(47 days)
Not Found
No
The device is described as an immunochromatographic assay (lateral flow system), which is a traditional biochemical test method. There is no mention of AI, ML, image processing, or any computational analysis of the results. The performance studies focus on the analytical characteristics of the biochemical reaction and user interpretation, not on algorithmic performance.
No.
This device is an in vitro diagnostic device used to detect the presence of certain drugs in urine, not to treat a condition.
Yes
Explanation: The "Intended Use / Indications for Use" section explicitly states, "For in vitro diagnostic use only." Additionally, the "Device Description" mentions, "The products are single-use in vitro diagnostic devices." These statements clearly indicate its purpose in diagnosis.
No
The device is an immunochromatographic assay, which is a physical test kit (hardware) for detecting substances in urine. It is not a software-only device.
Yes, this device is an IVD (In Vitro Diagnostic).
Here's why:
- Explicit Statement: The "Intended Use / Indications for Use" section clearly states: "For in vitro diagnostic use only."
- Device Description: The "Device Description" section also explicitly states: "The products are single-use in vitro diagnostic devices..."
- Nature of the Test: The device performs an immunochromatographic assay on human urine to detect the presence of specific substances (drugs of abuse). This is a classic example of an in vitro diagnostic test, as it analyzes a sample taken from the body outside of the body itself to aid in diagnosis or monitoring.
N/A
Intended Use / Indications for 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.
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 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.
Product codes
DIO, DKZ, LDJ
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.
Mentions image processing
Not Found
Mentions AI, DNN, or ML
Not Found
Input Imaging Modality
Not Found
Anatomical Site
Not Found
Indicated Patient Age Range
Not Found
Intended User / Care Setting
For over-the-counter and for prescription use.
Description of the training set, sample size, data source, and annotation protocol
Not Found
Description of the test set, sample size, data source, and annotation protocol
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.
Summary of Performance Studies (study type, sample size, AUC, MRMC, standalone performance, key results)
Performance Characteristics:
-
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.
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.
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 below -25% cut-off for Amphetamine, Cocaine and Marijuana.
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.
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.
g. 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. -
Comparison Studies:
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. -
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. Urine samples were prepared at the following concentrations; negative, +/-75%, +/-25% of the cutoff by spiking drugs into drug free-pooled urine specimens. Each participant was provided with the package insert, 1 blind labeled sample and a device. The results demonstrated high percentages of correct results across all tested concentrations for Amphetamine, Cocaine, and THC, generally ranging from 85% to 100%. -
Clinical Studies: Not applicable.
Key Metrics (Sensitivity, Specificity, PPV, NPV, etc.)
Key metrics for lay user study (percentage of correct results):
AMP DipCard:
- -100%Cutoff: 100%
- -75% Cutoff: 100%
- -50% Cutoff: 100%
- -25% Cutoff: 95% (1 positive result out of 20)
- +25% Cutoff: 90% (2 negative results out of 20)
- +50% Cutoff: 100%
- +75% Cutoff: 100%
AMP Cup:
- -100% Cutoff: 100%
- -75% Cutoff: 100%
- -50% Cutoff: 100%
- -25% Cutoff: 90% (2 positive results out of 20)
- +25% Cutoff: 95% (1 negative result out of 20)
- +50% Cutoff: 100%
- +75% Cutoff: 100% (data for +75% missing in table but implied as 20 positive, 0 negative in row)
COC DipCard:
- -100% Cutoff: 100%
- -75% Cutoff: 100%
- -50% Cutoff: 100%
- -25% Cutoff: 85% (3 positive results out of 20)
- +25% Cutoff: 95% (1 negative result out of 20)
- +50% Cutoff: 100%
- +75% Cutoff: 100%
COC Cup:
- -100%Cutoff: 100%
- -75%Cutoff: 100%
- -50% Cutoff: 100%
- -25% Cutoff: 90% (2 positive results out of 20)
- +25% Cutoff: 100%
- +50% Cutoff: 100%
- +75% Cutoff: 100%
THC DipCard:
- -100% Cutoff: 100%
- -75% Cutoff: 100%
- -50% Cutoff: 100%
- -25% Cutoff: 95% (1 positive result out of 20)
- +25% Cutoff: 100%
- +50% Cutoff: 100%
- +75% Cutoff: 100%
THC Cup:
- -100% Cutoff: 100%
- -75% Cutoff: 100%
- -50% Cutoff: 100%
- -25% Cutoff: 95% (1 positive result out of 20)
- +25% Cutoff: 95% (1 negative result out of 20)
- +50% Cutoff: 100%
- +75% Cutoff: 100%
Predicate Device(s)
Reference Device(s)
Not Found
Predetermined Change Control Plan (PCCP) - All Relevant Information
Not Found
§ 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).
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)
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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 Wan |
| W.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
| Product
| Code | 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 of
cocaine in human urine. | Same |
| Calibrator | Benzoylecgonine | Same |
| Methodology | Competitive binding, lateral flow
immunochromatographic assays based on
the principle of antigen antibody
immunochemistry. | Same |
| Specimen Type | Human Urine | Same |
| Cut-Off Values | 300 ng/mL | Same |
| Intended
Population | For over-the-counter and prescription
uses. | For
over-the-counter
use. |
| 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 of | |
| amphetamine in human urine. | Same | |
| Calibrator | D-amphetamine | Same |
| Methodology | Competitive binding, lateral flow | Same |
5
| Item | Device | Predicate - K052115 |
|---|---|---|
| immunochromatographic assays based | ||
| on the principle of antigen antibody | ||
| immunochemistry. | ||
| Specimen Type | Human Urine | Same |
| Cut-Off Values | 1000 ng/mL | Same |
| Intended | ||
| Population | For over-the-counter and prescription | |
| uses. | For over-the-counter | |
| use. | ||
| 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 of | |
| marijuana in human urine. | Same | |
| Calibrator | 11-nor- $\u0394$ 9-THC-9 COOH | Same |
| Methodology | Competitive binding, lateral flow | |
| immunochromatographic assays based | ||
| on the principle of antigen antibody | ||
| immunochemistry. | 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.
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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-Methylene | |
| dioxyamphetamine | Temazepam | |
| Clomipramine | hydrochloride(±)-3,4-Methyle | |
| ne- dioxymethamphetamine | ||
| hydrochloride | Tetracycline | |
| Clonidine | Morphine-3-β-D glucuronide | Tetrahydrocortisone |
| 3-(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 | 100000 | 100000 | 100000 | 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 Card | ||||||
| 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 | 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 |
| 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 | 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 Card
format | Negative | 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 | 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 |
| 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 | 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 Format
Viewer 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 Format
Viewer 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 | Number
of
samples | COC Concentration by
GC/MS
(ng/mL) | Lay person results | | The
percentage of
correct results
(%) |
|--------------|-------------------------|------------------------------------------|--------------------|--------------------|------------------------------------------------|
| -100% Cutoff | 20 | 0 | No. of
Positive | No. of
Negative | 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 | Number | ||||
| of | |||||
| samples | COC Concentration by | ||||
| GC/MS | |||||
| (ng/mL) | Lay person results | The | |||
| percentage of | |||||
| correct results | |||||
| (%) | |||||
| No. of | |||||
| Positive | No. of | ||||
| Negative | |||||
| -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 | Number
of
samples | THC Concentration by
GC/MS
(ng/mL) | Lay person results | | The
percentage of
correct 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 | Number
of
samples | THC Concentration by
GC/MS
(ng/mL) | Lay person results | | The
percentage of
correct results
(%) |
|--------------|-------------------------|------------------------------------------|--------------------|--------------------|------------------------------------------------|
| | | | No. of
Positive | No. of
Negative | |
| -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.