(28 days)
Not Found
No
The device description and performance studies focus on immunochromatographic assays and do not mention any AI or ML components for analysis or interpretation.
No
Explanation: This device is an in vitro diagnostic (IVD) device used for qualitative and simultaneous detection of various substances in human urine. It is explicitly stated as "for in vitro diagnostic use only" and provides "only preliminary results." It does not provide any treatment or therapy.
Yes
The "Intended Use / Indications for Use" section explicitly states, "It is for in vitro diagnostic use only."
No
The device description explicitly states it is a "cup format" and an "immunochromatographic assay that use a lateral flow system," indicating it is a physical hardware device for testing urine samples.
Yes, this device is an IVD (In Vitro Diagnostic).
Here's why:
- Explicit Statement: The "Intended Use / Indications for Use" section explicitly states: "It is for in vitro diagnostic use only."
- Nature of the Test: The device performs a test on a biological sample (human urine) to detect the presence of specific substances (drugs). This is a core characteristic of an in vitro diagnostic device, which is used to examine specimens from the human body to provide information for diagnosis, monitoring, or screening.
- Intended Use: The intended use is for the qualitative and simultaneous detection of various drugs in human urine, which is a diagnostic purpose (even if preliminary).
N/A
Intended Use / Indications for Use
AllTest Multi-Drug Urine Test Cup tests are competitive binding, lateral flow immunochromatographic assays for qualitative and simultaneous detection of Amphetamine, Secobarbital, Oxazepam, Cocaine, Methamphetamine, Methylenedioxymetamine, Morphine, Methadone, Oxycodone, Phencyclidine, Nortriptyline, Marijuana and Fentanyl in human urine at the cutoff concentrations of:
| Drug (Identifier) | Cut-off level |
|---|---|
| Amphetamine (AMP) | 500 ng/mL |
| Buprenorphine (BUP) | 10 ng/mL |
| Secobarbital (BAR) | 300 ng/mL |
| Oxazepam (BZO) | 300 ng/mL |
| Cocaine (COC) | 150 ng/mL |
| Methamphetamine (MET) | 500 ng/mL |
| Methylenedioxymethamphetamine (MDMA) | 500 ng/mL |
| Morphine (MOP/OPI) | 300 ng/mL |
| Methadone (MTD) | 300 ng/mL |
| Oxycodone (OXY) | 100 ng/mL |
| Phencyclidine (PCP) | 25 ng/mL |
| Nortriptyline (TCA) | 1000 ng/mL |
| Marijuana (THC) | 50 ng/mL |
| Fentanyl(FYL) | 1 ng/mL |
AllTest Multi-Drug Urine Test Cup can be a single drug test cup or used for any combination of the above listed analytes. It is for in vitro diagnostic use only. It is intended for OTC use.
The tests may yield positive results for the prescription drugs when taken at or above prescribed doses. It is not intended to distinguish between prescription use or abuse of these crugs. Clinical consideration and professional judgment should be applied to any drug of abuse test result, particularly in evaluating a preliminary positive result.
The tests provide only preliminary results. To obtain a confirmed analytical result, a more specific alternate chemical method must be used. GC/MS or LC/MS is the recommended confirmatory method.
AllTest Multi-Drug Rapid Urine Test Cup tests are competitive binding, lateral flow immunochromatographic assays for qualitative and simultaneous detection of Amphetamine, Secobarbital, Oxazepam, Cocaine, Methamphetamine, Methylenedioxymetamine, Morphine, Methadone, Oxycodone, Phencyclidine, Nortriptyline, Marijuana and Fentanyl in human urine at the cutoff concentrations of:
| Drug (Identifier) | Calibrator | Cut-off (ng/mL) |
|---|---|---|
| Amphetamine (AMP) | d-Amphetamine | 500 |
| Buprenorphine (BUP) | Buprenorphine | 10 |
| Secobarbital (BAR) | Secobarbital | 300 |
| Oxazepam (BZO) | Oxazepam | 300 |
| Cocaine (COC) | Benzoylecgonine | 150 |
| Methamphetamine (MET) | d-Methamphetamine | 500 |
| Methylenedioxymethamphetamine (MDMA) | d,l-Methylenedioxymethamphetamine | 500 |
| Morphine (MOP/OPI) | Morphine | 300 |
| Methadone (MTD) | Methadone | 300 |
| Oxycodone (OXY) | Oxycodone | 100 |
| Phencyclidine (PCP) | Phencyclidine | 25 |
| Nortriptyline (TCA) | Nortriptyline | 1000 |
| Marijuana (THC) | 11-nor-Δ9-THC-9 COOH | 50 |
| Fentanyl(FYL) | Fentanyl | 1 |
AllTest Multi-Drug Rapid Urine Test Cup can be a single drug test cup or used for any combination of the above listed analytes. It is for in vitro diagnostic use only.
The tests may yield positive results for the prescription drugs 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 applied to any drug of abuse test result, particularly in evaluating a preliminary positive result.
The tests provide only preliminary results. To obtain a confirmed analytical result, a more specific alternate chemical method must be used. GC/MS or LC/MS is the recommended confirmatory method.
Product codes (comma separated list FDA assigned to the subject device)
NFT, PTH, NGL, NFV, NFY, PTG, NGG, NGM, QAW, NFW
Device Description
AllTest Multi-Drug Urine Test Cup and AllTest Multi-Drug Rapid Urine Test Cup are immunochromatographic assays that use a lateral flow system for the qualitative detection of single or multiple drugs in human urine.
The devices are a cup format. Each test device is sealed with sachets of desiccant in an aluminum pouch. The device is in a ready-to-use format and no longer requires assembly before use.
Mentions image processing
Not Found
Mentions AI, DNN, or ML
Not Found
Input Imaging Modality
Not Found
Anatomical Site
human urine
Indicated Patient Age Range
Not Found
Intended User / Care Setting
OTC 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/Reproducibility):
Precision studies were carried out for samples with concentrations of +100% cutoff, +75% cutoff, +50% cutoff, +25% cutoff, cutoff, -25% cutoff, -50% cutoff, -75% cut off and -100% cutoff. Samples were prepared by spiking target drugs in drug-free urine samples. Each drug concentration was confirmed by LC-MS/MS. For each concentration, tests were performed two runs per day for 25 days using three lots of test cups.
The results for each drug (AMP, BAR, BUP, BZO, MDMA, MET, MOP/OPI, MTD, OXY, PCP, TCA, THC, COC, FYL) and each Lot Number (Lot 1, Lot 2, Lot 3) show the count of negative (-) and positive (+) results out of 50 tests at various concentrations relative to the cutoff. For example, for AMP 500, at +100% cutoff, all 50 tests across all 3 lots were positive (0-/50+). At -100% cutoff, all 50 tests across all 3 lots were negative (50-/0+). At the cutoff concentration, the results show a mix of negative and positive results, e.g., for AMP, Lot 1: 23-/27+, Lot 2: 22-/28+, Lot 3: 20-/30+.
Analytical Performance (Linearity/assay reportable range):
Not applicable. This device is intended for qualitative use only.
Analytical Performance (Stability):
The device is stable at 2-30℃ for 24 months based on real time stability study.
Analytical Performance (Analytical specificity/Interference):
Specificity was tested using drug metabolites and other components spiked into drug-free urine samples using three lots of the device. Percent cross-reactivity was calculated as (cutoff concentration / concentration of analyte yielding positive result) * 100.
Interference by pH and specific gravity were also evaluated using pooled urine specimens at 0 (drug-free), 50% below, and 50% above corresponding cutoffs. pH levels of 4 to 9 and specific gravity levels of 1.000 to 1.035 did not affect the assay results.
Method Comparison Study:
The method comparison studies for the device were performed in-house with three operators. Operators ran 80 (40 negative and 40 positive) unaltered urine clinical samples for each drug. The samples were blind labeled and compared to LC-MS/MS results. The results are presented in tables showing positive and negative results for each drug by each operator across different concentration ranges relative to the cutoff (Drug-Free, Low Negative, Near Cutoff Negative, Near Cutoff Positive, High Positive).
For example, for AMP, Operator A had 0 positive out of 12 drug-free samples, 0 positive out of 13 low negative samples, 1 positive out of 14 near cutoff negative samples, 9 positive out of 9 near cutoff positive samples, and 30 positive out of 30 high positive samples. (The total sample number per concentration category varies).
Key results were presented as discordant results, listing specific sample numbers, LC/MS/MS results, and whether the device result was accurate.
Lay Person Study:
A lay user study was performed at three intended user sites with 140 lay persons (51 male, 89 female, age range 20 to > 50). Urine samples were prepared at -100%, +/-75%, +/-50%, +/-25% of the cutoff by spiking drug(s) into drug-free pooled urine specimens, and confirmed by LC-MS/MS. Each participant received 1 blind-labeled sample and a device with instructions.
The results are summarized showing the number of negative and positive results for each drug at different concentrations. Agreement percentages were calculated. For example, for AMP 500, at -100% cutoff, there was 100% agreement for negative results (20 negative, 0 positive). At +100% cutoff, there was 100% agreement for positive results (0 negative, 20 positive). At -25% cutoff, the agreement was 90.0% (18 negative, 2 positive). At +25% cutoff, the agreement was 90.0% (2 negative, 18 positive).
Participants were given surveys on the ease of understanding the instruction for use. All participants indicated that the device instruction is easy to understand and follow. A Flesch-Kincaid reading analysis was performed on each package insert and the scores revealed a reading Grade Level of 7.
Key Metrics (Sensitivity, Specificity, PPV, NPV, etc.)
Key metrics are presented in terms of counts of positive/negative results at various concentrations and agreement percentages for the lay person study. Specific sensitivity, specificity, PPV, NPV values are not explicitly calculated or presented as single metrics in the summary.
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.
AllTest Multi-Drug Rapid Test Cup (K233019)
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.
Not Found
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: the Department of Health & Human Services seal on the left and the FDA acronym and name on the right. The FDA acronym is in a blue square, and the full name "U.S. Food & Drug Administration" is in blue text to the right of the square.
Hangzhou Alltest Biotech Co.,Ltd % Jenny Xia Director LSI International Inc. 504 East Diamond Ave., Suite H Gaithersburg, Maryland 20877
Re: K241428
Trade/Device Name: AllTest Multi-Drug Urine Test Cup ; AllTest Multi-Drug Rapid Urine Test Cup Regulation Number: 21 CFR 862.3100 Regulation Name: Amphetamine test system Regulatory Class: Class II Product Code: NFT, PTH, NGL, NFV, NFY, PTG, NGG, NGM, QAW, NFW Dated: May 16, 2024 Received: May 20, 2024
Dear Jenny Xia:
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 (the 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 available 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.
Additional information about changes that may require a new premarket notification are provided in the FDA guidance documents entitled "Deciding When to Submit a 510(k) for a Change to an Existing Device" (https://www.fda.gov/media/99812/download) and "Deciding When to Submit a 510(k) for a Software Change to an Existing Device" (https://www.fda.gov/media/99785/download).
Your device is also subject to, among other requirements, the Quality System (QS) regulation (21 CFR Part 820), which includes, but is not limited to, 21 CFR 820.30, Design controls; 21 CFR 820.90, Nonconforming product; and 21 CFR 820.100, Corrective and preventive action. Please note that regardless of whether a change requires premarket review, the QS regulation requires device manufacturers to review and approve
1
changes to device design and production (21 CFR 820.70) and document changes and approvals in the device master record (21 CFR 820.181).
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 Part 803) for devices or postmarketing safety reporting (21 CFR Part 4, Subpart B) for combination products (see https://www.fda.gov/combination-products/guidance-regulatory-information/postmarketing-safetyreporting-combination-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 Part 4, Subpart A) for combination products; and, if applicable, the electronic product radiation control provisions (Sections 531-542 of the Act); 21 CFR Parts 1000-1050.
Also, please note the regulation entitled, "Misbranding by reference to premarket notification" (21 CFR 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,
Joseph A.
Kotarek -S
Digitally signed by Joseph A. Kotarek -S Date: 2024.06.17 15:25:55 -04'00'
Joseph Kotarek Branch Chief for Toxicology Division of Chemistry and Toxicology Devices OHT7: Office of In Vitro Diagnostics Office of Product Evaluation and Quality Center for Devices and Radiological Health
Enclosure
2
Indications for Use
510(k) Number (if known) K241428
Device Name
AllTest Multi-Drug Urine Test Cup AllTest Multi-Drug Rapid Urine Test Cup
Indications for Use (Describe)
AllTest Multi-Drug Urine Test Cup tests are competitive binding, lateral flow immunochromatographic assays for qualitative and simultaneous detection of Amphetamine, Secobarbital, Oxazepam, Cocaine, Methamphetamine, Methylenedioxymetamine, Morphine, Methadone, Oxycodone, Phencyclidine, Nortriptyline, Marijuana and Fentanyl in human urine at the cutoff concentrations of:
| Drug (Identifier) | Cut-off level |
|---|---|
| Amphetamine (AMP) | 500 ng/mL |
| Buprenorphine (BUP) | 10 ng/mL |
| Secobarbital (BAR) | 300 ng/mL |
| Oxazepam (BZO) | 300 ng/mL |
| Cocaine (COC) | 150 ng/mL |
| Methamphetamine (MET) | 500 ng/mL |
| Methylenedioxymethamphetamine (MDMA) | 500 ng/mL |
| Morphine (MOP/OPI) | 300 ng/mL |
| Methadone (MTD) | 300 ng/mL |
| Oxycodone (OXY) | 100 ng/mL |
| Phencyclidine (PCP) | 25 ng/mL |
| Nortriptyline (TCA) | 1000 ng/mL |
| Marijuana (THC) | 50 ng/mL |
| Fentanyl(FYL) | 1 ng/mL |
AllTest Multi-Drug Urine Test Cup can be a single drug test cup or used for any combination of the above listed analytes. It is for in vitro diagnostic use only. It is intended for OTC use.
The tests may yield positive results for the prescription drugs when taken at or above prescribed doses. It is not intended to distinguish between prescription use or abuse of these crugs. Clinical consideration and professional judgment should be applied to any drug of abuse test result, particularly in evaluating a preliminary positive result.
The tests provide only preliminary results. To obtain a confirmed analytical result, a more specific alternate chemical method must be used. GC/MS or LC/MS is the recommended confirmatory method.
AllTest Multi-Drug Rapid Urine Test Cup tests are competitive binding, lateral flow immunochromatographic assays for qualitative and simultaneous detection of Amphetamine, Secobarbital, Oxazepam, Cocaine,
Methamphetamine, Methylenedioxymetamine, Morphine, Methadone, Oxycodone, Phencyclidine, Nortriptyline, Marijuana and Fentanyl in human urine at the cutoff concentrations of:
| Drug (Identifier) | Calibrator | Cut-off (ng/mL) |
|---|---|---|
| Amphetamine (AMP) | d-Amphetamine | 500 |
| Buprenorphine (BUP) | Buprenorphine | 10 |
| Secobarbital (BAR) | Secobarbital | 300 |
| Oxazepam (BZO) | Oxazepam | 300 |
| Cocaine (COC) | Benzoylecgonine | 150 |
| Methamphetamine (MET) | d-Methamphetamine | 500 |
| Methylenedioxymethamphetamine (MDMA) | d,l-Methylenedioxymethamphetamine | 500 |
| Morphine (MOP/OPI) | Morphine | 300 |
| Methadone (MTD) | Methadone | 300 |
| Oxycodone (OXY) | Oxycodone | 100 |
| Phencyclidine (PCP) | Phencyclidine | 25 |
3
| Nortriptyline (TCA) | Nortriptyline | 1000 |
|---|---|---|
| Marijuana (THC) | 11-nor-Δ9-THC-9 COOH | 50 |
| Fentanyl(FYL) | Fentanyl | 1 |
AllTest Multi-Drug Rapid Urine Test Cup can be a single drug test cup or used for any combination of the above listed analytes. It is for in vitro diagnostic use only.
The tests may yield positive results for the prescription drugs 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 applied to any drug of abuse test result, particularly in evaluating a preliminary positive result.
The tests provide only preliminary results. To obtain a confirmed analytical result, a more specific alternate chemical method must be used. GC/MS or LC/MS is the recommended confirmatory method.
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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510(k) SUMMARY K241428
- June 15, 2024 1. Date: Hangzhou AllTest Biotech Co., Ltd. 2. Submitter: Plant Bldg. 3, 4, 5, No. 550 Yinhai Street, Baiyang Street, Hangzhou ETDZ, Jianggan District Contact person: 3. Jenny Xia LSI International Inc. 504 East Diamond Ave., Suite H Gaithersburg, MD 20877 Telephone: 301-525-6856 Email: jxia@lsi-consulting.org
- Device Name: AllTest Multi-Drug Urine Test Cup 4. AllTest Multi-Drug Rapid Urine Test Cup Classification: 5. Class II
| Product Code
| Target Drug | Regulation Section | Panel |
|---|---|---|
| NFT | ||
| Amphetamine (AMP) | 862.3100, Amphetamine Test System | Toxicology |
| PTH | ||
| Secobarbital (BAR) | 862.3150, Barbiturate Test System | Toxicology |
| NGL | ||
| Buprenorphine (BUP) | ||
| Fentanyl (FYL) | ||
| Morphine (MOP/OPI) | ||
| Oxycodone (OXY) | 862.3650, Opiate Test System | Toxicology |
| NFV | ||
| Oxazepam (BZO) | 862.3170, Benzodiazepine Test System | Toxicology |
| NFY | ||
| Cocaine (COC) | 862.3250, Cocaine and cocaine | |
| metabolite test system | Toxicology | |
| PTG | ||
| Methadone (MTD) | 862.3620, Methadone Test System | Toxicology |
| NGG | ||
| Methylenedioxymethamphetamine (MDMA) | ||
| Methamphetamine (MET) | 862.3610, | |
| Methamphetamine Test System | Toxicology | |
| NGM | ||
| Phencyclidine (PCP) | Unclassified | Toxicology |
| QAW | ||
| Nortriptyline (TCA) | 862.3910 Tricyclic antidepressant drugs | |
| test system | Toxicology | |
| NFW | 862.3870, Cannabinoids Test System | Toxicology |
5
Predicate Devices: 6.
AllTest Multi-Drug Rapid Test Cup (K233019)
7. Intended Use
AllTest Multi-Drug Urine Test Cup tests are competitive binding, lateral flow immunochromatographic assays for qualitative and simultaneous detection of Amphetamine, Buprenorphine, Secobarbital, Oxazepam, Cocaine, Methamphetamine, Methylenedioxymethamphetamine, Morphine, Methadone, Oxycodone, Phencyclidine, Nortriptyline, Marijuana and Fentanyl in human urine at the cutoff concentrations of:
| Drug (Identifier) | Cut-off level |
|---|---|
| Amphetamine (AMP) | 500 ng/mL |
| Buprenorphine (BUP) | 10 ng/mL |
| Secobarbital (BAR) | 300 ng/mL |
| Oxazepam (BZO) | 300 ng/mL |
| Cocaine (COC) | 150 ng/mL |
| Methamphetamine (MET) | 500 ng/mL |
| Methylenedioxymethamphetamine (MDMA) | 500 ng/mL |
| Morphine (MOP/OPI) | 300 ng/mL |
| Methadone (MTD) | 300 ng/mL |
| Oxycodone (OXY) | 100 ng/mL |
| Phencyclidine (PCP) | 25 ng/mL |
| Nortriptyline (TCA) | 1000 ng/mL |
| Marijuana (THC) | 50 ng/mL |
| Fentanyl(FYL) | 1 ng/mL |
AllTest Multi-Drug Urine Test Cup can be a single drug test cup or used for any combination of the above listed analytes. It is for in vitro diagnostic use only. It is intended for OTC use.
The tests may yield positive results for the prescription drugs 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 applied to any drug of abuse test result, particularly in evaluating a preliminary positive result.
The tests provide only preliminary results. To obtain a confirmed analytical result, a more specific alternate chemical method must be used. GC/MS or LC/MS is the recommended confirmatory method.
6
AllTest Multi-Drug Rapid Urine Test Cup tests are competitive binding, lateral flow immunochromatographic assays for qualitative and simultaneous detection of Amphetamine, Buprenorphine, Secobarbital, Oxazepam, Cocaine, Methamphetamine, Methylenedioxymethamphetamine, Morphine, Methadone, Oxycodone, Phencyclidine, Nortriptyline, Marijuana and Fentanyl in human urine at the cutoff concentrations of:
| Drug (Identifier) | Calibrator | Cut-off (ng/mL) |
|---|---|---|
| Amphetamine (AMP) | d-Amphetamine | 500 |
| Buprenorphine (BUP) | Buprenorphine | 10 |
| Secobarbital (BAR) | Secobarbital | 300 |
| Oxazepam (BZO) | Oxazepam | 300 |
| Cocaine (COC) | Benzoylecgonine | 150 |
| Methamphetamine | ||
| (MET) | d-Methamphetamine | 500 |
| Methylenedioxymetham | ||
| phetamine (MDMA) | d,l- | |
| Methylenedioxymethamphetamine | 500 | |
| Morphine (MOP/OPI) | Morphine | 300 |
| Methadone (MTD) | Methadone | 300 |
| Oxycodone (OXY) | Oxycodone | 100 |
| Phencyclidine (PCP) | Phencyclidine | 25 |
| Nortriptyline (TCA) | Nortriptyline | 1000 |
| Marijuana (THC) | 11-nor-Δ9-THC-9 | |
| COOH | 50 | |
| Fentanyl (FYL) | Fentanyl | 1 |
AllTest Multi-Drug Rapid Urine Test Cup can be a single drug test cup or used for any combination of the above listed analytes. It is for in vitro diagnostic use only.
The tests may yield positive results for the prescription drugs 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 applied to any drug of abuse test result, particularly in evaluating a preliminary positive result.
The tests provide only preliminary results. To obtain a confirmed analytical result, a more specific alternate chemical method must be used. GC/MS is the recommended confirmatory method.
8. Device Description
AllTest Multi-Drug Urine Test Cup and AllTest Multi-Drug Rapid Urine Test Cup are immunochromatographic assays that use a lateral flow system for the qualitative detection of single or multiple drugs in human urine.
The devices are a cup format. Each test device is sealed with sachets of desiccant in an aluminum pouch. The device is in a ready-to-use format and no longer requires assembly before use.
7
| 9. Substantial Equivalence Information
| Similarities | ||
|---|---|---|
| Item | Device | Predicate (K233019) |
| Intended use | Qualitative detection of drugs of abuse in urine. For prescription use or over-the-counter use | Same. |
| Methodology | Competitive binding, lateral flow | |
| immunochromatographic | ||
| assay based on antigen-antibody reaction | Same | |
| Type of Test | Qualitative | Same |
| Specimen Type | Human urine | Same |
| Target Drug and | ||
| Cut Off Values | Target Drugs | Cutoff (ng/mL) |
| Amphetamine(AMP) | 500 | |
| Secobarbital (BAR) | 300 | |
| Buprenorphine (BUP) | 10 | |
| Oxazepam (BZO) | 300 | |
| Cocaine (COC) | 150 | |
| Fentanyl (FYL) | 1 | |
| Methylenedioxymethamphetamine (MDMA) | 500 | |
| Methamphetamine (MET) | 500 | |
| Morphine (MOP/OPI) | 300 | |
| Methadone (MTD) | 300 | |
| Oxycodone (OXY) | 100 | |
| Phencyclidine (PCP) | 25 | |
| Nortriptyline (TCA) | 1000 | |
| Cannabinoids (THC) | 50 | |
| Configurations | Test Cup | Same |
Substantial Equivalence Information 0
10. Standard/Guidance Document Reference (if applicable)
None referenced.
11. Test Principle
AllTest Multi-Drug Urine Test Cup or AllTest Multi-Drug Rapid Urine Test Cup is a competitive immunoassay that is used to screen for the presence of various drugs and drug metabolites in urine. It is chromatographic absorbent device in which, drugs within a urine sample, competitively combined to a limited number of drug monoclonal antibody (mouse) conjugate binding sites.
When the test is activated, the urine is absorbed into each test strip by capillary action, mixes with the respective drug monoclonal antibody conjugate, and flows across a pre-coated membrane. When drug within the urine sample is below the detection level of the test, respective drug monoclonal antibody conjugate binds to the respective drug-protein conjugate immobilized in the Test Region (T) of the test strip. This produces a colored Test line in the Test Region (T) of the strip, which, regardless of its intensity, indicates a negative test result.
8
When sample drug levels are at or above the detection level of the test, the free drug in the sample binds to the respective drug monoclonal antibody conjugate, preventing the respective drug monoclonal antibody conjugate from binding to the respective drug-protein conjugate immobilized in the Test Region (T) of the device. This prevents the development of a distinct colored band in the test region, indicating a preliminary positive result.
To serve as a procedure control, a colored line will appear at the Control Region (C) of each strip, if the test has been performed properly.
12. Performance Characteristics
A. Analytical performance
a. Precision/Reproducibility:
Precision studies were carried out for samples with concentrations of +100% cutoff, +75% cutoff, +50% cutoff, +25% cutoff, cutoff, -25% cutoff, -50% cutoff, -75% cut off and -100% cutoff. Samples were prepared by spiking target drugs in drug-free urine samples. Each drug concentration was confirmed by LC-MS/MS. For each concentration, tests were performed two runs per day for 25 days using three lots of test cups. The results obtained are summarized in the following tables:
| Drug | Lot
Number | +100%
cutoff | +75%
cutoff | +50%
cutoff | +25%
cutoff | Cutoff | -25%
cutoff | -50%
cutoff | -75%
cutoff | -100%
cut-off |
|-------------|---------------|-----------------|----------------|----------------|----------------|---------|----------------|----------------|----------------|------------------|
| AMP
500 | Lot 1 | 0-/50+ | 0-/50+ | 0-/50+ | 0-/50+ | 23-/27+ | 49-/1+ | 50-/0+ | 50-/0+ | 50-/0+ |
| | Lot 2 | 0-/50+ | 0-/50+ | 0-/50+ | 1-/49+ | 22-/28+ | 50-/0+ | 50-/0+ | 50-/0+ | 50-/0+ |
| | Lot 3 | 0-/50+ | 0-/50+ | 0-/50+ | 0-/50+ | 20-/30+ | 50-/0+ | 50-/0+ | 50-/0+ | 50-/0+ |
| BAR
300 | Lot 1 | 0-/50+ | 0-/50+ | 0-/50+ | 1-/49+ | 23-/27+ | 50-/0+ | 50-/0+ | 50-/0+ | 50-/0+ |
| | Lot 2 | 0-/50+ | 0-/50+ | 0-/50+ | 0-/50+ | 20-/30+ | 50-/0+ | 50-/0+ | 50-/0+ | 50-/0+ |
| | Lot 3 | 0-/50+ | 0-/50+ | 0-/50+ | 1-/49+ | 21-/29+ | 50-/0+ | 50-/0+ | 50-/0+ | 50-/0+ |
| BUP 10 | Lot 1 | 0-/50+ | 0-/50+ | 0-/50+ | 1-/49+ | 21-/29+ | 50-/0+ | 50-/0+ | 50-/0+ | 50-/0+ |
| | Lot 2 | 0-/50+ | 0-/50+ | 0-/50+ | 0-/50+ | 24-/26+ | 49-/1+ | 50-/0+ | 50-/0+ | 50-/0+ |
| | Lot 3 | 0-/50+ | 0-/50+ | 0-/50+ | 1-/49+ | 22-/28+ | 50-/0+ | 50-/0+ | 50-/0+ | 50-/0+ |
| BZO
300 | Lot 1 | 0-/50+ | 0-/50+ | 0-/50+ | 0-/50+ | 22-/28+ | 50-/0+ | 50-/0+ | 50-/0+ | 50-/0+ |
| | Lot 2 | 0-/50+ | 0-/50+ | 0-/50+ | 0-/50+ | 25-/25+ | 49-/1+ | 50-/0+ | 50-/0+ | 50-/0+ |
| | Lot 3 | 0-/50+ | 0-/50+ | 0-/50+ | 0-/50+ | 24-/26+ | 50-/0+ | 50-/0+ | 50-/0+ | 50-/0+ |
| MDMA
500 | Lot 1 | 0-/50+ | 0-/50+ | 0-/50+ | 0-/50+ | 24-/26+ | 50-/0+ | 50-/0+ | 50-/0+ | 50-/0+ |
| | Lot 2 | 0-/50+ | 0-/50+ | 0-/50+ | 0-/50+ | 21-/29+ | 50-/0+ | 50-/0+ | 50-/0+ | 50-/0+ |
| | Lot 3 | 0-/50+ | 0-/50+ | 0-/50+ | 1-/49+ | 22-/28+ | 50-/0+ | 50-/0+ | 50-/0+ | 50-/0+ |
| MET
500 | Lot 1 | 0-/50+ | 0-/50+ | 0-/50+ | 0-/50+ | 23-/27+ | 50-/0+ | 50-/0+ | 50-/0+ | 50-/0+ |
| | Lot 2 | 0-/50+ | 0-/50+ | 0-/50+ | 0-/50+ | 21-/29+ | 50-/0+ | 50-/0+ | 50-/0+ | 50-/0+ |
| | Lot 3 | 0-/50+ | 0-/50+ | 0-/50+ | 1-/49+ | 23-/27+ | 50-/0+ | 50-/0+ | 50-/0+ | 50-/0+ |
| | Lot 1 | 0-/50+ | 0-/50+ | 0-/50+ | 0-/50+ | 22-/28+ | 50-/0+ | 50-/0+ | 50-/0+ | 50-/0+ |
| | Lot 2 | 0-/50+ | 0-/50+ | 0-/50+ | 1-/49+ | 23-/27+ | 50-/0+ | 50-/0+ | 50-/0+ | 50-/0+ |
9
| MOP/
OPI
| 300 | Lot 3 | 0-/50+ | 0-/50+ | 0-/50+ | 0-/50+ | 20-/30+ | 50-/0+ | 50-/0+ | 50-/0+ | 50-/0+ |
|---|---|---|---|---|---|---|---|---|---|---|
| MTD | ||||||||||
| 300 | Lot 1 | 0-/50+ | 0-/50+ | 0-/50+ | 0-/50+ | 24-/26+ | 50-/0+ | 50-/0+ | 50-/0+ | 50-/0+ |
| Lot 2 | 0-/50+ | 0-/50+ | 0-/50+ | 1-/49+ | 24-/26+ | 50-/0+ | 50-/0+ | 50-/0+ | 50-/0+ | |
| Lot 3 | 0-/50+ | 0-/50+ | 0-/50+ | 0-/50+ | 25-/25+ | 50-/0+ | 50-/0+ | 50-/0+ | 50-/0+ | |
| OXY | ||||||||||
| 100 | Lot 1 | 0-/50+ | 0-/50+ | 0-/50+ | 0-/50+ | 24-/26+ | 49-/1+ | 50-/0+ | 50-/0+ | 50-/0+ |
| Lot 2 | 0-/50+ | 0-/50+ | 0-/50+ | 1-/49+ | 25-/25+ | 50-/0+ | 50-/0+ | 50-/0+ | 50-/0+ | |
| Lot 3 | 0-/50+ | 0-/50+ | 0-/50+ | 0-/50+ | 22-/28+ | 50-/0+ | 50-/0+ | 50-/0+ | 50-/0+ | |
| PCP 25 | Lot 1 | 0-/50+ | 0-/50+ | 0-/50+ | 0-/50+ | 23-/27+ | 50-/0+ | 50-/0+ | 50-/0+ | 50-/0+ |
| Lot 2 | 0-/50+ | 0-/50+ | 0-/50+ | 0-/50+ | 20-/30+ | 50-/0+ | 50-/0+ | 50-/0+ | 50-/0+ | |
| Lot 3 | 0-/50+ | 0-/50+ | 0-/50+ | 1-/49+ | 21-/29+ | 50-/0+ | 50-/0+ | 50-/0+ | 50-/0+ | |
| TCA | ||||||||||
| 1000 | Lot 1 | 0-/50+ | 0-/50+ | 0-/50+ | 0-/50+ | 21-/29+ | 50-/0+ | 50-/0+ | 50-/0+ | 50-/0+ |
| Lot 2 | 0-/50+ | 0-/50+ | 0-/50+ | 1-/49+ | 22-/28+ | 50-/0+ | 50-/0+ | 50-/0+ | 50-/0+ | |
| Lot 3 | 0-/50+ | 0-/50+ | 0-/50+ | 0-/50+ | 24-/26+ | 50-/0+ | 50-/0+ | 50-/0+ | 50-/0+ | |
| THC | ||||||||||
| 50 | Lot 1 | 0-/50+ | 0-/50+ | 0-/50+ | 0-/50+ | 20-/30+ | 49-/1+ | 50-/0+ | 50-/0+ | 50-/0+ |
| Lot 2 | 0-/50+ | 0-/50+ | 0-/50+ | 0-/50+ | 22-/28+ | 49-/1+ | 50-/0+ | 50-/0+ | 50-/0+ | |
| Lot 3 | 0-/50+ | 0-/50+ | 0-/50+ | 1-/49+ | 23-/27+ | 50-/0+ | 50-/0+ | 50-/0+ | 50-/0+ | |
| COC | ||||||||||
| 150 | Lot 1 | 0-/50+ | 0-/50+ | 0-/50+ | 1-/49+ | 22-/28+ | 50-/0+ | 50-/0+ | 50-/0+ | 50-/0+ |
| Lot 2 | 0-/50+ | 0-/50+ | 0-/50+ | 0-/50+ | 22-/28+ | 50-/0+ | 50-/0+ | 50-/0+ | 50-/0+ | |
| Lot 3 | 0-/50+ | 0-/50+ | 0-/50+ | 0-/50+ | 23-/27+ | 49-/1+ | 50-/0+ | 50-/0+ | 50-/0+ | |
| FYL 1 | Lot 1 | 0-/50+ | 0-/50+ | 0-/50+ | 0-/50+ | 25-/25+ | 48-/2+ | 50-/0+ | 50-/0+ | 50-/0+ |
| Lot 2 | 0-/50+ | 0-/50+ | 0-/50+ | 0-/50+ | 23-/27+ | 50-/0+ | 50-/0+ | 50-/0+ | 50-/0+ | |
| Lot 3 | 0-/50+ | 0-/50+ | 0-/50+ | 0-/50+ | 23-/27+ | 49-/1+ | 50-/0+ | 50-/0+ | 50-/0+ |
b. Linearity/assay reportable range:
Not applicable. This device is intended for qualitative use only.
c. Stability:
The device is stable at 2-30℃ for 24 months based on real time stability study.
d. Analytical specificity/Interference:
To test the specificity, drug metabolites and other components that are likely to cross-react in urine samples were spiked into drug-free urine samples were tested using three lots of the device.
Percent cross-reactivity, provided in the below table, was calculated as the cutoff concentration divided by the concentration of analyte tested that yielded a positive result, multiplied by 100.
| Drug/Cutoff | Compound | Minimum
concentration
required to obtain
a positive result | % Cross-
Reactivity |
|--------------------------------|-------------------------------------------------------|---------------------------------------------------------------------|------------------------|
| | | (ng/mL) | |
| | Hydroxyamphetamine | 5000 | 10% |
| | (+/-)- Methylenedioxyamphetamine(MD A) | 25 | 2000% |
| | D,L-Amphetamine | 500 | 100% |
| | D-Amphetamine | 500 | 100% |
| | Diethylstilbestrol | >100000 | 100000 | 100000 | 100000 | 100000 | 100000 | 100000 | 100000 | 100000 | 100000 | 100000 | 100000 | 100000 | 100000 | 100000 | 100000 | 100000 | 100000 | 100000 | 100000 | 100000 | 100000 | 100000 | 100000 | 100000 | 100000 | 100000 | 100000 | 100000 | 100000 | 100000 | 100000 | 100000 | 100000 | 100000 | 100000 | 100000 | 100000 | 100000 | 100000 | 100000 | 100000 | 100000 | 100000 | 100000 | 100000 | 100000 | 100000 | 100000 | 100000 | 100000 | 100000 | 100000 | 100000 | 100000 | 100000 | 100000 | 100000 | 100000 | 100000 | 100000 | 100000 | 100000 | 100000 | 100000 | 100000 | 100000 | 100000 | 100000 | 100000 | 100000 | 100000 | 100000 | 100000 | 100000 | 100000 | 100000 | 100000 | 100000 | 100000 | 100000 | 100000 | 100000 | 100000 | 100000 | 100000 | 100000 | 100000 | 100000 | 100000 | 100000 | 100000 | 100000 | 100000 | 100000 | 100000 | 100000 | 100000 | 100000 | 100000 | 100000 | 100000 | 100000 | 100000 | 100000 | 100000 | 100000 | 50. Urine samples were prepared at the following concentrations; -100%, +/-75%, +/-50%, +/-25% of the cutoff by spiking drug(s) into drug freepooled urine specimens. The concentrations of the samples were confirmed by LC-MS/MS. Each sample was aliquoted into individual containers and blind-labeled. Each participant was provided with the package insert, 1 blind labeled sample and a device. The results are summarized below.
| Drug | Cutoff
(ng/mL) | Concentration | | | | | | | |
|------|-------------------|---------------|-----------------|----------------|----------------|----------------|----------------|----------------|----------------|
| | | Results | -100%
cutoff | -75%
cutoff | -50%
cutoff | -25%
cutoff | +25%
cutoff | +50%
cutoff | +75%
cutoff |
| AMP | 500 | Negative | 20 | 20 | 20 | 18 | 2 | 0 | 0 |
| | | Positive | 0 | 0 | 0 | 2 | 18 | 20 | 20 |
| | | Total | 20 | 20 | 20 | 20 | 20 | 20 | 20 |
| | | Agreement (%) | 100% | 100% | 100% | 90.0% | 90.0% | 100% | 100% |
| BAR | 300 | Negative | 20 | 20 | 20 | 19 | 2 | 0 | 0 |
| | | Positive | 0 | 0 | 0 | 1 | 18 | 20 | 20 |
| | | Total | 20 | 20 | 20 | 20 | 20 | 20 | 20 |
| | | Agreement (%) | 100% | 100% | 100% | 95.0% | 90.0% | 100% | 100% |
| | | Negative | 20 | 20 | 20 | 18 | 2 | 0 | 0 |
| BZO | | Positive | 0 | 0 | 0 | 2 | 18 | 20 | 20 |
| | 300 | Total | 20 | 20 | 20 | 20 | 20 | 20 | 20 |
| | | Agreement (%) | 100% | 100% | 100% | 90.0% | 90.0% | 100% | 100% |
| | | Negative | 20 | 20 | 20 | 19 | 1 | 0 | 0 |
| | | Positive | 0 | 0 | 0 | 1 | 19 | 20 | 20 |
| BUP | 10 | Total | 20 | 20 | 20 | 20 | 20 | 20 | 20 |
| | | Agreement (%) | 100% | 100% | 100% | 95.0% | 95.0% | 100% | 100% |
| | | Negative | 20 | 20 | 20 | 18 | 1 | 0 | 0 |
| | | Positive | 0 | 0 | 0 | 2 | 19 | 20 | 20 |
| COC | 150 | Total | 20 | 20 | 20 | 20 | 20 | 20 | 20 |
| | | Agreement (%) | 100% | 100% | 100% | 90.0% | 95.0% | 100% | 100% |
| | | Negative | 20 | 20 | 20 | 19 | 2 | 0 | 0 |
| | | Positive | 0 | 0 | 0 | 1 | 18 | 20 | 20 |
| MDMA | 500 | Total | 20 | 20 | 20 | 20 | 20 | 20 | 20 |
| | | Agreement (%) | 100% | 100% | 100% | 95.0% | 90.0% | 100% | 100% |
| | | Negative | 20 | 20 | 20 | 19 | 1 | 0 | 0 |
| MET | 500 | Positive | 0 | 0 | 0 | 1 | 19 | 20 | 20 |
| | | Total | 20 | 20 | 20 | 20 | 20 | 20 | 20 |
| | | Agreement (%) | 100% | 100% | 100% | 95.0% | 95.0% | 100% | 100% |
| | 300 | Negative | 20 | 20 | 20 | 18 | 1 | 0 | 0 |
| MOP | | Positive | 0 | 0 | 0 | 2 | 19 | 20 | 20 |
| | | Total | 20 | 20 | 20 | 20 | 20 | 20 | 20 |
| | | Agreement (%) | 100% | 100% | 100% | 90.0% | 95.0% | 100% | 100% |
| | | Negative | 20 | 20 | 20 | 19 | 1 | 0 | 0 |
| MTD | 300 | Positive | 0 | 0 | 0 | 1 | 19 | 20 | 20 |
| | | Total | 20 | 20 | 20 | 20 | 20 | 20 | 20 |
| | | Agreement (%) | 100% | 100% | 100% | 95.0% | 95.0% | 100% | 100% |
| | | Negative | 20 | 20 | 20 | 19 | 2 | 0 | 0 |
| OXY | 100 | Positive | 0 | 0 | 0 | 1 | 18 | 20 | 20 |
| | | Total | 20 | 20 | 20 | 20 | 20 | 20 | 20 |
| | | Agreement (%) | 100% | 100% | 100% | 95.0% | 90.0% | 100% | 100% |
| | | Negative | 20 | 20 | 20 | 19 | 1 | 0 | 0 |
| PCP | 25 | Positive | 0 | 0 | 0 | 1 | 19 | 20 | 20 |
| | | Total | 20 | 20 | 20 | 20 | 20 | 20 | 20 |
| | | Agreement (%) | 100% | 100% | 100% | 95.0% | 95.0% | 100% | 100% |
| | | Negative | 20 | 20 | 20 | 19 | 2 | 0 | 0 |
| TCA | 1000 | Positive | 0 | 0 | 0 | 1 | 18 | 20 | 20 |
| | | Total | 20 | 20 | 20 | 20 | 20 | 20 | 20 |
| | | Agreement (%) | 100% | 100% | 100% | 95.0% | 90.0% | 100% | 100% |
| THC | 50 | Negative | 20 | 20 | 20 | 18 | 2 | 0 | 0 |
| | | Positive | 0 | 0 | 0 | 2 | 18 | 20 | 20 |
| | | Total | 20 | 20 | 20 | 20 | 20 | 20 | 20 |
| | | Agreement (%) | 100% | 100% | 100% | 90.0% | 90.0% | 100% | 100% |
| FYL | 1 | Negative | 20 | 20 | 20 | 18 | 0 | 0 | 0 |
| | | Positive | 0 | 0 | 0 | 2 | 20 | 20 | 20 |
| | | Total | 20 | 20 | 20 | 20 | 20 | 20 | 20 |
| | | Agreement (%) | 100% | 100% | 100% | 90.0% | 100.0% | 100% | 100% |
Result of AllTest Multi-Drug Urine Test Cup:
24
25
Participants were given surveys on the ease of understanding the instruction for use. All participants indicated that the device instruction is easy to understand and follow. 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.
13. Conclusion
Based on the test principle and performance characteristics of the device including precision, cut-off, interference, specificity, method comparison and lay-user studies of the devices, it's concluded that AllTest Multi-Drug Urine Test Cup and AllTest Multi-Drug Rapid Urine Test Cup are substantially equivalent to the predicate device.