BioSieveTM Multi-Drug Urine Test Panel; BioSieveTM Multi-Drug Urine Test Panel Rx
Device Facts
| Record ID | K233062 |
|---|---|
| Device Name | BioSieveTM Multi-Drug Urine Test Panel; BioSieveTM Multi-Drug Urine Test Panel Rx |
| Applicant | Vivachek Biotech (Hangzhou) Co., Ltd. |
| Product Code | NFT · Clinical Toxicology |
| Decision Date | Nov 2, 2023 |
| Decision | SESE |
| Submission Type | Traditional |
| Regulation | 21 CFR 862.3100 |
| Device Class | Class 2 |
Intended Use
BioSieve™ Multi-Drug Urine Test Panel tests are competitive binding, lateral flow immunochromatographic assays for qualitative and simultaneous detection of Amphetamine, Buprenorphine, Secobarbital, 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: [Table of drugs and cutoffs]. BioSieve™ Multi-Drug Urine Test Panel offers any combinations from 1 to 15 drugs of abuse tests but only one cutoff concentration under same drug condition will be included per device. It is for in vitro diagnostic use only. It is intended for OTC use. The tests may yield positive results for the prescription drugs Buprenorphine, Oxazepam, Secobarbital, 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 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.
Device Story
Rapid, single-use lateral flow immunochromatographic assay for qualitative detection of drugs of abuse in human urine. Input: urine sample; Principle: competitive binding antigen-antibody reaction. If drug concentration is below cutoff, target drug does not saturate antibody-coated particles, allowing capture by immobilized drug-conjugate to form a visible colored test line. If concentration exceeds cutoff, binding sites are saturated, preventing test line formation. Control line confirms proper test performance. Used in OTC or clinical settings; operated by patients or healthcare providers. Output: visual qualitative result (positive/negative). Results are preliminary; requires GC/MS or LC/MS confirmation. Benefits: rapid, simultaneous screening for multiple substances to aid clinical decision-making.
Clinical Evidence
Bench testing only. Performance validated via precision studies (25 days, 3 lots), interference studies (100+ compounds), specificity/cross-reactivity, and method comparison against LC/MS. Lay-user study (n=280) confirmed ease of use and performance across diverse demographics. No clinical prospective/retrospective trials required for this device class.
Technological Characteristics
Lateral flow immunochromatographic assay. Single-use test panel format. Materials: test strip, desiccant, pouch. Energy source: none (capillary action). Connectivity: none. Sterilization: not stated. Software: none.
Indications for Use
Indicated for the qualitative, simultaneous detection of 15 drugs of abuse (Amphetamine, Buprenorphine, Secobarbital, Oxazepam, Cocaine, EDDP, Methamphetamine, MDMA, Morphine, Methadone, Oxycodone, Phencyclidine, Propoxyphene, Nortriptyline, Marijuana) in human urine. Intended for OTC or prescription use. Not intended to distinguish between prescription use and abuse.
Regulatory Classification
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.
Special Controls
*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).
Related Devices
- K220685 — HIGHTOP Multi-Drug Urine Test Cup, HIGHTOP Multi-Drug Urine Test Cup Rx · Qingdao Hightop Biotech Co., Ltd. · May 5, 2022
- K233019 — AllTest Multi-Drug Rapid Test Cup; AllTest Multi-Drug Rapid Test Panel; AllTest Multi-Drug Rapid Test Cup Rx; AllTest Multi-Drug Rapid Test Panel Rx · Hangzhou AllTest Biotech Co., Ltd. · Dec 13, 2023
- K202453 — SAFECARE Multi-Drug Urine Test Cup, SAFECARE Multi-Drug Urine Test Dip-Card · Safecare Biotech (Hangzhou) Co., Ltd. · Mar 24, 2021
Submission Summary (Full Text)
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Image /page/0/Picture/0 description: The image contains two logos. On the left is the Department of Health & Human Services logo. On the right is the FDA logo, which includes the letters "FDA" in a blue square, followed by the words "U.S. FOOD & DRUG ADMINISTRATION" in blue text.
VivaChek Biotech (Hangzhou) Co., Ltd. % Joe Shia LSI International 504 E Diamond Ave., Suite I Gaithersburg, Maryland 20877
### Re: K233062
Trade/Device Name: BioSieve™ Multi-Drug Urine Test Panel: BioSieve™ Multi-Drug Urine Test Panel Rx Regulation Number: 21 CFR 21 CFR 862.3100 Regulation Name: Amphetamine test system Regulatory Class: Class II Product Code: NFT, NFY, NGL, PTH, NFV, PTG, NGG, LCM, QBF, QAW, NFW Dated: September 21, 2023 Received: September 26, 2023
### 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 (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.
If your device is classified (see above) into either class II (Special Controls) or class III (PMA), it may be subject to additional controls. Existing major regulations affecting your device can be found in the Code of Federal Regulations, Title 21, Parts 800 to 898. In addition, FDA may publish further announcements concerning your device in the Federal Register.
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).
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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 OS regulation requires device manufacturers to review and approve changes to device design and production (21 CFR 820.30 and 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 (OS) 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. Digitally signed by Joseph
> Kotarek -S
> Date: 2023.11.02 14:50:57 Kotarek -S Joseph Kotarek, Ph.D. Branch Chief Division of Chemistry and Toxicology Devices OHT7: Office of In Vitro Diagnostics Office of Product Evaluation and Quality Center for Devices and Radiological Health
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# Indications for Use
510(k) Number (if known) K233062
#### Device Name
BioSieve™ Multi-Drug Urine Test Panel
# Indications for Use (Describe)
BioSieve™ Multi-Drug Urine Test Panel tests are competitive binding, lateral flow immunochromatographic assays for qualitative and simultaneous detection of Amphetamine, Secobarbital, 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) | 1000 ng/mL or 500 ng/mL |
| Buprenorphine (BUP) | 10 ng/mL |
| Secobarbital (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 |
BioSieve™ Multi-Drug Urine Test Panel offers any combinations from 1 to 15 drugs of abuse tests but only one cutoff concentration under same drug condition will be included per device. It is for in vitro diagnostic use only. It is intended for OTC use.
The tests may yield positive results for the prescription drugs Buprenorphine, Oxazepam, Secobarbital, 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 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.
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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)
#### CONTINUE ON A SEPARATE PAGE IF NEEDED.
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# Indications for Use
510(k) Number (if known) K233062
#### Device Name
BioSieve™ Multi-Drug Urine Test Panel Rx
#### Indications for Use (Describe)
BioSieve™ Multi-Drug Urine Test Panel Rx tests are competitive binding, lateral flow immunochromatographic assays for qualitative and simultaneous detection of Amphetamine, Secobarbital, Oxazepam, Cocaine, 2-ethylidene-1.5-dimenylpyrrolidine, Methamphetamine, Methylenedioxymethamphetamine, Morphine, Methadone, Oxycodone, Phencyclidine, Propoxyphene, Nortriptyline and Cannabinoids in human urine at the cutoff concentrations of:
| Drug | Calibrator | Cut-off (ng/mL) |
|--------------------------------------------------------------|-------------------------------------------------------|-----------------|
| Amphetamine (AMP) | D-Amphetamine | 1,000 or 500 |
| Barbiturates (BAR) | Secobarbital | 300 |
| Buprenorphine (BUP) | Buprenorphine | 10 |
| Oxazepam (BZO) | Oxazepam | 300 |
| Cocaine (COC) | Benzoylecgonine | 300 or 150 |
| 2-ethylidene-1,5-dimethyl-3,3-<br>diphenylpyrrolidine (EDDP) | 2-ethylidene-1,5-dimethyl-3,3-<br>diphenylpyrrolidine | 300 |
| Ecstasy (MDMA) | D,L- Methylenedioxy-methamphetamine | 500 |
| Methamphetamine (MET) | D-Methamphetamine | 1,000 or 500 |
| Morphine (MOP/OPI) | Morphine | 2,000 or 300 |
| Methadone (MTD) | Methadone | 300 |
| Oxycodone (OXY) | Oxycodone | 100 |
| Phencyclidine (PCP) | Phencyclidine | 25 |
| Propoxyphene (PPX) | Propoxyphene | 300 |
| Nortriptyline (TCA) | Nortriptyline | 1,000 |
| Marijuana (THC) | 11-nor-Δ9-THC-9 COOH | 50 |
BioSieve™ Multi-Drug Urine Test Panel Rx offers any combinations from 1 to 15 drugs of abuse tests but only one cutoff concentration under same drug condition will be included per device. It is for in vitro diagnostic use only. It is intended for prescription use.
The tests may yield positive results for the prescription drugs Buprenorphine, Oxazepam, Secobarbital, 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 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.
{5}------------------------------------------------
Type of Use (Select one or both, as applicable)
X Prescription Use (Part 21 CFR 801 Subpart D)
| Over-The-Counter Use (21 CFR 801 Subpart C)
#### CONTINUE ON A SEPARATE PAGE IF NEEDED.
This section applies only to requirements of the Paperwork Reduction Act of 1995.
#### *DO NOT SEND YOUR COMPLETED FORM TO THE PRA STAFF EMAIL ADDRESS BELOW.*
The burden time for this collection of information is estimated to average 79 hours per response, including the time to review instructions, search existing data sources, gather and maintain the data needed and complete and review the collection of information. Send comments regarding this burden estimate or any other aspect of this information collection, including suggestions for reducing this burden, to:
> Department of Health and Human Services Food and Drug Administration Office of Chief Information Officer Paperwork Reduction Act (PRA) Staff PRAStaff@fda.hhs.gov
"An agency may not conduct or sponsor, and a person is not required to respond to, a collection of information unless it displays a currently valid OMB number."
FORM FDA 3881 (6/20)
Page 1 of 1
PSC Publishing Services (301) 443-6740 EF
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# 510(k) SUMMARY
#### K233062
| 1 | Date | October 25, 2023 |
|---|----------------|---------------------------------------------------------------------------------------------------------------------------------------------------------------------------|
| 2 | Submitter | VivaChek Biotech (Hangzhou) Co., Ltd.<br>Level 2, Block 2, 146 East Chaofeng Rd.<br>Hangzhou, China |
| 3 | Contact Person | Joe Shia<br>LSI International Inc.<br>504 East Diamond Ave., Suite H<br>Gaithersburg, MD 20877<br>Telephone: 240-505-7880<br>Fax: 301-916-6213<br>Email: shiajl@yahoo.com |
- BioSieve™ Multi-Drug Urine Test Panel 4 Device Name BioSieve™ Multi-Drug Urine Test Panel Rx
- 5 Classification Class II
| Class II | | |
|----------------------------------------------------------------------------|------------------------------------------|------------|
| Product Code<br>Target Drug | Regulation Section | Panel |
| NFT<br>Amphetamine (AMP) | 862.3100, Amphetamine Test System | Toxicology |
| NGL<br>Buprenorphine (BUP) | 862.3650, Opiate Test System | Toxicology |
| PTH<br>Secobarbital (BAR) | 862.3150, Barbiturate Test System | Toxicology |
| NFV<br>Oxazepam (BZO) | 862.3170,<br>Benzodiazepine Test System | Toxicology |
| NFY<br>Cocaine (COC) | 862.3250, Cocaine Test System | Toxicology |
| PTG<br>2-ethylidene-1,5-<br>dimethyl-3,3-<br>diphenylpyrrolidine<br>(EDDP) | 862.3620, Methadone Test System | Toxicology |
| NGG<br>Methamphetamine<br>(MET) | 862.3610,<br>Methamphetamine Test System | Toxicology |
| NGG<br>Methylenedioxymethamphetamine (MDMA) | 862.3610,<br>Methamphetamine Test System | Toxicology |
| NGL | 862.3650, Opiate Test System | Toxicology |
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| Morphine (MOP/OPI) | | |
|------------------------------|--------------------------------------------------------|------------|
| PTG<br>Methadone (MTD) | 862.3620, Methadone Test System | Toxicology |
| NGL<br>Oxycodone (OXY) | 862.3650, Opiate Test System | Toxicology |
| LCM<br>Phencyclidine (PCP) | Unclassified | Toxicology |
| QBF<br>Propoxyphene (PPX) | 862.3700 Propoxyphene test<br>system. | Toxicology |
| QAW<br>Nortriptyline (TCA) | 862.3910 Tricyclic antidepressant<br>drugs test system | Toxicology |
| NFW<br>Cannabinoids (THC 50) | 862.3870, Cannabinoids Test<br>System | Toxicology |
#### 6. Predicate Device K202567
Wondfo T-Dip® Multi-Drug Urine Test Panel
#### 7. Intended Use
BioSieve™ Multi-Drug Urine Test Panel tests are competitive binding, lateral flow immunochromatographic assays for qualitative and simultaneous detection of Amphetamine, Buprenorphine, Secobarbital, 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:
| Drug (Identifier) | Cut-off level |
|----------------------------------------------------------|-------------------------|
| Amphetamine (AMP) | 1000 ng/mL or 500 ng/mL |
| Buprenorphine (BUP) | 10 ng/mL |
| Secobarbital (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 |
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| Marijuana (THC) | 50 ng/mL |
|-----------------|----------|
|-----------------|----------|
BioSieve™ Multi-Drug Urine Test Panel offers any combinations from 1 to 15 drugs of abuse tests but only one cutoff concentration under same drug condition will be included per device. It is for in vitro diagnostic use only. It is intended for OTC use.
The test may yield positive results for the prescription drugs Buprenorphine, Oxazepam, Secobarbital, 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 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 alternative chemical method must be used. GC/MS or LC/MS is the recommended confirmatory method.
BioSieve™ Multi-Drug Urine Test Panel Rx tests are competitive binding, lateral flow immunochromatographic assays for qualitative and simultaneous detection of Amphetamine, Buprenorphine, Secobarbital, Oxazepam, Cocaine, 2- ethylidene-1.5-dimethyl-3.3diphenylpyrrolidine, Methamphetamine, Methylenedioxymethamphetamine, Methadone, Oxycodone, Phencyclidine, Propoxyphene, Nortriptyline and Cannabinoids in human urine at the cutoff concentrations of:
| Drug | Calibrator | Cut-off (ng/mL) |
|--------------------------------------------------------------|-------------------------------------------------------|-----------------|
| Amphetamine (AMP) | D-Amphetamine | 1,000 or 500 |
| Secobarbital (BAR) | Secobarbital | 300 |
| Buprenorphine (BUP) | Buprenorphine | 10 |
| Oxazepam (BZO) | Oxazepam | 300 |
| Cocaine (COC ) | Benzoylecgonine | 300 or 150 |
| 2-ethylidene-1,5-dimethyl-3,3-<br>diphenylpyrrolidine (EDDP) | 2-ethylidene-1,5-dimethyl-3,3-<br>diphenylpyrrolidine | 300 |
| Ecstasy (MDMA) | D,L- Methylenedioxy-methamphetamine | 500 |
| Methamphetamine (MET) | D-Methamphetamine | 1,000 or 500 |
| Morphine (MOP/OPI ) | Morphine | 2,000 or 300 |
| Methadone (MTD) | Methadone | 300 |
| Oxycodone (OXY ) | Oxycodone | 100 |
| Phencyclidine (PCP) | Phencyclidine | 25 |
| Propoxyphene (PPX) | Propoxyphene | 300 |
| Nortriptyline (TCA) | Nortriptyline | 1,000 |
| Marijuana (THC ) | 11-nor-Δ9-THC-9 COOH | 50 |
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BioSieve™ Multi-Drug Urine Test Panel Rx offers any combinations from 1 to 15 drugs of abuse tests but only one cutoff concentration under same drug condition will be included per device. It is for in vitro diagnostic use only. It is intended for prescription use.
The tests may yield positive results for the prescription drugs Buprenorphine, Nortriptyline, Oxazepam, Secobarbital, 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 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.
#### Device Description 8.
The BioSieve™ Multi-Drug Urine Test Panel and BioSieve™ Multi-Drug Urine Test Panel Rx are rapid, single-use in vitro diagnostic devices. Each test kit contains a test device in one pouch. One pouch contains a test BioSieve™ Panel and two desiccants, and a package insert. The BioSieve™ Multi-Drug Urine Test Panel is intended for over-the-counter use and the BioSieve™ Multi-Drug Urine Test Panel Rx is intended for prescription use.
| Item | Proposed Device | Predicate<br>(K202567) |
|--------------------------------------|----------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------|------------------------|
| Indication(s) for<br>use | For the qualitative determination of Amphetamine,<br>Buprenorphine, Secobarbital, Oxazepam, Cocaine, 2-<br>ethylidene-1,5-dimethyl-3,3-diphenylpyrrolidine,<br>Methamphetamine, Methylenedioxymethamphetamine,<br>Morphine, Methadone, Oxycodone, Phencyclidine,<br>Propoxyphene, Nortriptyline and Cannabinoids in human urine. | Same |
| Methodology | Competitive binding, lateral flow immunochromatographic<br>assay based on antigen-antibody reaction | Same |
| Type of Test | Qualitative | Same |
| Specimen Type | Human urine | Same |
| Target Drug<br>and Cut Off<br>Values | Target Drug | Cutoff (ng/mL) |
| | Amphetamine (AMP) | 1000 or 500 |
| | Buprenorphine (BUP) | 10 |
| | Secobarbital (BAR) | 300 |
| | Oxazepam (BZO) | 300 |
| | Cocaine (COC) | 300 or 150 |
| | 2-ethylidene-1,5-dimethyl-3,3-<br>diphenylpyrrolidine (EDDP) | 300 |
| | Methamphetamine (MET) | 1000 or 500 |
| | | |
#### Substantial Equivalence Information 9.
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| Methylenedioxymethamphetamine (MDMA) | 500 | |
|--------------------------------------|-------------------------------------------|-------------------------------------------|
| Morphine (MOP 300/OPI 2000) | 2000 or 300 | |
| Methadone (MTD) | 300 | |
| Oxycodone (OXY) | 100 | |
| Phencyclidine (PCP) | 25 | |
| Propoxyphene (PPX) | 300 | |
| Nortriptyline (TCA) | 1000 | |
| Cannabinoids (THC 50) | 50 | |
| Configurations | Test Panel | Panel |
| Intended Use | Prescription Use and over-the-counter use | Prescription Use and over-the-counter use |
#### 10. Test Principle
BioSieve™ Multi-Drug Urine Test Panel and BioSieve™M Multi-Drug Urine Test Panel Rx are rapid tests for the qualitative detection of Amphetamine, Buprenorphine, Secobarbital. Oxazepam, Cocaine, 2-ethylidene-1,5-dimethyl-3,3-diphenylpyrrolidine, Methamphetamine, Methylenedioxymethamphetamine, Morphine, Methadone, Oxycodone, Phencyclidine, Propoxyphene, Nortriptyline and Cannabinoids in urine samples. They are lateral flow chromatographic immunoassay. When urine sample is added to the Panel device, urine is absorbed into the test strip and migrates upwards by capillary action. If the concentration of target drug presented in the urine sample is below the cutoff level, the target drug will not saturate the binding sites of its specific monoclonal antibody-coated particles. The antibody-coated particles will then be captured by immobilized drug-conjugate and a visible colored band will be formed on the test line region. If the concentration of target is beyond the cutoff level, the target drug will saturate the binding sites of its specific monoclonal antibody-particles, thus the antibody-coated particles will not be captured by immobilized drug-conjugate hence no colored band will be formed on the test line region.
A band should be formed on the control line region regardless of the presence of target drug or metabolite in the sample to indicate that the tests have been performed properly.
#### 11. Performance Characteristics
- 1. Analytical Performance
- Precision a.
Precision studies were carried out for samples with concentrations of -100% cut off, - 50% cut off, -25% cut off, cutoff, +25% cut off, +75% cut off, +75% cut off and +100% cut off. Samples with concentration of -100% cutoff were drug-free urines samples. Other samples were prepared by spiking target drug in drug-free urine samples. Each drug concentration was confirmed by LC/MS. For each concentration, tests were performed two runs per day for 25 days using three lots of test Panels. The results obtained are summarized in the following tables:
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# BioSieve™ Multi-Drug Urine Test Panel BUP 10
| Concentration by<br>LC/MS<br>(ng/mL) | +100%<br>cutoff | +75%<br>cutoff | +50%<br>cutoff | +25%<br>cutoff | Cutoff | -25%<br>cutoff | -50%<br>cutoff | -75%<br>cutoff | -100%<br>cut-off |
|--------------------------------------|-----------------|----------------|----------------|----------------|---------|----------------|----------------|----------------|------------------|
| | 20.0 | 17.1 | 13.6 | 11.8 | 10.2 | 6.9 | 5.4 | 2.7 | 0 |
| Lot Number | | | | | | | | | |
| Lot I | 0-/50+ | 0-/50+ | 0-/50+ | 0-/50+ | 26-/24+ | 50-/0+ | 50-/0+ | 50-/0+ | 50-/0+ |
| Lot II | 0-/50+ | 0-/50+ | 0-/50+ | 0-/50+ | 24-/26+ | 50-/0+ | 50-/0+ | 50-/0+ | 50-/0+ |
| Lot III | 0-/50+ | 0-/50+ | 0-/50+ | 0-/50+ | 26-/24+ | 50-/0+ | 50-/0+ | 50-/0+ | 50-/0+ |
BioSieve™ Multi-Drug Urine Test Panel PCP 25
| Concentration by<br>LC/MS<br>(ng/mL) | +100%<br>cutoff | +75%<br>cutoff | +50%<br>cutoff | +25%<br>cutoff | Cutoff | -25%<br>cutoff | -50%<br>cutoff | -75%<br>cutoff | -100%<br>cut-off |
|--------------------------------------|-----------------|----------------|----------------|----------------|---------|----------------|----------------|----------------|------------------|
| Lot Number | 52.1 | 43.1 | 37.3 | 29.4 | 25.2 | 17.7 | 12.2 | 6.5 | 0 |
| Lot I | 0-/50+ | 0-/50+ | 0-/50+ | 0-/50+ | 26-/24+ | 50-/0+ | 50-/0+ | 50-/0+ | 50-/0+ |
| Lot II | 0-/50+ | 0-/50+ | 0-/50+ | 0-/50+ | 23-/27+ | 50-/0+ | 50-/0+ | 50-/0+ | 50-/0+ |
| Lot III | 0-/50+ | 0-/50+ | 0-/50+ | 0-/50+ | 23-/27+ | 50-/0+ | 50-/0+ | 50-/0+ | 50-/0+ |
BioSieve™ Multi-Drug Urine Test Panel THC 50
| Concentration by | +100% | +75% | +50% | +25% | Cutoff | -25% | -50% | -75% | -100% |
|------------------|--------|--------|--------|--------|---------|--------|--------|--------|---------|
| LC/MS | cutoff | cutoff | cutoff | cutoff | | cutoff | cutoff | cutoff | cut-off |
| (ng/mL) | 96.5 | 84.3 | 75.7 | 60.1 | 52.5 | 35.9 | 24.1 | 12.1 | 0 |
| Lot Number | | | | | | | | | |
| Lot I | 0-/50+ | 0-/50+ | 0-/50+ | 0-/50+ | 25-/25+ | 50-/0+ | 50-/0+ | 50-/0+ | 50-/0+ |
| Lot II | 0-/50+ | 0-/50+ | 0-/50+ | 0-/50+ | 27-/23+ | 50-/0+ | 50-/0+ | 50-/0+ | 50-/0+ |
| Lot III | 0-/50+ | 0-/50+ | 0-/50+ | 0-/50+ | 27-/23+ | 50-/0+ | 50-/0+ | 50-/0+ | 50-/0+ |
# BioSieve™ Multi-Drug Urine Test Panel OXY 100
| Concentration by<br>LC/MS<br>(ng/mL)<br>Lot Number | +100%<br>cutoff | +75%<br>cutoff | +50%<br>cutoff | +25%<br>cutoff | Cutoff | -25%<br>cutoff | -50%<br>cutoff | -75%<br>cutoff | -100%<br>cut-off |
|----------------------------------------------------|-----------------|----------------|----------------|----------------|---------|----------------|----------------|----------------|------------------|
| | 200.3 | 177.1 | 158.9 | 131.7 | 108.5 | 78.0 | 51.6 | 27.6 | 0 |
| Lot I | 0-/50+ | 0-/50+ | 0-/50+ | 0-/50+ | 25-/25+ | 50-/0+ | 50-/0+ | 50-/0+ | 50-/0+ |
| Lot II | 0-/50+ | 0-/50+ | 0-/50+ | 0-/50+ | 27-/23+ | 50-/0+ | 50-/0+ | 50-/0+ | 50-/0+ |
| Lot III | 0-/50+ | 0-/50+ | 0-/50+ | 0-/50+ | 25-/25+ | 50-/0+ | 50-/0+ | 50-/0+ | 50-/0+ |
{12}------------------------------------------------
# BioSieve™ Multi-Drug Urine Test Panel BAR 300
| Concentration by<br>LC/MS<br>(ng/mL) | +100%<br>cutoff | +75%<br>cutoff | +50%<br>cutoff | +25%<br>cutoff | Cutoff | -25%<br>cutoff | -50%<br>cutoff | -75%<br>cutoff | -100%<br>cut-off |
|--------------------------------------|-----------------|----------------|----------------|----------------|---------|----------------|----------------|----------------|------------------|
| | 588.4 | 525.8 | 457.6 | 383.8 | 301.6 | 228.3 | 157.1 | 80.2 | 0 |
| Lot Number | | | | | | | | | |
| Lot I | 0-/50+ | 0-/50+ | 0-/50+ | 0-/50+ | 25-/25+ | 50-/0+ | 50-/0+ | 50-/0+ | 50-/0+ |
| Lot II | 0-/50+ | 0-/50+ | 0-/50+ | 0-/50+ | 26-/24+ | 50-/0+ | 50-/0+ | 50-/0+ | 50-/0+ |
| Lot III | 0-/50+ | 0-/50+ | 0-/50+ | 0-/50+ | 23-/27+ | 50-/0+ | 50-/0+ | 50-/0+ | 50-/0+ |
BioSieve™ Multi-Drug Urine Test Panel BZO 300
| Concentration by | +100% | +75% | +50% | +25% | Cutoff | -25% | -50% | -75% | -100% |
|-----------------------|--------|--------|--------|--------|---------|--------|--------|--------|---------|
| LC/MS | cutoff | cutoff | cutoff | cutoff | | cutoff | cutoff | cutoff | cut-off |
| (ng/mL)<br>Lot Number | 596.1 | 536.5 | 470.4 | 370.3 | 290.4 | 219.8 | 157.3 | 78.5 | 0 |
| Lot I | 0-/50+ | 0-/50+ | 0-/50+ | 0-/50+ | 27-/23+ | 50-/0+ | 50-/0+ | 50-/0+ | 50-/0+ |
| Lot II | 0-/50+ | 0-/50+ | 0-/50+ | 0-/50+ | 25-/25+ | 50-/0+ | 50-/0+ | 50-/0+ | 50-/0+ |
| Lot III | 0-/50+ | 0-/50+ | 0-/50+ | 0-/50+ | 25-/25+ | 50-/0+ | 50-/0+ | 50-/0+ | 50-/0+ |
BioSieve™ Multi-Drug Urine Test Panel EDDP 300
| Concentration by | +100% | +75% | +50% | +25% | Cutoff | -25% | -50% | -75% | -100% |
|------------------|--------|--------|--------|--------|---------|--------|--------|--------|---------|
| LC/MS<br>(ng/mL) | cutoff | cutoff | cutoff | cutoff | | cutoff | cutoff | cutoff | cut-off |
| | 646.2 | 545.3 | 455.1 | 371.0 | 290.7 | 229.5 | 148.8 | 77.0 | 0 |
| Lot Number | | | | | | | | | |
| Lot I | 0-/50+ | 0-/50+ | 0-/50+ | 0-/50+ | 28-/22+ | 50-/0+ | 50-/0+ | 50-/0+ | 50-/0+ |
| Lot II | 0-/50+ | 0-/50+ | 0-/50+ | 0-/50+ | 27-/23+ | 50-/0+ | 50-/0+ | 50-/0+ | 50-/0+ |
| Lot III | 0-/50+ | 0-/50+ | 0-/50+ | 0-/50+ | 26-/24+ | 50-/0+ | 50-/0+ | 50-/0+ | 50-/0+ |
### BioSieve™ Multi-Drug Urine Test Panel MTD 300
| Concentration by<br>LC/MS<br>(ng/mL)<br>Lot Number | +100%<br>cutoff | +75%<br>cutoff | +50%<br>cutoff | +25%<br>cutoff | Cutoff | -25%<br>cutoff | -50%<br>cutoff | -75%<br>cutoff | -100%<br>cut-off |
|----------------------------------------------------|-----------------|----------------|----------------|----------------|---------|----------------|----------------|----------------|------------------|
| | 620.5 | 547.0 | 469.9 | 380.9 | 328.6 | 240.2 | 143.9 | 71.4 | 0 |
| Lot I | 0-/50+ | 0-/50+ | 0-/50+ | 0-/50+ | 23-/27+ | 50-/0+ | 50-/0+ | 50-/0+ | 50-/0+ |
| Lot II | 0-/50+ | 0-/50+ | 0-/50+ | 0-/50+ | 23-/27+ | 50-/0+ | 50-/0+ | 50-/0+ | 50-/0+ |
| Lot III | 0-/50+ | 0-/50+ | 0-/50+ | 0-/50+ | 27-/23+ | 50-/0+ | 50-/0+ | 50-/0+ | 50-/0+ |
{13}------------------------------------------------
# BioSieve™ Multi-Drug Urine Test Panel MOP 300
| Concentration by | +100% | +75% | +50% | +25% | Cutoff | -25% | -50% | -75% | -100% |
|------------------|--------|--------|--------|--------|---------|--------|--------|--------|---------|
| LC/MS<br>(ng/mL) | cutoff | cutoff | cutoff | cutoff | | cutoff | cutoff | cutoff | cut-off |
| Lot Number | 622.4 | 530.2 | 468.8 | 381.8 | 322.8 | 220.8 | 159.0 | 75.4 | 0 |
| Lot I | 0-/50+ | 0-/50+ | 0-/50+ | 0-/50+ | 25-/25+ | 50-/0+ | 50-/0+ | 50-/0+ | 50-/0+ |
| Lot II | 0-/50+ | 0-/50+ | 0-/50+ | 0-/50+ | 26-/24+ | 50-/0+ | 50-/0+ | 50-/0+ | 50-/0+ |
| Lot III | 0-/50+ | 0-/50+ | 0-/50+ | 0-/50+ | 25-/25+ | 50-/0+ | 50-/0+ | 50-/0+ | 50-/0+ |
BioSieve™ Multi-Drug Urine Test Panel PPX 300
| Concentration by | +100% | +75% | +50% | +25% | Cutoff | -25% | -50% | -75% | -100% |
|------------------|--------|--------|--------|--------|---------|--------|--------|--------|---------|
| LC/MS | cutoff | cutoff | cutoff | cutoff | | cutoff | cutoff | cutoff | cut-off |
| (ng/mL) | 622.3 | 562.7 | 451.3 | 383.3 | 297.7 | 218.3 | 152.5 | 75.8 | 0 |
| Lot Number | | | | | | | | | |
| Lot I | 0-/50+ | 0-/50+ | 0-/50+ | 0-/50+ | 28-/22+ | 50-/0+ | 50-/0+ | 50-/0+ | 50-/0+ |
| Lot II | 0-/50+ | 0-/50+ | 0-/50+ | 0-/50+ | 27-/23+ | 50-/0+ | 50-/0+ | 50-/0+ | 50-/0+ |
| Lot III | 0-/50+ | 0-/50+ | 0-/50+ | 0-/50+ | 27-/23+ | 50-/0+ | 50-/0+ | 50-/0+ | 50-/0+ |
BioSieve™ Multi-Drug Urine Test Panel COC 150
| Concentration by<br>LC/MS<br>(ng/mL)<br><br>Lot Number | +100%<br>cutoff | +75%<br>cutoff | +50%<br>cutoff | +25%<br>cutoff | Cutoff | -25%<br>cutoff | -50%<br>cutoff | -75%<br>cutoff | -100%<br>cut-off |
|--------------------------------------------------------|-----------------|----------------|----------------|----------------|---------|----------------|----------------|----------------|------------------|
| | 298.2 | 246.1 | 237.0 | 193.6 | 157.7 | 106.5 | 76.2 | 36.0 | 0 |
| | Lot I | 0-/50+ | 0-/50+ | 0-/50+ | 0-/50+ | 23-/27+ | 50-/0+ | 50-/0+ | 50-/0+ |
| Lot II | 0-/50+ | 0-/50+ | 0-/50+ | 0-/50+ | 23-/27+ | 50-/0+ | 50-/0+ | 50-/0+ | 50-/0+ |
| Lot III | 0-/50+ | 0-/50+ | 0-/50+ | 0-/50+ | 25-/25+ | 50-/0+ | 50-/0+ | 50-/0+ | 50-/0+ |
BioSieve™ Multi-Drug Urine Test Panel MDMA 500
| Concentration by<br>LC/MS<br>(ng/mL) | +100%<br>cutoff | +75%<br>cutoff | +50%<br>cutoff | +25%<br>cutoff | Cutoff | -25%<br>cutoff | -50%<br>cutoff | -75%<br>cutoff | -100%<br>cut-off |
|--------------------------------------|-----------------|----------------|----------------|----------------|---------|----------------|----------------|----------------|------------------|
| Lot Number | | | | | | | | | |
| | 1048.5 | 861.5 | 740.8 | 614.9 | 522.8 | 342.0 | 250.6 | 128.4 | 0 |
| Lot I | 0-/50+ | 0-/50+ | 0-/50+ | 0-/50+ | 26-/24+ | 50-/0+ | 50-/0+ | 50-/0+ | 50-/0+ |
| Lot II | 0-/50+ | 0-/50+ | 0-/50+ | 0-/50+ | 26-/24+ | 50-/0+ | 50-/0+ | 50-/0+ | 50-/0+ |
| Lot III | 0-/50+ | 0-/50+ | 0-/50+ | 0-/50+ | 25-/25+ | 50-/0+ | 50-/0+ | 50-/0+ | 50-/0+ |
{14}------------------------------------------------
# BioSieve™ Multi-Drug Urine Test Panel TCA 1000
| | Concentration by<br>LC/MS<br>(ng/mL)<br>Lot Number | +100%<br>cutoff | +75%<br>cutoff | +50%<br>cutoff | +25%<br>cutoff | Cutoff | -25%<br>cutoff | -50%<br>cutoff | -75%<br>cutoff | -100%<br>cut-off |
|---------|----------------------------------------------------|-----------------|----------------|----------------|----------------|--------|----------------|----------------|----------------|------------------|
| | 2175.2 | 1841.2 | 1597.5 | 1261.6 | 1081.5 | 708.2 | 493.1 | 251.5 | 0 | |
| Lot I | 0-/50+ | 0-/50+ | 0-/50+ | 0-/50+ | 24-/26+ | 50-/0+ | 50-/0+ | 50-/0+ | 50-/0+ | |
| Lot II | 0-/50+ | 0-/50+ | 0-/50+ | 0-/50+ | 26-/24+ | 50-/0+ | 50-/0+ | 50-/0+ | 50-/0+ | |
| Lot III | 0-/50+ | 0-/50+ | 0-/50+ | 0-/50+ | 24-/26+ | 50-/0+ | 50-/0+ | 50-/0+ | 50-/0+ | |
BioSieve™ Multi-Drug Urine Test Panel AMP 500
| Concentration | +100% | +75% | +50% | +25% | Cutoff | -25% | -50% | -75% | -100% |
|-----------------------|--------|--------|--------|--------|---------|--------|--------|--------|---------|
| by LC/MS | cutoff | cutoff | cutoff | cutoff | | cutoff | cutoff | cutoff | cut-off |
| (ng/mL)<br>Lot Number | 1011.8 | 846.4 | 772.7 | 646.8 | 544.3 | 357.6 | 225.0 | 120.9 | 0 |
| Lot I | 0-/50+ | 0-/50+ | 0-/50+ | 0-/50+ | 24-/26+ | 50-/0+ | 50-/0+ | 50-/0+ | 50-/0+ |
| Lot II | 0-/50+ | 0-/50+ | 0-/50+ | 0-/50+ | 24-/26+ | 50-/0+ | 50-/0+ | 50-/0+ | 50-/0+ |
| Lot III | 0-/50+ | 0-/50+ | 0-/50+ | 0-/50+ | 27-/23+ | 50-/0+ | 50-/0+ | 50-/0+ | 50-/0+ |
BioSieve™ Multi-Drug Urine Test Panel MET 500
| Concentration by<br>LC/MS<br>(ng/mL) | +100%<br>cutoff | +75%<br>cutoff | +50%<br>cutoff | +25%<br>cutoff | Cutoff | -25%<br>cutoff | -50%<br>cutoff | -75%<br>cutoff | -100%<br>cut-off |
|--------------------------------------|-----------------|----------------|----------------|----------------|---------|----------------|----------------|----------------|------------------|
| | 1072.7 | 873.9 | 731.7 | 633.1 | 477.8 | 386.1 | 249.2 | 122.5 | 0 |
| Lot Number | | | | | | | | | |
| Lot I | 0-/50+ | 0-/50+ | 0-/50+ | 0-/50+ | 27-/23+ | 50-/0+ | 50-/0+ | 50-/0+ | 50-/0+ |
| Lot II | 0-/50+ | 0-/50+ | 0-/50+ | 0-/50+ | 27-/23+ | 50-/0+ | 50-/0+ | 50-/0+ | 50-/0+ |
| Lot III | 0-/50+ | 0-/50+ | 0-/50+ | 0-/50+ | 24-/26+ | 50-/0+ | 50-/0+ | 50-/0+ | 50-/0+ |
# BioSieve™ Multi-Drug Urine Test Panel OPI 2000
| Concentration by<br>LC/MS<br>(ng/mL)<br>Lot Number | +100%<br>cutoff | +75%<br>cutoff | +50%<br>cutoff | +25%<br>cutoff | Cutoff | -25%<br>cutoff | -50%<br>cutoff | -75%<br>cutoff | -100%<br>cut-off |
|----------------------------------------------------|-----------------|----------------|----------------|----------------|---------|----------------|----------------|----------------|------------------|
| | 4208.2 | 3672.9 | 3119.0 | 2590.5 | 2050.0 | 1460.4 | 1007.5 | 493.0 | 0 |
| Lot I | 0-/50+ | 0-/50+ | 0-/50+ | 0-/50+ | 26-/24+ | 50-/0+ | 50-/0+ | 50-/0+ | 50-/0+ |
| Lot II | 0-/50+ | 0-/50+ | 0-/50+ | 0-/50+ | 26-/24+ | 50-/0+ | 50-/0+ | 50-/0+ | 50-/0+ |
| Lot III | 0-/50+ | 0-/50+ | 0-/50+ | 0-/50+ | 25-/25+ | 50-/0+ | 50-/0+ | 50-/0+ | 50-/0+ |
{15}------------------------------------------------
# BioSieve™ Multi-Drug Urine Test Panel COC 300
| Concentration by | +100% | +75% | +50% | +25% | Cutoff | -25% | -50% | -75% | -100% |
|-----------------------|--------|--------|--------|--------|---------|--------|--------|--------|---------|
| LC/MS | cutoff | cutoff | cutoff | cutoff | | cutoff | cutoff | cutoff | cut-off |
| (ng/mL)<br>Lot Number | 610.6 | 558.5 | 461.6 | 373.4 | 329.9 | 235.6 | 156.7 | 74.5 | 0 |
| Lot I | 0-/50+ | 0-/50+ | 0-/50+ | 0-/50+ | 24-/26+ | 50-/0+ | 50-/0+ | 50-/0+ | 50-/0+ |
| Lot II | 0-/50+ | 0-/50+ | 0-/50+ | 0-/50+ | 27-/23+ | 50-/0+ | 50-/0+ | 50-/0+ | 50-/0+ |
| Lot III | 0-/50+ | 0-/50+ | 0-/50+ | 0-/50+ | 26-/24+ | 50-/0+ | 50-/0+ | 50-/0+ | 50-/0+ |
BioSieve™ Multi-Drug Urine Test Panel AMP 1000
| Concentration by | +100% | +75% | +50% | +25% | Cutoff | -25% | -50% | -75% | -100% |
|-----------------------|--------|--------|--------|--------|---------|--------|--------|--------|---------|
| LC/MS | cutoff | cutoff | cutoff | cutoff | | cutoff | cutoff | cutoff | cut-off |
| (ng/mL)<br>Lot Number | 1933.3 | 1805.2 | 1562.7 | 1262.0 | 1051.1 | 812.0 | 540.9 | 271.9 | 0 |
| Lot I | 0-/50+ | 0-/50+ | 0-/50+ | 0-/50+ | 26-/24+ | 50-/0+ | 50-/0+ | 50-/0+ | 50-/0+ |
| Lot II | 0-/50+ | 0-/50+ | 0-/50+ | 0-/50+ | 25-/25+ | 50-/0+ | 50-/0+ | 50-/0+ | 50-/0+ |
| Lot III | 0-/50+ | 0-/50+ | 0-/50+ | 0-/50+ | 27-/23+ | 50-/0+ | 50-/0+ | 50-/0+ | 50-/0+ |
BioSieve™ Multi-Drug Urine Test Panel MET 1000
| Concentration by | +100% | +75% | +50% | +25% | Cutoff | -25% | -50% | -75% | -100% |
|-----------------------|--------|--------|--------|--------|---------|--------|--------|--------|---------|
| LC/MS | cutoff | cutoff | cutoff | cutoff | | cutoff | cutoff | cutoff | cut-off |
| (ng/mL)<br>Lot Number | 1954.6 | 1824.2 | 1593.1 | 1304.9 | 1003.4 | 736.7 | 464.8 | 251.1 | 0 |
| Lot I | 0-/50+ | 0-/50+ | 0-/50+ | 0-/50+ | 27-/23+ | 50-/0+ | 50-/0+ | 50-/0+ | 50-/0+ |
| Lot II | 0-/50+ | 0-/50+ | 0-/50+ | 0-/50+ | 23-/27+ | 50-/0+ | 50-/0+ | 50-/0+ | 50-/0+ |
| Lot III | 0-/50+ | 0-/50+ | 0-/50+ | 0-/50+ | 26-/24+ | 50-/0+ | 50-/0+ | 50-/0+ | 50-/0+ |
The following cutoff values are verified:
| Target Drug | Cut-off level |
|----------------------------------------------------------|-------------------------|
| Amphetamine (AMP) | 1000 ng/mL or 500 ng/mL |
| Buprenorphine (BUP) | 10 ng/mL |
| Secobarbital (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 |
{16}------------------------------------------------
| 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 |
| Cannabinoids (THC 50) | 50 ng/mL |
#### b. Linearity
Not applicable
#### c. Stability
The devices are stable at 2-30°C for 24 months based on real time stability studies at 2°C and 30°C.
### d. Interference
Potential interfering substances were added to drug-free urine sample and samples with target drugs of -25% cutoff and +25% cutoff level.
Compounds that show no interference at a concentration of 100µg/mL are summarized in the following table.
| Acetaminophen | Effexor | Nikethamide |
|-------------------------------|----------------------------|------------------------------------------|
| Acetophenetidin | Enalapril Maleate | Nimodipine |
| Acetylsalicylic Acid | Epinephrine Hydrochloride | Nitroglycerin |
| Acyclovir | Erythromycin | Norethindrone |
| Afrin | Esomeprazole Magnesium | O-Hydroxyhippuric Acid |
| Albumin (100mg/dL) | ß-Estradiol | Olanzapine |
| Aminophylline | Ethanol (1%) | Omeprazole |
| Aminopyrine | Fenofibrate | Ondansetran |
| Amiodarone Hydrochloride | Fenoprofen | Oxalic Acid |
| Amlodipine Mesylate | Fentanyl Citrate | Oxolinic Acid |
| Amoxicillin | Fluoxetine Hydrochloride | Oxymetazoline |
| Ampicillin | Fluvoxamine | Paliperidone |
| Apomorphine | Furosemide | Pantoprazole |
| Aripiprazole | Gabapentin | Papaverine |
| Aspartame | Gentisic Acid | Paroxetine Hydrochloride |
| Atomoxetine | Glibenclamide | Penfluridol |
| Atorvastatin Calcium | Gliclazide | Penicillin-G |
| Atropine | Glipizide | PenicillinV Potassium |
| Benzilic Acid | Glucose | Phenelzine |
| Benzoic Acid | Haloperidol | Pioglitazone Hydrochloride |
| Bilirubin | Hemoglobin | Piracetam |
| Bupropion | Hydrochlorothiazide | Pravastatin Sodium |
| Captopril | Hydrocortisone | Prednisone |
| Carbamazepine | 3-Hydroxytyramine | Promethazine |
| Cefradine | Ibuprofen | Propylthiouracil |
| Cephalexin | Isosorbide Dinitrate | Quetiapine Fumarate |
| Chloral Hydrate | Isoxsuprine | Quinine |
| Chloramphenicol | Ketamine | Ranitidine |
| Chlorothiazide | Ketoconazole | Rifampicin |
| chlorpheniramine | Ketoprofen | Risperidone |
| Cholesterol | Kratom powder | Salicylic Acid |
| Ciprofloxacin Hydrochloride | Labetalol | Serotonin |
| Citalopram | Lamotrigine | Sertraline Hydrochloride |
| Clarithromycin | Levofloxacin Hydrochloride | Sildenafil Citrate |
| Clonidine | Levonorgestrel | Simvastatin |
| Clopidogrel Hydrogen Sulphate | Levothyroxine Sodium | Sodium Valproate |
| Clozapine | Lidocaine Hydrochloride | Spironolactone |
| Conjugated Estrogens | Lisinopril | Sulfamethazine |
| Cortisone | Lithium Carbonate | Sulindac |
| (-) Cotinine | Liverite | Tetracycline |
| Creatinine | Loperamide | Tetrahydrocortisone 3- (β-D glucuronide) |
| D-Pseudoephedrine | Loratadine | Tetrahydrocortsone 3 -acetate |
| D,L-Octopamine | Magnesium | Tetrahydrozoline |
| D,L-Propranolol | Meperidine | Thiamine |
| D,L-Tyrosine | Meprobamate | Thioridazine |
| Deoxy- corticosterone | Metoprolol Tartrate | Topiramate |
| Dextromethorphan | Mifepristone | Tramadol Hydrochloride |
| Diclofenac | Minocycline | Trazodone Hydrochloride |
| Dicyclomine | Mirtazapine | Triamterene |
| Diflunisal | Montelukast Sodium | Trifluoperazine |
| Digoxin | Mosapride Citrate | Trimethoprim |
| Diphenhydramine | N-Acetylprocain-amide | Uric Acid |
| Dirithromycin | Nalidixic Acid | Valproate |
| Domperidone | Naproxen | Verapamil |
| Doxylamine | Niacinamide | Vitamin B2 |
| Duloxetine | Nifedipine | Vitamin C |
| Ecgonine Methyl Ester | | |
{17}------------------------------------------------
{18}------------------------------------------------
- Specificity e.
To test the specificity, drug metabolites and other components that are likely to cross-react in urine samples were spiked into drug-free urine. These urine samples were tested using three lots of each 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; compounds that did not yield a positive result at the highest concentration tested have relative cross reactivity results represented by a dash in the table below:
| BUP 10 (Buprenorphine,<br>Cutoff=10 ng/mL) | Minimum concentration<br>required to obtain a<br>positive result (ng/mL) | % Cross-<br>Reactivity |
|--------------------------------------------|--------------------------------------------------------------------------|------------------------|
| Buprenorphine -3-D-Glucuronide | 15 | 66.67% |
| Norbuprenorphine | 20 | 50% |
| Norbuprenorphine-3-D-Glucuronide | 200 | 5% |
| Morphine | >100000 | - |
| Oxymorphone | >100000 | - |
| Hydromorphone | >100000 | - |
| PCP (Phencyclidine)<br>(Phencyclidine,<br>Cutoff=25 ng/mL) | Minimum concentration<br>required to obtain a<br>positive result (ng/mL) | % Cross-<br>Reactivity |
|------------------------------------------------------------|--------------------------------------------------------------------------|------------------------|
| 4-Hydroxyphencyclidine | 12500 | 0.2% |
| THC 50<br>(11-nor-Δ9-THC-9-COOH,<br>Cutoff=50 ng/mL) | Minimum concentration<br>required to obtain a<br>positive result (ng/mL) | % Cross-<br>Reactivity |
|------------------------------------------------------|--------------------------------------------------------------------------|------------------------|
| (-)-11-nor-9-carboxy-Δ9-THC | 50 | 100% |
| 11-nor-Δ8-THC-9-COOH | 50 | 100% |
| 11-nor-Δ9-THC-carboxy glucuronide | 100 | 50% |
| Cannabidiol | 100,000 | -- |
| Cannabinol | 100,000 | -- |
| Δ8- Tetrahydrocannabinol | 15,000 | 0.3% |
| Δ9- Tetrahydrocannabinol | 15,000 | 0.3% |
| 11-hydroxy-Δ9-Tetrahydrocannabinol | 5,000 | 1% |
| OXY 100<br>(Oxycodone, Cutoff=100 ng/mL) | Minimum concentration<br>required to obtain a<br>positive result (ng/mL) | % Cross-<br>Reactivity |
|------------------------------------------|--------------------------------------------------------------------------|------------------------|
| Dihydrocodeine | 20,000 | 0.5% |
| Hydrocodone | 80 | 125% |
{19}------------------------------------------------
| Oxymorphone | 1,000 | 10% |
|----------------|---------|-------|
| Codeine | 100,000 | -- |
| Hydromorphone | 36,000 | 0.28% |
| Morphine | 100,000 | -- |
| Acetylmorphine | 100,000 | -- |
| Buprenorphine | 100,000 | -- |
| Ethylmorphine | 100,000 | -- |
| Thebaine | 100,000 | -- |
| COC 150<br>(Benzoylecgonine, Cutoff=150 ng/mL) | Minimum concentration<br>required to obtain a<br>positive result (ng/mL) | % Cross-<br>Reactivity |
|------------------------------------------------|--------------------------------------------------------------------------|------------------------|
| Cocaine | 375 | 40% |
| Cocaethylene | 6,250 | 2.4% |
| Ecgonine | 16,000 | 0.9% |
| Ecgonine methyl ester | 100,000 | -- |
| Norcocaine | 100,000 | -- |
| BAR 300<br>(Secobarbital, Cutoff=300ng/mL) | Minimum concentration<br>required to obtain a<br>positive result (ng/mL) | % Cross-<br>Reactivity |
|--------------------------------------------|--------------------------------------------------------------------------|------------------------|
| Amobarbital | 300 | 100% |
| Alphenol | 600 | 50% |
| Aprobarbital | 200 | 150% |
| Butabarbital | 100 | 300% |
| Butethal | 200 | 150% |
| Butalbital | 2,000 | 15% |
| Cyclopentobarbital | 400 | 75% |
| Pentobarbital | 200 | 150% |
| Phenobarbital | 200 | 150% |
| BZO 300<br>(Oxazepam, Cutoff=300ng/mL) | Minimum concentration<br>required to obtain a<br>positive result (ng/mL) | % Cross-<br>Reactivity |
|----------------------------------------|--------------------------------------------------------------------------|------------------------|
| Alprazolam | 190 | 157.9% |
| a-Hydroxyalprazolam | 300 | 100% |
| Bromazepam | 500 | 60% |
| Chlordiazepoxide | 1,500 | 20% |
| Clobazam | 110 | 272.7% |
| Clonazepam | 100,000 | -- |
| Clorazepate dipotassium | 300 | 100% |
| Delorazepam | 100,000 | -- |
{20}------------------------------------------------
| Desalkylflurazepam | 200 | 150% |
|---------------------|---------|--------|
| Diazepam | 190 | 157.9% |
| Estazolam | 5,000 | 6% |
| Flunitrazepam | 400 | 75% |
| Midazolam | 2,200 | 13.6% |
| Nitrazepam | 200 | 150% |
| Norchlordiazepoxide | 800 | 37.5% |
| Nordiazepam | 150 | 200% |
| Temazepam | 100 | 300% |
| Triazolam | 6,000 | 5% |
| Demoxepam | 2,000 | 15% |
| Flurazepam | 100,000 | -- |
| D,L-Lorazepam | 75,000 | 0.4% |
| EDDP 300<br>(2-ethylidene-1,5-dimethyl-3,3-<br>diphenylpyrrolidine, Cutoff = 300 ng/mL) | Minimum concentration<br>required to obtain a<br>positive result (ng/mL) | % Cross-<br>Reactivity |
|-----------------------------------------------------------------------------------------|--------------------------------------------------------------------------|------------------------|
| Methadone | >100000 | - |
| EMDP | >100000 | - |
| Doxylamine | >100000 | - |
| Disopyramide | >100000 | - |
| LAAM (Levo-alpha-acetylmethadol) HCl | >100000 | - |
| Alpha Methadol | >100000 | - |
| MTD 300<br>(Methadone, Cutoff=300ng/mL) | Minimum concentration<br>required to obtain a<br>positive result (ng/mL) | % Cross-<br>Reactivity |
|-----------------------------------------|--------------------------------------------------------------------------|------------------------|
| Doxylamine | >100000 | - |
| EDDP | >100000 | - |
| EMDP | >100000 | - |
| LAAM | >100000 | - |
| Alpha Methadol | >100000 | - |
| MOP 300<br>(Morphine, Cutoff=300ng/mL) | Minimum concentration<br>required to obtain a<br>positive result (ng/mL) | % Cross-<br>Reactivity |
|----------------------------------------|--------------------------------------------------------------------------|------------------------|
| Normorphine | 300 | 100% |
| Codeine | 300 | 100% |
| s-Monoacetylmorphine | 300 | 100% |
| Ethyl Morphine | 200 | 150% |
| Heroin | 300 | 100% |
| Hydrocodone | 700 | 42.9% |
{21}------------------------------------------------
| Hydromorphone | 200 | 150% |
|------------------------------|---------|------|
| Morphinie-3-β-d-glucuronide | 1,000 | 30% |
| Oxycodone | 100,000 | -- |
| Oxymorphone | 100,000 | -- |
| Thebaine | 20,000 | 1.5% |
| Levorphanol | 10,000 | 3% |
| 6-Monoacetylmorphine (6-MAM) | 300 | 100% |
| Norcodeine | 6,250 | 4.8% |
| Procaine | 100,000 | -- |
| PPX 300<br>(d-Propoxyphene, Cutoff=300ng/mL) | Minimum concentration<br>required to obtain a<br>positive result (ng/mL) | % Cross-<br>Reactivity |
|----------------------------------------------|--------------------------------------------------------------------------|------------------------|
| d-Norpropoxyphene | 300 | 100% |
| MDMA 500<br>(3,4-Methylenedioxymethamphetamine HCl,<br>Cutoff=500ng/mL) | Minimum concentration<br>required to obtain a<br>positive result (ng/mL) | % Cross-<br>Reactivity |
|-------------------------------------------------------------------------|--------------------------------------------------------------------------|------------------------|
| 3,4-Methylenedioxyamphetamine HCl (MDA) | 4,000 | 12.5% |
| 3,4-Methylenedioxyethylamphetamine (MDE) | 400 | 125% |
| d-methamphetamine | >100000 | - |
| d-amphetamine | >100000 | - |
| l-methamphetamine | >100000 | - |
| l-amphetamine…
