclofenac | Norcodein | Trifluoperazine |
| Diflunisal | Norethindrone | Trimethoprim |
| Digoxin | D-Norpropox yphene | Trimipramine |
| Diphenhydramine | Noscapine | Tryptamine |
| Doxylamine | D,L-Octopamine | D, L-Tyrosine |
| Ecgonine hydrochloride | Oxalic acid | Uric acid |
| Ecgonine methylester | Oxazepam | Verapamil |
| (IR,2S)-(-)-Ephedrine | Oxolinic acid | Zomepirac |
COC
| Acetominophen | Estrone-3-sulfate | Oxymetazoline |
|---|---|---|
| Acetophenetidin | Ethyl-p-aminobenzoate | Papaverine |
| N-Acetylprocainamide | Fenoprofen | Penicillin-G |
| Acetylsalicylic acid | Furosemide | Pentobarbital |
| Aminopyrine | Gentisic acid | Perphenazine |
| Amitryptyline | Hemoglobin | Phencyclidine |
| Amobarbital | Hydralazine | Phenelzine |
| Amoxicillin | Hydrochlorothiazide | Phenobarbital |
| Ampicillin | Hydrocodone | Phentermine |
| L-Ascorbic acid | Hydrocortisone | L-Phenylephrine |
| DL-Amphetamine Sulfate | O-Hydroxyhippuric acid | β-Phenylethylamine |
| Apomorphine | p-Hydroxymethamphetamine | Phenylpropanolamine |
| Aspartame | 3-Hydroxytyramine | Prednisolone |
| Atropine | Ibuprofen | Prednisone |
| Benzilic acid | Imipramine | Procaine |
{10}------------------------------------------------
| Benzoic acid | Iproniazid | Promazine |
|---|---|---|
| Benzphetamine | (±) - Isoproterenol | Promethazine |
| (±) -Brompheniramine | Isoxsuprine | DL-Propranolol |
| Caffeine | Ketamine | D-Propoxyphene |
| Cannabidiol | Ketoprofen | D-Pseudoephedrine |
| Cannabinol | Labetalol | Quinidine |
| Chloralhydrate | Levorphanol | Quinine |
| Chloramphenicol | Loperamide | Ranitidine |
| Chlordiazepoxide | Maprotiline | Salicylic acid |
| Chlorothiazide | Meperidine | Secobarbital |
| (±) -Chlorpheniramine | Meprobamate | Serotonin |
| Chlorpromazine | Methadone | Sulfamethazine |
| Chlorquine | Methoxyphenamine | Sulindac |
| Cholesterol | (±) -3,4-Methylenedioxyamphetamine | Temazepam |
| Clomipramine | hydrochloride(±)-3,4-Methylene- dioxymethamphetaminehydrochloride | Tetracycline |
| Clonidine | Morphine-3-β-D glucuronide | Tetrahydrocortisone3-(β-D glucuronide) |
| Codeine | Morphine Sulfate | Tetrahydrozoline |
| Cortisone | Nalidixic acid | Thebaine |
| (-) Cotinine | Naloxone | Thiamine |
| Creatinine | Naltrexone | Thioridazine |
| Deoxycorticosterone | Naproxen | DL-Tyrosine |
| Dextromethorphan | Niacinamide | Tolbutamide |
| Diazepam | Nifedipine | Triamterene |
| Diclofenac | Norcodein | Trifluoperazine |
| Diflunisal | Norethindrone | Trimethoprim |
| Digoxin | D-Norpropoxyphene | Trimipramine |
| Diphenhydramine | Noscapine | Tryptamine |
| Doxylamine | DL-Octopamine | DL-Tryptophan |
| Ecgonine methylester | Oxalic acid | Tyramine |
| (-) - Ψ-Ephedrine | Oxazepam | Uric acid |
| Erythromycin | Oxolinic acid | Verapamil |
| β-Estradiol | Oxycodone | Zomepirac |
THC
| 4-Acetamidophenol | β-Estradiol | Papaverine |
|---|---|---|
| Acetophenetidin | Estrone-3-sulfate | Penicillin-G |
{11}------------------------------------------------
| N-Acetylprocainamide | Ethyl-p-aminobenzoate | Pentazocine |
|---|---|---|
| Acetylsalicylic acid | Fenoprofen | Pentobarbital |
| Aminopyrine | Furosemide | Perphenazine |
| Amitryptyline | Gentisic acid | Phencyclidine |
| Amobarbital | Hemoglobin | Phenelzine |
| Amoxicillin | Hydralazine | Phenobarbital |
| Ampicillin | Hydrochlorothiazide | Phentermine |
| Ascorbic acid | Hydrocodone | L-Phenylephrine |
| D,L-Amphetamine | Hydrocortisone | β-Phenylethlamine |
| L-Amphetamine | O-Hydroxyhippuric acid | β-Phenyllethylamine |
| Apomorphine | 3-Hydroxytyramine | Phenylpropanolamine |
| Aspartame | Ibuprofen | Prednisolone |
| Atropine | Imipramine | Prednisone |
| Benzilic acid | Iproniazid | Procaine |
| Benzoic acid | (-) Isoproterenol | Promazine |
| Benzoylecgonine | Isoxsuprine | Promethazine |
| Benzphetamine | Ketamine | D,L-Propanolol |
| Bilirubin | Labetalol | D-Propoxyphene |
| Brompheniramine | Levorphanol | D-Pseudoephedrine |
| Caffeine | Loperamide | Quinidine |
| Chloralhydrate | Maprotiline | Quinine |
| Chloramphenicol | Meprobamate | Ranitidine |
| Chlordiazepoxide | Methadone | Salicylic acid |
| Chlorothiazide | Methoxyphenamine | Secobarbital |
| (+) | Serotonin | |
| (±) Chlorpheniramine | 3,4-Methylenedioxyamphetamine | (5-Hydroxytyramine) |
| Chlorpromazine | (+)3,4-Methylenedioxymethamphetamine | Sulfamethazine |
| Chlorquine | Methylphenidate | Sulindac |
| Cholesterol | Methyprylon | Temazepam |
| Clomipramine | Morphine-3-β-Dglucuronide | Tetracycline |
| Clonidine | Nalorphine | Tetrahydrocortisone3(5-Dglucuronide) |
| Cocaine hydrochloride | Naloxone | Tetrahydrozoline |
| Codeine | Nalidixic acid | Thebaine |
| Cortisone | Naltrexone | Thiamine |
| (-) Cotinine | Naproxen | Thioridazine |
| Creatinine | Niacinamide | D, L-Thyroxine |
| Deoxycorticosterone | Nifedipine | Tolbutamine |
| Dextromethorphan | Norcodein | Triamterene |
| Diazepam | Norethindrone | Trifluoperazine |
| Diclofenac | D-Norpropoxyphene | Trimethoprim |
| Diflunisal | Noscapine | Trimipramine |
| Digoxin | D,L-Octopamine | Tryptamine |
| Diphenhydramine | Oxalic acid | D, L-Tryptophan |
| Doxylamine | Oxazepam | Tyramine |
| Ecgonine hydrochloride | Oxolinic acid | PrD, L-Tyrosine |
| Ecgonine methylester | Oxycodone | Uric acid |
| (-) Y Ephedrine | Oxymetazoline | Verapamil |
| Erythromycin | p-Hydroxymethamphetamine | Zomepirac |
{12}------------------------------------------------
f. Specificity
To test the specificity, drug metabolites and other components that are likely to interfere in urine samples were tested using three batches of each device for all formats. The obtained lowest detectable concentration was used to calculate the cross-reactivity. There were no differences observed for different formats.
| AMP(Amphetamine, Cut-off=1000 ng/mL) | Result | %Cross-Reactivity |
|---|---|---|
| d,1-Amphetamine | Positive at 500 ng/mL | 200% |
| 1-Amphetamine | Positive at 100000 ng/mL | 1% |
| (+/-) 3,4-methylene-dioxyamphetamine(MDA) | Positive at 1300 ng/mL | 77% |
| Phentermine | Positive at 100000 ng/mL | 1% |
| Apomorphine | Positive at 50000 ng/mL | 2% |
| β-Phenylethlamine | Positive at 25000 ng/mL | 4% |
| Tyramine | Positive at 10000 ng/mL | 10% |
| Tryptamine | Positive at 25000 ng/mL | 4% |
| d-Methamphetamine | >100000 | <1% |
| l-Methamphetamine | >100000 | <1% |
| ephedrine | >100000 | <1% |
{13}------------------------------------------------
| 3,4-Methylenedioxyethylamphetamine(MDEA) | >100000 | <1% |
|---|---|---|
| ---------------------------------------------- | --------- | ----- |
| COC(Benzoylecogonine,Cut-off=300 ng/mL) | Result | %Cross-Reactivity |
|---|---|---|
| Cocaine HCl | Positive at 500 ng/mL | 60% |
| Cocaethylene | >100000 | Not detected |
| Ecgonine | >100000 | Not detected |
| THC(Cannabinoids, Cut-off=50 ng/mL) | Result | %Cross-Reactivity |
|---|---|---|
| 11-hydroxy-Δ9-Tetrahydrocannabinol | Positive at 15000 ng/mL | 0.3% |
| Δ8- Tetrahydrocannabinol | Positive at 8000 ng/mL | 0.6% |
| Δ9- Tetrahydrocannabinol | Positive at 7000 ng/mL | 0.7% |
| Cannabinol | >200000 | Not detected |
| Cannabidiol | >200000 | Not detected |
g. Effect of Urine Specific Gravity and Urine pH
To investigate the effect of urine specific gravity and urine pH, urine samples with a range of 1.000 to 1.030 specific gravity or urine samples with a range of pH 4 to 9 were spiked with target drugs at 25% below and 25% above cut-off levels. These samples were tested using three batches of each device for all formats. Results were all positive for samples at and above +25% cut-off and all negative for samples at and below -25% Cut-Off. There were no differences observed for different formats.
2. Comparison Studies
The method comparison studies for the First Sign™ Drug Tests (Cup and Dip Card) for Amphetamine, Cocaine and Marijuana were performed in-house with three different laboratory assistants for each format of the device. Operators ran 80 (40 negative and 40 positive) unaltered clinical samples for each drug. The samples were blind labeled and compared to GC/MS results. The results are presented in the tables below:
{14}------------------------------------------------
| AMP | ||||||
|---|---|---|---|---|---|---|
| Dip Cardformat | Negative | LowNegativeby GC/MS(less than-50%) | Near CutoffNegative byGC/MS(Between-50% andcut-off) | NearCutoffPositive byGC/MS(Betweenthe cut-offand +50%) | HighPositive byGC/MS(greaterthan +50%) | |
| Viewer A | Positive | 0 | 0 | 1 | 10 | 26 |
| Negative | 10 | 10 | 19 | 4 | 0 | |
| Viewer B | Positive | 0 | 0 | 1 | 11 | 26 |
| Negative | 10 | 10 | 19 | 3 | 0 | |
| Viewer C | Positive | 0 | 0 | 1 | 12 | 26 |
| Negative | 10 | 10 | 19 | 2 | 0 |
Discordant Results of AMP Dip Card
| Viewer | Sample Number | GC/MS Result | Dipcard Format Viewer Results |
|---|---|---|---|
| Viewer A | 92410741 | 883 | Positive |
| Viewer B | 92410218 | 870 | Positive |
| Viewer C | 92410218 | 870 | Positive |
| Viewer A | 92410789 | 1125 | Negative |
| Viewer A | 92410801 | 1119 | Negative |
| Viewer A | 92410205 | 1086 | Negative |
| Viewer A | 92410909 | 1086 | Negative |
| Viewer B | 92410789 | 1125 | Negative |
| Viewer B | 92410801 | 1119 | Negative |
| Viewer B | 92410909 | 1086 | Negative |
| Viewer C | 92410801 | 1119 | Negative |
| Viewer C | 92410205 | 1086 | Negative |
| Cupformat | Negative | LowNegativeby GC/MS(less than-50%) | Near CutoffNegative byGC/MS(Between-50% andcut-off) | NearCutoffPositive byGC/MS(Betweenthe cut-offand +50%) | HighPositive byGC/MS(greaterthan +50%) | |
|---|---|---|---|---|---|---|
| Viewer A | Positive | 0 | 0 | 1 | 13 | 26 |
| Viewer A | Negative | 10 | 10 | 19 | 1 | 0 |
| Viewer B | Positive | 0 | 0 | 1 | 12 | 26 |
{15}------------------------------------------------
| Negative | 10 | 10 | 19 | 2 | 0 | |
|---|---|---|---|---|---|---|
| Viewer C | Positive | 0 | 0 | 0 | 13 | 26 |
| Negative | 10 | 10 | 20 | 1 | 0 |
Discordant Results of AMP Cup
| Viewer | Sample Number | GC/MS Result | Cup Format Viewer Results |
|---|---|---|---|
| Viewer A | 92410741 | 883 | Positive |
| Viewer B | 92410209 | 971 | Positive |
| Viewer A | 92410801 | 1119 | Negative |
| Viewer B | 92410205 | 1086 | Negative |
| Viewer B | 92410801 | 1119 | Negative |
| Viewer C | 92410789 | 1125 | Negative |
COC
| Dip Cardformat | Negative | Negative | LowNegativeby GC/MS(less than-50%) | Near CutoffNegative byGC/MS(Between-50% andcut-off) | NearCutoffPositive byGC/MS(Betweenthe cut-offand +50%) | HighPositive byGC/MS(greaterthan +50%) |
|---|---|---|---|---|---|---|
| Viewer A | Positive | 0 | 0 | 1 | 10 | 26 |
| Negative | 10 | 10 | 19 | 4 | 0 | |
| Viewer B | Positive | 0 | 0 | 1 | 10 | 26 |
| Negative | 10 | 10 | 19 | 4 | 0 | |
| Viewer C | Positive | 0 | 0 | 0 | 11 | 26 |
| Negative | 10 | 10 | 20 | 3 | 0 |
Discordant Results of COC DipCard
| Viewer | Sample Number | GC/MS Result | DipCard Format Viewer Results |
|---|---|---|---|
| Viewer A | 92410950 | 261 | Positive |
| Viewer B | 92410950 | 261 | Positive |
| Viewer A | 92410940 | 347 | Negative |
| Viewer A | 92410942 | 356 | Negative |
| Viewer A | 92410941 | 362 | Negative |
| Viewer A | 92410947 | 357 | Negative |
| Viewer B | 92410940 | 347 | Negative |
| Viewer B | 92410942 | 356 | Negative |
| Viewer B | 92410941 | 362 | Negative |
| Viewer B | 92410947 | 357 | Negative |
{16}------------------------------------------------
| Viewer | Sample Number | GC/MS Result | DipCard Format Viewer Results |
|---|---|---|---|
| Viewer C | 92410942 | 356 | Negative |
| Viewer C | 92410941 | 362 | Negative |
| Viewer C | 92410947 | 357 | Negative |
| Cupformat | Negative | LowNegativeby GC/MS(less than-50%) | Near CutoffNegative byGC/MS(Between-50% andcut-off) | NearCutoffPositive byGC/MS(Betweenthe cut-offand +50%) | HighPositive byGC/MS(greaterthan +50%) | |
|---|---|---|---|---|---|---|
| Viewer A | Positive | 0 | 0 | 1 | 12 | 26 |
| Negative | 10 | 10 | 19 | 2 | 0 | |
| Viewer B | Positive | 0 | 0 | 0 | 12 | 26 |
| Negative | 10 | 10 | 20 | 2 | 0 | |
| Viewer C | Positive | 0 | 0 | 1 | 13 | 26 |
| Negative | 10 | 10 | 19 | 1 | 0 |
Discordant Results of COC Cup
| Viewer | Sample Number | GC/MS Result | Cup Format Viewer Results |
|---|---|---|---|
| Viewer A | 92410824 | 285 | Positive |
| Viewer C | 92410950 | 261 | Positive |
| Viewer A | 92410961 | 335 | Negative |
| Viewer A | 92410941 | 362 | Negative |
| Viewer B | 92410941 | 362 | Negative |
| Viewer B | 92410942 | 356 | Negative |
| Viewer C | 92410941 | 362 | Negative |
THC
| DipCard | Low | Near Cutoff | Near Cutoff | High | ||
|---|---|---|---|---|---|---|
| format | Negative | Negative | Negative by | Positive by | Positive by | |
| by GC/MS | GC/MS | GC/MS | GC/MS | |||
| (less than | (Between | (Between | (greater | |||
| -50%) | -50% and | the cut-off | than | |||
| cut-off) | and +50%) | +50%) | ||||
| Viewer A | Positive | 0 | 0 | 2 | 14 | 26 |
| Negative | 10 | 10 | 18 | 0 | 0 | |
| Viewer B | Positive | 0 | 0 | 1 | 14 | 26 |
{17}------------------------------------------------
| Negative | 10 | 10 | 19 | 0 | 0 | |
|---|---|---|---|---|---|---|
| Viewer C | Positive | 0 | 0 | 1 | 14 | 26 |
| Negative | 10 | 10 | 19 | 0 | 0 |
| Viewer | Sample Number | GC/MS Result | DipCard FormatViewer Results |
|---|---|---|---|
| Viewer A | 92410924 | 43 | Positive |
| Viewer A | 92410995 | 47 | Positive |
| Viewer B | 92410995 | 47 | Positive |
| Viewer C | 92410995 | 47 | Positive |
Discordant Results of THC DipCard
| Cup format | Negative | Low Negative by GC/MS (less than -50%) | Near Cutoff Negative by GC/MS (Between -50% and cut-off) | Near Cutoff Positive by GC/MS (Between the cut-off and +50%) | High Positive by GC/MS (greater than +50%) | |
|---|---|---|---|---|---|---|
| Viewer A | Positive | 0 | 0 | 1 | 14 | 26 |
| Negative | 10 | 10 | 19 | 0 | 0 | |
| Viewer B | Positive | 0 | 0 | 0 | 14 | 26 |
| Negative | 10 | 10 | 20 | 0 | 0 | |
| Viewer C | Positive | 0 | 0 | 1 | 14 | 26 |
| Negative | 10 | 10 | 19 | 0 | 0 |
Discordant Results of THC Cup
| Viewer | Sample Number | GC/MS Result | Cup FormatViewer Results |
|---|---|---|---|
| Viewer A | 92410924 | 43 | Positive |
| Viewer C | 92410181 | 42 | Positive |
Lay-user study
A lay user study was performed at three intended user sites with 280 lay persons testing the amphetamine devices, 280 lay persons testing the cocaine devices and 280 lay persons testing the marijuana devices. A total of 140 females and 140 males tested the amphetamine samples, 138 females and 142 males tested cocaine samples, and 139 females and 141 males tested the marijuana samples. They had diverse educational and professional backgrounds and ranged in age from 21 to > 50 years. Urine samples were prepared at the following concentrations; negative, +/-75%, +/-25% of the cutoff by spiking drugs into drug free-pooled urine specimens. The concentrations of the samples were confirmed by GC/MS. Each sample was aliquoted into individual containers and blind-labeled.
{18}------------------------------------------------
Each participant was provided with the package insert, 1 blind labeled sample and a device. The results are summarized below.
| Comparison between GC/MS and Lay Person Results (AMP DipCard) | |||||
|---|---|---|---|---|---|
| % of Cutoff | Number of samples | AMP Concentration by GC/MS (ng/mL) | No. of Positive | No. of Negative | The percentage of correct results (%) |
| -100%Cutoff | 20 | 0 | 0 | 20 | 100% |
| -75% Cutoff | 20 | 246 | 0 | 20 | 100% |
| -50% Cutoff | 20 | 492 | 0 | 20 | 100% |
| -25% Cutoff | 20 | 738 | 1 | 19 | 95% |
| +25% Cutoff | 20 | 1267.5 | 18 | 2 | 90% |
| +50% Cutoff | 20 | 1521 | 20 | 0 | 100% |
| +75% Cutoff | 20 | 1774.5 | 20 | 0 | 100% |
| Comparison between GC/MS and Lay Person Results (AMP Cup) | |||||
| % of Cutoff | Number of samples | AMP Concentration by GC/MS (ng/mL) | No. of Positive | No. of Negative | The percentage of correct results (%) |
| -100% Cutoff | 20 | 0 | 0 | 20 | 100% |
| -75% Cutoff | 20 | 246 | 0 | 20 | 100% |
| -50% Cutoff | 20 | 492 | 0 | 20 | 100% |
| -25% Cutoff | 20 | 738 | 2 | 18 | 90% |
| +25% Cutoff | 20 | 1267.5 | 19 | 1 | 95% |
| +50% Cutoff | 20 | 1521 | 20 | 0 | 100% |
Comparison between GC/MS and Lay Person Results (AMP DipCard)
Comparison between GC/MS and Lay Person Results (COC DipCard)
| % of Cutoff | Numberofsamples | COC Concentration byGC/MS(ng/mL) | Lay person results | Thepercentage ofcorrect results(%) | |
|---|---|---|---|---|---|
| -100% Cutoff | 20 | 0 | No. ofPositive | No. ofNegative | 100% |
| -75% Cutoff | 20 | 71 | 0 | 20 | 100% |
| -50% Cutoff | 20 | 142.5 | 0 | 20 | 100% |
| -25% Cutoff | 20 | 213.75 | 3 | 17 | 85% |
| +25% Cutoff | 20 | 379 | 19 | 1 | 95% |
| +50% Cutoff | 20 | 454.5 | 20 | 0 | 100% |
| +75% Cutoff | 20 | 530 | 20 | 0 | 100% |
{19}------------------------------------------------
| Comparison between GC/MS and Lay Person Results (COC Cup) | |||||
|---|---|---|---|---|---|
| % of Cutoff | Numberofsamples | COC Concentration byGC/MS(ng/mL) | Lay person results | Thepercentage ofcorrect results(%) | |
| No. ofPositive | No. ofNegative | ||||
| -100%Cutoff | 20 | 0 | 0 | 20 | 100% |
| -75%Cutoff | 20 | 71 | 0 | 20 | 100% |
| -50% Cutoff | 20 | 142.5 | 0 | 20 | 100% |
| -25% Cutoff | 20 | 213.75 | 2 | 18 | 90% |
| +25% Cutoff | 20 | 379 | 20 | 0 | 100% |
| +50% Cutoff | 20 | 454.5 | 20 | 0 | 100% |
| +75% Cutoff | 20 | 530 | 20 | 0 | 100% |
Comparison between GC/MS and Lay Person Results (COC Cup)
Comparison between GC/MS and Lay Person Results (THC DipCard)
| % of Cutoff | Numberofsamples | THC Concentration byGC/MS(ng/mL) | Lay person results | Thepercentage ofcorrect results(%) | |
|---|---|---|---|---|---|
| -100% Cutoff | 20 | 0 | 0 | 20 | 100% |
| -75% Cutoff | 20 | 12 | 0 | 20 | 100% |
| -50% Cutoff | 20 | 24.5 | 0 | 20 | 100% |
| -25% Cutoff | 20 | 36.75 | 1 | 19 | 95% |
| +25% Cutoff | 20 | 64.25 | 20 | 0 | 100% |
| +50% Cutoff | 20 | 77 | 20 | 0 | 100% |
| +75% Cutoff | 20 | 90 | 20 | 0 | 100% |
Comparison between GC/MS and Lay Person Results (THC Cup)
| % of Cutoff | Numberofsamples | THC Concentration byGC/MS(ng/mL) | Lay person results | Thepercentage ofcorrect results(%) | |
|---|---|---|---|---|---|
| No. ofPositive | No. ofNegative | ||||
| -100% Cutoff | 20 | 0 | 0 | 20 | 100% |
| -75% Cutoff | 20 | 12 | 0 | 20 | 100% |
| -50% Cutoff | 20 | 24.5 | 0 | 20 | 100% |
| -25% Cutoff | 20 | 36.75 | 1 | 19 | 95% |
| +25% Cutoff | 20 | 64.25 | 19 | 1 | 95% |
| +50% Cutoff | 20 | 77 | 20 | 0 | 100% |
| +75% Cutoff | 20 | 90 | 20 | 0 | 100% |
{20}------------------------------------------------
Lay-users were also given surveys on the ease of understanding the package insert instructions. All lay users indicated that the device instructions can be easily followed. A Flesch-Kincaid reading analysis was performed on each package insert and the scores revealed a reading Grade Level of 7.
-
- Clinical Studies Not applicable.
-
- Conclusion
Based on the test principle and acceptable performance characteristics including precision, cut-off, interference, specificity and method comparison of the devices, it's concluded that the First Sign™ Drug of Abuse Dip Card Test and First Sign™ Drug of Abuse Cup Test are substantially equivalent to the predicate.
§ 862.3250 Cocaine and cocaine metabolite test system.
(a)
Identification. A cocaine and cocaine metabolite test system is a device intended to measure cocaine and a cocaine metabolite (benzoylecgonine) in serum, plasma, and urine. Measurements obtained by this device are used in the diagnosis and treatment of cocaine use or overdose.(b)
Classification. Class II (special controls). A cocaine and cocaine metabolite 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).