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.

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.

AI/ML Overview

The provided document is a 510(k) Premarket Notification for in vitro diagnostic devices designed to detect Buprenorphine and Methadone in human urine. It details the performance characteristics of these devices.

Here's an analysis of the acceptance criteria and the study proving the device meets them, based on the provided text:

1. Table of Acceptance Criteria (Implicit) and Reported Device Performance

The acceptance criteria are generally implied by the performance goals set for the device, particularly regarding concordance with GC/MS results and successful performance across various drug concentrations. The precision studies and comparison studies demonstrate the device's performance against these implicit criteria.

Note: The document doesn't explicitly state numeric "acceptance criteria" for accuracy (e.g., "must achieve 90% positive agreement with GC/MS at +25% cutoff"). Instead, the data is presented, and the conclusion states that the performance characteristics are "acceptable." We can infer the acceptance criteria from the observed performance and the nature of qualitative drug tests.

Here is a summary of the reported device performance from the "Precision" and "Comparison Studies" sections:

Precision Studies (Table Summarization):

Test Setup: Samples at -100%, -75%, -50%, -25%, +25%, +50%, +75%, +100% of the cut-off concentration. Confirmed by GC/MS. Blindly labeled. 2 runs per day for 25 days per device (total of 50 tests per concentration per lot). Three lots of each device were tested.
Performance:
- Buprenorphine: For all device types (Strip, Panel Dip, Turn-Key Split Cup, Quick Cup) across three lots:
  - All true negative concentrations (-100% to -25% cut-off) consistently yielded 50-/0+ (50 negative, 0 positive) results.
  - All true positive concentrations (+25% to +100% cut-off) consistently yielded 50+/0- (50 positive, 0 negative) results.
  - Results at the "cut off" (0% cut-off, which should be 10 ng/mL) showed some variability, as expected for qualitative tests around the threshold. For example, for Buprenorphine Strip, Lot 1 showed 4-/46+ (4 negative, 46 positive) at cut-off, while Lot 2 showed 1-/49+. This indicates the ability to correctly identify samples near the cutoff, with some expected variation around the 50/50 mark.
- Methadone: Similar trends were observed for Methadone across all device types and lots.
  - All true negative concentrations (-100% to -25% cut-off) consistently yielded 50-/0+ results.
  - All true positive concentrations (+25% to +100% cut-off) consistently yielded 50+/0- results.
  - Results at the "cut off" (0% cut-off, 300 ng/mL) showed variability, e.g., Methadone Strip, Lot 1 showed 2-/48+.

Comparison Studies with GC/MS (Table Summarization using a general view as specific numerical acceptance criteria like sensitivity/specificity are not given, but concordance is key):

Setup: In-house study with 80 unaltered clinical samples (40 negative, 40 positive) per drug per device type. Operators ran blind-labeled samples. GC/MS was the reference method. Each device type (Strip, Panel Dip, Turn-Key Split Cup, Quick Cup) was evaluated for both Buprenorphine and Methadone.
General Performance (Across all device types for Buprenorphine and Methadone):
- Negative Samples: Consistently showed 10 Negative (from true negative GC/MS) and 20 Low Negative (GC/MS < -50% cut-off) results.
- Near Cutoff Negative: Showed 8 or 9 Negative results and 1 or 2 Positive results (e.g., Buprenorphine Strip, Viewer A, had 8 Negative, 2 Positive). This indicates some "false positives" or reads as positive for samples slightly below the cutoff.
- Near Cutoff Positive: Showed mostly Positive results (13-15 positive, 0-2 negative). This indicates some "false negatives" or reads as negative for samples slightly above the cutoff.
- High Positive: Consistently showed 25 Positive results.
Discordant Results: The tables explicitly list the GC/MS result and the device's viewer result for discordant samples (those where the device's reading did not match the GC/MS result, usually near the cutoff). For instance, for Buprenorphine Strip, sample 11178 (GC/MS 9.8 ng/mL, cutoff 10 ng/mL) was read as Positive by Viewer A, while sample 31718 (GC/MS 10.9 ng/mL) was read as Negative by Viewer A. This highlights the inherent variability near the cutoff for qualitative assays.

Lay-User Study (Table Summarization):

Setup: 1113 lay persons at three user sites. Urine samples prepared at -100%, -75%, -50%, -25%, +25%, +50%, +75% of the cut-off. Confirmed by GC/MS. Blind-labeled. Each participant received 1 sample and 1 device.
Performance (Overall, aggregated results across all device types show good agreement):
- Buprenorphine Strip (Example):
  - -100%, -75%, -50% cut-off: 100% correct negative results.
  - -25% cut-off: 95% correct negative results (1 positive out of 21).
  - +25%, +50%, +75% cut-off: 95-100% correct positive results. (e.g., +25% cutoff, 20+/1- for Buprenorphine Strip, 95% correct).
- Methadone Strip (Example): Similar strong performance to Buprenorphine.
  - -100%, -75%, -50% cut-off: 100% correct negative results.
  - -25% cut-off: 95% correct negative results (1 positive out of 21).
  - +25%, +50%, +75% cut-off: 95-100% correct positive results. (e.g., +25% cutoff, 20+/1- for Methadone Strip, 95% correct).
- Panel Dip/Turn-Key/Quick Cup: Similar high percentages of correct results, with slight variations around the -25% and +25% cut-off points, as observed in the Strip tests.

2. Sample Size Used for the Test Set and Data Provenance

Test Set (Precision Studies): For each drug (Buprenorphine, Methadone), for each device type (Strip, Panel Dip, Turn-Key Split Cup, Quick Cup), and for each of the 3 lots, samples were tested across 8 concentration levels. Each concentration was tested 50 times (2 runs/day for 25 days). So, for one drug and one device type, it's 3 lots * 8 concentrations * 50 tests = 1200 tests. Given there are 4 device types, this would be 4800 tests for Buprenorphine and similarly for Methadone.
Test Set (Comparison Studies): For each device type (e.g., Buprenorphine Strip), 80 unaltered clinical samples (40 negative and 40 positive) were used. This was done for each drug (Buprenorphine, Methadone) and for each of the 4 device types. So total: 4 (device types) * 2 (drugs) * 80 (samples) = 640 clinical samples.
Test Set (Lay-user study): 1113 lay persons participated. Urine samples were prepared at 7 concentration levels. Each participant was provided with one blind-labeled sample and one device. Assuming each person tested one sample, the sample size for this test is 1113 unique sample-device readings. However, the data presented in the tables for the lay-user study shows 21 samples per concentration level, for each drug and device type. This means multiple subjects tested samples from the same concentration group.
Data Provenance:
- Precision and Interference/Specificity/Cut-off Studies: Samples were "prepared by spiking drug in negative samples" which were confirmed by GC/MS. This suggests controlled laboratory samples.
- Comparison Studies: "unaltered clinical samples." The document does not specify the country of origin of these clinical samples, nor does it explicitly state if they were retrospective or prospective, but the phrasing "unaltered clinical samples" suggests real-world specimens.
- Lay-user study: "Urine samples were prepared... by spiking drug(s) into drug free-pooled urine specimens." Again, controlled laboratory samples, not clinical samples. Three "intended user sites" were used, but their location/country is not specified.

3. Number of Experts and Qualifications to Establish Ground Truth

Precision/Prepared Samples: The ground truth for these samples was established chemically by GC/MS (Gas Chromatography/Mass Spectrometry), which is stated as the "preferred confirmatory method" and the method used to "confirm" sample concentrations. No human experts are explicitly mentioned for establishing ground truth for these spiked samples, as GC/MS is a quantitative analytical method providing objective chemical concentrations.
Comparison Studies (Clinical Samples): The ground truth for the 80 unaltered clinical samples was also established by GC/MS.
Lay-user Study: Ground truth for these prepared samples was established by GC/MS.
Qualifications of Experts: The document states that the GC/MS confirmation was done. This method itself provides the "ground truth." While laboratory personnel would operate the GC/MS, their specific qualifications for establishing ground truth (like radiologists for imaging studies) are not pertinent in this chemical assay context.

4. Adjudication Method for the Test Set

No formal adjudication method (e.g., 2+1, 3+1) is described for the test set.
For the precision studies, results were observed ("50-/0+", "4-/46+", etc.) across multiple runs and lots.
For the comparison studies, "three laboratory assistants" operated the device, and their results (labeled Viewer A, B, C) were directly compared to the GC/MS truth. There is no mention of these "viewers" adjudicating their readings or a consensus process. Discordant results are simply listed.
For the lay-user study, lay persons read the device results. The comparison is between the lay person's reading and the GC/MS-confirmed concentration.

5. If a Multi-Reader Multi-Case (MRMC) Comparative Effectiveness Study was done

No, an MRMC comparative effectiveness study was not performed in the traditional sense as described for AI vs. human assistance. This is a qualitative drug test, not an AI imaging device where human readers interpret cases and AI provides assistance.
The "Comparison Studies" involved "three laboratory assistants" (analogous to multiple readers), who read the results of the device on clinical samples. Their readings were compared against GC/MS. This is a form of multi-reader study, but it's evaluating the device's performance when read by different individuals, rather than AI assisting human interpretation.
Therefore, an "effect size of how much human readers improve with AI vs. without AI assistance" is not applicable or provided.

6. If a Standalone (i.e., algorithm only without human-in-the-loop performance) was done

This device is a rapid immunochromatographic assay (a "dipstick" type test), not a software algorithm. Therefore, the concept of a "standalone" algorithmic performance without human interpretation does not apply. The device produces a visual result (lines appearing or not appearing), which requires human observation to interpret.

7. The Type of Ground Truth Used

The primary ground truth used throughout the studies is Gas Chromatography/Mass Spectrometry (GC/MS). GC/MS is a highly accurate and widely accepted analytical method for confirming the presence and concentration of substances, making it a robust 'gold standard' for drug testing.

8. The Sample Size for the Training Set

This document describes performance characteristics for a rapid immunochromatographic assay, which is a chemical and biological test, not a machine learning model.
Therefore, there is no "training set" in the context of an AI/ML algorithm. The device's performance is inherent to its physical and chemical design and manufacturing process.

9. How the Ground Truth for the Training Set Was Established

As there is no "training set" for an AI/ML model, this question is not applicable.

Summary

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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

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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

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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 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 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.

For in vitro diagnostic use only. The tests are intended for over-the-counter and for prescription use.

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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)

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510(k) SUMMARY

1. Date:	September 17, 2015
2. Submitter:	Assure Tech. Co., Ltd.Building 1, No.10, Xiyuansan Road, WestlakeEconomic ZoneHangzhou, China, 310030
3. Contact person:	Eric LinAssure Tech. Co., Ltd.Building 1, No.10, Xiyuansan Road, WestlakeEconomic ZoneHangzhou, China, 310030Telephone: 510-860-4680Email: customerservice@assurelabs.com.
4. Device Name:	AssureTech Buprenorphine StripAssureTech Methadone StripAssureTech Buprenorphine/Methadone Panel DipAssureTech Buprenorphine/Methadone Quick CupAssureTech 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

1. Predicate Devices: K142396
  The Chemtrue® Multi-Panel Drug Screen Dip Card Tests
1. 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).

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

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determination of Methadone in human urine at a Cut-Off concentration of 300ng/mL. This test is calibrated to Methadone (calibrator).

For in vitro diagnostic use only. The test is intended for over-the-counter and for prescription use.

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

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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.

1. 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.
1. 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.

Item	Device	Predicate - K142396
Indication(s)for Use	For the qualitative determination of drugs ofabuse in human urine.	Same (but the number ofdrugs detected is different)
Calibrator	Buprenorphine	Same
Methodology	Competitive binding, lateral flowimmunochromatographic assays based on theprinciple of antigen antibodyimmunochemistry.	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
------	--------	---------------------

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Indication(s)for Use	For the qualitative determination ofdrugs of abuse in human urine.	Same (but the number ofdrugs detected is different)
Calibrator	Methadone	Same
Methodology	Competitive binding, lateral flowimmunochromatographic assays based on theprinciple of antigen antibodyimmunochemistry.	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 ofdrugs of abuse in human urine.	Same (but the number ofdrugs detected is different)
Calibrator	Buprenorphine and Methadone	Same
Methodology	Competitive binding, lateral flowimmunochromatographic assays based on theprinciple of antigen antibodyimmunochemistry.	Same
Type of Test	Qualitative	Same
Specimen Type	Human Urine	Same
Cut-Off Values	10ng/mL for Buprenorphine and 300 ng/mL forMethadone	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 ofdrugs of abuse in human urine.	Same (but the number ofdrugs detected is different)

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Calibrator	Buprenorphine and Methadone	Same
Methodology	Competitive binding, lateral flowimmunochromatographic assays based on theprinciple of antigen antibodyimmunochemistry.	Same
Type of Test	Qualitative	Same
Specimen Type	Human Urine	Same
Cut-Off Values	10ng/mL for Buprenorphine and 300 ng/mL forMethadone	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

1. 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

LotNumber	-100%cut off	-75%cut off	-50%cut off	-25%cutoff		+25%cut off	+50%cut off	+75%cut off	+100%cut off
---------------	------------------	-----------------	-----------------	----------------	--	-----------------	-----------------	-----------------	------------------

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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

LotNumber	-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

LotNumber	-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

LotNumber	-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

LotNumber	-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

LotNumber	-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

LotNumber	-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	TriflupromazineHydrochloride
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	<0.01%

{13}------------------------------------------------

Oxymorphone	Negative at 100,000	<0.01%
Hydromorphone	Negative at 100,000	<0.01%

Methadone(Cut-off=300 ng/mL)	Result	%Cross-Reactivity
Methadone	Positive at 300 ng/mL	100%
Doxylamine	Positive at 5000 ng/mL	6%
LAAM HCl	Positive at 10000 ng/mL	3%
Alpha Methadol	Positive at 2000 ng/mL	15%
EDDP	Negative at 100,000	<0.3%
EMDP	Negative at 100,000	<0.3%

g. Effect of Urine Specific Gravity and Urine pH

To investigate the effect of urine specific gravity and urine pH, urine samples, with 1.000 to 1.035 specific gravity or urine samples with pH 4 to 9 were spiked with target drugs at 25% below and 25% above Cut-Off levels. These samples were tested using three lots of each device. Results were all positive for samples at and above +25% Cut-Off and all negative for samples at and below -25% Cut-Off. There were no differences observed for different devices.

2. Comparison Studies

Method comparison studies for the AssureTech Buprenorphine Tests and the AssureTech Methadone Tests were performed in-house with three laboratory assistants for each device. Operators ran 80 (40 negative and 40 positive) unaltered clinical samples. The samples were blind labeled and compared to GC/MS results. The results are presented in the tables below:

Strip		Negative	LowNegative byGC/MS(less than-50%)	Near CutoffNegative byGC/MS(Between-50% andcutoff)	Near CutoffPositive byGC/MS(Between thecutoff and+50%)	High Positiveby GC/MS(greater than+50%)
Buprenorphine
Viewer	Positive	0	0	2	14	25
A	Negative	10	20	8	1	0
Viewer	Positive	0	0	1	14	25
B	Negative	10	20	9	1	0
Viewer	Positive	0	0	1	15	25
C	Negative	10	20	9	0	0

Discordant Results of Buprenorphine Strip

Viewer	Sample Number	GC/MS Result	StripViewer Results
Viewer A	11178	9.8	Positive
Viewer A	20805	9.6	Positive
Viewer B	20805	9.6	Positive
Viewer C	20805	9.6	Positive

{14}------------------------------------------------

Viewer A	31718	10.9	Negative
Viewer B	18342	10.6	Negative

PanelDip		Negative	LowNegative byGC/MS(less than-50%)	Near CutoffNegative byGC/MS(Between-50% andcutoff)	Near CutoffPositive byGC/MS(Between thecutoff and+50%)	High Positiveby GC/MS(greater than+50%)
ViewerA	Positive	0	0	2	14	25
	Negative	10	20	8	1	0
ViewerB	Positive	0	0	2	14	25
	Negative	10	20	8	1	0
ViewerC	Positive	0	0	2	14	25
	Negative	10	20	8	1	0

Discordant Results of Buprenorphine Panel Dip

Viewer	Sample Number	GC/MS Result	Panel DipViewer Results
Viewer A	11178	9.8	Positive
Viewer A	20805	9.6	Positive
Viewer B	11178	9.8	Positive
Viewer B	20805	9.6	Positive
Viewer C	11178	9.8	Positive
Viewer C	20805	9.6	Positive
Viewer A	18342	10.6	Negative
Viewer B	31718	10.9	Negative
Viewer C	31718	10.9	Negative

Turn-KeySplitCup		Negative	Low Negative byGC/MS(less than-50%)	Near CutoffNegative byGC/MS(Between-50% andcutoff)	Near CutoffPositive byGC/MS(Between thecutoff and+50%)	High Positiveby GC/MS(greater than+50%)
ViewerA	Positive	0	0	1	14	25
ViewerA	Negative	1	20	9	1	0
ViewerB	Positive	0	0	1	14	25
ViewerB	Negative	1	20	9	1	0
ViewerC	Positive	0	0	1	13	25
	Negative	1	20	9	2	0

Discordant Results of Buprenorphine Turn-Key Split Cup

Viewer	Sample Number	GC/MS Result	Turn-Key SplitCup
Viewer A	20805	9.6	Positive
Viewer B	11178	9.8	Positive

{15}------------------------------------------------

Viewer C	11178	9.8	Positive
Viewer A	31718	10.9	Negative
Viewer B	18342	10.6	Negative
Viewer C	18342	10.6	Negative
Viewer C	31718	10.9	Negative

QuickCup		Negative	Low Negative byGC/MS(less than-50%)	Near Cutoff Negative byGC/MS(Between-50% andcutoff)	Near Cutoff Positive byGC/MS(Between thecutoff and+50%)	High Positiveby GC/MS(greater than+50%)
ViewerA	Positive	0	0	1	14	25
	Negative	10	20	9	1	0
ViewerB	Positive	0	0	1	15	25
	Negative	10	20	9	0	0
ViewerC	Positive	0	0	2	14	25
	Negative	10	20	8	1	0

Discordant Results of Buprenorphine Quick Cup

Viewer	Sample Number	GC/MS Result	Quick CupViewer Results

Viewer A	20805	9.6	Positive
Viewer B	11178	9.8	Positive
Viewer C	11178	9.8	Positive
Viewer C	20805	9.6	Positive
Viewer A	31718	10.9	Negative
Viewer C	18342	10.6	Negative

Methadone (MTD)

Strip			Methadone (MTD)
		Negative	LowNegative byGC/MS(less than-50%)	Near CutoffNegative byGC/MS(Between-50% andcutoff)	Near CutoffPositive byGC/MS(Between thecutoff and+50%)	High Positiveby GC/MS(greater than+50%)
Viewer	Positive	0	0	2	14	25
A	Negative	10	20	8	1	0
Viewer	Positive	0	0	1	14	25
B	Negative	10	20	9	1	0
Viewer	Positive	0	0	1	14	25
C	Negative	10	20	9	1	0

Discordant Results of MTD Strip

Viewer	Sample Number	GC/MS Result	Strip Viewer Results
Viewer A	36406	293	Positive

{16}------------------------------------------------

Viewer A	15168	291	Positive
Viewer B	15168	291	Positive
Viewer C	15168	291	Positive
Viewer A	82949	305	Negative
Viewer B	82949	305	Negative
Viewer C	82949	305	Negative

Panel Dip		Negative	Low Negative by GC/MS (less than -50%)	Near Cutoff Negative by GC/MS (Between -50% and cutoff)	Near Cutoff Positive by GC/MS (Between the cutoff and +50%)	High Positive by GC/MS (greater than +50%)
Viewer A	Positive	0	0	2	15	25
Viewer A	Negative	10	20	8	0	0
Viewer B	Positive	0	0	1	14	25
Viewer B	Negative	10	20	9	1	0
Viewer C	Positive	0	0	1	15	25
Viewer C	Negative	10	20	9	0	0

Discordant Results of MTD Panel Dip

Viewer	Sample Number	GC/MS Result	Panel DipViewer Results
Viewer A	36406	293	Positive
Viewer A	15168	291	Positive
Viewer B	15168	291	Positive
Viewer C	15168	291	Positive
Viewer B	82949	305	Negative

Turn-KeySplit Cup		Negative	Low Negative by GC/MS(less than -50%)	Near Cutoff Negative by GC/MS(Between -50% and cutoff)	Near Cutoff Positive by GC/MS(Between the cutoff and +50%)	High Positive by GC/MS(greater than +50%)
Viewer A	Positive	0	0	1	14	25
Viewer A	Negative	1	20	9	1	0
Viewer B	Positive	0	0	1	15	25
Viewer B	Negative	1	20	9	0	0
Viewer C	Positive	0	0	1	14	25
Viewer C	Negative	1	20	9	1	0

Discordant Results of MTD Turn-Key Split Cup

Viewer	Sample Number	GC/MS Result	Split CupViewer Results
Viewer A	15168	291	Positive
Viewer B	15168	291	Positive

{17}------------------------------------------------

Viewer C	36406	293	Positive
Viewer A	82949	305	Negative
Viewer C	82949	305	Negative

QuickCup		Negative	LowNegative byGC/MS(less than-50%)	Near CutoffNegative byGC/MS(Between-50% andcutoff)	Near CutoffPositive byGC/MS(Between thecutoff and+50%)	High Positiveby GC/MS(greater than+50%)
ViewerA	Positive	0	0	1	14	25
	Negative	10	20	9	1	0
ViewerB	Positive	0	0	2	14	25
	Negative	10	20	8	1	0
ViewerC	Positive	0	0	1	15	25
	Negative	10	20	9	0	0

Discordant Results of MTD Quick Cup

Viewer	Sample Number	GC/MS Result	Quick CupViewer Results
Viewer A	36406	293	Positive
Viewer B	36406	293	Positive
Viewer B	15168	291	Positive
Viewer C	36406	293	Positive
Viewer A	82949	305	Negative
Viewer B	82949	305	Negative

Lay-user study

A lay user study was performed at three intended user sites with 1113 lay persons. The lay users had diverse educational and professional backgrounds and ranged in age from 18 to > 50 years. Urine samples were prepared at the following concentrations; negative, +/-75%, +/-50%, +/-25% of the cutoff by spiking 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	Numberofsamples	BuprenorphineConcentration by GC/MS(ng/mL)	Lay person results		Thepercentage ofcorrect 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	Numberofsamples	Methadone Concentrationby GC/MS (ng/mL)	Lay person results		Thepercentage ofcorrect results(%)
			No. ofPositive	No. ofNegative
-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 ofsamples	Concentration byGC/MS(ng/mL)		Lay personresults		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 ofsamples	Concentration byGC/MS(ng/mL)		Lay personresults		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.

Regulation Number and Section

§ 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).