(75 days)
Not Found
No
The device description and performance studies describe a standard immunochromatographic assay (lateral flow test) for qualitative detection. There is no mention of any computational analysis, image processing, or algorithms that would suggest the use of AI or ML.
No
Explanation: The device is an in vitro diagnostic test for detecting Buprenorphine and Methadone in urine. It does not provide any form of therapy or treatment.
Yes
Explanation: The device is explicitly stated to be for "in vitro diagnostic use only" and "intended for over-the-counter and for prescription use" to qualitatively determine Buprenorphine and Methadone in human urine. It provides preliminary test results that require further confirmation, aligning with the definition of a diagnostic device.
No
The device description clearly states that the devices are "immunochromatographic assays that use a lateral flow system," which are physical test strips/cups, not software.
Based on the provided text, the devices described are IVDs (In Vitro Diagnostics).
Here's why:
- Explicit Statement: The text repeatedly states "For in vitro diagnostic use only." This is a clear indication that the devices are intended for use outside of a living organism to diagnose or detect conditions.
- Intended Use: The intended use is the "qualitative determination of Buprenorphine and/or Methadone in human urine." This involves analyzing a biological sample (urine) to detect the presence of specific substances, which is a core function of IVDs.
- Device Description: The devices are described as "immunochromatographic assays," which are common types of IVD tests.
- Testing of Biological Samples: The tests are performed on "human urine," a biological specimen.
- Clinical Context: The text mentions "Clinical consideration and professional judgment should be exercised with any drug of abuse test result," indicating the results have clinical relevance.
- Comparison to Confirmatory Methods: The need for a "more specific alternative chemical method" like GC/MS for confirmation further reinforces that these are preliminary diagnostic tests.
Therefore, the AssureTech Buprenorphine Strip, AssureTech Methadone Strip, AssureTech Buprenorphine/Methadone Panel Dip, AssureTech Buprenorphine/Methadone Quick Cup, and AssureTech Buprenorphine/Methadone Turn Key-Split Cup are all IVD devices.
N/A
Intended Use / Indications for Use
The AssureTech Buprenorphine Strip test is an immunochromatographic assay for the qualitative determination of Buprenorphine in human urine at a Cut-Off concentration of 10ng/mL. This test is calibrated to Buprenorphine (calibrator).
The test may yield preliminary positive results when prescription drug Buprenorphine is ingested, even at or above therapeutic doses. There are no uniformly recognized drug levels for Buprenorphine in urine. The test provides only preliminary test results. A more specific alternative chemical method must be used in order to obtain a confirmed analytical result. Gas Chromatography/Mass Spectrometry is the preferred confirmatory method. Clinical consideration and professional judgment should be exercised with any drug of abuse test result, particularly when the preliminary result is positive.
For in vitro diagnostic use only. The test is intended for over-the-counter and for prescription use.
The AssureTech Methadone Strip test is an immunochromatographic assay for the qualitative determination of Methadone in human urine at a Cut-Off concentration of 300ng/mL. This test is calibrated to Methadone (calibrator).
The test provides only preliminary test results. A more specific alternative chemical method must be used in order to obtain a confirmed analytical result. Gas Chromatography/Mass Spectrometry is the preferred confirmatory method. Clinical consideration and professional judgment should be exercised with any drug of abuse test result, particularly when the preliminary result is positive.
For in vitro diagnostic use only. The test is intended for over-the-counter and for prescription use.
The AssureTech Buprenorphine/Methadone Panel Dip test is an immunochromatographic assay for the qualitative determination of Buprenorphine and Methadone in human urine at a Cut-Off concentration of 10ng/mL, respectively. These tests are calibrated to Buprenorphine and Methadone (calibrators).
The test may yield preliminary positive results when prescription drug Buprenorphine is ingested, even at or above therapeutic doses. There are no uniformly recognized drug levels for Buprenorphine in urine. The test provides only preliminary test results. A more specific alternative chemical method must be used in order to obtain a confirmed analytical result. Gas Chromatography/Mass Spectrometry is the preferred confirmatory method. Clinical consideration and professional judgment should be exercised with any drug of abuse test result, particularly when the preliminary result is positive.
For in vitro diagnostic use only. The tests are intended for over-the-counter and for prescription use.
The AssureTech Buprenorphine/Methadone Quick Cup test is an immunochromatographic assay for the qualitative determination of Buprenorphine and Methadone in human urine at a Cut-Off concentration of 10ng/mL, and 300 ng/mL, respectively. These tests are calibrated to Buprenorphine and Methadone (calibrators).
The test may yield preliminary positive results when prescription drug Buprenorphine is ingested, even at or above therapeutic doses. There are no uniformly recognized drug levels for Buprenorphine in urine. The test provides only preliminary test results. A more specific alternative chemical method must be used in order to obtain a confirmed analytical result. Gas Chromatography/Mass Spectrometry is the preferred confirmatory method. Clinical consideration and professional judgment should be exercised with any drug of abuse test result, particularly when the preliminary result is positive.
For in vitro diagnostic use only. The tests are intended for over-the-counter and for prescription use.
The AssureTech BuprenorphineMethadone Turn Key-Split Cup test is an immunochromatographic assay for the qualitative determination of Buprenorphine and Methadone in human urine at a Cut-Off concentration of 10ng/mL and 300 ng/mL, respectively. These tests are calibrated to Buprenorphine and Methadone (calibrators).
The test may yield preliminary positive results when prescription drug Buprenorphine is ingested, even at or above therapeutic doses. There are no uniformly recognized drug levels for Buprenorphine in urine. The test provides only preliminary test results. A more specific alternative chemical method must be used in order to obtain a confirmed analytical result. Gas Chromatography/Mass Spectrometry is the preferred confirmatory method. Clinical consideration and professional judgment should be exercised with any drug of abuse test result, particularly when the preliminary result is positive.
For in vitro diagnostic use only. The tests are intended for over-the-counter and for prescription use.
Product codes (comma separated list FDA assigned to the subject device)
DJR, DJG
Device Description
The AssureTech Bunrenorphine Strip, AssureTech Methadone Strip, AssureTech Buprenorphine/Methadone Panel Dip, AssureTech Buprenorphine/Methadone Quick Cup and AssureTech Buprenorphine/Methadone Turn Key-Split Cup are immunochromatographic assays that use a lateral flow system for the qualitative detection of Buprenorphine and/or Methadone (target analytes) in human urine. The Quick Cup format does not contain a turn-key for device activation. The tests are the first step in a two-step process. The second step is to send the sample for laboratory testing if preliminary positive results are obtained.
Mentions image processing
Not Found
Mentions AI, DNN, or ML
Not Found
Input Imaging Modality
Not Found
Anatomical Site
Not Found
Indicated Patient Age Range
Not Found
Intended User / Care Setting
For in vitro diagnostic use only. The test is intended for over-the-counter and for prescription use.
Description of the training set, sample size, data source, and annotation protocol
Not Found
Description of the test set, sample size, data source, and annotation protocol
- Precision: Samples with concentrations of -100% cut off, -75% cut off, -50% cut off, -25% cut off, +25% cut off, +50% cut off , +75% cut off and +100% cut off were used. These samples were prepared by spiking drug in negative samples. Each drug concentration was confirmed by GC/MS. All sample aliquots were blindly labeled by the person who prepared the samples and didn't take part in the sample testing. For each concentration, tests were performed two runs per day for 25 days per device in a randomized order.
- Cut-off: A total of 150 samples equally distributed at concentrations of -50% Cut-Off; -25% Cut-Off; Cut-Off; +25% Cut-Off; +50% Cut-Off were tested using three different lots of each device by three different operators.
- Interference: Potential interfering substances found in human urine of physiological or pathological conditions were added to drug-free urine and target drugs urine with concentrations at 25% below and 25% above Cut-Off levels. These urine samples were tested using three batches of each device.
- Specificity: Drug metabolites and other components that are likely to interfere in urine samples were tested using three batches of each device.
- Effect of Urine Specific Gravity and Urine pH: Urine samples, with 1.000 to 1.035 specific gravity or urine samples with pH 4 to 9 were spiked with target drugs at 25% below and 25% above Cut-Off levels. These samples were tested using three lots of each device.
- Comparison Studies: 80 (40 negative and 40 positive) unaltered clinical samples were used. The samples were blind labeled and compared to GC/MS results.
- Lay-user study: 1113 lay persons participated. Urine samples were prepared at the following concentrations; negative, +/-75%, +/-50%, +/-25% of the cutoff by spiking drug(s) into drug free-pooled urine specimens. The concentrations of the samples were confirmed by GC/MS. Each sample was aliquoted into individual containers and blind-labeled. Each participant was provided with the package insert, 1 blind labeled sample and a device. Each device was tested.
Summary of Performance Studies (study type, sample size, AUC, MRMC, standalone performance, key results)
- Analytical Performance (Precision): Samples were prepared at -100%, -75%, -50%, -25%, +25%, +50%, +75%, +100% of the cut-off. For Buprenorphine products, concentrations at -100% to -25% were 100% negative, and concentrations at +25% to +100% were 100% positive, with slight variations at the cut-off (-25% to +25%). Similar results were observed for Methadone products.
- Stability: The devices are stable at 4-30 ℃ for 24 months based on the accelerated stability study at 45 °C and real time stability determination at both 4 °C and 30 °C.
- Cut-off: For both Buprenorphine and Methadone, results were all positive at and above +25% Cut-off and all negative at and below -25% Cut-off.
- Interference: A list of numerous compounds tested at 100µg/mL showed no interference.
- Specificity: Cross-reactivity was determined for several related and unrelated compounds for Buprenorphine and Methadone.
- Effect of Urine Specific Gravity and Urine pH: Results were all positive for samples at and above +25% Cut-Off and all negative for samples at and below -25% Cut-Off, indicating no significant effect within the tested ranges.
- Comparison Studies: In-house studies with three laboratory assistants comparing device results to GC/MS for 80 clinical samples (40 negative, 40 positive) showed high concordance. Discordant results were generally near the cut-off concentration.
- Lay-user study: 1113 lay persons participated. The percentage of correct results for Buprenorphine ranged from 95% to 100% across various concentrations. For Methadone, the percentage of correct results ranged from 90% to 100%. All lay users indicated that the device instructions can be easily followed, and the Flesch-Kincaid reading analysis showed a reading Grade Level of 7.
Key Metrics (Sensitivity, Specificity, PPV, NPV, etc.)
Not directly stated as Sensitivity, Specificity, PPV, NPV. Performance data is presented as observed positive/negative results at specific concentrations relative to cut-off.
Predicate Device(s): If the device was cleared using the 510(k) pathway, identify the Predicate Device(s) K/DEN number used to claim substantial equivalence and list them here in a comma separated list exactly as they appear in the text. List the primary predicate first in the list.
Reference Device(s): Identify the Reference Device(s) K/DEN number and list them here in a comma separated list exactly as they appear in the text.
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
§ 862.3620 Methadone test system.
(a)
Identification. A methadone test system is a device intended to measure methadone, an addictive narcotic pain-relieving drug, in serum and urine. Measurements obtained by this device are used in the diagnosis and treatment of methadone use or overdose and to determine compliance with regulations in methadone maintenance treatment.(b)
Classification. Class II (special controls). A methadone test system is not exempt if it is intended for any use other than employment or insurance testing or is intended for Federal drug testing programs. The device is exempt from the premarket notification procedures in subpart E of part 807 of this chapter subject to the limitations in § 862.9, provided the test system is intended for employment and insurance testing and includes a statement in the labeling that the device is intended solely for use in employment and insurance testing, and does not include devices intended for Federal drug testing programs (e.g., programs run by the Substance Abuse and Mental Health Services Administration (SAMHSA), the Department of Transportation (DOT), and the U.S. military).
0
Image /page/0/Picture/1 description: The image shows the logo for the U.S. Department of Health & Human Services. The logo consists of a circular seal with the text "DEPARTMENT OF HEALTH & HUMAN SERVICES - USA" around the perimeter. Inside the circle is a stylized symbol that resembles three human profiles connected by flowing lines.
Food and Drug Administration 10903 New Hampshire Avenue Document Control Center - WO66-G609 Silver Spring, MD 20993-0002
October 5, 2015
ASSURE TECH. CO., LTD. C/O JOE SHIA MANAGER 504 E DIAMOND AVE., SUITE I GAITHERSBURG MD 20877
Re: K152025
Trade/Device Name: Assuretech Buprenorphine Tests (Strip, Panel Dip, Quick Cup, Turnkey Split Cup), Assuretech Methadone Tests (Strip, Panel Dip, Quick Cup, Turn-key Split Cup) Regulation Number: 21 CFR 862.3620 Regulation Name: Methadone test system Regulatory Class: II Product Code: DJR, DJG Dated: July 17, 2015 Received: July 22, 2015
Dear Mr. Shia:
We have reviewed your Section 510(k) premarket notification of intent to market the device referenced above and have determined the device is substantially equivalent (for the indications for use stated in the enclosure) to legally marketed predicate devices marketed in interstate commerce prior to May 28, 1976, the enactment date of the Medical Device Amendments, or to devices that have been reclassified in accordance with the provisions of the Federal Food. Drug. and Cosmetic Act (Act) that do not require approval of a premarket approval application (PMA). You may, therefore, market the device, subject to the general controls provisions of the Act. The general controls provisions of the Act include requirements for annual registration, listing of devices, good manufacturing practice, labeling, and prohibitions against misbranding and adulteration. Please note: CDRH does not evaluate information related to contract liability warranties. We remind you, however, that device labeling must be truthful and not misleading.
If your device is classified (see above) into either class II (Special Controls) or class III (PMA), it may be subject to additional controls. Existing major regulations affecting your device can be found in the Code of Federal Regulations, Title 21, Parts 800 to 898. In addition, FDA may publish further announcements concerning your device in the Federal Register.
Please be advised that FDA's issuance of a substantial equivalence determination does not mean that FDA has made a determination that your device complies with other requirements of the Act or any Federal statutes and regulations administered by other Federal agencies. You must comply with all the Act's requirements, including, but not limited to: registration and listing (21 CFR Part 807); labeling (21 CFR Parts 801 and 809); medical device reporting (reporting of medical device-related adverse events) (21 CFR 803); good manufacturing practice requirements as set forth in the quality systems (QS) regulation (21 CFR Part 820); and if applicable, the
1
electronic product radiation control provisions (Sections 531-542 of the Act): 21 CFR 1000-1050.
If you desire specific advice for your device on our labeling regulations (21 CFR Parts 801 and 809), please contact the Division of Industry and Consumer Education at its toll-free number (800) 638 2041 or (301) 796-7100 or at its Internet address
http://www.fda.gov/MedicalDevices/Resourcesfor You/Industry/default.htm. Also, please note the regulation entitled, "Misbranding by reference to premarket notification" (21 CFR Part 807.97). For questions regarding the reporting of adverse events under the MDR regulation (21 CFR Part 803), please go to
http://www.fda.gov/MedicalDevices/Safety/ReportaProblem/default.htm for the CDRH's Office of Surveillance and Biometrics/Division of Postmarket Surveillance.
You may obtain other general information on your responsibilities under the Act from the Division of Industry and Consumer Education at its toll-free number (800) 638-2041 or (301) 796-7100 or at its Internet address
http://www.fda.gov/MedicalDevices/ResourcesforYou/Industry/default.htm.
Sincerely yours,
Courtney H. Lias -S
Courtney H. Lias, Ph.D. Director Division of Chemistry and Toxicology Devices Office of In Vitro Diagnostics and Radiological Health Center for Devices and Radiological Health
Enclosure
2
Indications for Use
510(k) Number (if known) K152025
Device Name
AssureTech Buprenorphine Strip; AssureTech Methadone Strip AssureTech Buprenorphine/Methadone Panel Dip AssureTech Buprenorphine/Methadone Turn Key-Split Cup; AssureTech Buprenorphine/Methadone Quick Cup
Indications for Use (Describe)
The AssureTech Buprenorphine Strip test is an immunochromatographic assay for the qualitative determination of Buprenorphine in human urine at a Cut-Off concentration of 10ng/mL. This test is calibrated to Buprenorphine (calibrator).
The test may yield preliminary positive results when prescription drug Buprenorphine is ingested, even at or above therapeutic doses. There are no uniformly recognized drug levels for Buprenorphine in urine. The test provides only preliminary test results. A more specific alternative chemical method must be used in order to obtain a confirmed analytical result. Gas Chromatography/Mass Spectrometry is the preferred confirmatory method. Clinical consideration and professional judgment should be exercised with any drug of abuse test result, particularly when the preliminary result is positive.
For in vitro diagnostic use only. The test is intended for over-the-counter and for prescription use.
The AssureTech Methadone Strip test is an immunochromatographic assay for the qualitative determination of Methadone in human urine at a Cut-Off concentration of 300ng/mL. This test is calibrated to Methadone (calibrator).
The test provides only preliminary test results. A more specific alternative chemical method must be used in order to obtain a confirmed analytical result. Gas Chromatography/Mass Spectrometry is the preferred confirmatory method. Clinical consideration and professional judgment should be exercised with any drug of abuse test result, particularly when the preliminary result is positive.
For in vitro diagnostic use only. The test is intended for over-the-counter and for prescription use.
The AssureTech Buprenorphine/Methadone Panel Dip test is an immunochromatographic assay for the qualitative determination of Buprenorphine and Methadone in human urine at a Cut-Off concentration of 10ng/mL, respectively. These tests are calibrated to Buprenorphine and Methadone (calibrators).
The test may yield preliminary positive results when prescription drug Buprenorphine is ingested, even at or above therapeutic doses. There are no uniformly recognized drug levels for Buprenorphine in urine. The test provides only preliminary test results. A more specific alternative chemical method must be used in order to obtain a confirmed analytical result. Gas Chromatography/Mass Spectrometry is the preferred confirmatory method. Clinical consideration and professional judgment should be exercised with any drug of abuse test result, particularly when the preliminary result is positive.
For in vitro diagnostic use only. The tests are intended for over-the-counter and for prescription use.
The AssureTech Buprenorphine/Methadone Quick Cup test is an immunochromatographic assay for the qualitative determination of Buprenorphine and Methadone in human urine at a Cut-Off concentration of 10ng/mL, and 300 ng/mL, respectively. These tests are calibrated to Buprenorphine and Methadone (calibrators).
The test may yield preliminary positive results when prescription drug Buprenorphine is ingested, even at or above therapeutic doses. There are no uniformly recognized drug levels for Buprenorphine in urine. The test provides only preliminary test results. A more specific alternative chemical method must be used in order to obtain a confirmed
3
analytical result. Gas Chromatography/Mass Spectrometry is the preferred confirmatory method. Clinical consideration and professional judgment should be exercised with any drug of abuse test result, particularly when the preliminary result is positive.
For in vitro diagnostic use only. The tests are intended for over-the-counter and for prescription use.
The AssureTech BuprenorphineMethadone Turn Key-Split Cup test is an immunochromatographic assay for the qualitative determination of Buprenorphine and Methadone in human urine at a Cut-Off concentration of 10ng/mL and 300 ng/mL, respectively. These tests are calibrated to Buprenorphine and Methadone (calibrators).
The test may yield preliminary positive results when prescription drug Buprenorphine is ingested, even at or above therapeutic doses. There are no uniformly recognized drug levels for Buprenorphine in urine. The test provides only preliminary test results. A more specific alternative chemical method must be used in order to obtain a confirmed analytical result. Gas Chromatography/Mass Spectrometry is the preferred confirmatory method. Clinical consideration and professional judgment should be exercised with any drug of abuse test result, particularly when the preliminary result is positive.
For in vitro diagnostic use only. The tests are intended for over-the-counter and for prescription use.
| Type of Use (Select one or both, as applicable) |
|---|
| ------------------------------------------------- |
X Prescription Use (Part 21 CFR 801 Subpart D)
X Over-The-Counter Use (21 CFR 801 Subpart C)
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."
4
510(k) SUMMARY
| 1. Date: | September 17, 2015 |
|---|---|
| 2. Submitter: | Assure Tech. Co., Ltd. |
| Building 1, No.10, Xiyuansan Road, Westlake | |
| Economic Zone | |
| Hangzhou, China, 310030 | |
| 3. Contact person: | Eric Lin |
| Assure Tech. Co., Ltd. | |
| Building 1, No.10, Xiyuansan Road, Westlake | |
| Economic Zone | |
| Hangzhou, China, 310030 | |
| Telephone: 510-860-4680 | |
| Email: customerservice@assurelabs.com. | |
| 4. Device Name: | AssureTech Buprenorphine Strip |
| AssureTech Methadone Strip | |
| AssureTech Buprenorphine/Methadone Panel Dip | |
| AssureTech Buprenorphine/Methadone Quick Cup | |
| AssureTech Buprenorphine/Methadone Turn Key-Split Cup |
Classification:
| Product Code | CFR | Panel |
|---|---|---|
| DJR | 21 CFR, 862.3620 Methadone Test System | Toxicology |
| DJG | 21 CFR, 862.3650 Opiate Test System | Toxicology |
-
- Predicate Devices: K142396
The Chemtrue® Multi-Panel Drug Screen Dip Card Tests
- Predicate Devices: K142396
-
- Intended Use
The AssureTech Buprenorphine Strip test is an immunochromatographic assay for the qualitative determination of Buprenorphine in human urine at a Cut-Off concentration of 10ng/mL. This test is calibrated to Buprenorphine (calibrator).
- Intended Use
The test may vield preliminary positive results when prescription drug Buprenorphine is ingested, even at or above therapeutic doses. There are no uniformly recognized drug levels for Buprenorphine in urine. The test provides only preliminary test results. A more specific alternative chemical method must be used in order to obtain a confirmed analytical result. Gas Chromatography/Mass Spectrometry is the preferred confirmatory method. Clinical consideration and professional judgment should be exercised with any drug of abuse test result, particularly when the preliminary result is positive.
For in vitro diagnostic use only. The test is intended for over-the-counter and for prescription use.
The AssureTech Methadone Strip test is an immunochromatographic assay for the qualitative
5
determination of Methadone in human urine at a Cut-Off concentration of 300ng/mL. This test is calibrated to Methadone (calibrator).
The test provides only preliminary test results. A more specific alternative chemical method must be used in order to obtain a confirmed analytical result. Gas Chromatography/Mass Spectrometry is the preferred confirmatory method. Clinical consideration and professional judgment should be exercised with any drug of abuse test result, particularly when the preliminary result is positive.
For in vitro diagnostic use only. The test is intended for over-the-counter and for prescription use.
The AssureTech Buprenorphine/Methadone Panel Dip test is an immunochromatographic assay for the qualitative determination of Buprenorphine and Methadone in human urine at a Cut-Off concentration of 10ng/mL and 300 ng/mL, respectively. These tests are calibrated to Buprenorphine and Methadone (calibrators).
The test may vield preliminary positive results when prescription drug Buprenorphine is ingested, even at or above therapeutic doses. There are no uniformly recognized drug levels for Buprenorphine in urine. The test provides only preliminary test results. A more specific alternative chemical method must be used in order to obtain a confirmed analytical result. Gas Chromatography/Mass Spectrometry is the preferred confirmatory method. Clinical consideration and professional judgment should be exercised with any drug of abuse test result, particularly when the preliminary result is positive.
For in vitro diagnostic use only. The tests are intended for over-the-counter and for prescription use.
The AssureTech Buprenorphine/Methadone Quick Cup test is an immunochromatographic assay for the qualitative determination of Buprenorphine and Methadone in human urine at a Cut-Off concentration of 10ng/mL and 300 ng/mL, respectively. These tests are calibrated to Buprenorphine and Methadone (calibrators).
The test may yield preliminary positive results when prescription drug Buprenorphine is ingested, even at or above therapeutic doses. There are no uniformly recognized drug levels for Buprenorphine in urine. The test provides only preliminary test results. A more specific alternative chemical method must be used in order to obtain a confirmed analytical result. Gas Chromatography/Mass Spectrometry is the preferred confirmatory method. Clinical consideration and professional judgment should be exercised with any drug of abuse test result, particularly when the preliminary result is positive.
For in vitro diagnostic use only. The tests are intended for over-the-counter and for prescription use.
The AssureTech Buprenorphine/Methadone Turn Key-Split Cup test is an immunochromatographic assay for the qualitative determination of Buprenorphine and Methadone in human urine at a Cut-Off concentration of 10ng/mL and 300 ng/mL, respectively. These tests are calibrated to Buprenorphine and Methadone (calibrators).
The test may yield preliminary positive results when prescription drug Buprenorphine is
6
ingested, even at or above therapeutic doses. There are no uniformly recognized drug levels for Buprenorphine in urine. The test provides only preliminary test results. A more specific alternative chemical method must be used in order to obtain a confirmed analytical result. Gas Chromatography/Mass Spectrometry is the preferred confirmatory method. Clinical consideration and professional judgment should be exercised with any drug of abuse test result, particularly when the preliminary result is positive.
For in vitro diagnostic use only. The tests are intended for over-the-counter and for prescription use.
-
- Device Description
Strip. AssureTech Methadone The AssureTech Bunrenorphine Strip. AssureTech Buprenorphine/Methadone Panel Dip, AssureTech Buprenorphine/Methadone Quick Cup and AssureTech Buprenorphine/Methadone Turn Key-Split Cup are immunochromatographic assays that use a lateral flow system for the qualitative detection of Buprenorphine and/or Methadone (target analytes) in human urine. The Quick Cup format does not contain a turn-key for device activation. The tests are the first step in a two-step process. The second step is to send the sample for laboratory testing if preliminary positive results are obtained.
- Device Description
-
- Substantial Equivalence Information
A summary comparison of features of the AssureTech Buprenorphine Tests and AssureTech Methadone Tests and the predicate devices is provided in Table 1 & Table 2.
- Substantial Equivalence Information
| Item | Device | Predicate - K142396 |
|---|---|---|
| Indication(s) | ||
| for Use | For the qualitative determination of drugs of | |
| abuse in human urine. | Same (but the number of | |
| drugs detected is different) | ||
| Calibrator | Buprenorphine | Same |
| Methodology | Competitive binding, lateral flow | |
| immunochromatographic assays based on the | ||
| principle of antigen antibody | ||
| immunochemistry. | Same | |
| Type of Test | Qualitative | Same |
| Specimen Type | Human Urine | Same |
| Cut-Off Values | 10 ng/mL | Same |
| Intended Use | For over-the-counter and prescription uses. | Same |
| Configurations | Strip | Dip Card |
Table 1: Features Comparison of AssureTech Buprenorphine Strip and the Predicate Devices
Table 2: Features Comparison of AssureTech Methadone Strip and the Predicate Devices
| Item | Device | Predicate - K142396 |
|---|---|---|
| ------ | -------- | --------------------- |
7
| Indication(s)
for Use | For the qualitative determination of
drugs of abuse in human urine. | Same (but the number of
drugs detected is different) |
|--------------------------|-------------------------------------------------------------------------------------------------------------------------------------|---------------------------------------------------------|
| Calibrator | Methadone | Same |
| Methodology | Competitive binding, lateral flow
immunochromatographic assays based on the
principle of antigen antibody
immunochemistry. | Same |
| Type of Test | Qualitative | Same |
| Specimen Type | Human Urine | Same |
| Cut-Off Values | 300 ng/mL | Same |
| Intended Use | For over-the-counter and prescription uses. | Same |
| Configurations | Strip | Dip Card |
Table 3: Features Comparison of AssureTech Buprenorphine/Methadone Panel Dip and the Predicate Devices
| Item | Device | Predicate - K142396 |
|---|---|---|
| Indication(s) | ||
| for Use | For the qualitative determination of | |
| drugs of abuse in human urine. | Same (but the number of | |
| drugs detected is different) | ||
| Calibrator | Buprenorphine and Methadone | Same |
| Methodology | Competitive binding, lateral flow | |
| immunochromatographic assays based on the | ||
| principle of antigen antibody | ||
| immunochemistry. | Same | |
| Type of Test | Qualitative | Same |
| Specimen Type | Human Urine | Same |
| Cut-Off Values | 10ng/mL for Buprenorphine and 300 ng/mL for | |
| Methadone | Same | |
| Intended Use | For over-the-counter and prescription uses. | Same |
| Configurations | Panel Dip | Same |
Table 4: Features Comparison of AssureTech Buprenorphine/Methadone Cup and the Predicate Devices
| Item | Device | Predicate - K142396 |
|---|---|---|
| Indication(s) | ||
| for Use | For the qualitative determination of | |
| drugs of abuse in human urine. | Same (but the number of | |
| drugs detected is different) |
8
| Calibrator | Buprenorphine and Methadone | Same |
|---|---|---|
| Methodology | Competitive binding, lateral flow | |
| immunochromatographic assays based on the | ||
| principle of antigen antibody | ||
| immunochemistry. | Same | |
| Type of Test | Qualitative | Same |
| Specimen Type | Human Urine | Same |
| Cut-Off Values | 10ng/mL for Buprenorphine and 300 ng/mL for | |
| Methadone | Same | |
| Intended Use | For over-the-counter and prescription uses. | Same |
| Configurations | Cup with or without turn-key | Dip Card |
9. Test Principle
AssureTech Buprenorphine Strip, AssureTech Methadone Strip, AssureTech Buprenorphine/Methadone Panel Dip, AssureTech Buprenorphine/Methadone Quick Cup and AssureTech Buprenorphine/Methadone Turn Key-Split Cup are rapid tests for the qualitative detection of Buprenorphine and/or Methadone in urine samples. The tests are lateral flow chromatographic immunoassays. During testing, a urine specimen migrates upward by capillary action. If target drugs present in the urine specimen are below the cut-off concentration, it will not saturate the binding sites of its specific monoclonal mouse antibody coated on the particles. The antibody-coated particles will then be captured by immobilized drug-conjugate and a visible colored line will show up in the test line region. The will not form in the test line region if the target drug level exceeds its cutoff-concentration because it will saturate all the binding sites of the antibody coated on the particles. A band should form in the control region of the devices regardless of the presence of drug or metabolite in the sample to indicate that the tests have been performed properly.
10. Performance Characteristics
-
- Analytical Performance
- a. Precision
Precision studies were carried out for samples with concentrations of -100% cut off, -75% cut off, -50% cut off, -25% cut off, +25% cut off, +50% cut off , +75% cut off and +100% cut off. These samples were prepared by spiking drug in negative samples. Each drug concentration was confirmed by GC/MS. All sample aliquots were blindly labeled by the person who prepared the samples and didn't take part in the sample testing. For each concentration, tests were performed two runs per day for 25 days per device in a randomized order. The results obtained are summarized in the following tables.
Buprenorphine
AssureTech Buprenorphine Strip
| Lot
Number | -100%
cut off | -75%
cut off | -50%
cut off | -25%
cutoff | | +25%
cut off | +50%
cut off | +75%
cut off | +100%
cut off |
| --------------- | ------------------ | ----------------- | ----------------- | ---------------- | -- | ----------------- | ----------------- | ----------------- | ------------------ |
|---|
9
| Lot 1 | 50-/0+ | 50-/0+ | 50-/0+ | 50-/0+ | 4-/46+ | 50+/0- | 50+/0- | 50+/0- | 50+/0- |
|---|---|---|---|---|---|---|---|---|---|
| Lot 2 | 50-/0+ | 50-/0+ | 50-/0+ | 50-/0+ | 1-/49+ | 50+/0- | 50+/0- | 50+/0- | 50+/0- |
| Lot 3 | 50-/0+ | 50-/0+ | 50-/0+ | 50-/0+ | 3-/47+ | 50+/0- | 50+/0- | 50+/0- | 50+/0- |
AssureTech Buprenorphine /Methadone Panel Dip
| Lot
Number | -100%
cut off | -75%
cut off | -50%
cut off | -25%
cutoff | +25%
cut off | +50%
cut off | +75%
cut off | +100%
cut off |
|---------------|------------------|-----------------|-----------------|----------------|-----------------|-----------------|-----------------|------------------|
| Lot 1 | 50-/0+ | 50-/0+ | 50-/0+ | 50-/0+ | 3-/47+ | 50+/0- | 50+/0- | 50+/0- |
| Lot 2 | 50-/0+ | 50-/0+ | 50-/0+ | 50-/0+ | 2-/48+ | 50+/0- | 50+/0- | 50+/0- |
| Lot 3 | 50-/0+ | 50-/0+ | 50-/0+ | 50-/0+ | 2-/48+ | 50+/0- | 50+/0- | 50+/0- |
AssureTech Buprenorphine/Methadone Turn-Key Split Cup
| Lot
Number | -100%
cut off | -75%
cut off | -50%
cut off | -25%
cutoff | cut off | +25%
cut off | +50%
cut off | +75%
cut off | +100%
cut off |
|---------------|------------------|-----------------|-----------------|----------------|---------|-----------------|-----------------|-----------------|------------------|
| Lot 1 | 50-/0+ | 50-/0+ | 50-/0+ | 50-/0+ | 4-/46+ | 50+/0- | 50+/0- | 50+/0- | 50+/0- |
| Lot 2 | 50-/0+ | 50-/0+ | 50-/0+ | 50-/0+ | 2-/48+ | 50+/0- | 50+/0- | 50+/0- | 50+/0- |
| Lot 3 | 50-/0+ | 50-/0+ | 50-/0+ | 50-/0+ | 2-/48+ | 50+/0- | 50+/0- | 50+/0- | 50+/0- |
AssureTech Buprenorphine/Methadone Quick Cup
| Lot
Number | -100%
cut off | -75%
cut off | -50%
cut off | -25%
cutoff | +25%
cut off | +50%
cut off | +75%
cut off | +100%
cut off |
|---------------|------------------|-----------------|-----------------|----------------|-----------------|-----------------|-----------------|------------------|
| Lot 1 | 50-/0+ | 50-/0+ | 50-/0+ | 50-/0+ | 2-/48+ | 50+/0- | 50+/0- | 50+/0- |
| Lot 2 | 50-/0+ | 50-/0+ | 50-/0+ | 50-/0+ | 2-/48+ | 50+/0- | 50+/0- | 50+/0- |
| Lot 3 | 50-/0+ | 50-/0+ | 50-/0+ | 50-/0+ | 3-/47+ | 50+/0- | 50+/0- | 50+/0- |
Methadone
AssureTech Methadone Strip
| Lot Number | -100% cut off | -75% cut off | -50% cut off | -25% cutoff | cut off | +25% cut off | +50% cut off | +75% cut off | +100% cut off |
|---|---|---|---|---|---|---|---|---|---|
| Lot 1 | 50-/0+ | 50-/0+ | 50-/0+ | 50-/0+ | 2-/48+ | 50+/0- | 50+/0- | 50+/0- | 50+/0- |
| Lot 2 | 50-/0+ | 50-/0+ | 50-/0+ | 50-/0+ | 3-/47+ | 50+/0- | 50+/0- | 50+/0- | 50+/0- |
| Lot 3 | 50-/0+ | 50-/0+ | 50-/0+ | 50-/0+ | 4-/46+ | 50+/0- | 50+/0- | 50+/0- | 50+/0- |
AssureTech Buprenorphine/Methadone Panel Dip
| Lot
Number | -100%
cut off | -75%
cut off | -50%
cut off | -25%
cutoff | +25%
cut off | +50%
cut off | +75%
cut off | +100%
cut off |
|---------------|------------------|-----------------|-----------------|----------------|-----------------|-----------------|-----------------|------------------|
| Lot 1 | 50-/0+ | 50-/0+ | 50-/0+ | 50-/0+ | 2-/48+ | 50+/0- | 50+/0- | 50+/0- |
| Lot 2 | 50-/0+ | 50-/0+ | 50-/0+ | 50-/0+ | 3-/47+ | 50+/0- | 50+/0- | 50+/0- |
| Lot 3 | 50-/0+ | 50-/0+ | 50-/0+ | 50-/0+ | 2-/48+ | 50+/0- | 50+/0- | 50+/0- |
AssureTech Buprenorphine/Methadone Turn-Key Split Cup
| Lot
Number | -100%
cut off | -75%
cut off | -50%
cut off | -25%
cutoff | cut off | +25%
cut off | +50%
cut off | +75%
cut off | +100%
cut off |
|---------------|------------------|-----------------|-----------------|----------------|---------|-----------------|-----------------|-----------------|------------------|
| Lot 1 | 50-/0+ | 50-/0+ | 50-/0+ | 50-/0+ | 1-/49+ | 50+/0- | 50+/0- | 50+/0- | 50+/0- |
| Lot 2 | 50-/0+ | 50-/0+ | 50-/0+ | 50-/0+ | 2-/48+ | 50+/0- | 50+/0- | 50+/0- | 50+/0- |
| Lot 3 | 50-/0+ | 50-/0+ | 50-/0+ | 50-/0+ | 3-/47+ | 50+/0- | 50+/0- | 50+/0- | 50+/0- |
AssureTech Buprenorphine/Methadone Quick Cup
| Lot
Number | -100%
cut off | -75%
cut off | -50%
cut off | -25%
cutoff | cut off | +25%
cut off | +50%
cut off | +75%
cut off | +100%
cut off |
|---------------|------------------|-----------------|-----------------|----------------|---------|-----------------|-----------------|-----------------|------------------|
| Lot 1 | 50-/0+ | 50-/0+ | 50-/0+ | 50-/0+ | 3-/47+ | 50+/0- | 50+/0- | 50+/0- | 50+/0- |
10
| Lot 2 | 50-/0+ | 50-/0+ | 50-/0+ | 50-/0+ | 2-/48+ | 50+/0- | 50+/0- | 50+/0- | 50+/0- |
|---|---|---|---|---|---|---|---|---|---|
| Lot 3 | 50-/0+ | 50-/0+ | 50-/0+ | 50-/0+ | 2-/48+ | 50+/0- | 50+/0- | 50+/0- | 50+/0- |
b. Linearity
Not applicable.
- c. Stability
The devices are stable at 4-30 ℃ for 24 months based on the accelerated stability study at 45 °C and real time stability determination at both 4 °C and 30 °C.
d. Cut-off
A total of 150 samples equally distributed at concentrations of -50% Cut-Off; -25% Cut-Off; Cut-Off; +25% Cut-Off; +50% Cut-Off were tested using three different lots of each device by three different operators. Results were all positive at and above +25% Cut-off and all negative at and below -25% Cut-off for both Buprenorphine and Methadone.
The following cut-off values for the candidate devices have been verified.
| Calibrator | Cut-off (ng/mL) |
|---|---|
| Buprenorphine | 10 |
| Methadone | 300 |
e. Interference
Potential interfering substances found in human urine of physiological or pathological conditions were added to drug-free urine and target drugs urine with concentrations at 25% below and 25% above Cut-Off levels. These urine samples were tested using three batches of each device. Compounds that showed no interference at a concentration of 100µg/mL are summarized in the following tables. There were no differences observed for different devices.
Buprenorphine:
| Acetophenetidin | Ethyl-p-aminobenzoate | Phencyclidine |
|---|---|---|
| N-Acetylprocainamide | Fenoprofen | Phenelzine |
| Acetylsalicylic Acid | Furosemide | Phenobarbital |
| Aminopyrine | Gentisic acid | Phentermine |
| Amitriptyline | Hemoglobin | Phenylephrine-L |
| Amoxicillin | Hydralazine | Phenylethylamine |
| Amobarbital | (+/-)-4-Hydroxyamphetamine HCL | Phenylpropanolamine |
| D-Amphetamine | Hydrochlorothiazide | Prednisolone Acetate |
| L-Amphetamine | Hydrocodone | Prednisone |
| Amphetamine Sulfate | Hydrocortisone | Procaine(Novocaine) |
| Ampicinine(Ampicillin) | Hydroxyhippuric acid | Promazine |
| Apomorphine | p-Hydroxymethamphetamine | Promethazine |
| L-Ascorbic Acid | Ibuprofen | Propoxyphene,d- |
| Aspartame | Imipramine | Propranolol |
| Atropine | Isoxsuprine | Pseudoephedrine HCL |
| Benzilic acid | Isoproterenol-(+/-) | Quinidine |
| Benzphetamine | Ketamine | Quinine |
11
| Bezoic Acid | Labetalol | Ranitidine(Zantac) |
|---|---|---|
| Bilirubin | Levorphanol | Salicylic Acid |
| Caffeine | Loperamide | Secobarbital |
| Chloramphenicol | Maprotiline | Serotonin |
| Chlordiazepoxide HCL | Meprobamate | Sulfamethazine |
| Chloroquine | Methadone | Sulindac |
| Chlorothiazide | Methoxyphenamine | Temazepam |
| Chlorpheniramine | (+/-)- | |
| Methylenedioxyamphetamine(MDA) | 11-Nor-Δ9- | |
| Tetrahydrocannabinol | ||
| Chlorpromazine | Methylphenidate | Tetracycline |
| Cholesterol | Nalbuphine | Tetrahydrozoline |
| Clomipramine | Nalidixic acid | Thiamine |
| Clonidine hydrochloride | Naloxone hydrochloride | L-Thyroxine |
| Cortisone | Naltrexone hydrochloride | ThioridazineHydrochloride |
| Cotinine(-) | Naproxen | Triamterene |
| Creatinine | Niacinamide | Triflupromazine |
| Hydrochloride | ||
| Deoxyepinephrine | Nifedipine | Trimethoprim |
| Dextromethorphan | Norethindrone | Trimipramine |
| Diazepam | Norpropoxyphene | Tryptamine |
| Diflunisal | Noscapine | DL-Tryptophan |
| Digoxin | Oxazepam | Tyramine |
| Doxylamine | Oxymetazoline | D/L-Tyrosine |
| Ecgonine methylester | Papaverine | Uric Acid |
| R(-)-Epinephrine | Penicillin | Verapamil |
| Erythromycin | Pentobarbital | Zomepirac |
| Estrone-3-sulfate | Perphenazine |
Methadone
| Acetophenetidin | Ethyl-p-aminobenzoate | Phenelzine |
|---|---|---|
| N-Acetylprocainamide | Fenoprofen | Phenobarbital |
| Acetylsalicylic Acid | Furosemide | Phentermine |
| Aminopyrine | Gentisic acid | Phenylephrine-L |
| Amitriptyline | Hemoglobin | Phenylethylamine |
| Amoxicillin | Hydralazine | Phenylpropanolamine |
| Amobarbital | (+/-)-4-Hydroxyamphetamine HCL | Prednisolone Acetate |
| D-Amphetamine | Hydrochlorothiazide | Prednisone |
| L-Amphetamine | Hydrocodone | Procaine(Novocaine) |
| Amphetamine Sulfate | Hydrocortisone | Promazine |
| Ampicinine(Ampicillin) | a -Hydroxyhippuric acid | Promethazine |
| Apomorphine | p-Hydroxymethamphetamine | Propoxyphene,d- |
| L-Ascorbic Acid | Ibuprofen | Propranolol |
| Aspartame | Imipramine | Pseudoephedrine HCL |
12
| Atropine | Isoxsuprine | Quinidine |
|---|---|---|
| Benzilic acid | Isoproterenol-(+/-) | Quinine |
| Benzphetamine | Ketamine | Ranitidine(Zantac) |
| Bezoic Acid | Labetalol | Salicylic Acid |
| Bilirubin | Levorphanol | Secobarbital |
| Caffeine | Loperamide | Serotonin |
| Chloramphenicol | Maprotiline | Sulfamethazine |
| Chlordiazepoxide HCL | Meprobamate | Sulindac |
| Chloroquine | Methoxyphenamine | Temazepam |
| Chlorothiazide | (+/-)- | 11-Nor-49- |
| Chlorpheniramine | Methylphenidate | Tetracycline |
| Chlorpromazine | Nalbuphine | Tetrahydrozoline |
| Cholesterol | Nalidixic acid | Thiamine |
| Clomipramine | Naloxone hydrochloride | L-Thyroxine |
| Clonidine hydrochloride | Naltrexone hydrochloride | ThioridazineHydrochloride |
| Cortisone | Naproxen | Triamterene |
| Cotinine(-) | Niacinamide | Triflupromazine |
| Creatinine | Nifedipine | Trimethoprim |
| Deoxyepinephrine | Norethindrone | Trimipramine |
| Dextromethorphan | Norpropoxyphene | Tryptamine |
| Diazepam | Noscapine | DL-Tryptophan |
| Diflunisal | Oxazepam | Tyramine |
| Digoxin | Oxymetazoline | D/L-Tyrosine |
| Doxylamine | Papaverine | Uric Acid |
| Ecgonine methylester | Penicillin | Verapamil |
| R(-)-Epinephrine | Pentobarbital | Zomepirac |
| Erythromycin | Perphenazine | |
| Estrone-3-sulfate | Phencyclidine |
f. Specificity
To test specificity, drug metabolites and other components that are likely to interfere in urine samples were tested using three batches of each device. The lowest concentration that caused a positive result for each compound are listed below. There were no differences observed for different devices.
| Buprenorphine
(Cut-off=10 ng/mL) | Result | %
Cross-Reactivity |
|-------------------------------------|-----------------------|-----------------------|
| Buprenorphine | Positive at 10 ng/mL | 100% |
| Buprenorphine -3-D- | Positive at 10 ng/mL | 100% |
| Norbuprenorphine | Positive at 50 ng/mL | 20% |
| Norbuprenorphine-3-D- | Positive at 100 ng/mL | 10% |
| Morphine | Negative at 100,000 | 50 years. Urine samples were prepared at the following concentrations; negative, +/-75%, +/-50%, +/-25% of the cutoff by spiking drug(s) into drug free-pooled urine specimens. The concentrations of the samples were confirmed by GC/MS. Each sample was aliquoted into individual containers and blind-labeled. Each participant was provided with the package insert, 1 blind labeled sample and a device. Each device was tested.
Comparison between GC/MS and Lay Person Results for Buprenorphine Strip
| % of Cutoff | Number
of
samples | Buprenorphine
Concentration by GC/MS
(ng/mL) | Lay person results | | The
percentage of
correct results
(%) |
|--------------|-------------------------|----------------------------------------------------|--------------------|----|------------------------------------------------|
| -100% Cutoff | 21 | 0 | 0 | 21 | 100 |
| -75% Cutoff | 21 | 2.2 | 0 | 21 | 100 |
| -50% Cutoff | 21 | 5.5 | 0 | 21 | 100 |
| -25% Cutoff | 21 | 7.6 | 1 | 20 | 95 |
| +25% Cutoff | 21 | 12.6 | 21 | 0 | 100 |
| +50% Cutoff | 21 | 16.2 | 21 | 0 | 100 |
18
| +75% Cutoff | 21 | 17.8 | 21 | 0 | 100 |
|---|---|---|---|---|---|
| ------------- | ---- | ------ | ---- | --- | ----- |
| % of Cutoff | Number
of
samples | Methadone Concentration
by GC/MS (ng/mL) | Lay person results | | The
percentage of
correct results
(%) |
|--------------|-------------------------|---------------------------------------------|--------------------|--------------------|------------------------------------------------|
| | | | No. of
Positive | No. of
Negative | |
| -100% Cutoff | 21 | 0 | 0 | 21 | 100 |
| -75% Cutoff | 21 | 69 | 0 | 21 | 100 |
| -50% Cutoff | 21 | 162 | 0 | 21 | 100 |
| -25% Cutoff | 21 | 251 | 1 | 20 | 95 |
| +25% Cutoff | 21 | 389 | 20 | 1 | 95 |
| +50% Cutoff | 21 | 463 | 21 | 0 | 100 |
| +75% Cutoff | 21 | 510 | 21 | 0 | 100 |
Comparison between GC/MS and Lay Person Results for MTD Strip
Comparison between GC/MS and Lay Person Results for BUP/MTD Panel DipCard
| % Cutoff | No of samples | Concentration by GC/MS(ng/mL) | Lay person results | Correct Results (%) | |||
|---|---|---|---|---|---|---|---|
| Buprenorphine | Methadone | BUP | MTD | BUP | MTD | ||
| -100% | 21 | 0 | 0 | 0+/21- | 0+/21- | 100 | 100 |
| -75% | 21 | 2.2 | 69 | 0+/21- | 0+/21- | 100 | 100 |
| -50% | 21 | 5.5 | 162 | 0+/21- | 0+/21- | 100 | 100 |
| -25% | 21 | 7.6 | 251 | 1+/20- | 2+/19- | 95 | 90 |
| +25% | 21 | 12.6 | 389 | 20+/1- | 20+/1- | 95 | 95 |
| +50% | 21 | 16.2 | 463 | 21+/0- | 21+/0- | 100 | 100 |
| +75% | 21 | 17.8 | 510 | 21+/0- | 21+/0- | 100 | 100 |
Comparison between GC/MS and Lay Person Results for BUP/MTD Turn-Key Split Cup
| % Cutoff | No of
samples | Concentration by
GC/MS(ng/mL) | | Lay person
results | | Correct Results
(%) | |
|----------|------------------|----------------------------------|-----------|-----------------------|--------|------------------------|-----|
| | | Buprenorphine | Methadone | BUP | MTD | BUP | MTD |
| -100% | 21 | 0 | 0 | 0+/21- | 0+/21- | 100 | 100 |
| -75% | 21 | 2.2 | 69 | 0+/21- | 0+/21- | 100 | 100 |
| -50% | 21 | 5.5 | 162 | 0+/21- | 0+/21- | 100 | 100 |
| -25% | 21 | 7.6 | 251 | 2+/19- | 0+/21- | 90 | 100 |
| +25% | 21 | 12.6 | 389 | 20+/1- | 20+/1- | 95 | 95 |
| +50% | 21 | 16.2 | 463 | 21+/0- | 21+/0- | 100 | 100 |
| +75% | 21 | 17.8 | 510 | 21+/0- | 21+/0- | 100 | 100 |
Comparison between GC/MS and Lay Person Results for BUP/MTD Quick Cup
| % Cutoff | No of
samples | Concentration by
GC/MS(ng/mL) | | Lay person
results | | Correct Results
(%) | |
|----------|------------------|----------------------------------|-----------|-----------------------|--------|------------------------|-----|
| | | Buprenorphine | Methadone | BUP | MTD | BUP | MTD |
| -100% | 21 | 0 | 0 | 0+/21- | 0+/21- | 100 | 100 |
| -75% | 21 | 2.2 | 69 | 0+/21- | 0+/21- | 100 | 100 |
19
| -50% | 21 | ર્ . રે | 162 | 0+/21- | 0+/21- | 100 | 100 |
|---|---|---|---|---|---|---|---|
| -25% | 21 | 7.6 | 251 | 0+/21- | 1+/20- | 100 | તેરી જેવી સવલતો પ્રાપ્ય થયેલી છે. આ ગામનાં પ્રાથમિક શાળા, પંચાયતઘર, આંગણવાડી તેમ જ દૂધની ડેરી જેવી સવલતો પ્રાપ્ય થયેલી છે. આ ગામનાં પ્રાથમિક શાળા, પંચાયતઘર, આંગણવાડી તેમ જ |
| +25% | 21 | 12.6 | 389 | 20+/1- | 21+/0- | તેર | 100 |
| +50% | 21 | 16.2 | 463 | 21+/0- | 21+/0- | 100 | 100 |
| +75% | 21 | 17.8 | 510 | 21+/0- | 21+/0- | 100 | 100 |
Lay-users were also given surveys on the ease of understanding the package insert instructions. All lay users indicated that the device instructions can be easily followed. A Flesch-Kincaid reading analysis was performed on each package insert and the scores revealed a reading Grade Level of 7.
3. Clinical Studies
Not applicable.
11. Conclusion
Based on the test principle and acceptable performance characteristics including precision, cut-off, interference, specificity, method comparison, and lay-user studies of the devices, it's concluded that Strip, AssureTech Buprenorphine Strip, AssureTech Methadone the AssureTech Buprenorphine/Methadone Panel Dip, AssureTech Buprenorphine/Methadone Quick Cup and AssureTech Buprenorphine/Methadone Turn Key-Split Cup are substantially equivalent to the predicate.