(88 days)
Not Found
No
The device description and performance studies indicate a standard immunochromatographic assay (lateral flow test) which relies on chemical reactions for qualitative detection, not AI/ML for analysis or interpretation. There is no mention of any computational analysis or learning algorithms.
No.
This device is an in vitro diagnostic device used for rapid qualitative detection of substances in human urine; it does not provide any therapeutic function.
Yes
The text explicitly states multiple times that the device is "For in vitro diagnostic use only."
No
The device description clearly states it is an immunochromatographic assay in the form of DipCards, Cups, or Cassettes, which are physical hardware components used for testing urine samples.
Based on the provided text, the device is an IVD (In Vitro Diagnostic).
Here's why:
- Explicit Statement: The text repeatedly states "For in vitro diagnostic use only." for each of the listed tests.
- Intended Use: The intended use is the qualitative detection of specific substances (Amphetamine, Benzoylecgonine, Cannabinoids) in human urine, which is a biological sample. This aligns with the definition of an in vitro diagnostic device, which is used to examine specimens taken from the human body to provide information for diagnostic purposes.
- Device Description: The device is described as a "single-use in vitro diagnostic device."
- Performance Studies: The performance studies involve testing human urine samples and comparing results to a reference method (GC/MS), which is typical for validating IVD performance.
Therefore, the SAFECARE Urine Test devices described are indeed In Vitro Diagnostic devices.
N/A
Intended Use / Indications for Use
SAFECARE Urine Test Amphetamine Cassette is a rapid test for the qualitative detection of Amphetamine in human urine at a cutoff concentration of 1000 ng/mL.
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.
SAFECARE Urine Test Amphetamine Cup is a rapid test for the qualitative detection of Amphetamine in human urine at a cutoff concentration of 1000 ng/mL.
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.
SAFECARE Urine Test Amphetamine DipCard is a rapid test for the qualitative detection of Amphetamine in human urine at a cutoff concentration of 1000 ng/mL.
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.
SAFECARE Urine Test Cocaine Cassette is a rapid test for the qualitative detection of Benzoylecgonine in human urine at a cutoff concentration of 300 ng/ml.
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.
SAFECARE Urine Test Cocaine Cup is a rapid test for the qualitative detection of Benzoylecgonine in human urine at a cutoff concentration of 300 ng/ml.
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.
SAFECARE Urine Test Cocaine DipCard is a rapid test for the qualitative detection of Benzoylecgonine in human urine at a cutoff concentration of 300 ng/ml.
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.
SAFECARE Urine Test Marijuana Cassette is a rapid test for the qualitative detection of Cannabinoids in human urine at a cutoff concentration of 50 ng/mL.
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.
SAFECARE Urine Test Marijuana Cup is a rapid test for the qualitative detection of Cannabinoids in human urine at a cutoff concentration of 50 ng/mL.
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.
SAFECARE Urine Test Marijuana DipCard is a rapid test for the qualitative detection of Cannabinoids in human urine at a cutoff concentration of 50 ng/mL.
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
SAFECARE Urine Test devices are immunochromatographic assays for cocaine, amphetamine and marijuana. Each assay test is a lateral flow, one step system for the qualitative detection of Benzoylecgonine, or D-amphetamine or 11-nor-A9-THC-9 COOH (target analyte) in human urine. The product is a single-use in vitro diagnostic device, which comes in the form of: DipCards, or Cups or Cassettes. It contains a Test Device (in one of the three formats), a package insert and a urine cup. 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 prescription uses.
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
Analytical Performance:
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 blinded labeled and randomized. For each concentration, tests were performed two runs per day for 25 days. The results were summarized in tables for Amphetamine (AMP) Dip Card Format, Amphetamine (AMP) Cup Format, Amphetamine (AMP) Cassette Format, Cocaine (COC) Dip Card Format, COC Cup Format, COC Cassette Format, Marijuana (THC) Dip Card Format, THC Cup Format, and THC Cassette Format. Each lot for each format and concentration had 50 results (e.g., 50-/0+, 24-/26+, 49+/1-).
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 +50% cut-off and all negative at and below -50% cut-off for Amphetamine, Cocaine and Marijuana.
Interference:
Potential interfering substances found in human urine of physiological conditions were added to drug-free urine and target drugs urine with concentration at 25% above cut-off levels. These urine samples were tested using three batches of each device for all formats. No differences were observed for different formats.
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. No differences were observed for different formats.
Effect of Urine Specific Gravity and Urine pH:
Urine samples with 1.000 to 1.035 specific gravity or urine samples with 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. No differences were observed for different formats.
Summary of Performance Studies (study type, sample size, AUC, MRMC, standalone performance, key results)
Comparison Studies:
The method comparison studies for the SAFECARE Urine Test (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. Discordant results tables are provided for each drug and format (Cassette, Dip Card, Cup).
Lay-user study:
A lay user study was performed at three intended user sites with 420 lay persons testing the amphetamine devices, 420 lay persons testing the cocaine devices and 420 lay persons testing the marijuana devices. A total of 208 females and 212 males tested the amphetamine samples, 205 females and 215 males tested cocaine samples, and 212 females and 208 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. Each participant was provided with the package insert, 1 blind labeled sample and a device. The results are summarized in tables comparing GC/MS and Lay Person Results for each drug and format (Cup, Dip Card, Cassette). The percentage of correct results for lay persons generally ranged from 85% to 100% depending on the concentration relative to the cut-off. 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.
Key Metrics (Sensitivity, Specificity, PPV, NPV, etc.)
Not Found (Raw data for positive/negative counts are provided, but not the calculated metrics).
Predicate Device(s)
K052115 First Check Multi Drug Cup 12
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 seal with the text "DEPARTMENT OF HEALTH & HUMAN SERVICES - USA" arranged around the perimeter. Inside the circle is a stylized symbol featuring three human profiles facing to the right, stacked on top of each other.
Food and Drug Administration 10903 New Hampshire Avenue Document Control Center - WO66-G609 Silver Spring, MD 20993-0002
March 18, 2016
SAFECARE BIOTECH C/O JOE SHIA LSI INTERNATIONAL 504 E DIAMOND AVE, SUITE I GAITHERSBURG, MD, 20877
Re: K153646
Trade/Device Name: SAFECARE Urine Test Amphetamine (Cassette, Cup, DipCard), SAFECARE Urine Test Cocaine (Cassette, Cup, DipCard), SAFECARE Urine Test Marijuana (Cassette, Cup, DipCard) Regulation Number: 21 CFR 862.3250 Regulation Name: Cocaine and Cocaine Metabolite Test System Regulatory Class: Class II Product Code: DIO, LAF, LDJ Dated: December 15th, 2015 Received: December 21st, 2015
Dear Mr. 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 Parts 801 and 809); medical device reporting (reporting of
1
medical 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 H. Lias -S
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
Indications for Use
510(k) Number (if known) K153646
Device Name
SAFECARE Urine Test Amphetamine (Cassette, Cup, DipCard) SAFECARE Urine Test Cocaine (Cassette, Cup, DipCard) SAFECARE Urine Test Marijuana (Cassette, Cup, DipCard)
Indications for Use (Describe)
SAFECARE Urine Test Amphetamine Cassette is a rapid test for the qualitative detection of Amphetamine in human urine at a cutoff concentration of 1000 ng/mL.
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.
SAFECARE Urine Test Amphetamine Cup is a rapid test for the qualitative detection of Amphetamine in human urine at a cutoff concentration of 1000 ng/mL.
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.
SAFECARE Urine Test Amphetamine DipCard is a rapid test for the qualitative detection of Amphetamine in human urine at a cutoff concentration of 1000 ng/mL.
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.
SAFECARE Urine Test Cocaine Cassette is a rapid test for the qualitative detection of Benzoylecgonine in human urine at a cutoff concentration of 300 ng/ml.
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.
SAFECARE Urine Test Cocaine Cup is a rapid test for the qualitative detection of Benzoylecgonine in human urine at a cutoff concentration of 300 ng/ml.
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.
SAFECARE Urine Test Cocaine DipCard is a rapid test for the qualitative detection of Benzoylecgonine in human urine at a cutoff concentration of 300 ng/ml.
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.
SAFECARE Urine Test Marijuana Cassette is a rapid test for the qualitative detection of Cannabinoids in human urine at
3
a cutoff concentration of 50 ng/mL.
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 positive. For in vitro diagnostic use only. The tests are intended for over-the-counter and for prescription use.
SAFECARE Urine Test Marijuana Cup is a rapid test for the qualitative detection of Cannabinoids in human urine at a cutoff concentration of 50 ng/mL.
The tests provide only preliminary test results. A more specific alternative chemical 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.
SAFECARE Urine Test Marijuana DipCard is a rapid test for the qualitative detection of Cannabinoids in human urine at a cutoff concentration of 50 ng/mL.
The tests provide only preliminary test results. A more specific alternative chemical 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.
| Type of Use ( Select one or both, as applicable ) | |
|---|---|
|X Prescription Use (Part 21 CFR 801 Subpart D)
|X | Over-The-Counter Use (21 CFR 801 Subpart C)
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510(k) SUMMARY
| 1. Date: | March 17, 2016 |
|---|---|
| 2. Submitter: | Safecare Biotech Co. Ltd. |
| 18 Haishu Road, Yuhang District | |
| Hangzhou, China | |
| 3. Contact person: | Alex Qiu |
| Safecare Biotech | |
| 18 Haishu Road, Yuhang District | |
| Hangzhou, China | |
| Telephone: 86 571-89712897 | |
| Fax: 86 571-80389223 | |
| Email: alexqiu@safecare.com.cn |
-
- Device Name: SAFECARE Urine Test Amphetamine (Cassette, Cup, DipCard) SAFECARE Urine Test Cocaine (Cassette, Cup, DipCard) SAFECARE Urine Test Marijuana (Cassette, Cup, DipCard)
| 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
SAFECARE Urine Test Amphetamine Cassette is a rapid test for the qualitative detection of Amphetamine in human urine at a cutoff concentration of 1000 ng/mL.
- 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. 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.
5
SAFECARE Urine Test Amphetamine Cup is a rapid test for the qualitative detection of Amphetamine in human urine at a cutoff concentration of 1000 ng/mL.
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.
SAFECARE Urine Test Amphetamine DipCard is a rapid test for the qualitative detection of Amphetamine in human urine at a cutoff concentration of 1000 ng/mL.
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.
SAFECARE Urine Test Cocaine Cassette is a rapid test for the qualitative detection of Benzoylecgonine in human urine at a cutoff concentration of 300 ng/ml.
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.
SAFECARE Urine Test Cocaine Cup is a rapid test for the qualitative detection of Benzoylecgonine in human urine at a cutoff concentration of 300 ng/ml.
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.
SAFECARE Urine Test Cocaine DipCard is a rapid test for the qualitative detection of Benzoylecgonine in human urine at a cutoff concentration of 300 ng/ml.
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.
6
SAFECARE Urine Test Marijuana Cassette is a rapid test for the qualitative detection of Cannabinoids in human urine at a cutoff concentration of 50 ng/mL.
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.
SAFECARE Urine Test Marijuana Cup is a rapid test for the qualitative detection of Cannabinoids in human urine at a cutoff concentration of 50 ng/mL.
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.
SAFECARE Urine Test Marijuana DipCard is a rapid test for the qualitative detection of Cannabinoids in human urine at a cutoff concentration of 50 ng/mL.
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.
-
- Device Description
SAFECARE Urine Test devices are immunochromatographic assays for cocaine, amphetamine and marijuana. Each assay test is a lateral flow, one step system for the qualitative detection of Benzoylecgonine, or D-amphetamine or 11-nor-A9-THC-9 COOH (target analyte) in human urine. The product is a single-use in vitro diagnostic device, which comes in the form of: DipCards, or Cups or Cassettes. It contains a Test Device (in one of the three formats), a package insert and a urine cup. Each test device is sealed with a desiccant in an aluminum pouch.
- Device Description
8. Substantial Equivalence Information
A summary comparison of features of the SAFECARE Urine Test and the predicate device is provided in Table 1, Table 2 & Table 3.
| Table 1: Features Comparison of SAFECARE Cocaine Test and the Predicate Device | |||||||
|---|---|---|---|---|---|---|---|
| -------------------------------------------------------------------------------- | -- | -- | -- | -- | -- | -- | -- |
| Item | Device | Predicate -
K052115 |
| ------ | -------- | ------------------------ |
|---|
7
| Item | Device | Predicate - K052115 |
|---|---|---|
| Indication(s) | ||
| for Use | For the qualitative determination of | |
| Benzoylecgonine 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, Cassette | Cup |
Table 2: Features Comparison of SAFECARE Amphetamine Test and the Predicate Device
| Item | Device | Predicate - K052115 |
|---|---|---|
| Indication(s) | ||
| for Use | For the qualitative determination of | |
| D-amphetamine in human urine. | Same | |
| Calibrator | D-amphetamine | 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 | 1000 ng/mL | Same |
| Intended | ||
| Population | For over-the-counter and prescription | |
| uses. | For over-the-counter | |
| use. | ||
| Configurations | Cup, Dip Card, Cassette | Cup |
Table 3: Features Comparison of SAFECARE Marijuana Test and the Predicate Device
| Item | Device | Predicate - K052115 |
|---|---|---|
| Indication(s) | For the qualitative determination of | Same |
8
| Item | Device | Predicate - K052115 |
|---|---|---|
| for Use | 11-nor-Δ9-THC-9 COOH in human urine. | |
| Calibrator | 11-nor-Δ9-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 | ||
| Population | For over-the-counter and prescription uses. | For over-the-counter use. |
| Configurations | Cup, Dip Card, Cassette | Cup |
9. Test Principle
SAFECARE Urine Tests are rapid tests for the qualitative detection of Benzoylecgonine, or D-amphetamine or 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 cutoff-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.
10. 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 blinded 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:
Amphetamine (AMP) Dip Card Format
9
| 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 1 | | 50-/0+ | 50-/0+ | 50-/0+ | 47-/3+ | 24-/26+ | 49+/1- | 50+/0- | 50+/0- | 50+/0- |
| Lot 2 | | 50-/0+ | 50-/0+ | 50-/0+ | 48-/2+ | 26-/24+ | 48+/2- | 50+/0- | 50+/0- | 50+/0- |
| Lot 3 | | 50-/0+ | 50-/0+ | 50-/0+ | 49-/1+ | 26-/24+ | 47+/3- | 50+/0- | 50+/0- | 50+/0- |
Amphetamine (AMP) Cup 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 1 | 50-/0+ | 50-/0+ | 50-/0+ | 48-/2+ | 24-/26+ | 48+/2- | 50+/0- | 50+/0- | 50+/0- | |
| Lot 2 | 50-/0+ | 50-/0+ | 50-/0+ | 47-/3+ | 24-/26+ | 48+/2- | 50+/0- | 50+/0- | 50+/0- | |
| Lot 3 | 50-/0+ | 50-/0+ | 50-/0+ | 47-/3+ | 27-/23+ | 48+/2- | 50+/0- | 50+/0- | 50+/0- |
Amphetamine (AMP) Cassette 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 1 | | 50-/0+ | 50-/0+ | 50-/0+ | 47-/3+ | 25-/25+ | 48+/2- | 50+/0- | 50+/0- | 50+/0- |
| Lot 2 | | 50-/0+ | 50-/0+ | 50-/0+ | 48-/2+ | 26-/24+ | 48+/2- | 50+/0- | 50+/0- | 50+/0- |
| Lot 3 | | 50-/0+ | 50-/0+ | 50-/0+ | 48/2+ | 25-/25+ | 47+/3- | 50+/0- | 50+/0- | 50+/0- |
Cocaine (COC) Dip Card Format
| Result
Drug | -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 1 | 50-/0+ | 50-/0+ | 50-/0+ | 48-/2+ | 24-/26+ | 47+/3- | 50+/0- | 50+/0- | 50+/0- |
| Lot 2 | 50-/0+ | 50-/0+ | 50-/0+ | 48-/2+ | 26-/24+ | 47+/3- | 50+/0- | 50+/0- | 50+/0- |
| Lot 3 | 50-/0+ | 50-/0+ | 50-/0+ | 47-/3+ | 26-/24+ | 48+/2- | 50+/0- | 50+/0- | 50+/0- |
COC Cup 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 |
| ------ | ---------------------------- | ----------------- | ----------------- | ----------------- | --------- | ----------------- | ----------------- | ----------------- | ------------------ |
|---|
10
| 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 1 | 50-/0+ | 50-/0+ | 50-/0+ | 48-/2+ | 24-/26+ | 48+/2- | 50+/0- | 50+/0- | 50+/0- |
| Lot 2 | 50-/0+ | 50-/0+ | 50-/0+ | 48-/2+ | 25-/25+ | 48+/2- | 50+/0- | 50+/0- | 50+/0- |
| Lot 3 | 50-/0+ | 50-/0+ | 50-/0+ | 48-/2+ | 26-/24+ | 47+/3- | 50+/0- | 50+/0- | 50+/0- |
COC Cassette 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 1 | 50-/0+ | 50-/0+ | 50-/0+ | 47-/3+ | 31-/29+ | 48+/2- | 50+/0- | 50+/0- | 50+/0- |
| | Lot 2 | 50-/0+ | 50-/0+ | 50-/0+ | 48-/2+ | 28-/22+ | 47+/3- | 50+/0- | 50+/0- | 50+/0- |
| | Lot 3 | 50-/0+ | 50-/0+ | 50-/0+ | 47-/3+ | 28-/22+ | 49+/1- | 50+/0- | 50+/0- | 50+/0- |
Marijuana (THC) 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 1 | | 50-/0+ | 50-/0+ | 50-/0+ | 49-/1+ | 24-/26+ | 47+/3- | 50+/0- | 50+/0- | 50+/0- |
| Lot 2 | | 50-/0+ | 50-/0+ | 50-/0+ | 48-/2+ | 26-/24+ | 48+/2- | 50+/0- | 50+/0- | 50+/0- |
| Lot 3 | | 50-/0+ | 50-/0+ | 50-/0+ | 48-/2+ | 26-/24+ | 48+/2- | 50+/0- | 50+/0- | 50+/0- |
THC 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 1 | | 50-/0+ | 50-/0+ | 50-/0+ | 48-/2+ | 24-/26+ | 48+/2- | 50+/0- | 50+/0- | 50+/0- |
| Lot 2 | | 50-/0+ | 50-/0+ | 50-/0+ | 48-/2+ | 26-/24+ | 49+/1- | 50+/0- | 50+/0- | 50+/0- |
| Lot 3 | | 50-/0+ | 50-/0+ | 50-/0+ | 48-/2+ | 27-/23+ | 47+/3- | 50+/0- | 50+/0- | 50+/0- |
THC Cassette 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 |
|---|---|---|---|---|---|---|---|---|---|---|
11
| | 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 1 | | 50-/0+ | 50-/0+ | 50-/0+ | 48-/2+ | 25-/25+ | 48+/2- | 50+/0- | 50+/0- | 50+/0- |
| Lot 2 | | 50-/0+ | 50-/0+ | 50-/0+ | 47-/3+ | 26-/24+ | 49+/1- | 50+/0- | 50+/0- | 50+/0- |
| Lot 3 | | 50-/0+ | 50-/0+ | 50-/0+ | 49-/1+ | 25-/25+ | 47+/3- | 50+/0- | 50+/0- | 50+/0- |
b. Linearity
Not applicable, these are visually read devices.
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 +50% cut-off and all negative at and below -50% 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 | 50 |
e. Interference
Potential interfering substances found in human urine of physiological conditions were added to drug-free urine and target drugs urine with concentration at 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.
12
| 4-Acetamidophenol | L-Ephedrine | Oxycodone |
|---|---|---|
| Acetophenetidin | (-) Y Ephedrine | Oxymetazoline |
| N-Acetylprocainamide | Erythromycin | Papaverine |
| Acetylsalicylic acid | ẞ-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 |
| 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 | 49-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 |
13
| Diflunisal | Norethindrone | Trimethoprim |
|---|---|---|
| Digoxin | D-Norpropoxyphene | 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 |
| 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 |
14
| Clomipramine | hydrochloride(±)-3,4-Methyle
ne- dioxymethamphetamine
hydrochloride | Tetracycline |
|----------------------|---------------------------------------------------------------------------|--------------------------------------------|
| Clonidine | Morphine-3-B-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 |
| 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 |
| (±) Chlorpheniramine | (+) | |
| 3,4-Methylenedioxyamphetamine | Serotonin | |
| (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 | D, L-Tyrosine |
| Ecgonine methylester | Oxycodone | Uric acid |
| (-) Y Ephedrine | Oxymetazoline | Verapamil |
| Erythromycin | p-Hydroxymethamphetamine | Zomepirac |
15
f. Specificity
16
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
(d-Amphetamine, Cut-off=1000 ng/mL) | Result | %
Cross-Reactivity |
|--------------------------------------------|-------------------------|-----------------------|
| d1-Amphetamine | Positive at 3000 ng/mL | 33% |
| l-Amphetamine | Positive at 20000 ng/mL | 5% |
| (+/-) 3,4-methylene-dioxyamphetamine (MDA) | Positive at 20000 ng/mL | 5% |
| Phentermine | Positive at 30000 ng/mL | 3% |
| Hydroxyamphetamine | Positive at 8000 ng/mL | 12.5% |
| d-Methamphetamine | >100000 | 100000 | 100000 | 100000 | 100000 | 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. Each participant was provided with the package insert, 1 blind labeled sample and a device. The results are summarized below.
| % of Cutoff | Number of samples | d-Amphetamine
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 | 250 | 0 | 20 | 100 |
| -50% Cutoff | 20 | 500 | 0 | 20 | 100 |
| -25% Cutoff | 20 | 750 | 2 | 18 | 90 |
| +25% Cutoff | 20 | 1250 | 17 | 3 | 85 |
| +50% Cutoff | 20 | 1500 | 20 | 0 | 100 |
| +75% Cutoff | 20 | 1750 | 20 | 0 | 100 |
Comparison between GC/MS and Lay Person Results AMP Cup
Comparison between GC/MS and Lay Person Results AMP Dip Card
| % of Cutoff | Number | d-Amphetamine | Lay person results | The |
|---|---|---|---|---|
| ------------- | -------- | --------------- | -------------------- | ----- |
25
| | of
samples | Concentration by GC/MS
(ng/mL) | No. of
Positive | No. of
Negative | percentage of
correct results
(%) |
|-------------|---------------|-----------------------------------|--------------------|--------------------|-----------------------------------------|
| -100%Cutoff | 20 | 0 | 0 | 20 | 100 |
| -75%Cutoff | 20 | 250 | 0 | 20 | 100 |
| -50% Cutoff | 20 | 500 | 0 | 20 | 100 |
| -25% Cutoff | 20 | 750 | 3 | 17 | 85 |
| +25% Cutoff | 20 | 1250 | 18 | 2 | 90 |
| +50% Cutoff | 20 | 1500 | 20 | 0 | 100 |
| +75% Cutoff | 20 | 1750 | 20 | 0 | 100 |
Comparison between GC/MS and Lay Person Results AMP Cassette
| % of Cutoff | Number of samples | d-Amphetamine Concentration by GC/MS (ng/mL) | Lay person results | The percentage of correct results (%) | |
|---|---|---|---|---|---|
| -100% Cutoff | 20 | 0 | 0 | 20 | 100 |
| -75% Cutoff | 20 | 250 | 0 | 20 | 100 |
| -50% Cutoff | 20 | 500 | 0 | 20 | 100 |
| -25% Cutoff | 20 | 750 | 2 | 18 | 90 |
| +25% Cutoff | 20 | 1250 | 18 | 2 | 90 |
| +50% Cutoff | 20 | 1500 | 20 | 0 | 100 |
| +75% Cutoff | 20 | 1750 | 20 | 0 | 100 |
Comparison between GC/MS and Lay Person Results COC Cup
| % of Cutoff | Number
of
samples | Benzoylecgonine
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 | 75 | 0 | 20 | 100 |
| -50% Cutoff | 20 | 150 | 0 | 20 | 100 |
| -25% Cutoff | 20 | 225 | 2 | 18 | 90 |
| +25% Cutoff | 20 | 375 | 18 | 2 | 90 |
| +50% Cutoff | 20 | 450 | 20 | 0 | 100 |
| +75% Cutoff | 20 | 525 | 20 | 0 | 100 |
Comparison between GC/MS and Lay Person Results COC Dip Card
26
| | Number
of
samples | Benzoylecgonine
Concentration by GC/MS
(ng/mL) | Lay person results | | The |
|-------------|-------------------------|------------------------------------------------------|--------------------|--------------------|-----------------------------------------|
| % of Cutoff | | | No. of
Positive | No. of
Negative | percentage of
correct results
(%) |
| -100%Cutoff | 20 | 0 | 0 | 20 | 100 |
| -75%Cutoff | 20 | 75 | 0 | 20 | 100 |
| -50% Cutoff | 20 | 150 | 0 | 20 | 100 |
| -25% Cutoff | 20 | 225 | 2 | 18 | 90 |
| +25% Cutoff | 20 | 375 | 17 | 3 | 85 |
| +50% Cutoff | 20 | 450 | 20 | 0 | 100 |
| +75% Cutoff | 20 | 525 | 20 | 0 | 100 |
Comparison between GC/MS and Lay Person Results COC Cassette
| % of Cutoff | Number of samples | Benzoylecgonine
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 | 75 | 0 | 20 | 100 |
| -50% Cutoff | 20 | 150 | 0 | 20 | 100 |
| -25% Cutoff | 20 | 225 | 3 | 17 | 85 |
| +25% Cutoff | 20 | 375 | 17 | 3 | 85 |
| +50% Cutoff | 20 | 450 | 20 | 0 | 100 |
| +75% Cutoff | 20 | 525 | 20 | 0 | 100 |
Comparison between GC/MS and Lay Person Results THC Cup
| % of Cutoff | Number of samples | 11-nor-D9-THC-9-COOH
Concentration by GC/MS
(ng/mL) | Lay person results | | The
percentage of
correct results
(%) |
|--------------|-------------------|-----------------------------------------------------------|--------------------|----|------------------------------------------------|
| -100% Cutoff | 20 | 0 | 0 | 20 | 100 |
| -75% Cutoff | 20 | 12.5 | 0 | 20 | 100 |
| -50% Cutoff | 20 | 25 | 0 | 20 | 100 |
| -25% Cutoff | 20 | 37.5 | 2 | 18 | 90 |
| +25% Cutoff | 20 | 62.5 | 18 | 2 | 90 |
| +50% Cutoff | 20 | 75 | 20 | 0 | 100 |
| +75% Cutoff | 20 | 87.5 | 20 | 0 | 100 |
Comparison between GC/MS and Lay Person Results THC Dip Card
27
| % of Cutoff | Number of samples | 11-nor-D9-THC-9-COOH
Concentration by GC/MS
(ng/mL) | Lay person results | | The
percentage of
correct results
(%) |
|--------------|-------------------|-----------------------------------------------------------|--------------------|----|------------------------------------------------|
| -100% Cutoff | 20 | 0 | 0 | 20 | 100 |
| -75% Cutoff | 20 | 12.5 | 0 | 20 | 100 |
| -50% Cutoff | 20 | 25 | 0 | 20 | 100 |
| -25% Cutoff | 20 | 37.5 | 3 | 17 | 85 |
| +25% Cutoff | 20 | 62.5 | 18 | 2 | 90 |
| +50% Cutoff | 20 | 75 | 20 | 0 | 100 |
| +75% Cutoff | 20 | 87.5 | 20 | 0 | 100 |
Comparison between GC/MS and Lay Person Results THC Cassette
| | Number
of
samples | 11-nor-D9-THC-9-COOH
Concentration by GC/MS
(ng/mL) | Lay person results | | The |
|--------------|-------------------------|-----------------------------------------------------------|--------------------|--------------------|-----------------------------------------|
| % of Cutoff | | | No. of
Positive | No. of
Negative | percentage of
correct results
(%) |
| -100% Cutoff | 20 | 0 | 0 | 20 | 100 |
| -75% Cutoff | 20 | 12.5 | 0 | 20 | 100 |
| -50% Cutoff | 20 | 25 | 0 | 20 | 100 |
| -25% Cutoff | 20 | 37.5 | 3 | 17 | 85 |
| +25% Cutoff | 20 | 62.5 | 17 | 3 | 85 |
| +50% Cutoff | 20 | 75 | 20 | 0 | 100 |
| +75% Cutoff | 20 | 87.5 | 20 | 0 | 100 |
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.
- Clinical Studies
-
11.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 SAFECARE Urine Test devices are substantially equivalent to the predicate.