(189 days)
No
The device is described as a lateral flow immunochromatographic assay, which is a traditional chemical-based test. There is no mention of any computational analysis, image processing, or algorithms that would suggest the use of AI or ML. The performance studies focus on analytical and lay-user performance of the chemical test itself.
No.
The device is for qualitative detection of various drugs in human urine (in vitro diagnostic use) and provides preliminary test results, not treatment or therapy.
Yes
The device is described as an "in vitro diagnostic device" and is intended for the qualitative and simultaneous detection of various drugs in human urine, which is a diagnostic purpose.
No
The device is described as an immunochromatographic assay using a lateral flow system, which is a physical test strip or cup that reacts with a urine sample. This involves hardware components, not just software.
Yes, this device is an IVD (In Vitro Diagnostic).
Here's why:
- Explicit Statement: The intended use and device description sections repeatedly state "For in vitro diagnostic use only."
- Nature of the Test: The device is a "competitive binding, lateral flow immunochromatographic assay for qualitative and simultaneous detection of [various drugs] in human urine." This describes a test performed on a biological sample (urine) outside of the body to provide information about a person's health status (presence of drugs). This is the definition of an in vitro diagnostic test.
- Intended Use: The intended use is to detect the presence of specific drugs in human urine, which is a diagnostic purpose.
N/A
Intended Use / Indications for Use
First Sign Multi-Drug Test Dip Card is competitive binding, lateral flow immunochromatographic assay for qualitative and simultaneous detection of Amphetamine, Butalbital, Oxazepam, Cocaine, 2-ethylidene-1.5-dimethyl-3,3-diphenylpyrrolidine, Methylenedioxymethamphetamine, Morphine, Methadone, Oxycodone, Phencyclidine, Propoxyphene, Nortriptyline and Marijuana in human urine at the cutoff concentrations of:
| Drug(Identifier) | Cut-off level |
|---|---|
| Amphetamine (AMP) | 1000ng/mL or 500 ng/mL |
| Buprenorphine (BUP) | 10 ng/mL |
| Butalbital (BAR) | 300 ng/mL |
| Oxazepam (BZO) | 300 ng/mL |
| Cocaine (COC) | 300ng/mL or 150 ng/mL |
| 2-ethylidene-1, 5-dimethyl-3, 3-diphenylpyrrolidine (EDDT) | 300 ng/mL |
| Methamphetamine (MET) | 1000ng/mL or 500 ng/mL |
| Methylenedioxy-methamphetamine (MDMA) | 500 ng/mL |
| Morphine (MOP 300/OPI 2000) | 2000ng/mL or 300 ng/mL |
| Methadone (MDT) | 300 ng/mL |
| Oxycodone (OXY) | 100 ng/mL |
| Phencyclidine (PCP) | 25 ng/mL |
| Propoxyphene (PPX) | 300 ng/mL |
| Nortriptyline (TCA) | 1000 ng/mL |
| Marijuana (THC) | 50 ng/mL |
Configuration of the First Sign Multi-Drug Test Dip Card can consist of any combination of the above listed drug analytes.
The test may yield positive results for the prescription drugs Buprenorphine, Oxazepam, Butalbital, Nortriptyline, Propoxyphene and Oxycodone 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. For in vitro diagnostic use only.
First Sign Multi-Drug Test Cup is competitive binding, lateral flow immunochromatographic assay for qualitative and simultaneous detection of Amphetamine, Butalbital, Oxazepam, Cocaine, 2-ethylidene-1,5-dimethyl-3,3-diphenylpyrrolidine, Methamphetamine, Methylenedioxymethamphetamine, Methadone, Oxycodone, Phencyclidine, Propoxyphene, Nortriptyline and Marijuana in human urine at the cutoff concentrations of:
| Drug(Identifier) | Cut-off level |
|---|---|
| Amphetamine (AMP) | 1000ng/mL or 500 ng/mL |
| Buprenorphine (BUP) | 10 ng/mL |
| Butalbital (BAR) | 300 ng/mL |
| Oxazepam (BZO) | 300 ng/mL |
| Cocaine (COC) | 300ng/mL or 150 ng/mL |
| 2-ethylidene-1, 5-dimethyl-3, 3-diphenylpyrrolidine (EDDT) | 300 ng/mL |
| Methamphetamine (MET) | 1000ng/mL or 500 ng/mL |
| Methylenedioxy-methamphetamine (MDMA) | 500 ng/mL |
| Morphine (MOP 300/OPI 2000) | 2000ng/mL or 300 ng/mL |
| Methadone (MDT) | 300 ng/mL |
| Oxycodone (OXY) | 100 ng/mL |
| Phencyclidine (PCP) | 25 ng/mL |
| Propoxyphene (PPX) | 300 ng/mL |
| Nortriptyline (TCA) | 1000 ng/mL |
| Marijuana (THC) | 50 ng/mL |
Configuration of the First Sign Multi-Drug Test Cup can consist of any combination of the above listed drug analytes. The test may yield positive results for the prescription drugs Buprenorphine, Oxazepam, Butalbital, Nortriptyline, Propoxyphene and Oxycodone 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.
For in vitro diagnostic use only.
First Sign Multi-Drug Screen Test Dip Card is competitive binding, lateral flow immunochromatographic assay for qualitative and simultaneous detection of Amphetamine, Butalbital, Oxazepam, Cocaine, 2-ethylidene-1,5-dimethyl-3,3-diphenylpyrrolidine, Methylenedioxymethamphetamine, Morphine, Methadone, Oxycodone, Phencyclidine, Propoxyphene, Nortriptyline and Marijuana in human urine at the cutoff concentrations of:
| Drug(Identifier) | Cut-off level |
|---|---|
| Amphetamine (AMP) | 1000ng/mL or 500 ng/mL |
| Buprenorphine (BUP) | 10 ng/mL |
| Butalbital (BAR) | 300 ng/mL |
| Oxazepam (BZO) | 300 ng/mL |
| Cocaine (COC) | 300ng/mL or 150 ng/mL |
| 2-ethylidene-1,5-dimethyl-3,3-diphenylpyrrolidine (EDDT) | 300 ng/mL |
| Methamphetamine (MET) | 1000ng/mL or 500 ng/mL |
| Methylenedioxy-methamphetamine (MDMA) | 500 ng/mL |
| Morphine (MOP 300/OPI 2000) | 2000ng/mL or 300 ng/mL |
| Methadone (MDT) | 300 ng/mL |
| Oxycodone (OXY) | 100 ng/mL |
| Phencyclidine (PCP) | 25 ng/mL |
| Propoxyphene (PPX) | 300 ng/mL |
| Nortriptyline (TCA) | 1000 ng/mL |
| Marijuana (THC) | 50 ng/mL |
Configuration of the First Sign Multi-Drug Screen Test Dip Card can consist of any combination of the above listed drug analytes.
The test may yield positive results for the prescription drugs Buprenorphine, Oxazepam, Butalbital, Nortriptyline, Propoxyphene and Oxycodone 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.
For in vitro diagnostic use only. It is for prescription use.
First Sign Multi-Drug Screen Test Cup is competitive binding, lateral flow immunochromatographic assay for qualitative and simultaneous detection of Amphetamine, Butalbital, Oxazepam, Cocaine, 2-ethylidene-1,5-dimethyl-3,3-diphenylpyrrolidine, Methylenedioxymethamphetamine, Morphine, Methadone, Oxycodone, Phencyclidine, Propoxyphene, Nortriptyline and Marijuana in human urine at the cutoff concentrations of:
| Drug(Identifier) | Cut-off level |
|---|---|
| Amphetamine (AMP) | 1000ng/mL or 500 ng/mL |
| Buprenorphine (BUP) | 10 ng/mL |
| Butalbital (BAR) | 300 ng/mL |
| Oxazepam (BZO) | 300 ng/mL |
| Cocaine (COC) | 300ng/mL or 150 ng/mL |
| 2-ethylidene-1, 5-dimethyl-3, 3-diphenylpyrrolidine (EDDT) | 300 ng/mL |
| Methamphetamine (MET) | 1000ng/mL or 500 ng/mL |
| Methylenedioxy-methamphetamine (MDMA) | 500 ng/mL |
| Morphine (MOP 300/OPI 2000) | 2000ng/mL or 300 ng/mL |
| Methadone (MDT) | 300 ng/mL |
| Oxycodone (OXY) | 100 ng/mL |
| Phencyclidine (PCP) | 25 ng/mL |
| Propoxyphene (PPX) | 300 ng/mL |
| Nortriptyline (TCA) | 1000 ng/mL |
| Marijuana (THC) | 50 ng/mL |
Configuration of the First Sign Multi-Drug Screen Test Cup combination of the above listed drug analytes.
The test may yield positive results for the prescription drugs Buprenorphine, Oxazepam, Butalbital, Nortriptyline, Propoxyphene and Oxycodone 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.
For in vitro diagnostic use only. It is for prescription use.
Product codes (comma separated list FDA assigned to the subject device)
QBF, NGG, NFY, NFT, NFW, NFV, NGL, PTG, LCM, PTH, QAW
Device Description
The First Sign Multi-Drug Test Dip Card, First Sign Multi-Drug Test Cup, First Sign Multi-Drug Screen Test Dip Card and First Sign Multi-Drug Screen Test Cup are immunochromatographic assays that use a lateral flow system for the qualitative detection of Amphetamine, Oxazepam, Cocaine, Marijuana, Methamphetamine, Morphine, Oxycodone, Butalbital, Methadone, Buprenorphine, Phencyclidine, Methylenedioxymethamphetamine, Tricyclic Antidepressants, EDDP and Propoxyphene (target analytes) in human urine. The products are single-use in vitro diagnostic devices. The Dip Card kits contain a Dip Card device, a package insert and a urine cup for sample collection. The Cup kits contain a Cup device, a package insert and a urine cup for sample collection. Each test device is sealed with a desiccant in an aluminum pouch.
Mentions image processing
Not Found
Mentions AI, DNN, or ML
Not Found
Input Imaging Modality
Not Found
Anatomical Site
Not Found
Indicated Patient Age Range
Not Found
Intended User / Care Setting
For over-the-counter and for prescription use.
Description of the training set, sample size, data source, and annotation protocol
Not Found
Description of the test set, sample size, data source, and annotation protocol
Not Found
Summary of Performance Studies (study type, sample size, AUC, MRMC, standalone performance, key results)
Analytical Performance
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 urine 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 were summarized in tables for Propoxyphene, and indicated accurate detection/non-detection based on cut-off levels. The cut-off value of 300ng/mL is verified for propoxyphene. Data for other analytes were reported in previously cleared K-numbers (K142353, K152551, K150162, K151441, K160793, K171695).
Linearity: Not applicable.
Stability: The devices are stable at 4-30 ℃ for 24 months based on accelerated stability study at 50°C. Real time stability studies are ongoing.
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 lots of each device. Compounds that showed no interference at a concentration of 100ug/mL were summarized. No differences observed between Dip Card and Cup formats.
Specificity: To test specificity, drug metabolites and other structurally related compounds that are likely to cross-react in urine samples were spiked into negative urine and were tested using three lots of each device. The lowest concentration that caused a positive result for each compound was listed for Propoxyphene (d-Propoxyphene: 300 ng/mL, 100% cross-reactivity; Norpropoxyphene: 1500 ng/mL, 20% cross-reactivity). Data for other analytes were reported in previously cleared K-numbers. No differences observed between the First Sign Multi-Drug Test Dip Card and First Sign Multi-Drug Test Cup.
Effect of Urine Specific Gravity and Urine pH: To investigate the 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 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 the First Sign Multi-Drug Test Dip Card and First Sign Multi-Drug Test Cup.
Comparison Studies
Method comparison studies for the First Sign Multi-Drug Test Dip Card and the First Sign Multi-Drug Test Cup were performed in-house with three laboratory assistants for each device. Operators ran 80 (40 negative and 40 positive) unaltered clinical samples for each drug. The samples were blind labeled and compared to LC/MS results. The results are presented in tables for Propoxyphene, showing high concordance. Discordant results were also listed with their LC/MS values and device results (e.g., Viewer A, Sample 20200406-030, LC/MS 268.2, Dip Card Positive; Viewer A, Sample 20200407-003, LC/MS 332.0, Dip Card Negative). Data for other analytes were reported in previously cleared K-numbers.
Lay-user study
A lay user study was performed at three intended user sites with 280 lay persons for each device format. The lay users had diverse educational and professional backgrounds and ranged in age from 18 to > 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. Tables show percentage of correct results for various assays and concentrations, generally high (100% for negative and higher positive concentrations, around 95% for +/-25% cutoff). Lay-users indicated that the device instructions can be easily followed, confirmed by a Flesch-Kincaid reading analysis showing a Grade Level of 7.
Key Metrics (Sensitivity, Specificity, PPV, NPV, etc.)
Key metrics are presented in tables within the "Summary of Performance Studies" for precision and lay-user studies as counts of positive/negative results and percentage of correct results at various analyte concentrations relative to cutoff. For example, for Propoxyphene Dip Card precision study, at -100% Cut-off (0 ng/mL), results were 50-/0+ across three lots, while at +100% Cut-off (677.3 ng/mL), results were 50+/0- across three lots. For the Lay-user study, for AMP 500 at -25% cutoff, 20 negative and 0 positive results were observed, resulting in 100% correct. At +25% cutoff, 1 negative and 19 positive were observed, resulting in 95% correct.
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.
K142353, K152551, K150162, K151441, K160793, K171695
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
§ 862.3700 Propoxyphene test system.
(a)
Identification. A propoxyphene test system is a device intended to measure propoxyphene, a pain-relieving drug, in serum, plasma, and urine. Measurements obtained by this device are used in the diagnosis and treatment of propoxyphene use or overdose or in monitoring levels of propoxyphene to ensure appropriate therapy.(b)
Classification. Class II (special controls). A propoxyphene 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). On the left is the Department of Health & Human Services logo. To the right of that is the FDA logo, which is a blue square with the letters "FDA" in white. To the right of the blue square is the text "U.S. FOOD & DRUG ADMINISTRATION" in blue.
August 12, 2021
W.H.P.M., Inc. % Joe Shia Manager LSI Consulting 504E Diamond Ave., Suite I Gaithersburg, Maryland 20877
| Trade/Device Name: First Sign Multi-Drug Test Dip Card |
|---|
| First Sign Multi-Drug Test Cup |
| First Sign Multi-Drug Screen Test Dip Card |
| First Sign Multi-Drug Screen Test Cup |
| Regulation Number: 21 CFR 862.3700 |
| Regulation Name: Propoxyphene Test System |
| Regulatory Class: Class II |
| Product Code: QBF, NGG, NFY, NFT, NFW, NFV, NGL, PTG, LCM, PTH, QAW |
| Dated: February 2, 2021 |
| Received: February 4, 2021 |
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. Although this letter refers to your product as a device, please be aware that some cleared products may instead be combination products. The 510(k) Premarket Notification Database located at https://www.accessdata.fda.gov/scripts/cdrh/cfdocs/cfpmn/pmn.cfm identifies combination product submissions. 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
1
Federal Regulations, Title 21, Parts 800 to 898. In addition, FDA may publish further announcements concerning your device in the Federal Register.
Please be advised that FDA's issuance of a substantial equivalence determination does not mean that FDA has made a determination that your device complies with other requirements of the Act or any Federal statutes and regulations administered by other Federal agencies. You must comply with all the Act's requirements, including, but not limited to: registration and listing (21 CFR Part 807); labeling (21 CFR Part 801 and Part 809); medical device reporting of medical device-related adverse events) (21 CFR 803) for devices or postmarketing safety reporting (21 CFR 4, Subpart B) for combination products (see https://www.fda.gov/combination-products/guidance-regulatory-information/postmarketing-safety-reportingcombination-products); good manufacturing practice requirements as set forth in the quality systems (QS) regulation (21 CFR Part 820) for devices or current good manufacturing practices (21 CFR 4, Subpart A) for combination products; 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 https://www.fda.gov/medical-device-safety/medical-device-reportingmdr-how-report-medical-device-problems.
For comprehensive regulatory information about medical devices and radiation-emitting products, including information about labeling regulations, please see Device Advice (https://www.fda.gov/medicaldevices/device-advice-comprehensive-regulatory-assistance) and CDRH Learn (https://www.fda.gov/training-and-continuing-education/cdrh-learn). 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 (https://www.fda.gov/medical-device-advice-comprehensive-regulatoryassistance/contact-us-division-industry-and-consumer-education-dice) for more information or contact DICE by email (DICE@fda.hhs.gov) or phone (1-800-638-2041 or 301-796-7100).
Sincerely,
Marianela Perez-Torres, Ph.D. Deputy Director Division of Chemistry and Toxicology Devices OHT7: Office of In Vitro Diagnostics and Radiological Health Office of Product Evaluation and Quality Center for Devices and Radiological Health
Enclosure
2
Indications for Use
510(k) Number (if known) K210327
Device Name
First Sign Multi-Drug Test Dip Card First Sign Multi-Drug Test Cup
Indications for Use (Describe)
First Sign Multi-Drug Test Dip Card is competitive binding, lateral flow immunochromatographic assay for qualitative and simultaneous detection of Amphetamine, Butalbital, Oxazepam, Cocaine, 2-ethylidene-1.5dimethyl-3,3-diphenylpyrrolidine, Methylenedioxymethamphetamine, Morphine, Methadone, Oxycodone, Phencyclidine, Propoxyphene, Nortriptyline and Marijuana in human urine at the cutoff concentrations of:
| Drug(Identifier) | Cut-off level |
|---|---|
| Amphetamine (AMP) | 1000ng/mL or 500 ng/mL |
| Buprenorphine (BUP) | 10 ng/mL |
| Butalbital (BAR) | 300 ng/mL |
| Oxazepam (BZO) | 300 ng/mL |
| Cocaine (COC) | 300ng/mL or 150 ng/mL |
| 2-ethylidene-1, 5-dimethyl-3, 3-diphenylpyrrolidine (EDDT) | 300 ng/mL |
| Methamphetamine (MET) | 1000ng/mL or 500 ng/mL |
| Methylenedioxy-methamphetamine (MDMA) | 500 ng/mL |
| Morphine (MOP 300/OPI 2000) | 2000ng/mL or 300 ng/mL |
| Methadone (MDT) | 300 ng/mL |
| Oxycodone (OXY) | 100 ng/mL |
| Phencyclidine (PCP) | 25 ng/mL |
| Propoxyphene (PPX) | 300 ng/mL |
| Nortriptyline (TCA) | 1000 ng/mL |
| Marijuana (THC) | 50 ng/mL |
Configuration of the First Sign Multi-Drug Test Dip Card can consist of any combination of the above listed drug analytes.
The test may yield positive results for the prescription drugs Buprenorphine, Oxazepam, Butalbital, Nortriptyline, Propoxyphene and Oxycodone 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. For in vitro diagnostic use only.
First Sign Multi-Drug Test Cup is competitive binding, lateral flow immunochromatographic assay for qualitative and simultaneous detection of Amphetamine, Butalbital, Oxazepam, Cocaine, 2-ethylidene-1,5-dimethyl-3,3diphenylpyrrolidine, Methamphetamine, Methylenedioxymethamphetamine, Methadone, Oxycodone, Phencyclidine, Propoxyphene, Nortriptyline and Marijuana in human urine at the cutoff concentrations of:
| Drug(Identifier) | Cut-off level |
|---|---|
| Amphetamine (AMP) | 1000ng/mL or 500 ng/mL |
| Buprenorphine (BUP) | 10 ng/mL |
| Butalbital (BAR) | 300 ng/mL |
| Oxazepam (BZO) | 300 ng/mL |
| Cocaine (COC) | 300ng/mL or 150 ng/mL |
3
| 2-ethylidene-1, 5-dimethyl-3, 3-diphenylpyrrolidine (EDDT) | 300 ng/mL |
|---|---|
| Methamphetamine (MET) | 1000ng/mL or 500 ng/mL |
| Methylenedioxy-methamphetamine (MDMA) | 500 ng/mL |
| Morphine (MOP 300/OPI 2000) | 2000ng/mL or 300 ng/mL |
| Methadone (MDT) | 300 ng/mL |
| Oxycodone (OXY) | 100 ng/mL |
| Phencyclidine (PCP) | 25 ng/mL |
| Propoxyphene (PPX) | 300 ng/mL |
| Nortriptyline (TCA) | 1000 ng/mL |
| Marijuana (THC) | 50 ng/mL |
Configuration of the First Sign Multi-Drug Test Cup can consist of any combination of the above listed drug analytes. The test may yield positive results for the prescription drugs Buprenorphine, Oxazepam, Butalbital, Nortriptyline, Propoxyphene and Oxycodone 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.
For in vitro diagnostic use only.
Type of Use (Select one or both, as applicable)
Prescription Use (Part 21 CFR 801 Subpart D)
X Over-The-Counter Use (21 CFR 801 Subpart C)
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4
Indications for Use
510(k) Number (if known)
K210327
Device Name
First Sign Multi-Drug Screen Test Dip Card First Sign Multi-Drug Screen Test Cup
Indications for Use (Describe)
First Sign Multi-Drug Screen Test Dip Card is competitive binding, lateral flow immunochromatographic assay for qualitative and simultaneous detection of Amphetamine, Butalbital, Oxazepam, Cocaine, 2ethylidene-1,5-dimethyl-3,3-dipheny|pyrrolidine, Methylenedioxymethamphetamine, Morphine, Methadone, Oxycodone, Phencyclidine, Propoxyphene, Nortriptyline and Marijuana in human urine at the cutoff concentrations of:
| Drug(Identifier) | Cut-off level |
|---|---|
| Amphetamine (AMP) | 1000ng/mL or 500 ng/mL |
| Buprenorphine (BUP) | 10 ng/mL |
| Butalbital (BAR) | 300 ng/mL |
| Oxazepam (BZO) | 300 ng/mL |
| Cocaine (COC) | 300ng/mL or 150 ng/mL |
| 2-ethylidene-1, 5-dimethyl-3, 3-diphenylpyrrolidine (EDDT) | 300 ng/mL |
| Methamphetamine (MET) | 1000ng/mL or 500 ng/mL |
| Methylenedioxy-methamphetamine (MDMA) | 500 ng/mL |
| Morphine (MOP 300/OPI 2000) | 2000ng/mL or 300 ng/mL |
| Methadone (MDT) | 300 ng/mL |
| Oxycodone (OXY) | 100 ng/mL |
| Phencyclidine (PCP) | 25 ng/mL |
| Propoxyphene (PPX) | 300 ng/mL |
| Nortriptyline (TCA) | 1000 ng/mL |
| Marijuana (THC) | 50 ng/mL |
Configuration of the First Sign Multi-Drug Screen Test Dip Card can consist of any combination of the above listed drug analytes.
The test may yield positive results for the prescription drugs Buprenorphine, Oxazepam, Butalbital, Nortriptyline, Propoxyphene and Oxycodone 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.
For in vitro diagnostic use only. It is for prescription use.
First Sign Multi-Drug Screen Test Cup is competitive binding, lateral flow immunochromatographic assay for qualitative and simultaneous detection of Amphetamine, Butalbital, Oxazepam, Cocaine, 2ethylidene-1,5-dimethyl-3,3-diphenylpyrrolidine, Methylenedioxymethamphetamine, Morphine, Methadone, Oxycodone, Phencyclidine, Propoxyphene, Nortriptyline and Marijuana in human urine at the cutoff concentrations of:
| ------------------------------------------------------------------------------------------------------------------------------------------------------------------------------ | D. |
|---|---|
| Butalbital (BAR) | 300 ng/mL |
| Buprenorphine (BUP) | 10 ng/mL |
| Amphetamine (AMP) | 1000ng/mL or 500 ng/mL |
| Drug(Identifier) | Cut-off level |
5
Oxazepam (BZO) 300 ng/mL Cocaine (COC) 300ng/mL or 150 ng/mL 2-ethylidene-1, 5-dimethyl-3, 3-diphenylpyrrolidine (EDDT) 300 ng/mL 1000ng/mL or 500 ng/mL Methamphetamine (MET) Methylenedioxy-methamphetamine (MDMA) 500 ng/mL Morphine (MOP 300/OPI 2000) 2000ng/mL or 300 ng/mL Methadone (MDT) 300 ng/mL Oxycodone (OXY) 100 ng/mL Phencyclidine (PCP) 25 ng/mL 300 ng/mL Propoxyphene (PPX) Nortriptyline (TCA) 1000 ng/mL Marijuana (THC) 50 ng/mL
Configuration of the First Sign Multi-Drug Screen Test Cup combination of the above listed drug analytes.
The test may yield positive results for the prescription drugs Buprenorphine, Oxazepam, Butalbital, Nortriptyline, Propoxyphene and Oxycodone 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.
For in vitro diagnostic use only. It is for prescription 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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6
510(k) SUMMARY K210327
- August 10, 2021 1. Date: 2. Submitter: W.H.P.M., Inc. 5358 Irwindale Ave. Irwindale, CA 91706
-
- Contact person: Joe Shia LSI International Inc 504E Diamond Ave., Suite J Gaithersburg, MD 20877 Telephone: 240-505-7880 Email: shiajl@yahoo.com.
- First Sign Multi-Drug Test Dip Card 4. Device Name: First Sign Multi-Drug Test Cup First Sign Multi-Drug Screen Test Dip Card First Sign Multi-Drug Screen Test Cup
| Classification: | |||
|---|---|---|---|
| Product Code | Classification | Regulation Section | Panel |
| NFT | |||
| Amphetamine | II | 862.3100, Amphetamine Test System | Toxicology |
| NGL | |||
| Buprenorphine | II | 862.3650, Opiate Test System | Toxicology |
| PTH | |||
| Secobarbital | II | 862.3150, Barbiturate Test System | Toxicology |
| NFV | |||
| Oxazepam | II | 862.3170, Benzodiazepine Test System | Toxicology |
| NFY | |||
| Cocaine | II | 862.3250, Cocaine Test System | Toxicology |
| PTG | |||
| 2-ethylidene-1,5-dimethyl-3,3- | |||
| diphenylpyrrolidine | II | 862.3620, Methadone Test System | Toxicology |
| NGG | |||
| Methamphetamine | II | 862.3610, Methamphetamine Test System | Toxicology |
| NGG | |||
| Methylenedioxymethamphetamine | II | 862.3610, Methamphetamine Test System | Toxicology |
| NGL | |||
| Morphine | II | 862.3650, Opiate Test System | Toxicology |
| PTG | |||
| Methadone | II | 862.3620, Methadone Test System | Toxicology |
| NGL | |||
| Oxycodone | II | 862.3650, Opiate Test System | Toxicology |
| LCM | |||
| Phencyclidine | Unclassified | Toxicology | |
| QBF | |||
| Propoxyphene | II | 862.3700 Propoxyphene test system. | Toxicology |
7
| QAW
Nortriptyline | II | 862.3910 Tricyclic antidepressant
drugs test system | Toxicology |
|----------------------|----|--------------------------------------------------------|------------|
| NFW
Cannabinoids | II | 862.3870, Cannabinoids Test
System | Toxicology |
-
- Predicate Devices: K182701
Wondfo T-Cup® Multi-Drug Urine Test Cup
- Predicate Devices: K182701
-
- Intended Use
First Sign Multi-Drug Test Dip Card is competitive binding, lateral flow immunochromatographic assay for qualitative and simultaneous detection of Amphetamine, Buprenorphine, Butalbital, Oxazepam. Cocaine, 2-ethylidene-1.5-dimethyl-3.3-diphenylpyrrolidine, Methamphetamine, Methylenedioxymethamphetamine, Morphine, Methadone, Oxycodone, Phencyclidine, Propoxyphene, Nortriptyline and Marijuana in human urine at the cutoff concentrations of:
- Intended Use
| Drug (Identifier) | Cut-off level |
|---|---|
| Amphetamine (AMP) | 1000 ng/mL or 500 ng/mL |
| Buprenorphine (BUP) | 10 ng/mL |
| Butalbital (BAR) | 300 ng/mL |
| Oxazepam (BZO) | 300 ng/mL |
| Cocaine (COC) | 300 ng/mL or 150 ng/mL |
| 2-ethylidene-1,5-dimethyl-3,3-diphenylpyrrolidine (EDDP) | 300 ng/mL |
| Methamphetamine (MET) | 1000 ng/mL or 500 ng/mL |
| Methylenedioxymethamphetamine (MDMA) | 500 ng/mL |
| Morphine (MOP 300/OPI 2000) | 2000 ng/mL or 300 ng/mL |
| Methadone (MTD) | 300 ng/mL |
| Oxycodone (OXY) | 100 ng/mL |
| Phencyclidine (PCP) | 25 ng/mL |
| Propoxyphene (PPX) | 300 ng/mL |
| Nortriptyline (TCA) | 1000 ng/mL |
| Marijuana (THC) | 50 ng/mL |
Configuration of the First Sign Multi-Drug Test Dip Card can consist of any combination of the above listed drug analytes.
The test may yield positive results for the prescription drugs Buprenorphine, Oxazepam, Butalbital, Nortriptyline, Propoxyphene and Oxycodone 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. For in vitro diagnostic use only.
First Sign Multi-Drug Test Cup is competitive binding, lateral flow immunochromatographic assay for qualitative and simultaneous detection of Amphetamine, Buprenorphine, Butalbital,
8
Oxazepam. Cocaine, 2-ethylidene-1.5-dimethyl-3.3-diphenvlpyrrolidine, Methamphetamine, Methylenedioxymethamphetamine, Morphine, Methadone, Oxycodone, Phencyclidine, Propoxyphene, Nortriptyline and Marijuana in human urine at the cutoff concentrations of:
| Drug (Identifier) | Cut-off level |
|---|---|
| Amphetamine (AMP) | 1000 ng/mL or 500 ng/mL |
| Buprenorphine (BUP) | 10 ng/mL |
| Butalbital (BAR) | 300 ng/mL |
| Oxazepam (BZO) | 300 ng/mL |
| Cocaine (COC) | 300 ng/mL or 150 ng/mL |
| 2-ethylidene-1,5-dimethyl-3,3-diphenylpyrrolidine (EDDP) | 300 ng/mL |
| Methamphetamine (MET) | 1000 ng/mL or 500 ng/mL |
| Methylenedioxymethamphetamine (MDMA) | 500 ng/mL |
| Morphine (MOP 300/OPI 2000) | 2000 ng/mL or 300 ng/mL |
| Methadone (MTD) | 300 ng/mL |
| Oxycodone (OXY) | 100 ng/mL |
| Phencyclidine (PCP) | 25 ng/mL |
| Propoxyphene (PPX) | 300 ng/mL |
| Nortriptyline (TCA) | 1000 ng/mL |
| Marijuana (THC) | 50 ng/mL |
Configuration of the First Sign Multi-Drug Test Cup can consist of any combination of the above listed drug analytes.
The test may yield positive results for the prescription drugs Buprenorphine, Oxazepam, Butalbital, Nortriptyline, Propoxyphene and Oxycodone 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. For in vitro diagnostic use only.
First Sign Multi-Drug Screen Test Dip Card is competitive binding, lateral flow immunochromatographic assay for qualitative and simultaneous detection of Amphetamine, Buprenorphine, Butalbital, Oxazepam, Cocaine, 2-ethylidene-1,5-dimethyl-3,3diphenylpyrrolidine, Methamphetamine, Methylenedioxymethamphetamine, Morphine, Methadone, Oxycodone, Phencyclidine, Propoxyphene, Nortriptyline and Marijuana in human urine at the cutoff concentrations of:
| Drug (Identifier) | Cut-off level |
|---|---|
| Amphetamine (AMP) | 1000 ng/mL or 500 ng/mL |
| Buprenorphine (BUP) | 10 ng/mL |
| Butalbital (BAR) | 300 ng/mL |
| Oxazepam (BZO) | 300 ng/mL |
9
| Cocaine (COC) | 300 ng/mL or 150 ng/mL |
|---|---|
| 2-ethylidene-1,5-dimethyl-3,3-diphenylpyrrolidine (EDDP) | 300 ng/mL |
| Methamphetamine (MET) | 1000 ng/mL or 500 ng/mL |
| Methylenedioxymethamphetamine (MDMA) | 500 ng/mL |
| Morphine (MOP 300/OPI 2000) | 2000 ng/mL or 300 ng/mL |
| Methadone (MTD) | 300 ng/mL |
| Oxycodone (OXY) | 100 ng/mL |
| Phencyclidine (PCP) | 25 ng/mL |
| Propoxyphene (PPX) | 300 ng/mL |
| Nortriptyline (TCA) | 1000 ng/mL |
| Marijuana (THC) | 50 ng/mL |
Configuration of the First Sign Multi-Drug Screen Test Dip Card can consist of any combination of the above listed drug analytes.
The test may yield positive results for the prescription drugs Buprenorphine, Oxazepam, Butalbital, Nortriptyline, Propoxyphene and Oxycodone 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.
For in vitro diagnostic use only. It is for prescription use.
First Sign Multi-Drug Screen Test Cup is competitive binding, lateral flow immunochromatographic assay for qualitative and simultaneous detection of Amphetamine, Buprenorphine, Butalbital, Oxazepam, Cocaine, 2-ethylidene-1,5-dimethyl-3,3diphenylpyrrolidine, Methamphetamine, Methylenedioxymethamphetamine, Morphine, Methadone, Oxycodone, Phencyclidine, Propoxyphene, Nortriptyline and Marijuana in human urine at the cutoff concentrations of:
| Drug (Identifier) | Cut-off level |
|---|---|
| Amphetamine (AMP) | 1000 ng/mL or 500 ng/mL |
| Buprenorphine (BUP) | 10 ng/mL |
| Butalbital (BAR) | 300 ng/mL |
| Oxazepam (BZO) | 300 ng/mL |
| Cocaine (COC) | 300 ng/mL or 150 ng/mL |
| 2-ethylidene-1,5-dimethyl-3,3-diphenylpyrrolidine (EDDP) | 300 ng/mL |
| Methamphetamine (MET) | 1000 ng/mL or 500 ng/mL |
| Methylenedioxymethamphetamine (MDMA) | 500 ng/mL |
| Morphine (MOP 300/OPI 2000) | 2000 ng/mL or 300 ng/mL |
| Methadone (MTD) | 300 ng/mL |
| Oxycodone (OXY) | 100 ng/mL |
| Phencyclidine (PCP) | 25 ng/mL |
10
| Propoxyphene (PPX) | 300 ng/mL |
|---|---|
| Nortriptyline (TCA) | 1000 ng/mL |
| Marijuana (THC) | 50 ng/mL |
Configuration of the First Sign Multi-Drug Screen Test Cup can consist of any combination of the above listed drug analytes.
The test may yield positive results for the prescription drugs Buprenorphine, Oxazepam, Butalbital, Nortriptyline, Propoxyphene and Oxycodone 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. For in vitro diagnostic use only. It is for prescription use.
7. Device Description
The First Sign Multi-Drug Test Dip Card, First Sign Multi-Drug Test Cup, First Sign Multi-Drug Screen Test Dip Card and First Sign Multi-Drug Screen Test Cup are immunochromatographic assays that use a lateral flow system for the qualitative detection of Amphetamine, Oxazepam, Cocaine, Marijuana, Methamphetamine, Morphine, Oxycodone, Butalbital, Methadone, Buprenorphine, Phencyclidine, Methylenedioxymethamphetamine, Tricyclic Antidepressants, EDDP and Propoxyphene (target analytes) in human urine. The products are single-use in vitro diagnostic devices. The Dip Card kits contain a Dip Card device, a package insert and a urine cup for sample collection. The Cup kits contain a Cup device, a package insert and a urine cup for sample collection. Each test device is sealed with a desiccant in an aluminum pouch.
-
- Substantial Equivalence Information
A summary comparison of features of the First Sign Multi-Drug Test Dip Card and First Sign Multi-Drug Test Cup and the predicate devices is provided in following tables.
- Substantial Equivalence Information
Table 1: Features Comparison of First Sign Multi-Drug Test Dip Card and the Predicate Devices
| Item | Device | Predicate - K182701 |
|---|---|---|
| Indication(s) for Use | For the qualitative determination of drugs of abuse in human urine. | Same |
| Calibrator and | ||
| Cut-Off Values | Amphetamine (AMP): 1,000 ng/ml or 500 ng/mL | |
| Oxazepam (BZO):300 ng/ml | ||
| Cocaine (COC): 300 ng/ml or 150 ng/mL | ||
| 11-Nor-Δ9-Tetrahydrocannabinol-9-COOH (THC):50 ng/ml | ||
| Methamphetamine (MET): 1,000 ng/ml or 500 ng/mL | ||
| Morphine (OPI 2000/MOP 300): 2000ng/mL or 300 ng/mL | ||
| Oxycodone (OXY) : 100 ng/ml | ||
| Butalbital (BAR): 300 ng/ml | ||
| Methadone (MTD): 300 ng/ml | Same |
11
| | Buprenorphine (BUP): 10 ng/ml
D,L-Methylenedioxymethamphetamine (MDMA): 500 ng/ml
Phencyclidine (PCP): 25 ng/ml
Nortriptyline (TCA): 1000 ng/ml
2-ethylidene-1,5-dimethyl-3,3- diphenylpyrrolidine (EDDP): 300 ng/ml
Propoxyphene (PPX): 300 ng/ml | |
|----------------|-------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------|------|
| 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 | Cup |
| Table 2: Features Comparison of First Sign Multi-Drug Test Cup Tests and the Predicate | |||
|---|---|---|---|
| Devices | |||
| Item | Device | Predicate - K18270 |
|---|---|---|
| Indication(s) | ||
| for Use | For the qualitative determination of | |
| drugs of abuse in human urine. | Same | |
| Calibrator and | ||
| Cut-Off Values | Amphetamine (AMP): 1,000 ng/ml or 500 ng/mL | |
| Oxazepam (BZO):300 ng/ml | ||
| Cocaine (COC): 300 ng/ml or 150 ng/mL | ||
| 11-Nor-Δ9-Tetrahydrocannabinol-9-COOH (THC):50 | ||
| ng/ml | ||
| Methamphetamine (MET): 1,000 ng/ml or 500 ng/mL | ||
| Morphine (OPI 2000/MOP 300): 2000ng/mL or 300 ng/mL | ||
| Oxycodone (OXY): 100 ng/ml | ||
| Butalbital (BAR): 300 ng/ml | ||
| Methadone (MTD): 300 ng/ml | ||
| Buprenorphine (BUP): 10 ng/ml | ||
| D,L-Methylenedioxymethamphetamine (MDMA): 500 | ||
| ng/ml | ||
| Phencyclidine (PCP): 25 ng/ml | ||
| Nortriptyline (TCA): 1000 ng/ml | ||
| 2-ethylidene-1,5-dimethyl-3,3- diphenylpyrrolidine | ||
| (EDDP): 300 ng/ml | ||
| Propoxyphene (PPX): 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 |
12
| Specimen Type | Human Urine | Same |
|---|---|---|
| Intended Use | For over-the-counter | Same |
| Configurations | Cup | Cup |
Table 3: Features Comparison of First Sign Multi-Drug Screen Test Dip Card and the Predicate Devices
| Item | Device | Predicate - K182701 |
|---|---|---|
| Indication(s) | ||
| for Use | For the qualitative determination of drugs of abuse in human | |
| urine. | Same | |
| Calibrator and | ||
| Cut-Off Values | Amphetamine (AMP): 1,000 ng/ml or 500 ng/mL | |
| Oxazepam (BZO):300 ng/ml | ||
| Cocaine (COC): 300 ng/ml or 150 ng/mL | ||
| 11-Nor-Δ9-Tetrahydrocannabinol-9-COOH (THC):50 ng/ml | ||
| Methamphetamine (MET): 1,000 ng/ml or 500 ng/mL | ||
| Morphine (OPI 2000/MOP 300): 2000ng/mL or 300 ng/mL | ||
| Oxycodone (OXY) : 100 ng/ml | ||
| Butalbital (BAR): 300 ng/ml | ||
| Methadone (MTD): 300 ng/ml | ||
| Buprenorphine (BUP): 10 ng/ml | ||
| D,L-Methylenedioxymethamphetamine (MDMA): 500 | ||
| ng/ml | ||
| Phencyclidine (PCP): 25 ng/ml | ||
| Nortriptyline (TCA): 1000 ng/ml | ||
| 2-ethylidene-1,5-dimethyl-3,3- diphenylpyrrolidine (EDDP): | ||
| 300 ng/ml | ||
| Propoxyphene (PPX): 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 prescription | For over-the-counter |
| Configurations | Dip Card | Cup |
Table 4: Features Comparison of First Sign Multi-Drug Screen Test Cup Tests and the Predicate Devices
| Item | Device | Predicate - K18270 |
|---|---|---|
| Indication(s) | ||
| for Use | For the qualitative determination of | |
| drugs of abuse in human urine. | Same | |
| Calibrator and | ||
| Cut-Off Values | Amphetamine (AMP): 1,000 ng/ml or 500 ng/mL | |
| Oxazepam (BZO):300 ng/ml | ||
| Cocaine (COC): 300 ng/ml or 150 ng/mL | Same |
13
| 11-Nor-Δ9-Tetrahydrocannabinol-9-COOH (THC):50 ng/ml | ||
|---|---|---|
| Methamphetamine (MET): 1,000 ng/ml or 500 ng/mL | ||
| Morphine (OPI 2000/MOP 300): 2000ng/mL or 300 ng/mL | ||
| Oxycodone (OXY): 100 ng/ml | ||
| Butalbital (BAR): 300 ng/ml | ||
| Methadone (MTD): 300 ng/ml | ||
| Buprenorphine (BUP): 10 ng/ml | ||
| D,L-Methylenedioxymethamphetamine (MDMA): 500 ng/ml | ||
| Phencyclidine (PCP): 25 ng/ml | ||
| Nortriptyline (TCA): 1000 ng/ml | ||
| 2-ethylidene-1,5-dimethyl-3,3- diphenylpyrrolidine | ||
| (EDDP): 300 ng/ml | ||
| Propoxyphene (PPX): 300 ng/ml | ||
| Competitive binding, lateral flow | ||
| immunochromatographic assays based on the principle | ||
| of antigen antibody immunochemistry. | ||
| 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 prescription | For over-the-counter |
| Configurations | Cup | Cup |
9. Test Principle
The First Sign Multi-Drug Test Dip Card, First Sign Multi-Drug Test Cup, First Sign Multi-Drug Screen Test Dip Card, and First Sign Multi-Drug Screen Test Cup are rapid tests for the qualitative detection of Amphetamine, Oxazepam, Cocaine, Methamphetamine, Morphine, Oxycodone, Butalbital, Methadone, Buprenorphine, Phencyclidine,
Methylenedioxymethamphetamine, Tricyclic Antidepressants, 2-ethylidene-1,5-dimethyl-3,3diphenylpyrrolidine and Propoxyphene 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 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 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
14
off and +100% cut off. These samples were prepared by spiking drug in negative urine 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 Propoxyphene. The data for AMP1000, COC300 and THC were reported in the cleared K142353. The data for BUP, BAR and MOP 300 were reported in the cleared K152551. The data for BZO, MET1000 and MOP 2000 were reported in the cleared K150162. The data for MTD, PCP and OXY were reported in the cleared K151441. The data for EDDP, MDMA and TCA were reported in the cleared K160793. The data for AMP 500, COC150 and MET 500 were reported in the cleared First Sign submission of K171695.
Propoxyphene
| Dip Card | ||||||||||
|---|---|---|---|---|---|---|---|---|---|---|
| Concentration by | ||||||||||
| LC/MS (ng/mL) | -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 | ||||||||||
| Number | 0 | 80.7 | 165.5 | 248.1 | 339.9 | 416.8 | 497.2 | 558.1 | 677.3 | |
| Lot 1 | 50-/0+ | 50-/0+ | 50-/0+ | 50-/0+ | 4-/46+ | 50+/0- | 50+/0- | 50+/0- | 50+/0- | |
| Lot 2 | 50-/0+ | 50-/0+ | 50-/0+ | 50-/0+ | 3-/47+ | 50+/0- | 50+/0- | 50+/0- | 50+/0- | |
| Lot 3 | 50-/0+ | 50-/0+ | 50-/0+ | 50-/0+ | 4-/46+ | 50+/0- | 50+/0- | 50+/0- | 50+/0- |
| Cup | |||||||||
|---|---|---|---|---|---|---|---|---|---|
| Concentration by | |||||||||
| LC/MS (ng/mL) | |||||||||
| Lot | |||||||||
| Number | -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 | |||||||||
| 0 | 80.7 | 165.5 | 248.1 | 339.9 | 416.8 | 497.2 | 558.1 | 677.3 | |
| Lot 1 | 50-/0+ | 50-/0+ | 50-/0+ | 50-/0+ | 3-/47+ | 50+/0- | 50+/0- | 50+/0- | 50+/0- |
| Lot 2 | 50-/0+ | 50-/0+ | 50-/0+ | 50-/0+ | 2-/48+ | 50+/0- | 50+/0- | 50+/0- | 50+/0- |
| Lot 3 | 50-/0+ | 50-/0+ | 50-/0+ | 50-/0+ | 2-/48+ | 50+/0- | 50+/0- | 50+/0- | 50+/0- |
The cut-off value of 300ng/mL is verified for propoxyphene.
b. Linearity
Not applicable.
- C. Stability
The devices are stable at 4-30 ℃ for 24 months based on the accelerated stability study at 50°C. Real time stability studies are ongoing.
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 lots 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 Dip Card and the Cup formats.
| Acetaminophen | ß-Estradiol | Oxalic acid |
|---|---|---|
| Acetophenetidin | Ethanol | Oxolinic acid |
| N-Acetylprocainamide | Erythromycin | Oxymetazoline |
15
| Acetylsalicylic acid | Fenoprofen | Papaverine |
|---|---|---|
| Albumin | Furosemide | Penicillin G |
| Aminopyrine | Gentisic acid | Perphenazine |
| Amoxicillin | Hemoglobin | Phenelzine |
| Ampicillin | Hydralazine | Prednisone |
| Apomorphine | Hydrochlorothiazide | (±)-Propranolol |
| Ascorbic acid | Hydrocortisone | Pseudoephedrine |
| Aspartame | O-Hydroxyhippuric acid | Quinine |
| Atropine | 3-Hydroxytyramine | Ranitidine |
| Benzilic acid | Ibuprofen | Salicylic acid |
| Benzoic acid | Isoproterenol | Serotonin (5- Hydroxytyramine) |
| Bilirubin | Isoxsuprine | Sulfamethazine |
| Chloral hydrate | Ketamine | Sulindac |
| Chloramphenicol | Ketoprofen | Tetrahydrocortisone 3-(β- |
| Dglucuronide) | ||
| Chlorothiazide | Labetalol | Tetrahydrocortisone 3-acetate |
| Chlorpromazine | Loperamide | Tetrahydrozoline |
| Cholesterol | Meperidine | Thiamine |
| Clonidine | Meprobamate | Thioridazine |
| Cortisone | Methoxyphenamine | Triamterene |
| (-)-Cotinine | Nalidixic acid | Trifluoperazine |
| Creatinine | Naloxone | Trimethoprim |
| Deoxycorticosterone | Naltrexone | DL-Tryptophan |
| Dextromethorphan | Naproxen | Tyramine |
| Diclofenac | Niacinamide | DL-Tyrosine |
| Diflunisal | Nifedipine | Uric acid |
| Digoxin | Norethindrone | Verapamil |
| Diphenhydramine | Noscapine | Zomepirac |
| Ecgonine methyl ester | (±)-Octopamine |
e. Specificity
To test specificity, drug metabolites and other structurally related compounds that are likely to cross-react in urine samples were spiked into negative urine and were tested using three lots of each device. The lowest concentration that caused a positive result for each compound are listed below for Propoxyphene. The data for AMP1000, COC300 and THC were reported in the cleared K142353. The data for BUP, BAR and MOP 300 were reported in the cleared K152551. The data for BZO, MET1000 and MOP 2000 were reported in the cleared K150162. The data for MTD, PCP and OXY were reported in the cleared K151441. The data for EDDP, MDMA and TCA were reported in the cleared K160793. The data for AMP 500, COC150 and MET 500 were reported in the cleared First Sign submission of K171695. There were no differences observed between the First Sign Multi-Drug Test Dip Card and First Sign Multi-Drug Test Cup.
| Propoxyphene
(Cut-off=300 ng/mL) | Result
Positive at(ng/ml) | %
Cross-Reactivity |
|-------------------------------------|------------------------------|-----------------------|
| d-Propoxyphene | 300 | 100% |
| Norpropoxyphene | 1500 | 20% |
16
f. Effect of Urine Specific Gravity and Urine pH
To investigate the 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 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. There were no differences observed between the First Sign Multi-Drug Test Dip Card and First Sign Multi-Drug Test Cup.
2. Comparison Studies
Method comparison studies for the First Sign Multi-Drug Test Dip Card and the First Sign Multi-Drug Test Cup were performed in-house with three laboratory assistants for each device. Operators ran 80 (40 negative and 40 positive) unaltered clinical samples for each drug. The samples were blind labeled and compared to LC/MS results. The results are presented in the tables below for Propoxyphene. The data for AMP1000, COC300 and THC were reported in the cleared K142353. The data for BUP, BAR and MOP 300 were reported in the cleared K152551. The data for BZO, MET1000 and MOP 2000 were reported in the cleared K150162. The data for MTD, PCP and OXY were reported in the cleared K151441. The data for EDDP, MDMA and TCA were reported in the cleared K160793. The data for AMP 500, COC150 and MET 500 were reported in the cleared First Sign submission of K171695.
Propoxyphene
| Dip Card | | Negative | Low Negative by
LC/MS
(less than
-50%) | Near Cutoff
Negative by
LC/MS
(Between
-50% and
cutoff) | Near Cutoff
Positive by
LC/MS
(Between the
cutoff and
+50%) | High Positive
by LC/MS
(greater than
+50%) |
|----------|----------|----------|-------------------------------------------------|------------------------------------------------------------------------|----------------------------------------------------------------------------|-----------------------------------------------------|
| Viewer | Positive | 0 | 0 | 1 | 19 | 20 |
| A | Negative | 10 | 15 | 14 | 1 | 0 |
| Viewer | Positive | 0 | 0 | 1 | 20 | 20 |
| B | Negative | 10 | 15 | 14 | 0 | 0 |
| Viewer | Positive | 0 | 0 | 0 | 20 | 20 |
| C | Negative | 10 | 15 | 15 | 0 | 0 |
Discordant Results
| Viewer | Sample Number | LC/MS Result | Dip Card
Viewer Results |
|----------|---------------|--------------|----------------------------|
| Viewer A | 20200406-030 | 268.2 | Positive |
| Viewer B | 20200408-001 | 277.6 | Positive |
| Viewer A | 20200407-003 | 332.0 | Negative |
17
| Cup | | Negative | Low
Negative by
LC/MS
(less than
-50%) | Near Cutoff
Negative by
LC/MS
(Between
-50% and
cutoff) | Near Cutoff
Positive by
LC/MS
(Between the
cutoff and
+50%) | High Positive
by LC/MS
(greater than
+50%) |
|--------|----------|----------|----------------------------------------------------|------------------------------------------------------------------------|----------------------------------------------------------------------------|-----------------------------------------------------|
| Viewer | Positive | 0 | 0 | 0 | 19 | 20 |
| A | Negative | 10 | 15 | 15 | 1 | 0 |
| Viewer | Positive | 0 | 0 | 1 | 20 | 20 |
| B | Negative | 10 | 15 | 14 | 0 | 0 |
| Viewer | Positive | 0 | 0 | 1 | 20 | 20 |
| C | Negative | 10 | 15 | 14 | 0 | 0 |
Discordant Results
| Viewer | Sample Number | LC/MS Result | Cup
Viewer Results |
|----------|---------------|--------------|-----------------------|
| Viewer B | 20200408-032 | 292.8 | Positive |
| Viewer C | 20200408-032 | 292.8 | Positive |
| Viewer A | 20200406-010 | 327.4 | Negative |
Lay-user study
A lay user study was performed at three intended user sites with 280 lay persons for each device format. The lay users had diverse educational and professional backgrounds and ranged in age from 18 to > 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. Typical Results are shown below.
First Sign Multi-Drug Test
Configuration 1 (including AMP 500, MET 500, MOP 300, COC 150):
| Assay | Results | Concentration | ||||||
|---|---|---|---|---|---|---|---|---|
| -100% | ||||||||
| cutoff | -75% | |||||||
| cutoff | -50% | |||||||
| cutoff | -25% | |||||||
| cutoff | +25% | |||||||
| cutoff | +50% | |||||||
| cutoff | +75% | |||||||
| cutoff | ||||||||
| Negative | 20 | 20 | 20 | 20 | 1 | 0 | 0 | |
| Positive | 0 | 0 | 0 | 0 | 19 | 20 | 20 | |
| AMP 500 | Total | 20 | 20 | 20 | 20 | 20 | 20 | 20 |
| Percentage of | ||||||||
| correct results (%) | 100% | 100% | 100% | 100% | 95% | 100% | 100% | |
| Negative | 20 | 20 | 20 | 20 | 1 | 0 | 0 | |
| BAR 300 | Positive | 0 | 0 | 0 | 0 | 19 | 20 | 20 |
| Total | 20 | 20 | 20 | 20 | 20 | 20 | 20 | |
| Percentage of | 100% | 100% | 100% | 100% | 95% | 100% | 100% | |
| correct results (%) | ||||||||
| BZO 300 | Negative | 20 | 20 | 20 | 20 | 0 | 0 | 0 |
| Positive | 0 | 0 | 0 | 0 | 20 | 20 | 20 | |
| Total | 20 | 20 | 20 | 20 | 20 | 20 | 20 | |
| Percentage of | ||||||||
| correct results (%) | 100% | 100% | 100% | 100% | 100% | 100% | 100% | |
| BUP 10 | Negative | 20 | 20 | 20 | 19 | 0 | 0 | 0 |
| Positive | 0 | 0 | 0 | 1 | 20 | 20 | 20 | |
| Total | 20 | 20 | 20 | 20 | 20 | 20 | 20 | |
| Percentage of | ||||||||
| correct results (%) | 100% | 100% | 100% | 95% | 100% | 100% | 100% | |
| COC 150 | Negative | 20 | 20 | 20 | 19 | 0 | 0 | 0 |
| Positive | 0 | 0 | 0 | 1 | 20 | 20 | 20 | |
| Total | 20 | 20 | 20 | 20 | 20 | 20 | 20 | |
| Percentage of | ||||||||
| correct results (%) | 100% | 100% | 100% | 95% | 100% | 100% | 100% | |
| EDDP 300 | Negative | 20 | 20 | 20 | 19 | 0 | 0 | 0 |
| Positive | 0 | 0 | 0 | 1 | 20 | 20 | 20 | |
| Total | 20 | 20 | 20 | 20 | 20 | 20 | 20 | |
| Percentage of | ||||||||
| correct results (%) | 100% | 100% | 100% | 95% | 100% | 100% | 100% | |
| MDMA 500 | Negative | 20 | 20 | 20 | 19 | 0 | 0 | 0 |
| Positive | 0 | 0 | 0 | 1 | 20 | 20 | 20 | |
| Total | 20 | 20 | 20 | 20 | 20 | 20 | 20 | |
| Percentage of | ||||||||
| correct results (%) | 100% | 100% | 100% | 95% | 100% | 100% | 100% | |
| MET 500 | Negative | 20 | 20 | 20 | 20 | 1 | 0 | 0 |
| Positive | 0 | 0 | 0 | 0 | 19 | 20 | 20 | |
| Total | 20 | 20 | 20 | 20 | 20 | 20 | 20 | |
| Percentage of | ||||||||
| correct results (%) | 100% | 100% | 100% | 100% | 95% | 100% | 100% | |
| MOP 300 | Negative | 20 | 20 | 20 | 19 | 0 | 0 | 0 |
| Positive | 0 | 0 | 0 | 1 | 20 | 20 | 20 | |
| Total | 20 | 20 | 20 | 20 | 20 | 20 | 20 | |
| Percentage of | ||||||||
| correct results (%) | 100% | 100% | 100% | 100% | 95% | 100% | 100% | |
| Negative | 20 | 20 | 20 | 20 | 1 | 0 | 0 | |
| Positive | 0 | 0 | 0 | 0 | 19 | 20 | 20 | |
| MTD 300 | Total | 20 | 20 | 20 | 20 | 20 | 20 | 20 |
| Percentage of | ||||||||
| correct results (%) | 100% | 100% | 100% | 100% | 95% | 100% | 100% | |
| Negative | 20 | 20 | 20 | 20 | 0 | 0 | 0 | |
| Positive | 0 | 0 | 0 | 0 | 20 | 20 | 20 | |
| OXY 100 | Total | 20 | 20 | 20 | 20 | 20 | 20 | 20 |
| Percentage of | ||||||||
| correct results (%) | 100% | 100% | 100% | 100% | 100% | 100% | 100% | |
| Negative | 20 | 20 | 20 | 19 | 0 | 0 | 0 | |
| Positive | 0 | 0 | 0 | 1 | 20 | 20 | 20 | |
| PCP 25 | Total | 20 | 20 | 20 | 20 | 20 | 20 | 20 |
| Percentage of | ||||||||
| correct results (%) | 100% | 100% | 100% | 95% | 100% | 100% | 100% | |
| Negative | 20 | 20 | 20 | 20 | 1 | 0 | 0 | |
| Positive | 0 | 0 | 0 | 0 | 19 | 20 | 20 | |
| PPX 300 | Total | 20 | 20 | 20 | 20 | 20 | 20 | 20 |
| Percentage of | ||||||||
| correct results (%) | 100% | 100% | 100% | 100% | 95% | 100% | 100% | |
| Negative | 20 | 20 | 20 | 19 | 0 | 0 | 0 | |
| Positive | 0 | 0 | 0 | 1 | 20 | 20 | 20 | |
| TCA 1000 | Total | 20 | 20 | 20 | 20 | 20 | 20 | 20 |
| Percentage of | ||||||||
| correct results (%) | 100% | 100% | 100% | 95% | 100% | 100% | 100% | |
| Negative | 20 | 20 | 20 | 19 | 0 | 0 | 0 | |
| Positive | 0 | 0 | 0 | 1 | 20 | 20 | 20 | |
| THC 50 | Total | 20 | 20 | 20 | 20 | 20 | 20 | 20 |
| Percentage of | ||||||||
| correct results (%) | 100% | 100% | 100% | 95% | 100% | 100% | 100% | |
| Assay | Results | Concentration | ||||||
| -100% | ||||||||
| cutoff | -75% | |||||||
| cutoff | -50% | |||||||
| cutoff | -25% | |||||||
| cutoff | +25% | |||||||
| cutoff | +50% | |||||||
| cutoff | +75% | |||||||
| cutoff | ||||||||
| Negative | 20 | 20 | 20 | 19 | 0 | 0 | 0 | |
| Positive | 0 | 0 | 0 | 1 | 20 | 20 | 20 | |
| AMP 1000 | Total | 20 | 20 | 20 | 20 | 20 | 20 | 20 |
| Percentage of | ||||||||
| correct results (%) | 100% | 100% | 100% | 95% | 100% | 100% | 100% | |
| Negative | 20 | 20 | 20 | 19 | 0 | 0 | 0 | |
| Positive | 0 | 0 | 0 | 1 | 20 | 20 | 20 | |
| BAR 300 | Total | 20 | 20 | 20 | 20 | 20 | 20 | 20 |
| Percentage of | ||||||||
| correct results (%) | 100% | 100% | 100% | 95% | 100% | 100% | 100% | |
| Negative | 20 | 20 | 20 | 20 | 1 | 0 | 0 | |
| Positive | 0 | 0 | 0 | 0 | 19 | 20 | 20 | |
| BZO 300 | Total | 20 | 20 | 20 | 20 | 20 | 20 | 20 |
| Percentage of | ||||||||
| correct results (%) | 100% | 100% | 100% | 100% | 95% | 100% | 100% | |
| Negative | 20 | 20 | 20 | 19 | 0 | 0 | 0 | |
| Positive | 0 | 0 | 0 | 1 | 20 | 20 | 20 | |
| BUP 10 | Total | 20 | 20 | 20 | 20 | 20 | 20 | 20 |
| Percentage of | ||||||||
| correct results (%) | 100% | 100% | 100% | 95% | 100% | 100% | 100% | |
| Negative | 20 | 20 | 20 | 20 | 1 | 0 | 0 | |
| Positive | 0 | 0 | 0 | 0 | 19 | 20 | 20 | |
| COC 300 | Total | 20 | 20 | 20 | 20 | 20 | 20 | 20 |
| Percentage of | ||||||||
| correct results (%) | 100% | 100% | 100% | 100% | 95% | 100% | 100% | |
| Negative | 20 | 20 | 20 | 20 | 1 | 0 | 0 | |
| Positive | 0 | 0 | 0 | 0 | 19 | 20 | 20 | |
| EDDP 300 | Total | 20 | 20 | 20 | 20 | 20 | 20 | 20 |
| Percentage of | ||||||||
| correct results (%) | 100% | 100% | 100% | 100% | 95% | 100% | 100% | |
| Negative | 20 | 20 | 20 | 20 | 1 | 0 | 0 | |
| MDMA 500 | Positive | 0 | 0 | 0 | 0 | 19 | 20 | 20 |
| Total | 20 | 20 | 20 | 20 | 20 | 20 | 20 | |
| Percentage of | ||||||||
| correct results (%) | 100% | 100% | 100% | 100% | 95% | 100% | 100% | |
| MET 1000 | Negative | 20 | 20 | 20 | 19 | 0 | 0 | |
| Positive | 0 | 0 | 0 | 1 | 20 | 20 | 20 | |
| Total | 20 | 20 | 20 | 20 | 20 | 20 | 20 | |
| Percentage of | ||||||||
| correct results (%) | 100% | 100% | 100% | 95% | 100% | 100% | 100% | |
| OPI 2000 | Negative | 20 | 20 | 20 | 19 | 0 | 0 | 0 |
| Positive | 0 | 0 | 0 | 1 | 20 | 20 | 20 | |
| Total | 20 | 20 | 20 | 20 | 20 | 20 | 20 | |
| Percentage of | ||||||||
| correct results (%) | 100% | 100% | 100% | 95% | 100% | 100% | 100% | |
| MTD 300 | Negative | 20 | 20 | 20 | 19 | 0 | 0 | 0 |
| Positive | 0 | 0 | 0 | 1 | 20 | 20 | 20 | |
| Total | 20 | 20 | 20 | 20 | 20 | 20 | 20 | |
| Percentage of | ||||||||
| correct results (%) | 100% | 100% | 100% | 95% | 100% | 100% | 100% | |
| OXY 100 | Negative | 20 | 20 | 20 | 19 | 0 | 0 | 0 |
| Positive | 0 | 0 | 0 | 1 | 20 | 20 | 20 | |
| Total | 20 | 20 | 20 | 20 | 20 | 20 | 20 | |
| Percentage of | ||||||||
| correct results (%) | 100% | 100% | 100% | 95% | 100% | 100% | 100% | |
| PCP 25 | Negative | 20 | 20 | 20 | 20 | 1 | 0 | 0 |
| Positive | 0 | 0 | 0 | 0 | 19 | 20 | 20 | |
| Total | 20 | 20 | 20 | 20 | 20 | 20 | 20 | |
| Percentage of | ||||||||
| correct results (%) | 100% | 100% | 100% | 100% | 95% | 100% | 100% | |
| PPX 300 | Negative | 20 | 20 | 20 | 20 | 1 | 0 | 0 |
| Positive | 0 | 0 | 0 | 0 | 19 | 20 | 20 | |
| Total | 20 | 20 | 20 | 20 | 20 | 20 | 20 | |
| Percentage of | ||||||||
| correct results (%) | 100% | 100% | 100% | 100% | તે તે જેન્જી જેવી સવલતો પ્રાપ્ય થયેલી છે. આ ગામનાં લોકોનો મુખ્ય વ્યવસાય ખેતી, ખેતમજૂરી તેમ જ પશુપાલન છે. આ ગામમાં પ્રાથમિક શાળા, પંચાયતઘર, આંગણવાડી તેમ જ દૂધની ડેરી જેવી સવલ | 100% | 100% | |
| TCA 1000 | Negative | 20 | 20 | 20 | 20 | 1 | 0 | 0 |
| Positive | 0 | 0 | 0 | 0 | 19 | 20 | 20 | |
| Total | 20 | 20 | 20 | 20 | 20 | 20 | 20 | |
| Percentage of | ||||||||
| correct results (%) | 100% | 100% | 100% | 100% | તે તે જેન્જી જેવી સવલતો પ્રાપ્ય થયેલી છે. આ ગામનાં લોકોનો મુખ્ય વ્યવસાય ખેતી, ખેતમજૂરી તેમ જ પશુપાલન છે. આ ગામમાં પ્રાથમિક શાળા, પંચાયતઘર, આંગણવાડી તેમ જ દૂધની ડેરી જેવી સવલ | 100% | 100% | |
| THC 50 | Negative | 20 | 20 | 20 | 19 | 0 | 0 | 0 |
| Positive | 0 | 0 | 0 | 1 | 20 | 20 | 20 | |
| Total | 20 | 20 | 20 | 20 | 20 | 20 | 20 | |
| Percentage of | ||||||||
| correct results (%) | 100% | 100% | 100% | તે જેન્જી જેવી સવલતો પ્રાપ્ય થયેલી છે. આ ગામનાં લોકોનો મુખ્ય વ્યવસાય ખેતી, ખેતમજૂરી તેમ જ પશુપાલન છે. આ ગામમાં પ્રાથમિક શાળા, પંચાયતઘર, આંગણવાડી તેમ જ દૂધની ડેરી જેવી સવલતો | 100% | 100% | 100% |
18
19
Configuration 2 (AMP 1000, MET 1000, MOP 2000 (OPI), COC 300):
20
21
22
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 First Sign Multi-Drug Test Dip Card, First Sign Multi-Drug Test Cup, First Sign Multi-Drug Screen Test Dip Card and First Sign Multi-Drug Screen Test Cup are substantially equivalent to the predicate.