(27 days)
No
The device is described as a lateral flow immunochromatographic assay, which is a traditional biochemical testing method. There is no mention of AI, ML, image processing, or any computational analysis of the results. The interpretation is based on visual detection of lines.
No
The device is used for diagnostic drug testing by detecting specific substances in urine, not for providing therapy or treatment.
Yes
The device detects specific drug analytes in human urine, which provides information about the presence of these substances in the body. The "Device Description" explicitly states that the products are "single-use in vitro diagnostic devices."
No
The device is described as a physical immunochromatographic assay in the form of dip cards or cups, which are hardware components used for in vitro diagnostic testing.
Yes, this device is an IVD (In Vitro Diagnostic).
Here's why:
- Intended Use: The intended use explicitly states that the device is for the "qualitative and simultaneous detection of [various drugs] in human urine". This is a diagnostic purpose, analyzing a biological sample (urine) to detect the presence of specific substances.
- Device Description: The device description clearly states that the products are "single-use in vitro diagnostic devices".
- Anatomical Site: The device analyzes "human urine", which is a biological specimen.
- Performance Studies: The document describes performance studies involving the analysis of clinical samples and comparison to a reference method (LC/MS), which are typical for IVD validation.
The fact that it is intended for "over-the-counter use" indicates its classification within the IVD category, specifically for lay users.
N/A
Intended Use / Indications for Use
SAFECARE® Multi-Drug Urine Test Dip Card is competitive binding, lateral flow immunochromatographic assays for qualitative and simultaneous detection of Amphetamine, Oxazepam, Cocaine, Cannabinoids, Methamphetamine, Morphine, Secobarbital and Methadone in human urine at the cutoff concentrations of:
| Drug (Identifier) | Cut-off level |
|---|---|
| Amphetamine | 1000 ng/mL |
| Oxazepam | 300 ng/mL |
| Cocaine | 300 ng/mL |
| Cannabinoids | 50 ng/mL |
| Methamphetamine | 1000 ng/mL |
| Morphine | 2000 ng/mL |
| Secobarbital | 300 ng/mL |
| Methadone | 300 ng/mL |
Configuration of SAFECARE® Multi-Drug Urine Test Dip Card can consist of any combination of the above listed drug analytes.
The test may yield positive results for the prescription drugs Oxazepam and Secobarbital when taken at or above prescribed doses. It is not intended to distinguish between prescription use or abuse of these drugs. Clinical consideration and professional judgment should be exercised with any drug of abuse test result, particularly when the preliminary result is positive. The test provides only preliminary test results. A more specific alternative chemical method must be used in order to obtain a confirmed analytical result. GC/MS or LC/MS is the preferred confirmatory method. The tests are intended for over-the-counter use.
SAFECARE® Multi-Drug Urine Test Cup is competitive binding, lateral flow immunochromatographic assays for qualitative and simultaneous detection of Amphetamine, Oxazepam, Cannabinoids, Methamphetamine, Morphine, Secobarbital and Methadone in human urine at the cutoff concentrations of:
| Drug (Identifier) | Cut-off level |
|---|---|
| Amphetamine | 1000 ng/mL |
| Oxazepam | 300 ng/mL |
| Cocaine | 300 ng/mL |
| Cannabinoids | 50 ng/mL |
| Methamphetamine | 1000 ng/mL |
| Morphine | 2000 ng/mL |
| Secobarbital | 300 ng/mL |
| Methadone | 300 ng/mL |
Configuration of SAFECARE® Multi-Drug Urine Test Cup combination of the above listed drug analytes.
The test may yield positive results for the prescription drugs Oxazepam and Secobarbital when taken at or above prescribed doses. It is not intended to distinguish between prescription use or abuse of these drugs. Clinical consideration and professional judgment should be exercised with any drug of abuse test result, particularly when the preliminary result is positive. The test provides 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. The tests are intended for over-the-counter use.
Product codes (comma separated list FDA assigned to the subject device)
NFT, NFW, NFY, NGG, NGL, NFV, PTH, PTG
Device Description
The SAFECARE Dip Card Tests and SAFECARE Cup Tests are immunochromatographic assays that use a lateral flow system for the qualitative detection of Amphetamine, Oxazepam, Cocaine, Marijuana, Methamphetamine, Morphine, Secobarbital and Methadone (target analytes) in human urine. The products are single-use in vitro diagnostic devices, which come in the formats of Dip Cards 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
Over-The-Counter 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
Not Found
Summary of Performance Studies (study type, sample size, AUC, MRMC, standalone performance, key results)
Analytical Performance
- Precision: Studies were carried out for samples with concentrations of -100% cut off, -75% cut off, -50% cut off, -25% cut off, cut off, +25% cut off, +50% 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 LC/MS. All sample aliquots were blindly labeled by the person who prepared the samples and didn't take part in the sample testing. For each concentration, tests were performed two runs per day for 25 days per device in a randomized order. Results are summarized in tables for Secobarbital, Oxazepam, Methamphetamine, Methadone, and Morphine.
- Linearity: Not applicable.
- Stability: The devices are stable at 4-30 ℃ for 24 months based on accelerated stability study at 50 °C and real time stability studies at 4°C and 30 °C.
- Interference: Potential interfering substances found in human urine of physiological or pathological conditions were added to drug-free urine and target drugs urine with concentrations at 25% below and 25% above Cut-Off levels. These urine samples were tested using three batches of each device. Compounds that showed no interference at a concentration of 100ug/mL are summarized in tables. No differences observed between Cup and Dip Card formats.
- Specificity: Drug metabolites and other structure related compounds that are likely to cross-react in urine samples were tested using three batches of each device. The lowest concentration that caused a positive result for each compound are listed for Secobarbital, Oxazepam, Methamphetamine, Methadone, and Morphine. No differences observed between Cup and Dip Card formats.
- Effect of Urine Specific Gravity and Urine pH: Urine samples with 1.000 to 1.035 specific gravity or pH 4 to 9 were spiked with target drugs at 25% below and 25% above Cut-Off levels. These samples were tested using three lots of each device. 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 observed between Cup and Dip Card formats.
Comparison Studies
- Method Comparison: Performed in-house with three laboratory assistants for each device. Operators ran 80 (40 negative and 40 positive) unaltered clinical samples for each drug. Samples were blind labeled and compared to LC/MS results. Results presented in tables for Secobarbital, Oxazepam, Methamphetamine, Methadone, and Morphine.
Lay-user study
- A lay user study was performed at three intended user sites with 240 lay persons for each device format. Urine samples were prepared at negative, +/-75%, +/-50%, +/-25% of the cutoff by spiking drugs into drug free-pooled urine specimens. The concentrations of the samples were confirmed by LC/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. Results are shown in tables for Amphetamine (AMP), Cocaine (COC), Cannabinoids (THC), Secobarbital (BAR), Oxazepam (BZO), Methamphetamine (MET), Methadone (MTD), and Morphine (OPI).
- 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 on each package insert revealed a reading Grade Level of 7.
Clinical Studies
- Not applicable.
Key Metrics (Sensitivity, Specificity, PPV, NPV, etc.)
Key metrics are presented in tables within the "Performance Characteristics" section, showing the number of positive/negative results at various percentages of the cutoff for precision studies and percentage of correct results for lay user studies.
For "Secobarbital Dip Card" precision:
- -100% Cut-off: 50-/0+ for all 3 lots
- -75% Cut-off: 50-/0+ for all 3 lots
- -50% Cut-off: 50-/0+ for all 3 lots
- -25% Cut-off: 50-/0+ for all 3 lots
- Cut-off: Lot 1: 50-/0+, Lot 2: 26-/24+, Lot 3: 26-/24+
- Cut-off +25%: Lot 1: 25-/25+, Lot 2: 50+/0-, Lot 3: 50+/0-
- Cut-off +50%: 50+/0- for all 3 lots
- Cut-off +75%: 50+/0- for all 3 lots
- Cut-off +100%: 50+/0- for all 3 lots
For "Lay person Results" in the lay user study, "Percentage of correct results (%)" is provided:
- AMP, COC, THC, BAR, BZO, MET, MTD, OPI for both Dip Card and Cup formats:
- -100% Cutoff: 100%
- -75% Cutoff: 100%
- -50% Cutoff: 100%
- -25% Cutoff: 85% to 95%
- +25% Cutoff: 90% to 95%
- +50% Cutoff: 100%
- +75% Cutoff: 100%
Predicate Device(s): If the device was cleared using the 510(k) pathway, identify the Predicate Device(s) K/DEN number used to claim substantial equivalence and list them here in a comma separated list exactly as they appear in the text. List the primary predicate first in the list.
Reference Device(s): Identify the Reference Device(s) K/DEN number and list them here in a comma separated list exactly as they appear in the text.
Predetermined Change Control Plan (PCCP) - All Relevant Information for the subject device only (e.g. presence / absence, what scope was granted / cleared under the PCCP, any restrictions, etc).
Not Found
§ 862.3100 Amphetamine test system.
(a)
Identification. An amphetamine test system is a device intended to measure amphetamine, a central nervous system stimulating drug, in plasma and urine. Measurements obtained by this device are used in the diagnosis and treatment of amphetamine use or overdose and in monitoring levels of amphetamine to ensure appropriate therapy.(b)
Classification. Class II (special controls). An amphetamine 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/0 description: The image shows the logo of the U.S. Food and Drug Administration (FDA). The logo consists of two parts: on the left, there is a symbol representing the Department of Health & Human Services-USA, and on the right, there is the text "FDA U.S. FOOD & DRUG ADMINISTRATION" in blue. The text is arranged in three lines, with "FDA" being the largest and boldest, followed by "U.S. FOOD & DRUG" and then "ADMINISTRATION" in a smaller font size.
August 20, 2018
Safecare Biotech (Hangzhou) Co.,Ltd. % Joe Shia, Manager LSI International 504 E Diamond Ave., Suite I Gaithersburg, MD 20877
Re: K181968
Trade/Device Name: SAFECARE Multi-Drug Urine Test Cup SAFECARE Multi-Drug Urine Test DipCard Regulation Number: 21 CFR 862.3100 Regulation Name: Amphetamine test system Regulatory Class: Class II Product Code: NFT, NFW, NFY, NGG, NGL, NFV, PTH, PTG Dated: July 18, 2018 Received: July 24, 2018
Dear 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
1
801 and Part 809); medical device reporting of 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.
Also, please note the regulation entitled, "Misbranding by reference to premarket notification" (21 CFR 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 comprehensive regulatory information about mediation-emitting products, including information about labeling regulations, please see Device Advice (https://www.fda.gov/MedicalDevices/DeviceRegulationandGuidance/) and CDRH Learn (http://www.fda.gov/Training/CDRHLearn). Additionally, you may contact the Division of Industry and Consumer Education (DICE) to ask a question about a specific regulatory topic. See the DICE website (http://www.fda.gov/DICE) for more information or contact DICE by email (DICE@fda.hhs.gov) or phone (1-800-638-2041 or 301-796-7100).
Sincerely,
Kellie B. Kelm -S
for 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) K181698
Device Name
SAFECARE® Multi-Drug Urine Test Dip Card SAFECARE® Multi-Drug Urine Test Cup
Indications for Use (Describe)
SAFECARE® Multi-Drug Urine Test Dip Card is competitive binding, lateral flow immunochromatographic assays for qualitative and simultaneous detection of Amphetamine, Oxazepam, Cocaine, Cannabinoids, Methamphetamine, Morphine, Secobarbital and Methadone in human urine at the cutoff concentrations of:
| Drug (Identifier) | Cut-off level |
|---|---|
| Amphetamine | 1000 ng/mL |
| Oxazepam | 300 ng/mL |
| Cocaine | 300 ng/mL |
| Cannabinoids | 50 ng/mL |
| Methamphetamine | 1000 ng/mL |
| Morphine | 2000 ng/mL |
| Secobarbital | 300 ng/mL |
| Methadone | 300 ng/mL |
Configuration of SAFECARE® Multi-Drug Urine Test Dip Card can consist of any combination of the above listed drug analytes.
The test may yield positive results for the prescription drugs Oxazepam and Secobarbital when taken at or above prescribed doses. It is not intended to distinguish between prescription use or abuse of these drugs. Clinical consideration and professional judgment should be exercised with any drug of abuse test result, particularly when the preliminary result is positive. The test provides only preliminary test results. A more specific alternative chemical method must be used in order to obtain a confirmed analytical result. GC/MS or LC/MS is the preferred confirmatory method. The tests are intended for over-the-counter use.
SAFECARE® Multi-Drug Urine Test Cup is competitive binding, lateral flow immunochromatographic assays for qualitative and simultaneous detection of Amphetamine, Oxazepam, Cannabinoids, Methamphetamine, Morphine, Secobarbital and Methadone in human urine at the cutoff concentrations of:
| Drug (Identifier) | Cut-off level |
|---|---|
| Amphetamine | 1000 ng/mL |
| Oxazepam | 300 ng/mL |
| Cocaine | 300 ng/mL |
| Cannabinoids | 50 ng/mL |
| Methamphetamine | 1000 ng/mL |
| Morphine | 2000 ng/mL |
| Secobarbital | 300 ng/mL |
| Methadone | 300 ng/mL |
Configuration of SAFECARE® Multi-Drug Urine Test Cup combination of the above listed drug analytes.
The test may yield positive results for the prescription drugs Oxazepam and Secobarbital when taken at or above prescribed doses. It is not intended to distinguish between prescription use or abuse of these drugs. Clinical consideration
3
and professional judgment should be exercised with any drug of abuse test result, particularly when the preliminary result is positive. The test provides 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. The tests are intended for over-the-counter use.
Type of Use (Select one or both, as applicable)
Prescription Use (Part 21 CFR 801 Subpart D)
Over-The-Counter Use (21 CFR 801 Subpart C)
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4
510(k) SUMMARY K181968
- August 17, 2018 1. Date: 2. Submitter: Safecare Biotech (Hangzhou) Co. Ltd. 18 Haishu Road, Yuhang District Hangzhou, China
- Alex Qiu 3. Contact person: 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 Multi-Drug Urine Test Dip Card SAFECARE Multi-Drug Urine Test Cup
| Classification: | Class 2 | ||
|---|---|---|---|
| Product Code | Classification | Regulation Section | Panel |
| NFT | |||
| Amphetamine | II | 21 CFR § 862.3100, Amphetamine Test System | Toxicology (91) |
| NFW | |||
| Cannabinoids | II | 21 CFR § 862.3870, Cannabinoids Test System | Toxicology (91) |
| NFY | |||
| Cocaine | II | 21 CFR § 862.3250, Cocaine Test System | Toxicology (91) |
| NGG | |||
| Methamphetamine | II | 21 CFR § 862.3610, Methamphetamine Test System | Toxicology (91) |
| NGL | |||
| Morphine | II | 21 CFR § 862.3650, Opiate Test System | Toxicology (91) |
| NFV | |||
| Oxazepam | II | 21 CFR § 862.3170, Benzodiazepine Test System | Toxicology (91) |
| PTH | |||
| Secobarbital | II | 21 CFR § 862.3150, Barbiturate Test System | Toxicology (91) |
| PTG | |||
| Methadone | II | 21 CFR § 862.3620, Methadone Test System | Toxicology (91) |
-
- Predicate Devices: K142396
The Chemtrue® Multi-Panel Drug Screen Dip Card Tests
- Predicate Devices: K142396
-
- Intended Use
SAFECARE® Multi-Drug Urine Test Dip Card is competitive binding, lateral flow immunochromatographic assays for qualitative and simultaneous detection of Amphetamine, Oxazepam, Cocaine, Cannabinoids, Methamphetamine, Morphine, Secobarbital and Methadone in human urine at the cutoff concentrations of:
- Intended Use
| Drug (Identifier) | Cut-off level |
|---|---|
| Amphetamine | 1000 ng/mL |
| Oxazepam | 300 ng/mL |
| Cocaine | 300 ng/mL |
| Cannabinoids | 50 ng/mL |
5
| Methamphetamine | 1000 ng/mL |
|---|---|
| Morphine | 2000 ng/mL |
| Secobarbital | 300 ng/mL |
| Methadone | 300 ng/mL |
Configuration of SAFECARE® Multi-Drug Urine Test Dip Card can consist of any combination of the above listed drug analytes.
The test may yield positive results for the prescription drugs Oxazepam and Secobarbital when taken at or above prescribed doses. It is not intended to distinguish between prescription use or abuse of these drugs. Clinical consideration and professional judgment should be exercised with any drug of abuse test result, particularly when the preliminary result is positive. The test provides only preliminary test results. A more specific alternative chemical must be used in order to obtain a confirmed analytical result. GC/MS or LC/MS is the preferred confirmatory method. The tests are intended for over-the-counter use.
SAFECARE® Multi-Drug Urine Test Cup is competitive binding, lateral flow immunochromatographic assays for qualitative and simultaneous detection of Amphetamine, Oxazepam, Cocaine, Cannabinoids, Methamphetamine, Morphine, Secobarbital and Methadone in human urine at the cutoff concentrations of:
| Drug (Identifier) | Cut-off level |
|---|---|
| Amphetamine | 1000 ng/mL |
| Oxazepam | 300 ng/mL |
| Cocaine | 300 ng/mL |
| Cannabinoids | 50 ng/mL |
| Methamphetamine | 1000 ng/mL |
| Morphine | 2000 ng/mL |
| Secobarbital | 300 ng/mL |
| Methadone | 300 ng/mL |
Configuration of SAFECARE® Multi-Drug Urine Test Cup can consist of any combination of the above listed drug analytes.
The test may yield positive results for the prescription drugs Oxazepam and Secobarbital when taken at or above prescribed doses. It is not intended to distinguish between prescription use or abuse of these drugs. Clinical consideration and professional judgment should be exercised with any drug of abuse test result, particularly when the preliminary result is positive. The test provides only preliminary test results. A more specific alternative chemical must be used in order to obtain a confirmed analytical result. GC/MS or LC/MS is the preferred confirmatory method. The tests are intended for over-the-counter use.
7. Device Description
The SAFECARE Dip Card Tests and SAFECARE Cup Tests are immunochromatographic assays that use a lateral flow system for the qualitative detection of Amphetamine, Oxazepam, Cocaine, Marijuana, Methamphetamine, Morphine, Secobarbital and Methadone (target analytes) in human urine. The products are single-use in vitro diagnostic devices, which come in the formats of Dip Cards 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.
6
-
- Substantial Equivalence Information
A summary comparison of features of the SAFECARE Dip Card Tests and SAFECARE Cup Tests and the predicate devices is provided in following tables.
- Substantial Equivalence Information
| Table 1: Features Comparison of SAFECARE Dip Card Tests and the Predicate | |||||
|---|---|---|---|---|---|
| Devices |
| Item | Device | Predicate - K142396 |
|---|---|---|
| Indication(s) | ||
| for Use | For the qualitative determination of drugs of | |
| abuse in human urine. | Same (but the number of | |
| drugs detected is | ||
| different) | ||
| Calibrator and Cut-Off | ||
| Values | Amphetamine (AMP): 1,000 ng/ml | |
| Oxazepam (BZO):300 ng/ml | ||
| Cocaine(COC): 300 ng/ml | ||
| 11-Nor-△9-Tetrahydrocannabinol-9-COOH | ||
| (THC):50 ng/ml | ||
| Methamphetamine (MET): 1,000 ng/ml | ||
| Morphine (OPI): 2000ng/mL | ||
| Secobarbital (BAR): 300 ng/ml | ||
| Methadone (MTD): 300 ng/ml | Same | |
| Methodology | Competitive binding, lateral flow | |
| immunochromatographic assays based on | ||
| the principle of antigen antibody | ||
| immunochemistry. | Same | |
| Type of Test | Qualitative | Same |
| Specimen Type | Human Urine | Same |
| Intended Use | For over-the-counter | Same |
| Configurations | Dip Card | Dip Card |
Table 2: Features Comparison of SAFECARE Cup Tests and the Predicate Devices
| Item | Device | Predicate - K142396 |
|---|---|---|
| Indication(s) | ||
| for Use | For the qualitative determination of | |
| drugs of abuse in human urine. | Same (but the number of | |
| drugs detected is different) | ||
| Calibrator and Cut-Off | ||
| Values | Amphetamine (AMP): 1,000 ng/ml | |
| Oxazepam (BZO):300 ng/ml | ||
| Cocaine(COC): 300 ng/ml | ||
| 11-Nor-△9-Tetrahydrocannabinol-9-COOH | ||
| (THC):50 ng/ml | ||
| Methamphetamine (MET): 1,000 ng/ml | ||
| Morphine (OPI): 2000ng/mL | ||
| Secobarbital (BAR): 300 ng/ml | ||
| Methadone (MTD): 300 ng/ml | Same |
7
| Methodology | Competitive binding, lateral flow
immunochromatographic assays based on
the principle of antigen antibody
immunochemistry. | Same |
|----------------|-------------------------------------------------------------------------------------------------------------------------------------|----------|
| Type of Test | Qualitative | Same |
| Specimen Type | Human Urine | Same |
| Intended Use | For over-the-counter | Same |
| Configurations | Cup | Dip Card |
9. Test Principle
The SAFECARE Dip Card Tests, and SAFECARE Cup Tests are rapid tests for the qualitative detection of Amphetamine, Oxazepam, Cocaine, Methamphetamine, Morphine, Secobarbital and Methadone in urine samples. The tests are lateral flow chromatographic immunoassays. During testing, a urine specimen migrates upward by capillary action. If target drugs present in the urine specimen are below the cut-off concentration, it will not saturate the binding sites of its specific monoclonal mouse antibody coated on the particles. The antibodycoated 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 to indicate that the tests have been performed properly.
10. Performance Characteristics
-
- Analytical Performance
- a. Precision
Precision studies were carried out for samples with concentrations of -100% cut off. -75% cut off, -50% cut off, -25% cut off, cut off, +25% cut off, +50% 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 LC/MS. All sample aliquots were blindly labeled by the person who prepared the samples and didn't take part in the sample testing. For each concentration, tests were performed two runs per day for 25 days per device in a randomized order. The results obtained are summarized in the following tables for Secobarbital, Oxazepam, Methamphetamine, Methadone and Morphine. The rest data were reported in K153646 for Amphetamine, Marijuana and Cocaine.
| Lot
Number | Results | -100%
Cut-off | -75%
Cut-off | -50%
Cut-off | -25%
Cut-off | Cut-off | Cut-off
+25% | Cut-off
+50% | Cut-off
+75% | Cut-off
+100% |
|---------------|---------|------------------|-----------------|-----------------|-----------------|---------|-----------------|-----------------|-----------------|------------------|
| | | Lot 1 | | 50-/0+ | 50-/0+ | 50-/0+ | 50-/0+ | 25-/25+ | 50+/0- | 50+/0- |
| Lot 2 | | 50-/0+ | 50-/0+ | 50-/0+ | 50-/0+ | 26-/24+ | 50+/0- | 50+/0- | 50+/0- | 50+/0- |
Secobarbital Din Card
8
| Results
Lot
Number | -100%
Cut-off | -75%
Cut-off | -50%
Cut-off | -25%
Cut-off | Cut-off | Cut-off
+25% | Cut-off
+50% | Cut-off
+75% | Cut-off
+100% |
|--------------------------|------------------|-----------------|-----------------|-----------------|---------|-----------------|-----------------|-----------------|------------------|
| Lot 3 | 50-/0+ | 50-/0+ | 50-/0+ | 50-/0+ | 26-/24+ | 50+/0- | 50+/0- | 50+/0- | 50+/0- |
| Results
Lot
Number | -100%
Cut-off | -75%
Cut-off | -50%
Cut-off | -25%
Cut-off | Cut-off | Cut-off
+25% | Cut-off
+50% | Cut-off
+75% | Cut-off
+100% |
| Lot 1 | 50-/0+ | 50-/0+ | 50-/0+ | 50-/0+ | 24-/26+ | 50+/0- | 50+/0- | 50+/0- | 50+/0- |
| Lot 2 | 50-/0+ | 50-/0+ | 50-/0+ | 50-/0+ | 25-/25+ | 50+/0- | 50+/0- | 50+/0- | 50+/0- |
| Lot 3 | 50-/0+ | 50-/0+ | 50-/0+ | 50-/0+ | 26-/24+ | 50+/0- | 50+/0- | 50+/0- | 50+/0- |
Oxazepam
Dip Card
| Dip Card | |||||||||
|---|---|---|---|---|---|---|---|---|---|
| Results | |||||||||
| Lot | |||||||||
| Number | -100% | ||||||||
| Cut-off | -75% | ||||||||
| Cut-off | -50% | ||||||||
| Cut-off | -25% | ||||||||
| Cut-off | Cut-off | Cut-off | |||||||
| +25% | Cut-off | ||||||||
| +50% | Cut-off | ||||||||
| +75% | Cut-off | ||||||||
| +100% | |||||||||
| Lot 1 | 50-/0+ | 50-/0+ | 50-/0+ | 50-/0+ | 25-/25+ | 50+/0- | 50+/0- | 50+/0- | 50+/0- |
| Lot 2 | 50-/0+ | 50-/0+ | 50-/0+ | 50-/0+ | 24-/26+ | 50+/0- | 50+/0- | 50+/0- | 50+/0- |
| Lot 3 | 50-/0+ | 50-/0+ | 50-/0+ | 50-/0+ | 24-/26+ | 50+/0- | 50+/0- | 50+/0- | 50+/0- |
| Cup |
| Cup | |||||||||
|---|---|---|---|---|---|---|---|---|---|
| Results | |||||||||
| Lot | |||||||||
| Number | -100% | ||||||||
| Cut-off | -75% | ||||||||
| Cut-off | -50% | ||||||||
| Cut-off | -25% | ||||||||
| Cut-off | Cut-off | Cut-off | |||||||
| +25% | Cut-off | ||||||||
| +50% | Cut-off | ||||||||
| +75% | Cut-off | ||||||||
| +100% | |||||||||
| Lot 1 | 50-/0+ | 50-/0+ | 50-/0+ | 50-/0+ | 23-/27+ | 50+/0- | 50+/0- | 50+/0- | 50+/0- |
| Lot 2 | 50-/0+ | 50-/0+ | 50-/0+ | 50-/0+ | 24-/26+ | 50+/0- | 50+/0- | 50+/0- | 50+/0- |
| Lot 3 | 50-/0+ | 50-/0+ | 50-/0+ | 50-/0+ | 25-/25+ | 50+/0- | 50+/0- | 50+/0- | 50+/0- |
Methamphetamine
Dip Card
| Dip Card | |||||||||
|---|---|---|---|---|---|---|---|---|---|
| Results | |||||||||
| Lot | |||||||||
| Number | -100% | ||||||||
| Cut-off | -75% | ||||||||
| Cut-off | -50% | ||||||||
| Cut-off | -25% | ||||||||
| Cut-off | Cut-off | Cut-off | |||||||
| +25% | Cut-off | ||||||||
| +50% | Cut-off | ||||||||
| +75% | Cut-off | ||||||||
| +100% | |||||||||
| Lot 1 | 50-/0+ | 50-/0+ | 50-/0+ | 50-/0+ | 24-/26+ | 50+/0- | 50+/0- | 50+/0- | 50+/0- |
| Lot 2 | 50-/0+ | 50-/0+ | 50-/0+ | 50-/0+ | 24-/26+ | 50+/0- | 50+/0- | 50+/0- | 50+/0- |
| Lot 3 | 50-/0+ | 50-/0+ | 50-/0+ | 50-/0+ | 25-/25+ | 50+/0- | 50+/0- | 50+/0- | 50+/0- |
| Cup Results | |||||||||
|---|---|---|---|---|---|---|---|---|---|
| Lot Number | -100% Cut-off | -75% Cut-off | -50% Cut-off | -25% Cut-off | Cut-off | Cut-off +25% | Cut-off +50% | Cut-off +75% | Cut-off +100% |
| Lot 1 | 50-/0+ | 50-/0+ | 50-/0+ | 50-/0+ | 25-/25+ | 50+/0- | 50+/0- | 50+/0- | 50+/0- |
| Lot 2 | 50-/0+ | 50-/0+ | 50-/0+ | 50-/0+ | 26-/24+ | 50+/0- | 50+/0- | 50+/0- | 50+/0- |
| Lot 3 | 50-/0+ | 50-/0+ | 50-/0+ | 50-/0+ | 24-/26+ | 50+/0- | 50+/0- | 50+/0- | 50+/0- |
9
Methadone
Dip Card
| Results | -100%
Cut-off | -75%
Cut-off | -50%
Cut-off | -25%
Cut-off | Cut-off | Cut-off
+25% | Cut-off
+50% | Cut-off
+75% | Cut-off
+100% |
|---------------|------------------|-----------------|-----------------|-----------------|---------|-----------------|-----------------|-----------------|------------------|
| Lot
Number | | | | | | | | | |
| Lot 1 | 50-/0+ | 50-/0+ | 50-/0+ | 50-/0+ | 26-/24+ | 50+/0- | 50+/0- | 50+/0- | 50+/0- |
| Lot 2 | 50-/0+ | 50-/0+ | 50-/0+ | 50-/0+ | 26-/24+ | 50+/0- | 50+/0- | 50+/0- | 50+/0- |
| Lot 3 | 50-/0+ | 50-/0+ | 50-/0+ | 50-/0+ | 24-/26+ | 50+/0- | 50+/0- | 50+/0- | 50+/0- |
| Cup Results | |||||||||
|---|---|---|---|---|---|---|---|---|---|
| Lot | |||||||||
| Number | -100% | ||||||||
| Cut-off | -75% | ||||||||
| Cut-off | -50% | ||||||||
| Cut-off | -25% | ||||||||
| Cut-off | Cut-off | Cut-off | |||||||
| +25% | Cut-off | ||||||||
| +50% | Cut-off | ||||||||
| +75% | Cut-off | ||||||||
| +100% | |||||||||
| Lot 1 | 50-/0+ | 50-/0+ | 50-/0+ | 50-/0+ | 25-/25+ | 50+/0- | 50+/0- | 50+/0- | 50+/0- |
| Lot 2 | 50-/0+ | 50-/0+ | 50-/0+ | 50-/0+ | 24-/26+ | 50+/0- | 50+/0- | 50+/0- | 50+/0- |
| Lot 3 | 50-/0+ | 50-/0+ | 50-/0+ | 50-/0+ | 23-/27+ | 50+/0- | 50+/0- | 50+/0- | 50+/0- |
Morphine
Dip Card
| Results
Lot
Number | -100%
Cut-off | -75%
Cut-off | -50%
Cut-off | -25%
Cut-off | Cut-off | Cut-off
+25% | Cut-off
+50% | Cut-off
+75% | Cut-off
+100% |
|--------------------------|------------------|-----------------|-----------------|-----------------|---------|-----------------|-----------------|-----------------|------------------|
| Lot 1 | 50-/0+ | 50-/0+ | 50-/0+ | 50-/0+ | 26-/24+ | 50+/0- | 50+/0- | 50+/0- | 50+/0- |
| Lot 2 | 50-/0+ | 50-/0+ | 50-/0+ | 50-/0+ | 25-/25+ | 50+/0- | 50+/0- | 50+/0- | 50+/0- |
| Lot 3 | 50-/0+ | 50-/0+ | 50-/0+ | 50-/0+ | 24-/26+ | 50+/0- | 50+/0- | 50+/0- | 50+/0- |
| Cup | |||||||||
|---|---|---|---|---|---|---|---|---|---|
| Results | |||||||||
| Lot | |||||||||
| Number | -100% | ||||||||
| Cut-off | -75% | ||||||||
| Cut-off | -50% | ||||||||
| Cut-off | -25% | ||||||||
| Cut-off | Cut-off | Cut-off | |||||||
| +25% | Cut-off | ||||||||
| +50% | Cut-off | ||||||||
| +75% | Cut-off | ||||||||
| +100% | |||||||||
| Lot 1 | 50-/0+ | 50-/0+ | 50-/0+ | 50-/0+ | 24-/26+ | 50+/0- | 50+/0- | 50+/0- | 50+/0- |
| Lot 2 | 50-/0+ | 50-/0+ | 50-/0+ | 50-/0+ | 23-/27+ | 50+/0- | 50+/0- | 50+/0- | 50+/0- |
| Lot 3 | 50-/0+ | 50-/0+ | 50-/0+ | 50-/0+ | 24-/26+ | 50+/0- | 50+/0- | 50+/0- | 50+/0- |
The following cut-off values are verified.
| Drug(Identifier) | Cut-off level |
|---|---|
| Secobarbital (BAR) | 300 ng/mL |
| Oxazepam (BZO) | 300 ng/mL |
| Methamphetamine (MET) | 1000 ng/mL |
| Methadone (MTD) | 300 ng/mL |
| Morphine (OPI) | 2000 ng/mL |
b. Linearity
10
Not applicable.
c. Stability
The devices are stable at 4-30 ℃ for 24 months based on the accelerated stability study at 50 °C and real time stability studies at 4°C and 30 °C.
d. Interference
Potential interfering substances found in human urine of physiological or pathological conditions were added to drug-free urine and target drugs urine with concentrations at 25% below and 25% above Cut-Off levels. These urine samples were tested using three batches of each device. Compounds that showed no interference at a concentration of 100ug/mL are summarized in the following tables. There were no differences observed between the SAFECARE Cup and Dip Card formats.
| Acetominophen (4-
| Acetamidophenol) | Ecgonine methyl ester | D,L-Octopamine |
|---|---|---|
| Acetophenetidin | EMDP | Oxalic acid |
| N-Acetylprocainamide | Erythromycin | Oxolinic acid |
| Acetylsalicylic acid | β-Estradiol | Oxymetazoline |
| Albumin | Fenoprofen | Papaverine |
| Aminopyrine | Furosemide | Penicillin-G |
| Amoxicillin | Gentisic acid | Perphenazine |
| Ampicillin | Hemoglobin | Phenelzine |
| Apomorphine | Hydralazine | Prednisone |
| Ascorbic acid | Hydrochlorothiazide | DL-Propranolol |
| Aspartame | Hydrocortisone | D-Pseudoephedrine |
| Atropine | O-Hydroxyhippuric acid | Quinine |
| Benzilic acid | 3-Hydroxytyramine | Ranitidine |
| Benzoic acid | Ibuprofen | Salicylic acid |
| Bilirubin | D,L-Isoproterenol | Serotonin (5- Hydroxytyramine) |
| Chloralhydrate | Isoxsuprine | Sulfamethazine |
| Chloramphenicol | Ketamine | Sulindac |
| Chlorothiazide | Ketoprofen | Tetrahydrocortisone, 3-acetate |
| Chlorpromazine | Labetalol | Tetrahydrocortisone 3-(β- |
| Dglucuronide) | ||
| Cholesterol | Loperamide | Tetrahydrozoline |
| Clonidine | Maprotiline | Thiamine |
| Cortisone | Meperidine | Thioridazine |
| (-) Cotinine | Meprobamate | Triamterene |
| Creatinine | Methoxyphenamine | DL-Tyrosine |
| Deoxycorticosterone | Nalidixic acid | Trifluoperazine |
| Dextromethorphan | Naloxone | Trimethoprim |
| Diclofenac | Naltrexone | D L-Tryptophan |
| Diflunisal | Naproxen | Tyramine |
| Digoxin | Niacinamide | Uric acid |
| Diphenhydramine | Nifedipine | Verapamil |
| Disopyramide | Norethindrone | Zomepirac |
| EDDP | Noscapine |
e. Specificity
To test specificity, drug metabolites and other structure related compounds that are likely to cross-react in urine samples were tested using three batches of each device. The lowest concentration that caused a positive result for each compound are listed below
11
for Secobarbital, Oxazepam, Methamphetamine, Methadone and Morphine. The rest data were reported in K153646 for Amphetamine, Marijuana and Cocaine. There were no differences observed between the SAFECARE Cup and Dip Card formats.
| Secobarbital
(Cut-off=300 ng/mL) | Result
Positive at (ng/mL) | % Cross-Reactivity |
|-------------------------------------|-------------------------------|--------------------|
| Secobarbital | 300 | 100% |
| Amobarbital | 625 | 48% |
| Alphenol | 625 | 48% |
| Aprobarbital | 200 | 150% |
| Butabarbital | 100 | 300% |
| Butathal | 200 | 150% |
| Butalbital | 2500 | 12% |
| Cyclopentobarbital | 400 | 75% |
| Pentobarbital | 1000 | 30% |
| Phenobarbital | 300 | 100% |
| Oxazepam
(Cut-off=300 ng/mL) | Result
Positive at (ng/mL) | % Cross-Reactivity |
|---------------------------------|-------------------------------|--------------------|
| Oxazepam | 300 | 100% |
| Alprazolam | 250 | 120% |
| a-Hydroxyalprazolam | 1000 | 30% |
| Bromazepam | 625 | 48% |
| Chlordiazepoxide | 2500 | 12% |
| Clonazepam | 2500 | 12% |
| Clobazam | 125 | 240% |
| Clorazepate dipotassium | 100 | 300% |
| Desalkylflurazepam | 250 | 120% |
| Diazepam | 250 | 120% |
| Estazolam | 5000 | 6% |
| Flunitrazepam | 375 | 80% |
| D,L-Lorazepam | 10000 | 3% |
| Midazolam | 90000 | 0.33% |
| Nitrazepam | 25000 | 1.2% |
| Norchlordiazepoxide | 250 | 120% |
| Nordiazepam | 500 | 60% |
| Temazepam | 125 | 240% |
| Triazolam | 5000 | 6% |
| Methamphetamine
(Cut-off=1000 ng/mL) | Result
Positive at (ng/mL) | % Cross-Reactivity |
|-------------------------------------------------------|-------------------------------|--------------------|
| D(+)-Methamphetamine | 1000 | 100% |
| (+/-)3,4-Methylenedioxy-n-
ethylamphetamine (MDEA) | 50000 | 2% |
| D/L-Methamphetamine | 1000 | 100% |
| p-Hydroxymethamphetamine | 10000 | 10% |
| D-Amphetamine | Negative at 100000 | ≤1% |
| L-Amphetamine | Negative at 100000 | ≤1% |
| Chloroquine | 25000 | 4% |
| (+/-)-Ephedrine | 4000 | 25% |
| L-Methamphetamine | 10000 | 10% |
| (+/-)3,4-Methylenedioxyamphetamine
(MDA) | Negative at 100000 | ≤1% |
| β -Phenylethylamine | 7500 | 13% |
| Trimethobenzamide | 20000 | 5% |
| (+/-)3,4-
methylenedioxymethamphetamine | 2000 | 50% |
12
| (MDMA) | ||
|---|---|---|
| -------- | -- | -- |
| Methadone
(Cut-off=300 ng/mL) | Result
Positive at(ng/ml) | % Cross-Reactivity |
|----------------------------------|------------------------------|--------------------|
| Methadone | 300 | 100% |
| Doxylamine | 5000 | 6% |
| LAAM HCl | 10000 | 3% |
| Alpha Methadol | 2000 | 15% |
| EDDP | >100000 | 100000 | 50 years. Urine samples were prepared at the following concentrations; negative, +/-75%, +/-50%, +/-25% of the cutoff by spiking drugs into drug free-pooled urine specimens. The concentrations of the samples were confirmed by LC/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. Each device was tested. Results are shown below. Dip Card
AMP
| % of Cutoff | Number of
samples | Drug
Concentration by
LC/MS (ng/mL) | Lay person Results | | Percentage of
correct results
(%) |
|--------------|----------------------|-------------------------------------------|--------------------|--------------------|-----------------------------------------|
| -100% Cutoff | 20 | 0 | No. of
Positive | No. of
Negative | 100 |
| -75% Cutoff | 20 | 248 | 0 | 20 | 100 |
18
| -50% Cutoff | 100 | રે રેણવાડી તેમ જ દિવસ તાલુકામાં આવેલું એક ગામનાં મુખ્યત્વે ખાતે ખાતે ખાતે ખાતે ખેતી કરવામાં આવેલું એક ગામનાં મુખ્યત્વે ખેત-ઉત્પત્તમજૂરી તેમ જ દૂધની ડેરી જેવી સવલતો પ્રાપ્ય થ | 100 | 100 | |
|---|---|---|---|---|---|
| -25% Cutoff | 20 | 754 | 19 | તેરિ | |
| +25% Cutoff | 20 | 1259 | 17 | ૪૨ | |
| +50% Cutoff | 40 | 1508 | 40 | 0 | 100 |
| +75% Cutoff | 20 | 1759 | 20 | 0 | 100 |
COC
| % of Cutoff | Number of samples | Drug Concentration by LC/MS (ng/mL) | Lay person Results | Percentage of correct results (%) | |
|---|---|---|---|---|---|
| No. of Positive | No. of Negative | ||||
| -100% Cutoff | 20 | 0 | 0 | 20 | 100 |
| -75% Cutoff | 20 | 74 | 0 | 20 | 100 |
| -50% Cutoff | 100 | 152 | 0 | 100 | 100 |
| -25% Cutoff | 20 | 224 | 2 | 18 | 90 |
| +25% Cutoff | 20 | 373 | 18 | 2 | 90 |
| +50% Cutoff | 40 | 452 | 40 | 0 | 100 |
| +75% Cutoff | 20 | 522 | 20 | 0 | 100 |
THC
| % of Cutoff | Number of
samples | Drug
Concentration by
LC/MS (ng/mL) | Lay person Results | | Percentage of
correct results
(%) |
|--------------|----------------------|-------------------------------------------|--------------------|--------------------|-----------------------------------------|
| | | | No. of
Positive | No. of
Negative | |
| -100% Cutoff | 20 | 0 | 0 | 20 | 100 |
| -75% Cutoff | 20 | 12.6 | 0 | 20 | 100 |
| -50% Cutoff | 100 | 25 | 0 | 100 | 100 |
| -25% Cutoff | 20 | 37.2 | 2 | 18 | 90 |
| +25% Cutoff | 20 | 62.3 | 19 | 1 | 95 |
| +50% Cutoff | 40 | 75 | 40 | 0 | 100 |
| +75% Cutoff | 20 | 87.4 | 20 | 0 | 100 |
BAR
| % of Cutoff | Number of
samples | Drug
Concentration by
LC/MS (ng/mL) | Lay person Results | | Percentage of
correct results
(%) |
|--------------|----------------------|-------------------------------------------|--------------------|--------------------|-----------------------------------------|
| | | | No. of
Positive | No. of
Negative | |
| -100% Cutoff | 20 | 0 | 0 | 20 | 100 |
| -75% Cutoff | 20 | 76 | 0 | 20 | 100 |
| -50% Cutoff | 100 | 151 | 0 | 100 | 100 |
| -25% Cutoff | 20 | 226 | 1 | 19 | 95 |
| +25% Cutoff | 20 | 372 | 18 | 2 | 90 |
| +50% Cutoff | 40 | 448 | 40 | 0 | 100 |
| +75% Cutoff | 20 | 529 | 20 | 0 | 100 |
| BZO | | | | | |
Lay person Results Number of Drug Percentage of % of Cutoff samples Concentration by correct results No. of No. of LC/MS (ng/mL) Positive Negative (%)
19
| -100% Cutoff | 20 | 0 | 0 | 20 | 100 |
|---|---|---|---|---|---|
| -75% Cutoff | 20 | 75 | 0 | 20 | 100 |
| -50% Cutoff | 100 | 149 | 0 | 100 | 100 |
| -25% Cutoff | 20 | 224 | 3 | 17 | 85 |
| +25% Cutoff | 20 | 376 | 19 | 1 | 95 |
| +50% Cutoff | 40 | 454 | 40 | 0 | 100 |
| +75% Cutoff | 20 | 520 | 20 | 0 | 100 |
MET
| % of Cutoff | Number of samples | Drug Concentration by LC/MS (ng/mL) | Lay person Results
No. of Positive | Lay person Results
No. of Negative | Percentage of correct results (%) |
|--------------|-------------------|-------------------------------------|---------------------------------------|---------------------------------------|-----------------------------------|
| -100% Cutoff | 20 | 0 | 0 | 20 | 100 |
| -75% Cutoff | 20 | 251 | 0 | 20 | 100 |
| -50% Cutoff | 100 | 502 | 0 | 100 | 100 |
| -25% Cutoff | 20 | 758 | 2 | 18 | 90 |
| +25% Cutoff | 20 | 1259 | 18 | 2 | 90 |
| +50% Cutoff | 40 | 1512 | 40 | 0 | 100 |
| +75% Cutoff | 20 | 1759 | 20 | 0 | 100 |
MTD
| % of Cutoff | Number of samples | Drug Concentration by LC/MS (ng/mL) | Lay person Results | Percentage of correct results (%) | |
|---|---|---|---|---|---|
| -100% Cutoff | 20 | 0 | 0 | 20 | 100 |
| -75% Cutoff | 20 | 74 | 0 | 20 | 100 |
| -50% Cutoff | 100 | 151 | 0 | 100 | 100 |
| -25% Cutoff | 20 | 225 | 1 | 19 | 95 |
| +25% Cutoff | 20 | 376 | 18 | 2 | 90 |
| +50% Cutoff | 40 | 447 | 40 | 0 | 100 |
| +75% Cutoff | 20 | 522 | 20 | 0 | 100 |
OPI
| OPI | ||||||
|---|---|---|---|---|---|---|
| % of Cutoff | Number of | |||||
| samples | Drug | |||||
| Concentration by | ||||||
| LC/MS (ng/mL) | Lay person Results | Percentage of | ||||
| correct results | ||||||
| (%) | ||||||
| No. of | ||||||
| Positive | No. of | |||||
| Negative | ||||||
| -100% Cutoff | 20 | 0 | 0 | 20 | 100 | |
| -75% Cutoff | 20 | 505 | 0 | 20 | 100 | |
| -50% Cutoff | 100 | 1009 | 0 | 100 | 100 | |
| -25% Cutoff | 20 | 1510 | 1 | 19 | 95 | |
| +25% Cutoff | 20 | 2511 | 18 | 2 | 90 | |
| +50% Cutoff | 40 | 3031 | 40 | 0 | 100 | |
| +75% Cutoff | 20 | 3521 | 20 | 0 | 100 |
20
| % of Cutoff | Number of
samples | Drug
Concentration by
LC/MS (ng/mL) | Lay person Results | | Percentage of
correct results
(%) |
|--------------|----------------------|-------------------------------------------|--------------------|--------------------|-----------------------------------------|
| | | | No. of
Positive | No. of
Negative | |
| -100% Cutoff | 20 | 0 | 0 | 20 | 100 |
| -75% Cutoff | 20 | 248 | 0 | 20 | 100 |
| -50% Cutoff | 100 | 505 | 0 | 100 | 100 |
| -25% Cutoff | 20 | 754 | 2 | 18 | 90 |
| +25% Cutoff | 20 | 1259 | 18 | 2 | 90 |
| +50% Cutoff | 40 | 1508 | 40 | 0 | 100 |
| +75% Cutoff | 20 | 1759 | 20 | 0 | 100 |
coc
| % of Cutoff | Number of
samples | Drug
Concentration by
LC/MS (ng/mL) | Lay person Results | | Percentage of
correct results
(%) |
|--------------|----------------------|-------------------------------------------|--------------------|-----|-----------------------------------------|
| -100% Cutoff | 20 | 0 | 0 | 20 | 100 |
| -75% Cutoff | 20 | 74 | 0 | 20 | 100 |
| -50% Cutoff | 100 | 152 | 0 | 100 | 100 |
| -25% Cutoff | 20 | 224 | 1 | 19 | 95 |
| +25% Cutoff | 20 | 373 | 18 | 2 | 90 |
| +50% Cutoff | 40 | 452 | 40 | 0 | 100 |
| +75% Cutoff | 20 | 522 | 20 | 0 | 100 |
THC
| % of Cutoff | Number of samples | Drug Concentration by LC/MS (ng/mL) | Lay person Results | Percentage of correct results (%) | |
|---|---|---|---|---|---|
| No. of Positive | No. of Negative | ||||
| -100% Cutoff | 20 | 0 | 0 | 20 | 100 |
| -75% Cutoff | 20 | 12.6 | 0 | 20 | 100 |
| -50% Cutoff | 100 | 25 | 0 | 100 | 100 |
| -25% Cutoff | 20 | 37.2 | 2 | 18 | 90 |
| +25% Cutoff | 20 | 62.3 | 19 | 1 | 95 |
| +50% Cutoff | 40 | 75 | 40 | 0 | 100 |
| +75% Cutoff | 20 | 87.4 | 20 | 0 | 100 |
BAR
| % of Cutoff | Number of samples | Drug Concentration by LC/MS (ng/mL) | Lay person Results | Percentage of correct results (%) | |
|---|---|---|---|---|---|
| -100% Cutoff | 20 | 0 | 0 | 20 | 100 |
| -75% Cutoff | 20 | 76 | 0 | 20 | 100 |
| -50% Cutoff | 100 | 151 | 0 | 100 | 100 |
| -25% Cutoff | 20 | 226 | 3 | 17 | 85 |
| +25% Cutoff | 20 | 372 | 19 | 1 | 95 |
| +50% Cutoff | 40 | 448 | 40 | 0 | 100 |
21
| +75% Cutoff | 20 | 529 | 20 | 0 | 100 |
|---|---|---|---|---|---|
| BZO | |||||
| % of Cutoff | Number of | ||||
| samples | Drug | ||||
| Concentration by | |||||
| LC/MS (ng/mL) | Lay person Results | Percentage of | |||
| No. of | |||||
| Positive | No. of | ||||
| Negative | correct results | ||||
| (%) | |||||
| -100% Cutoff | 20 | 0 | 0 | 20 | 100 |
| -75% Cutoff | 20 | 75 | 0 | 20 | 100 |
| -50% Cutoff | 100 | 149 | 0 | 100 | 100 |
| -25% Cutoff | 20 | 224 | 1 | 19 | 95 |
| +25% Cutoff | 20 | 376 | 18 | 2 | 90 |
| +50% Cutoff | 40 | 454 | 40 | 0 | 100 |
| +75% Cutoff | 20 | 520 | 20 | 0 | 100 |
MET
| % of Cutoff | Number of
samples | Drug
Concentration by
LC/MS (ng/mL) | Lay person Results | | Percentage of
correct results
(%) |
|--------------|----------------------|-------------------------------------------|--------------------|--------------------|-----------------------------------------|
| -100% Cutoff | 20 | 0 | No. of
Positive | No. of
Negative | 100 |
| -75% Cutoff | 20 | 251 | 0 | 20 | 100 |
| -50% Cutoff | 100 | 502 | 0 | 100 | 100 |
| -25% Cutoff | 20 | 758 | 3 | 17 | 85 |
| +25% Cutoff | 20 | 1259 | 19 | 1 | 95 |
| +50% Cutoff | 40 | 1512 | 40 | 0 | 100 |
| +75% Cutoff | 20 | 1759 | 20 | 0 | 100 |
MTD
| % of Cutoff | Number of
samples | Drug
Concentration by
LC/MS (ng/mL) | No. of
Positive | No. of
Negative | Percentage of
correct results
(%) |
|--------------|----------------------|-------------------------------------------|--------------------|--------------------|-----------------------------------------|
| -100% Cutoff | 20 | 0 | 0 | 20 | 100 |
| -75% Cutoff | 20 | 74 | 0 | 20 | 100 |
| -50% Cutoff | 100 | 151 | 0 | 100 | 100 |
| -25% Cutoff | 20 | 225 | 2 | 18 | 90 |
| +25% Cutoff | 20 | 376 | 19 | 1 | 95 |
| +50% Cutoff | 40 | 447 | 40 | 0 | 100 |
| +75% Cutoff | 20 | 522 | 20 | 0 | 100 |
| % of Cutoff | Number of samples | Drug Concentration by LC/MS (ng/mL) | Lay person Results | | Percentage of correct results (%) |
| -100% Cutoff | 20 | 0 | No. of Positive | No. of Negative | |
| -100% Cutoff | 20 | 0 | 0 | 20 | 100 |
| -75% Cutoff | 20 | 505 | 0 | 20 | 100 |
| -50% Cutoff | 100 | 1009 | 0 | 100 | 100 |
| -25% Cutoff | 20 | 1510 | 3 | 17 | 85 |
OPI
22
| +25% Cutoff | 20 | 2511 | 19 | 1 | 95 |
|---|---|---|---|---|---|
| +50% Cutoff | 40 | 3031 | 40 | 0 | 100 |
| +75% Cutoff | 20 | 3521 | 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.
11. Conclusion
Based on the test principle and acceptable performance characteristics including precision, cut-off, interference, specificity, method comparison, and lay-user studies of the devices, it's concluded that the SAFECARE Dip Card Tests and SAFECARE Cup Tests are substantially equivalent to the predicate.