AssureTech Buprenorphine Tests (Strip, Panel Dip, Quick Cup, Turn-Key Split Cup), AssureTech Methadone Tests (Strip, Panel Dip, Quick Cup, Turn-Key Split Cup)
Device Facts
| Record ID | K152025 |
|---|---|
| Device Name | AssureTech Buprenorphine Tests (Strip, Panel Dip, Quick Cup, Turn-Key Split Cup), AssureTech Methadone Tests (Strip, Panel Dip, Quick Cup, Turn-Key Split Cup) |
| Applicant | Assure Tech. Co., Ltd. |
| Product Code | DJR · Clinical Toxicology |
| Decision Date | Oct 5, 2015 |
| Decision | SESE |
| Submission Type | Traditional |
| Regulation | 21 CFR 862.3620 |
| Device Class | Class 2 |
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 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 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 Story
Lateral flow immunochromatographic assays for qualitative detection of Buprenorphine and Methadone in human urine; competitive binding principle; monoclonal mouse antibody-coated particles; target analytes compete with immobilized drug-conjugate for binding sites; visible colored line indicates negative result (drug below cutoff); absence of line indicates positive result (drug above cutoff); control line confirms proper test performance. Used in point-of-care or home settings by lay users or professionals. Results are visual; preliminary only; require confirmatory GC/MS testing. Benefits include rapid, accessible screening for drug presence to inform clinical or personal decision-making.
Clinical Evidence
No clinical trials performed. Evidence consists of analytical bench testing (precision, interference, specificity, stability, cut-off verification) and a lay-user study (n=1113) across three sites. Lay-user study demonstrated high concordance with GC/MS results across various drug concentrations relative to cut-offs. Flesch-Kincaid analysis of instructions yielded a 7th-grade reading level.
Technological Characteristics
Lateral flow immunochromatographic assay; competitive binding; monoclonal mouse antibody; visual readout; urine specimen; 10ng/mL (Buprenorphine) and 300ng/mL (Methadone) cut-offs; stable at 4-30°C for 24 months.
Indications for Use
Indicated for qualitative detection of Buprenorphine (10ng/mL) and/or Methadone (300ng/mL) in human urine. Intended for over-the-counter and prescription use in individuals requiring drug of abuse screening. Provides preliminary results; requires confirmatory testing via GC/MS.
Regulatory Classification
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.
Special Controls
*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).
Predicate Devices
- The Chemtrue® Multi-Panel Drug Screen Dip Card Tests (K142396)
Related Devices
- K150791 — Healgen Secobarbital Test(Strip, Cassette, Cup, Dip Card), Healgen Burprenorphine Test (Strip, Cassette, Cup, Dip Card), Healgen Methadone Test (Strip, Cassette, Cup, Dip Card) · Healgen Scientific,, LLC · Apr 24, 2015
- K152551 — First Sign® Drug of Abuse Buprenorphine Cup Test, First Sign® Drug of Abuse Buprenorphine Dip Card Test, First Sign® Drug of Abuse Butalbital Cup Test, First Sign® Drug of Abuse Butalbital Dip Card Test, First Sign® Drug of Abuse Morphine Cup Test, First Sign® Drug of Abuse Morphine Dip Card Test. · W.H.P.M., Inc. · Nov 9, 2015
Submission Summary (Full Text)
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510(k) SUBSTANTIAL EQUIVALENCE DETERMINATION
DECISION SUMMARY
ASSAY ONLY TEMPLATE
A. 510(k) Number:
k152025
B. Purpose for Submission:
New Device
C. Measurand:
Methadone and Buprenorphine
D. Type of Test:
Qualitative immunochromatographic assay
E. Applicant:
Assure Tech. Co., Ltd.
F. Proprietary and Established Names:
AssureTech Buprenorphine Strip
AssureTech Methadone Strip
AssureTech Buprenorphine/Methadone Panel Dip
AssureTech Buprenorphine/Methadone Quick Cup
AssureTech Buprenorphine/Methadone Turn Key-Split Cup
G. Regulatory Information:
1. Regulation section:
21 CFR, 862.3620 Methadone Test System
21 CFR 862.3650 Opiate test system
2. Classification:
Class II
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3. Product code:
DJR, DJG
4. Panel:
91, Toxicology
H. Intended Use:
1. Intended use(s):
See Indications for Use below.
2. Indication(s) for use:
AssureTech Buprenorphine Strip:
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.
AssureTech Methadone Strip:
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.
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AssureTech Buprenorphine/Methadone Panel Dip:
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 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.
AssureTech Buprenorphine/Methadone Quick Cup:
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.
AssureTech Buprenorphine/Methadone Turn Key-Split Cup:
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
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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.
3. Special conditions for use statement(s):
For Prescription and Over-the-counter Use
4. Special instrument requirements:
Not applicable; this is a visually read single use device.
I. Device Description:
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 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.
J. Substantial Equivalence Information:
1. Predicate device name(s):
Chemtrue® BUP/TCA Single/Multi-Panel Drug Screen Dip Card/Cup/Cassette Tests
Chemtrue® Multi-Panel Drug Screen Dip Card Tests
Chemtrue® Multi-Panel Drug Screen Dip Card with OPI 2000 Tests
2. Predicate 510(k) number(s):
k142396
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3. Comparison with predicate:
| Item | Device | Predicate |
| --- | --- | --- |
| Indication(s) for Use | For the qualitative determination of drugs of abuse in human urine. | Same |
| Calibrator | Buprenorphine, Methadone | Amphetamine, Cocaine, Marijuana, Morphine, Methamphetamine, Phencyclidine, Benzodiazepines, Barbiturates, Ecstasy, Methadone, Oxycodone and Tricyclic Antidepressants |
| Methodology | Competitive binding, lateral flow immunochromatographic assays based on the principle of antigen antibody immunochemistry. | Same |
| Type of Test | Qualitative | Same |
| Specimen | Human Urine | Same |
| Cut-Off Values | 10 ng/mL (Buprenophrine) and 300 ng/mL (Methadone) | Same |
| Intended Use | For over-the-counter and prescription useuses. | Same |
| Configurations | Strip, Panel Dip, Cup with or without turn-key | Dip Card, Cup, Cassette Tests |
K. Standard/Guidance Document Referenced (if applicable):
None referenced
L. 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
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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 colored line 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.
## M. Performance Characteristics (if/when applicable):
### 1. Analytical performance:
#### a. Precision/Reproducibility:
Precision studies were carried out for samples with concentrations of -100%, -75%, -50%, -25%, cutoff, +25%, +50%, +75% and +100% cut off. These samples were prepared by spiking drug in negative urine samples. Each drug concentration was confirmed by GC/MS. These studies were conducted by 3 operators with 3 lots of each device in two runs per day for 25 days (n=50). The results obtained are summarized in the following tables.
## Buprenorphine
### AssureTech Buprenorphine Strip
| Lot # | -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 |
| --- | --- | --- | --- | --- | --- | --- | --- | --- | --- |
| 1 | 50-/0+ | 50-/0+ | 50-/0+ | 50-/0+ | 4-/46+ | 50+/0- | 50+/0- | 50+/0- | 50+/0- |
| 2 | 50-/0+ | 50-/0+ | 50-/0+ | 50-/0+ | 1-/49+ | 50+/0- | 50+/0- | 50+/0- | 50+/0- |
| 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 # | -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 |
| --- | --- | --- | --- | --- | --- | --- | --- | --- | --- |
| 1 | 50-/0+ | 50-/0+ | 50-/0+ | 50-/0+ | 3-/47+ | 50+/0- | 50+/0- | 50+/0- | 50+/0- |
| 2 | 50-/0+ | 50-/0+ | 50-/0+ | 50-/0+ | 2-/48+ | 50+/0- | 50+/0- | 50+/0- | 50+/0- |
| 3 | 50-/0+ | 50-/0+ | 50-/0+ | 50-/0+ | 2-/48+ | 50+/0- | 50+/0- | 50+/0- | 50+/0- |
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AssureTech Buprenorphine/Methadone Turn-Key Split Cup
| Lot # | -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 |
| --- | --- | --- | --- | --- | --- | --- | --- | --- | --- |
| 1 | 50-/0+ | 50-/0+ | 50-/0+ | 50-/0+ | 4-/46+ | 50+/0- | 50+/0- | 50+/0- | 50+/0- |
| 2 | 50-/0+ | 50-/0+ | 50-/0+ | 50-/0+ | 2-/48+ | 50+/0- | 50+/0- | 50+/0- | 50+/0- |
| 3 | 50-/0+ | 50-/0+ | 50-/0+ | 50-/0+ | 2-/48+ | 50+/0- | 50+/0- | 50+/0- | 50+/0- |
| | -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 |
| --- | --- | --- | --- | --- | --- | --- | --- | --- | --- |
| 1 | 50-/0+ | 50-/0+ | 50-/0+ | 50-/0+ | 2-/48+ | 50+/0- | 50+/0- | 50+/0- | 50+/0- |
| 2 | 50-/0+ | 50-/0+ | 50-/0+ | 50-/0+ | 2-/48+ | 50+/0- | 50+/0- | 50+/0- | 50+/0- |
| 3 | 50-/0+ | 50-/0+ | 50-/0+ | 50-/0+ | 3-/47+ | 50+/0- | 50+/0- | 50+/0- | 50+/0- |
## Methadone
AssureTech Methadone Strip
| Lot # | -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 |
| --- | --- | --- | --- | --- | --- | --- | --- | --- | --- |
| 1 | 50-/0+ | 50-/0+ | 50-/0+ | 50-/0+ | 2-/48+ | 50+/0- | 50+/0- | 50+/0- | 50+/0- |
| 2 | 50-/0+ | 50-/0+ | 50-/0+ | 50-/0+ | 3-/47+ | 50+/0- | 50+/0- | 50+/0- | 50+/0- |
| 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 # | -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 |
| --- | --- | --- | --- | --- | --- | --- | --- | --- | --- |
| 1 | 50-/0+ | 50-/0+ | 50-/0+ | 50-/0+ | 2-/48+ | 50+/0- | 50+/0- | 50+/0- | 50+/0- |
| 2 | 50-/0+ | 50-/0+ | 50-/0+ | 50-/0+ | 3-/47+ | 50+/0- | 50+/0- | 50+/0- | 50+/0- |
| 3 | 50-/0+ | 50-/0+ | 50-/0+ | 50-/0+ | 2-/48+ | 50+/0- | 50+/0- | 50+/0- | 50+/0- |
AssureTech Buprenorphine/Methadone Turn-Key Split Cup
| Lot # | -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 |
| --- | --- | --- | --- | --- | --- | --- | --- | --- | --- |
| 1 | 50-/0+ | 50-/0+ | 50-/0+ | 50-/0+ | 1-/49+ | 50+/0- | 50+/0- | 50+/0- | 50+/0- |
| 2 | 50-/0+ | 50-/0+ | 50-/0+ | 50-/0+ | 2-/48+ | 50+/0- | 50+/0- | 50+/0- | 50+/0- |
| 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 # | -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 |
| --- | --- | --- | --- | --- | --- | --- | --- | --- | --- |
| 1 | 50-/0+ | 50-/0+ | 50-/0+ | 50-/0+ | 3-/47+ | 50+/0- | 50+/0- | 50+/0- | 50+/0- |
| 2 | 50-/0+ | 50-/0+ | 50-/0+ | 50-/0+ | 2-/48+ | 50+/0- | 50+/0- | 50+/0- | 50+/0- |
| 3 | 50-/0+ | 50-/0+ | 50-/0+ | 50-/0+ | 2-/48+ | 50+/0- | 50+/0- | 50+/0- | 50+/0- |
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b. Linearity/assay reportable range:
Not applicable.
c. Traceability, Stability, Expected values (controls, calibrators, or methods):
External control materials are not supplied with the devices; however, the package inserts list information on how to obtain control materials.
Sample Storage and Stability:
Protocols and acceptance criteria for real time, accelerated and transportation simulation stability studies were described and found to be acceptable. The real time stability data supports the sponsor's claim that the devices are stable at 4-30 °C for 24 months.
d. Detection limit:
Not applicable.
e. Analytical specificity:
The potential effect of endogenous and exogenous interferents was tested by spiking the interferents into drug-free urine and target drug(s) urine with concentrations at 25% below and 25% above the cut-off levels. Compounds that showed no positive or negative interference at a concentration of 100μg/mL are summarized in the following tables. The substances tested and concentrations are shown below:
Buprenorphine and Methadone:
| Acetophenetidin | Ethyl-p-aminobenzoate | Phencyclidine |
| --- | --- | --- |
| N-Acetylprocainamide | Fenoprofen | Phenelzine |
| Acetylsalicylic Acid (Aspirin) | 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 |
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| L-Ascorbic Acid | Ibuprofen | Propoxyphene,d- |
| --- | --- | --- |
| Aspartame | Imipramine | Propranolol |
| Atropine | Isoxsuprine | Pseudoephedrine HCL |
| Benzilic acid | Isoproterenol-(+/-) | Quinidine |
| Benzphetamine | Ketamine | Quinine |
| 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 | |
* Tested with Buprenorphine assay only
To test specificity, drug metabolites and other compounds structurally similar to methadone and buprenorphine were tested using three batches of each device. The lowest concentration that caused a positive result for each compound is listed below. There were no differences observed between the different formats. Results are summarized below:
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| Buprenorphine (Cut-off=10 ng/mL) | Result | % Cross-Reactivity |
| --- | --- | --- |
| Buprenorphine | Positive at 10 ng/mL | 100% |
| Buprenorphine -3-D-Glucuronide | Positive at 10 ng/mL | 100% |
| Norbuprenorphine | Positive at 50 ng/mL | 20% |
| Norbuprenorphine-3-D-Glucuronide | Positive at 100 ng/mL | 10% |
| Morphine | Negative at 100,000 | <0.01% |
| 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% |
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 the cutoff levels. These samples were tested using three lots of each device. Results were all positive for samples at and above +25% cutoff and all negative for samples at and below -25% Cut-Off. There were no differences observed for different formats.
f. Assay cut-off:
Characterization of how the device performs analytically around the claimed cutoff concentration appears in the precision/reproducibility section above.
2. Comparison studies:
a. Method comparison with predicate device:
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)
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unaltered clinical samples. The samples were compared to GC/MS results. The results are presented in the tables below:
## Buprenorphine
| Strip | | 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 | 14 | 25 |
| | Negative | 10 | 20 | 8 | 1 | 0 |
| Viewer B | Positive | 0 | 0 | 1 | 14 | 25 |
| | Negative | 10 | 20 | 9 | 1 | 0 |
| Viewer C | Positive | 0 | 0 | 1 | 15 | 25 |
| | Negative | 10 | 20 | 9 | 0 | 0 |
## Discordant Results of Buprenorphine Strip
| Viewer | Sample Number | GC/MS Result | Strip Viewer 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 |
| Viewer A | 31718 | 10.9 | Negative |
| Viewer B | 18342 | 10.6 | 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 | 14 | 25 |
| | Negative | 10 | 20 | 8 | 1 | 0 |
| Viewer B | Positive | 0 | 0 | 2 | 14 | 25 |
| | Negative | 10 | 20 | 8 | 1 | 0 |
| Viewer C | Positive | 0 | 0 | 2 | 14 | 25 |
| | Negative | 10 | 20 | 8 | 1 | 0 |
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Discordant Results of Buprenorphine Panel Dip
| Viewer | Sample Number | GC/MS Result | Panel Dip Viewer 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-Key Split 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 |
| | Negative | 1 | 20 | 9 | 1 | 0 |
| Viewer B | Positive | 0 | 0 | 1 | 14 | 25 |
| | Negative | 1 | 20 | 9 | 1 | 0 |
| Viewer C | 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 Split Cup |
| --- | --- | --- | --- |
| Viewer A | 20805 | 9.6 | Positive |
| Viewer B | 11178 | 9.8 | Positive |
| 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 |
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| Quick 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 |
| | Negative | 10 | 20 | 9 | 1 | 0 |
| Viewer B | Positive | 0 | 0 | 1 | 15 | 25 |
| | Negative | 10 | 20 | 9 | 0 | 0 |
| Viewer C | 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 Cup Viewer 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 | | 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 | 14 | 25 |
| | Negative | 10 | 20 | 8 | 1 | 0 |
| Viewer B | Positive | 0 | 0 | 1 | 14 | 25 |
| | Negative | 10 | 20 | 9 | 1 | 0 |
| Viewer C | Positive | 0 | 0 | 1 | 14 | 25 |
| | Negative | 10 | 20 | 9 | 1 | 0 |
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Discordant Results of MTD Strip
| Viewer | Sample Number | GC/MS Result | Strip Viewer Results |
| --- | --- | --- | --- |
| Viewer A | 36406 | 293 | Positive |
| 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 |
| | Negative | 10 | 20 | 8 | 0 | 0 |
| Viewer B | Positive | 0 | 0 | 1 | 14 | 25 |
| | Negative | 10 | 20 | 9 | 1 | 0 |
| Viewer C | Positive | 0 | 0 | 1 | 15 | 25 |
| | Negative | 10 | 20 | 9 | 0 | 0 |
Discordant Results of MTD Panel Dip
| Viewer | Sample Number | GC/MS Result | Panel Dip Viewer 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 |
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| Turn-Key Split 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 |
| | Negative | 1 | 20 | 9 | 1 | 0 |
| Viewer B | Positive | 0 | 0 | 1 | 15 | 25 |
| | Negative | 1 | 20 | 9 | 0 | 0 |
| Viewer C | Positive | 0 | 0 | 1 | 14 | 25 |
| | Negative | 1 | 20 | 9 | 1 | 0 |
Discordant Results of MTD Turn-Key Split Cup
| Viewer | Sample Number | GC/MS Result | Split Cup Viewer Results |
| --- | --- | --- | --- |
| Viewer A | 15168 | 291 | Positive |
| Viewer B | 15168 | 291 | Positive |
| Viewer C | 36406 | 293 | Positive |
| Viewer A | 82949 | 305 | Negative |
| Viewer C | 82949 | 305 | Negative |
| Quick 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 |
| | Negative | 10 | 20 | 9 | 1 | 0 |
| Viewer B | Positive | 0 | 0 | 2 | 14 | 25 |
| | Negative | 10 | 20 | 8 | 1 | 0 |
| Viewer C | Positive | 0 | 0 | 1 | 15 | 25 |
| | Negative | 10 | 20 | 9 | 0 | 0 |
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Discordant Results of MTD Quick Cup
| Viewer | Sample Number | GC/MS Result | Quick Cup Viewer 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 273 study subjects for 3 formats and 147 study subjects for 2 formats. 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 aliquotted into individual containers and blind-labeled. Each participant was provided with the package insert, 1 blind labeled sample and a device. Each device format 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 (%) |
| --- | --- | --- | --- | --- | --- |
| | | | No. of Positive | No. of Negative | |
| -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 |
| +75% Cutoff | 21 | 17.8 | 21 | 0 | 100 |
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Comparison between GC/MS and Lay Person Results for MTD Strip
| % of Cutoff | Number of sample | Methadone Concentration by GC/MS (ng/mL) | Lay person results | | The percentage of correct results (%) |
| --- | --- | --- | --- | --- | --- |
| | | | No. of Positive | No. of Negative | |
| -100%Cutoff | 2 | 0 | 0 | 21 | 100 |
| -75%Cutoff | 2 | 69 | 0 | 21 | 100 |
| -50% Cutoff | 2 | 162 | 0 | 21 | 100 |
| -25% Cutoff | 2 | 251 | 1 | 20 | 95 |
| +25% Cutoff | 2 | 389 | 20 | 1 | 95 |
| +50% Cutoff | 2 | 463 | 21 | 0 | 100 |
| +75% Cutoff | 2 | 510 | 21 | 0 | 100 |
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 |
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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 |
| -50% | 21 | 5.5 | 162 | 0+/21- | 0+/21- | 100 | 100 |
| -25% | 21 | 7.6 | 251 | 0+/21- | 1+/20- | 100 | 95 |
| +25% | 21 | 12.6 | 389 | 20+/1- | 21+/0- | 95 | 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.
b. Matrix comparison:
Not applicable
3. Clinical studies:
a. Clinical Sensitivity:
Not applicable
b. Clinical specificity:
Not applicable
c. Other clinical supportive data (when a. and b. are not applicable):
Not applicable
4. Clinical cut-off:
Not applicable
5. Expected values/Reference range:
Not applicable
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N. Proposed Labeling:
The labeling is sufficient and it satisfies the requirements of 21 CFR Part 809.10.
O. Conclusion:
The submitted information in this premarket notification is complete and supports a substantial equivalence decision.
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