(29 days)
The AssureTech Secobarbital Strip test is an immunochromatographic assay for the qualitative determination of Secobarbital in human urine at a Cut-Off concentration of 300ng/mL. The test may yield preliminary positive results when prescription drug Secobarbital is ingested, even at or above therapeutic doses. There are no uniformly recognized drug levels for Secobarbital 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 Oxycodone Strip test is an immunochromatographic assay for the qualitative determination of Oxycodone in human urine at a Cut-Off concentration of 100ng/mL. The test may yield preliminary positive results when prescription drug Oxycodone is ingested, even at or above therapeutic doses. There are no uniformly recognized drug levels for Oxycodone 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 Secobarbital/Oxycodone Panel Dip test is an immunochromatographic assay for the qualitative determination of Secobarbital and Oxycodone in human urine at a Cut-Off concentration of 300ng/mL and 100 ng/mL, respectively. The test may yield preliminary positive results when prescription drug Secobarbital or Oxycodone is ingested, even at or above therapeutic doses. There are no uniformly recognized drug levels for Secobarbital or Oxycodone in urine. The test provides only preliminary test results. A more specific alternative chemical 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 Secobarbital/Oxycodone Quick Cup test is an immunochromatographic assay for the qualitative determination of Secobarbital and Oxycodone in human urine at a Cut-Off concentration of 300ng/mL and 100 ng/mL, respectively. The test may yield preliminary positive results when prescription drug Secobarbital or Oxycodone is ingested, even at or above therapeutic doses. There are no uniformly recognized drug levels for Secobarbital or Oxycodone in urine. The test provides only preliminary test results. A more specific alternative chemical 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 Secobarbital/Oxycodone Turn Key-Split Cup test is an immunochromatographic assay for the qualitative determination of Secobarbital and Oxycodone in human urine at a Cut-Off concentration of 300ng/mL and 100 ng/mL. respectively. The test may yield preliminary positive results when prescription drug Secobarbital or Oxycodone is ingested, even at or above therapeutic doses. There are no uniformly recognized drug levels for Secobarbital or Oxycodone 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.
Secobarbital Strip. The AssureTech AssureTech Oxycodone Strip. AssureTech Secobarbital/Oxycodone Panel Dip, AssureTech Secobarbital/Oxycodone Quick Cup and AssureTech Secobarbial/Oxycodone Turn Key-Split Cup are immunochromatographic assays that use a lateral flow system for the qualitative detection of Secobarbital and/or Oxycodone (target analytes) in human urine. The Quick Cup 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.
The company, AssureTech, has conducted several studies to demonstrate that its urine drug tests (AssureTech Secobarbital Strip, AssureTech Oxycodone Strip, AssureTech Secobarbital/Oxycodone Panel Dip, AssureTech Secobarbital/Oxycodone Quick Cup, and AssureTech Secobarbital/Oxycodone Turn Key-Split Cup) meet acceptance criteria for qualitative determination of Secobarbital and Oxycodone in human urine.
Here's a breakdown of the acceptance criteria and study details:
1. Table of Acceptance Criteria (Implicit) and Reported Device Performance
The document does not explicitly state formal acceptance criteria values (e.g., "sensitivity must be >95%"). Instead, performance is demonstrated by the proportion of correct results at various drug concentrations, particularly around the cut-off. The implicit acceptance criterion is that the device should accurately classify samples as positive or negative relative to the established cut-off values, and that performance near the cut-off should be reasonable, accounting for the inherent variability of immunoassays.
| Study Type | Acceptance Criteria (Implicit) | Reported Device Performance (Summary) |
|---|---|---|
| Precision | Consistent results across different manufacturing lots and concentrations around the cut-off. | Highly Consistent: For both Secobarbital (cutoff 300 ng/mL) and Oxycodone (cutoff 100 ng/mL), across 3 lots and 4 different device configurations, the tests consistently showed:- 100% negative results for concentrations at -100%, -75%, -50%, and -25% of the cut-off.- High positive rates (typically 47/50 to 50/50, or 94-100%) at the cut-off.- 100% positive results for concentrations at +25%, +50%, +75%, and +100% of the cut-off. |
| Cut-off Verification | All samples below -25% cut-off should be negative, and all samples above +25% cut-off should be positive. | Met: All samples at and below -25% Cut-Off were negative, and all samples at and above +25% Cut-Off were positive for both Secobarbital and Oxycodone. |
| Interference | No significant interference from common physiological/pathological substances or non-target drugs. | Met: Numerous common substances (listed over two pages in the document) showed no interference at 100 µg/mL. |
| Specificity | Limited cross-reactivity with structurally similar compounds, with established approximate percentages relative to the target drug. | Met: Cross-reactivity percentages are provided for various related compounds (e.g., Amobarbital at 30% for Secobarbital, Oxymorphone at 40% for Oxycodone). |
| Effect of Urine Specific Gravity and pH | Accurate results across a range of urine specific gravity (1.000-1.035) and pH (4-9). | Met: All samples at/above +25% cut-off were positive, and all samples at/below -25% cut-off were negative within these ranges. |
| Method Comparison (Professional Use) | High agreement with GC/MS results, especially for samples far from the cut-off. Any discrepancies near the cut-off should be acceptable due to inherent variability. | High agreement shown: - Secobarbital: For most cases, 100% agreement for negative and high positive samples. Some discordant results were observed for specific samples near the cut-off (e.g., GC/MS 286 ng/mL reported as positive by device; GC/MS 306 ng/mL reported as negative by device).- Oxycodone: Similar high agreement, with some discordant results near the cut-off (e.g., GC/MS 96 ng/mL reported as positive by device; GC/MS 102 ng/mL reported as negative by device). |
| Lay-user Study (OTC Use) | High percentage of correct results for lay users, and ease of understanding instructions. | High Agreement & Understandability: - Secobarbital: 90-100% correct results across various concentrations, with 90% at -25% cut-off and 100% at +25% cut-off.- Oxycodone: 95-100% correct results, with 95% at -25% cut-off and 95% at +25% cut-off.- All lay users indicated instructions were easy to follow. Flesch-Kincaid reading Grade Level of 7. |
2. Sample Size Used for the Test Set and Data Provenance
-
Precision Study:
- For each drug (Secobarbital, Oxycodone) and each device configuration, 8 concentrations were tested (100%, 75%, 50%, 25% below cut-off, cut-off, and 25%, 50%, 75%, 100% above cut-off).
- For each concentration, tests were performed two runs per day for 25 days, using 3 different lots.
- Total tests per concentration per lot: 2 runs/day * 25 days = 50 tests.
- Total tests per concentration for all 3 lots: 50 tests * 3 lots = 150 tests.
- Total per drug per device: 150 tests/concentration * 8 concentrations = 1200 tests.
- Data Provenance: The samples were prepared by "spiking drug in negative samples." This indicates laboratory-prepared samples, not clinical samples. The country of origin is not explicitly stated but implied to be related to the submitter (China). This is a prospective experimental study.
-
Cut-off Verification Study:
- 150 samples were used, equally distributed at concentrations of -50%, -25%, Cut-Off, +25%, +50% Cut-Off.
- Tested using three different lots of each device by three different operators.
- Data Provenance: Laboratory-prepared spiked samples. This is a prospective experimental study.
-
Interference and Specificity Studies:
- Samples were prepared by adding potential interfering substances or cross-reactants to drug-free urine and target drug urine (at concentrations 25% below and 25% above Cut-Off levels).
- Tested using three batches of each device.
- Data Provenance: Laboratory-prepared spiked samples. This is a prospective experimental study.
-
Effect of Urine Specific Gravity and pH:
- Urine samples with specific gravity from 1.000 to 1.035 or pH from 4 to 9 were spiked with target drugs at 25% below and 25% above Cut-Off levels.
- Tested using three batches of each device.
- Data Provenance: Laboratory-prepared spiked samples. This is a prospective experimental study.
-
Method Comparison Studies (Professional Use):
- Sample Size: 80 "unaltered clinical samples" for each device (40 negative and 40 positive based on GC/MS). These 80 samples were further categorized into Negative, Low Negative, Near Cutoff Negative, Near Cutoff Positive, and High Positive.
- Data Provenance: "Unaltered clinical samples." The country of origin is not specified, but these are retrospective clinical samples with established GC/MS results.
-
Lay-user Study (OTC Use):
- Sample Size: 1060 lay persons.
- The document implies that each lay person tested one sample, so 1060 samples in total across all participants/devices.
- The samples used in this study were prepared at various concentrations (-100%, -75%, -50%, -25%, +25%, +50%, +75% of the cutoff) by spiking drug(s) into drug-free-pooled urine specimens.
- Data Provenance: Laboratory-prepared spiked samples. This is a prospective study involving human participants.
3. Number of Experts Used to Establish the Ground Truth for the Test Set and Qualifications of those Experts
- Precision, Cut-off, Interference, Specificity, Specific Gravity/pH Studies: Ground truth was established by GC/MS (Gas Chromatography/Mass Spectrometry), which is a gold standard analytical method. No human experts are explicitly mentioned for ground truth establishment for these analytical performance studies, as the concentrations are chemically determined.
- Method Comparison (Professional Use): The ground truth for the 80 "unaltered clinical samples" was established by GC/MS results. No human experts are explicitly mentioned for adjudicating the GC/MS results themselves. The "three laboratory assistants" performed the device tests, not established the ground truth.
- Lay-user Study: Ground truth was established by GC/MS for the spiked urine samples.
4. Adjudication Method for the Test Set
- For the analytical studies (Precision, Cut-off, Interference, Specificity, Specific Gravity/pH), the reference method is GC/MS, so there's no human adjudication in the traditional sense. The device's results are compared directly to the quantitative GC/MS values.
- For the Method Comparison study, the "three laboratory assistants" are described as "operators" who ran the samples. Their interpretations of the device results were then compared to the GC/MS results. It's not an adjudication of conflicting interpretations by different human readers, but rather a comparison of human interpretation of the device against the GC/MS "gold standard."
- For the Lay-user study, each lay person interpreted their single device result, which was then compared to the GC/MS result of the sample they tested. No inter-reader adjudication took place for the lay users' results.
5. Multi-Reader Multi-Case (MRMC) Comparative Effectiveness Study
- No, an MRMC comparative effectiveness study was not performed as described for AI vs. without AI assistance.
- The studies involved multiple "viewers" or "operators" (three laboratory assistants for the method comparison, and 1060 lay persons for the lay-user study), which could be considered multi-reader elements. However, these studies were not designed to compare reader performance with and without an AI system. Instead, they assessed the device's performance (interpreted by humans) against a gold standard (GC/MS).
- Therefore, there is no effect size reported for how much human readers improve with AI vs. without AI assistance, as AI is not part of this device.
6. Standalone (Algorithm Only) Performance
- Yes, in essence, standalone performance was assessed in the analytical studies (Precision, Cut-off, Interference, Specificity, Specific Gravity/pH). While a human manually reads the test line on the immunochromatographic assay, the "algorithm" is the biochemical reaction itself in the strip/cup. The performance metrics (e.g., 100% negative at -25% cut-off, 100% positive at +25% cut-off) directly reflect the performance of this chemical "algorithm."
- The "Method Comparison" and "Lay-user" studies assess the performance of the device in the hands of human users, thus incorporating a human-in-the-loop component. However, the foundational analytical performance is "standalone" for the immunoassay.
7. Type of Ground Truth Used
- The primary ground truth used across all studies is Gas Chromatography/Mass Spectrometry (GC/MS).
- For the analytical studies, GC/MS confirmed the exact concentrations of drugs in spiked samples.
- For the method comparison and lay-user studies, GC/MS served as the reference method for confirming the presence and concentration of drugs in clinical and spiked urine samples, respectively.
8. Sample Size for the Training Set
- This is an immunochromatographic assay, not an AI/machine learning device. Therefore, the concept of a "training set" for an algorithm doesn't directly apply.
- The "development" or "training" of such a device typically involves optimizing the chemical reagents (antibodies, conjugates, etc.) and physical design to achieve the desired sensitivity and specificity. The document does not provide details on the sample sizes used during the R&D phase for optimizing the assay components. The reported studies are for performance verification of the final product.
9. How the Ground Truth for the Training Set Was Established
- As mentioned above, there is no "training set" in the context of an AI algorithm.
- During the development of the immunoassay, the performance of various chemical formulations and designs would have been evaluated against known concentrations of analytes, likely confirmed by a gold standard method like GC/MS, to establish the optimal components and cut-off levels.
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Food and Drug Administration 10903 New Hampshire Avenue Document Control Center - WO66-G609 Silver Spring, MD 20993-0002
June 4, 2015
ASSURE TECH. CO., LTD C/O JOE SHIA REGULATORY CONSULTANT 504 E DIAMOND AVE., SUITE F GAITHERSBURG MD 20877
Re: K151211
Trade/Device Name: AssureTech Secobarbital Strip AssureTech Oxycodone Strip AssureTech Secobarbital/Oxycodone Panel Dip AssureTech Secobarbital/Oxycodone Quick Cup AssureTech Secobarbital/Oxycodone Turn Kev-Split Cup Regulation Number: 21 CFR 862.3150 Regulation Name: Barbiturate test system Regulatory Class: II
Product Code: DIS. DJG Dated: April 3, 2015 Received: May 6, 2015
Dear Mr. Joe Shia:
We have reviewed your Section 510(k) premarket notification of intent to market the device referenced above and have determined the device is substantially equivalent (for the indications for use stated in the enclosure) to legally marketed predicate devices marketed in interstate commerce prior to May 28, 1976, the enactment date of the Medical Device Amendments, or to devices that have been reclassified in accordance with the provisions of the Federal Food. Drug. and Cosmetic Act (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
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as set forth in the quality systems (QS) regulation (21 CFR Part 820); and if applicable, the 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.
Katherine Serrano -S
For: 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) K151211
Device Name
AssureTech Secobarbital Strip, AssureTech Oxycodone Strip, AssureTech Secobarbital/Oxycodone Panel Dip AssureTech Secobarbital/Oxycodone Quick Cup AssureTech Secobarbial/Oxycodone Turn Key-Split Cup
Indications for Use (Describe)
The AssureTech Secobarbital Strip test is an immunochromatographic assay for the qualitative determination of Secobarbital in human urine at a Cut-Off concentration of 300ng/mL.
The test may yield preliminary positive results when prescription drug Secobarbital is ingested, even at or above therapeutic doses. There are no uniformly recognized drug levels for Secobarbital 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 Oxycodone Strip test is an immunochromatographic assay for the qualitative determination of Oxycodone in human urine at a Cut-Off concentration of 100ng/mL.
The test may yield preliminary positive results when prescription drug Oxycodone is ingested, even at or above therapeutic doses. There are no uniformly recognized drug levels for Oxycodone 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 Secobarbital/Oxycodone Panel Dip test is an immunochromatographic assay for the qualitative determination of Secobarbital and Oxycodone in human urine at a Cut-Off concentration of 300ng/mL and 100 ng/mL, respectively.
The test may yield preliminary positive results when prescription drug Secobarbital or Oxycodone is ingested, even at or above therapeutic doses. There are no uniformly recognized drug levels for Secobarbital or Oxyoodone in urine. The test provides only preliminary test results. A more specific alternative chemical 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 Secobarbital/Oxycodone Quick Cup test is an immunochromatographic assay for the qualitative determination of Secobarbital and Oxycodone in human urine at a Cut-Off concentration of 300ng/mL and 100 ng/mL, respectively.
The test may yield preliminary positive results when prescription drug Secobarbital or Oxycodone is ingested, even at or above therapeutic doses. There are no uniformly recognized drug levels for Secobarbital or Oxycodone in urine. The test
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provides only preliminary test results. A more specific alternative chemical 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 Secobarbital/Oxycodone Turn Key-Split Cup test is an immunochromatographic assay for the qualitative determination of Secobarbital and Oxycodone in human urine at a Cut-Off concentration of 300ng/mL and 100 ng/mL. respectively.
The test may yield preliminary positive results when prescription drug Secobarbital or Oxycodone is ingested, even at or above therapeutic doses. There are no uniformly recognized drug levels for Secobarbital or Oxycodone 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.
| Type of Use (Select one or both, as applicable) | |
|---|---|
| Prescription Use (Part 21 CFR 801 Subpart D) | Over-The-Counter Use (21 CFR 801 Subpart C) |
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510(k) SUMMARY
| 1. Date: | June 3, 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 Secobarbital StripAssureTech Oxycodone StripAssureTech Secobarbital/Oxycodone Panel DipAssureTech Secobarbital/Oxycodone Quick CupAssureTech Secobarbital/Oxycodone Turn Key-Split Cup |
Classification:
| Product Code | CFR | Panel |
|---|---|---|
| DIS | 21 CFR, 862.3150 Barbiturate Test System | Toxicology |
| DJG | 21 CFR, 862.3650 Opiate Test System | Toxicology |
5. Predicate Devices: K052115
FIRST CHECK DIAGNOSTICS LLC FIRST CHECK MULTI DRUG CUP 12
-
- Intended Use
The AssureTech Secobarbital Strip test is an immunochromatographic assay for the qualitative determination of Secobarbital in human urine at a Cut-Off concentration of 300ng/mL.
- Intended Use
The test may vield preliminary positive results when prescription drug Secobarbital is ingested. even at or above therapeutic doses. There are no uniformly recognized drug levels for Secobarbital 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 Oxycodone Strip test is an immunochromatographic assay for the qualitative determination of Oxycodone in human urine at a Cut-Off concentration of 100ng/mL.
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The test may yield preliminary positive results when prescription drug Oxycodone is ingested, even at or above therapeutic doses. There are no uniformly recognized drug levels for Oxycodone 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 Secobarbital/Oxycodone Panel Dip test is an immunochromatographic assay for the qualitative determination of Secobarbital and Oxycodone in human urine at a Cut-Off concentration of 300ng/mL and 100 ng/mL, respectively.
The test may vield preliminary positive results when prescription drug Secobarbital or Oxycodone is ingested, even at or above therapeutic doses. There are no uniformly recognized drug levels for Secobarbital or Oxycodone in urine. The test provides only preliminary test results. A more specific alternative chemical 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 Secobarbital/Oxycodone Quick Cup test is an immunochromatographic assay for the qualitative determination of Secobarbital and Oxycodone in human urine at a Cut-Off concentration of 300ng/mL and 100 ng/mL, respectively.
The test may yield preliminary positive results when prescription drug Secobarbital or Oxycodone is ingested, even at or above therapeutic doses. There are no uniformly recognized drug levels for Secobarbital or Oxycodone 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 Secobarbital/Oxycodone Turn Key-Split Cup test is an immunochromatographic assay for the qualitative determination of Secobarbital and Oxycodone in human urine at a Cut-Off concentration of 300ng/mL and 100 ng/mL. respectively.
The test may yield preliminary positive results when prescription drug Secobarbital or Oxycodone is ingested, even at or above therapeutic doses. There are no uniformly recognized drug levels for Secobarbital or Oxycodone in urine. The test provides only preliminary test
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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.
-
- Device Description
Secobarbital Strip. The AssureTech AssureTech Oxycodone Strip. AssureTech Secobarbital/Oxycodone Panel Dip, AssureTech Secobarbital/Oxycodone Quick Cup and AssureTech Secobarbial/Oxycodone Turn Key-Split Cup are immunochromatographic assays that use a lateral flow system for the qualitative detection of Secobarbital and/or Oxycodone (target analytes) in human urine. The Quick Cup does not contain a turn-key for device activation. The tests are the first step in a two-step process. The second step is to send the sample for laboratory testing if preliminary positive results are obtained.
- Device Description
-
- Substantial Equivalence Information
A summary comparison of features of the candidate devices and the predicate devices is provided in Tables 1 to 4 below.
- Substantial Equivalence Information
| Item | Device | Predicate - K052115 |
|---|---|---|
| Indication(s)for Use | For the qualitative determination of drugs ofabuse in human urine. | Same (but the number ofdrugs detected is different) |
| Calibrator | Secobarbital (member of Barbiturates drug class) | Barbiturates |
| 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. | For over-the-counter use. |
| Configurations | Strip | Cup |
Table 1: Features Comparison of AssureTech Secobarbital Strip and the Predicate Devices
Table 2: Features Comparison of AssureTech Oxycodone Strip and the Predicate Devices
| Item | Device | Predicate - K052115 |
|---|---|---|
| Indication(s)for Use | For the qualitative determination ofdrugs of abuse in human urine. | Same (but the number ofdrugs detected is different) |
| Calibrator | Oxycodone | Same |
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| 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 | 100 ng/mL | Same |
| Intended Use | For over-the-counter and prescription uses. | For over-the-counter use. |
| Configurations | Strip | Cup |
Table 3: Features Comparison of AssureTech Secobarbital/Oxycodone Panel Dip and the Predicate Devices
| Item | Device | Predicate - K052115 |
|---|---|---|
| Indication(s)for Use | For the qualitative determination ofdrugs of abuse in human urine. | Same (but the number ofdrugs detected is different) |
| Calibrator | Secobarbital and Oxycodone | 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 | 300ng/mL for Secobarbital and 100 ng/mL forOxycodone | Same |
| Intended Use | For over-the-counter and prescription uses. | For over-the-counter use. |
| Configurations | Panel Dip | Cup |
Table 4: Features Comparison of AssureTech Secobarbital/Oxycodone Cup and the Predicate Devices
| Item | Device | Predicate - K052115 |
|---|---|---|
| Indication(s)for Use | For the qualitative determination ofdrugs of abuse in human urine. | Same (but the number ofdrugs detected is different) |
| Calibrator | Secobarbital and Oxycodone | Same |
{8}------------------------------------------------
| 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 | 300ng/mL for Secobarbital and 100 ng/mL forOxycodone | Same |
| Intended Use | For over-the-counter and prescription uses. | For over-the-counter use. |
| Configurations | Cup with or without turn-key | Cup |
9. Test Principle
AssureTech Secobarbital Strip, AssureTech Oxycodone Strip, AssureTech Secobarbital/Oxycodone Panel Dip, AssureTech Secobarbital/Oxycodone Quick Cup and AssureTech Secobarbial/Oxycodone Turn Key-Split Cup are rapid tests for the qualitative detection of Secobarbital and/or Oxycodone 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 antibodycoated 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.
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.
{9}------------------------------------------------
Secobarbital
| AssureTech Secobarbital Strip | ||
|---|---|---|
| ------------------------------- | -- | -- |
| Lot | -100% | -75% | -50% | -25% | cut off | +25% | +50% | +75% | +100% |
|---|---|---|---|---|---|---|---|---|---|
| Number | cut off | cut off | cut off | cutoff | cut off | cut off | cut off | 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+ | 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 Secobarbital/Oxycodone Panel Dip | |||||||||
| Lot | -100% | -75% | -50% | -25% | cut off | +25% | +50% | +75% | +100% |
| Number | cut off | cut off | cut off | cutoff | cut off | cut off | cut off | 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+ | 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 Secobarbital/Oxycodone Turn-Key Split Cup | |||||||||
| Lot | -100% | -75% | -50% | -25% | cut off | +25% | +50% | +75% | +100% |
| Number | cut off | cut off | cut off | cutoff | cut off | cut off | cut off | 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+ | 2-/48+ | 50+/0- | 50+/0- | 50+/0- | 50+/0- |
| AssureTech Secobarbital/Oxycodone Quick Cup | |||||||||
| Lot | -100% | -75% | -50% | -25% | cut off | +25% | +50% | +75% | +100% |
| Number | cut off | cut off | cut off | cutoff | cut off | cut off | cut off | 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+ | 2-/48+ | 50+/0- | 50+/0- |
|---|---|---|---|---|---|---|---|
| Lot 3 | 50-/0+ | 50-/0+ | 50-/0+ | 50-/0+ | 1-/49+ | 50+/0- | 50+/0- |
Oxycodone
AssureTech Oxycodone Strip
| 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+ | 2-/48+ | 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+ | 1-/49+ | 50+/0- | 50+/0- | 50+/0- | 50+/0- |
| AssureTech Secobarbital/Oxycodone Panel Dip |
| 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+ | 2-/48+ | 50+/0- | 50+/0- | 50+/0- | 50+/0- |
AssureTech Secobarbital/Oxycodone Turn-Key Split Cup
| Lot Number | -100% cut off | -75% cut off | -50% cut off | -25% cutoff | +25% cut off | +50% cut off | +75% cut off | +100% cut off | |
|---|---|---|---|---|---|---|---|---|---|
| Lot 1 | 50-/0+ | 50-/0+ | 50-/0+ | 50-/0+ | 3-/47+ | 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+ | 1-/49+ | 50+/0- | 50+/0- | 50+/0- | 50+/0- |
50+/0-
50+/0-
50+/0-
50+/0-
{10}------------------------------------------------
AssureTech Secobarbital/Oxycodone 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- |
| 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 Secobarbital and Oxycodone.
The following cut-off values for the candidate devices have been verified.
| Calibrator | Cut-off (ng/mL) |
|---|---|
| Secobarbital | 300 |
| Oxycodone | 100 |
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.
Secobarbital:
| Acetaminophen | Erythromycin | O-Hydroxyhippuric acid |
|---|---|---|
| Acetophenetidin | β-Estradiol | D,L-Octopamine |
| Acetylsalicylic acid | Estrone-3-sulfate | Oxalic acid |
| Aminopyrine | Ethyl-p-aminobenzoate | Oxazepam |
| Amitryptyline | Fenoprofen | Oxolinic acid |
| Amoxicillin | Furosemide | Oxycodone |
| DL-Amphetamine sulfate | Gentisic acid | Oxymetazoline |
| Ampicillin | Hemoglobin | Papaverine |
| Apomorphine | Hydralazine | Penicillin-G |
| Ascorbic acid | Hydrochlorothiazide | Pentazocaine |
| Aspartame | Hydrocodone | Perphenazine |
| Atropine | Hydrocortisone | Phencyclidine |
| Benzilic acid | p-Hydroxyamphetamine | Phenelzine |
7
{11}------------------------------------------------
| Benzoic acid | p-Hydroxymethamphetamine | β-Phenylethlamine |
|---|---|---|
| Benzoylecgonine | 3-Hydroxytyramine | Phenylpropanolamine |
| Bilirubin | Ibuprofen | Prednisolone |
| Brompheniramine | Imipramine | Prednisone |
| Caffeine | (-) Isoproterenol | Procaine |
| Cannabidiol | Isoxsuprine | Promazine |
| Cannabinol | Ketamine | Promethazine |
| Chloralhydrate | Ketoprofen | D,L-Propanolol |
| Chloramphenicol | Labetalol | D-Propoxyphene |
| Chlorothiazide | Levorphanol | Quinidine |
| (±) Chlorpheniramine | Loperamide | Quinine |
| Chlorpromazine | L-Phenylephrine | Ranitidine |
| Chlorquine | Maprotiline | Salicylic acid |
| Cholesterol | Meperidine | Serotonin |
| Clomipramine | Meprobamate | Sulfamethazine |
| Clonidine | Morphine-3-β-D glucuronide | Sulindac |
| Cocaine hydrochloride | Methadone | Temazepam |
| Codeine | Methamphetamine | Tetracycline |
| Cortisone | (±) - 3,4-Methylenedioxy-amphetamine | Tetrahydrozoline |
| (-) Cotinine | (±)-3,4-Methylenedioxy-methamphetaminehydrochloride | Thebaine |
| Creatinine | Morphine Sulfate | Thiamine |
| Deoxycorticosterone | N-Acetylprocainamide | Thioridazine |
| Dextromethorphan | Nalidixic acid | Triamterene |
| Diazepam | Naloxone | Trifluoperazine |
| Diclofenac | Naltrexone | Trimethoprim |
| Diflunisal | Naproxen | Trimipramine |
| Digoxin | Niacinamide | Tryptamine |
| Diphenhydramine | Nifedipine | D, L-Tyrosine |
| Doxylamine | Norcodein | Uric acid |
| Ecgonine hydrochloride | Norethindrone | Verapamil |
| Ecgonine methylester | D-Norpropoxyphene | Zomepirac |
| (IR 2S)-Ephedrine | Noscapine |
Oxycodone
| Acetophenetidin | L-Ephedrine | Oxymetazoline |
|---|---|---|
| Nalidixic acid | Ecgonine methylester | Papaverine |
| Acetylsalicylic acid | Ethyl-p-aminobenzoate | Penicillin-G |
| Aminopyrine | B-Estradiol | Perphenazine |
| Amoxicillin | Estrone-3-sulfate | Phenelzine |
| Ampicillin | Erythromycin | L-Phenylephrine |
| L-Phenylephrine | Fenoprofen | B-Phenylethylamine |
| Apomorphine | Furosemide | Phenylpropanolamine |
| Aspartame | Gentisic acid | Prednisone |
| Atropine | Hemoglobin | Loperamide |
{12}------------------------------------------------
| Benzilic acid | Hydralazine | Quinine |
|---|---|---|
| Benzoic acid | Hydrochlorothiazide | Quinidine |
| Benzphetamine | Hydrocortisone | Ranitidine |
| Bilirubin | O-Hydroxyhippuric acid | Salicylic acid |
| Deoxycorticosterone | 3-Hydroxytyramine | Serotonin |
| Caffeine | Labetalol | Sulfamethazine |
| Chloralhydrate | D, L-Isoproterenol | Sulindac |
| Chloramphenicol | Meprobamate | Tetracycline |
| Chlorothiazide | Methoxyphenamine | Tetrahydrocortisone |
| D,L-Chlolrpheniramine | Nalidixic acid | Morphine-3-β-D-gluc |
| Chlorpromazine | Naloxone | uronide |
| Chlorquine | Naltrexone | Tetrahydrozoline |
| Cholesterol | Naproxen | Thiamine |
| Clonidine | Niacinamide | Thioridazine |
| L-Cotinine | Nifedipine | D,L-Tyrosine |
| Cortisone | Isoxsuprine | Tolbutamide |
| Creatinine | D,L-Propanolol | Triamterene |
| D-Pseudoephedrine | Ketoprofen | Trifluoperazine |
| Dextromethorphan | Norethindrone | Trimethoprim |
| ß-Dglucuronide | D-Norpropoxyphene | Tyramine |
| Diclofenac | Noscapine | D,L-Tryptophan |
| Diflunisal | D,L-Octopamine | Urine acid |
| Digoxin | Oxalic acid | Verapamil |
| Diphenhydramine | Oxolinic acid | Zomepirac |
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.
| Secobarbital | 0/0 | |
|---|---|---|
| (Cut-off=300 ng/mL) | Result | Cross-Reactivity |
| Secobarbital | Positive at 300 ng/mL | 100% |
| Amobarbital | Positive at 1000 ng/mL | 30% |
| Alphenol | Positive at 62.5 ng/mL | 480% |
| Aprobarbital | Positive at 250 ng/mL | 120% |
| Butabarbital | Positive at 100 ng/mL | 300% |
| Butathal | Positive at 500 ng/mL | 60% |
| Butalbital | Positive at 5000ng/mL | 6% |
| Cyclopentobarbital | Positive at 500 ng/mL | 60% |
| Pentobarbital | Positive at 200 ng/mL | 150% |
| Phenobarbital | Positive at 300 ng/mL | 100% |
| Oxycodone(Cut-off=100 ng/mL) | Result | %Cross-Reactivity |
|---|---|---|
| Oxycodone | Positive at 100 ng/mL | 100% |
| Codeine | Positive at 100000 ng/mL | 0.1% |
| Acetylmorphine | Positive at 100000 ng/mL | 0.1% |
| Oxymorphone | Positive at 250 ng/mL | 40% |
{13}------------------------------------------------
| Dihydrocodeine | Positive at 100000 ng/mL | 0.1% |
|---|---|---|
| Hydromorphone | Positive at 100000 ng/mL | 0.1% |
| Hydrocodone | Positive at 3125 ng/mL | 3.2% |
| Morphine | Positive at 100000 ng/mL | 0.1% |
| Buprenorphine | Positive at 100000 ng/mL | 0.1% |
| Ethylmorphine | Positive at 100000 ng/mL | 0.1% |
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 batches 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 candidate devices 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%) | |
|---|---|---|---|---|---|---|
| Secobarbital | ||||||
| Viewer | Positive | 0 | 0 | 1 | 15 | 25 |
| A | Negative | 10 | 20 | 9 | 0 | 0 |
| Viewer | Positive | 0 | 0 | 1 | 15 | 25 |
| B | Negative | 10 | 20 | 9 | 0 | 0 |
| Viewer | Positive | 0 | 0 | 1 | 15 | 25 |
| C | Negative | 10 | 20 | 9 | 0 | 0 |
Discordant Results of Secobarbital Strip
| Viewer | Sample Number | GC/MS Result | Strip Viewer Results |
|---|---|---|---|
| Viewer A | 817130 | 286 | Positive |
| Viewer B | 817130 | 286 | Positive |
| Viewer C | 817130 | 286 | Positive |
{14}------------------------------------------------
| PanelDip | 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 | 1 | 15 | 25 |
| Negative | 10 | 20 | 9 | 0 | 0 |
Discordant Results of Secobarbital Panel Dip
| Viewer | Sample Number | GC/MS Result | Panel DipViewer Results |
|---|---|---|---|
| Viewer A | 817130 | 286 | Positive |
| Viewer B | 817130 | 286 | Positive |
| Viewer C | 817130 | 286 | Positive |
| Viewer A | 933321 | 306 | 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 |
| Negative | 1 | 20 | 9 | 1 | 0 | |
| ViewerB | Positive | 0 | 0 | 0 | 14 | 25 |
| Negative | 1 | 20 | 10 | 1 | 0 | |
| ViewerC | Positive | 0 | 0 | 1 | 14 | 25 |
| Negative | 1 | 20 | 9 | 1 | 0 |
Discordant Results of Secobarbital Turn-Key Split Cup
| Viewer | Sample Number | GC/MS Result | Turn-Key SplitCup |
|---|---|---|---|
| Viewer A | 817130 | 286 | Positive |
| Viewer A | 862382 | 310 | Negative |
| Viewer C | 817130 | 286 | Positive |
| Viewer B | 933321 | 306 | Negative |
| Viewer C | 722825 | 336 | Negative |
{15}------------------------------------------------
| 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 | 1 | 15 | 25 |
| Negative | 10 | 20 | 9 | 0 | 0 |
Discordant Results of Secobarbital Quick Cup
| Viewer | Sample Number | GC/MS Result | Quick Cup Viewer Results |
|---|---|---|---|
| Viewer A | 216041 | 241 | Positive |
| Viewer B | 126635 | 252 | Positive |
| Viewer C | 126635 | 252 | Positive |
| Viewer A | 358232 | 315 | Negative |
Oxycodone (OXY)
| 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%) | |
|---|---|---|---|---|---|---|
| ViewerA | Positive | 0 | 0 | 1 | 14 | 25 |
| ViewerA | Negative | 10 | 20 | 9 | 1 | 0 |
| ViewerB | Positive | 0 | 0 | 1 | 15 | 25 |
| ViewerB | Negative | 10 | 20 | 9 | 0 | 0 |
| ViewerC | Positive | 0 | 0 | 1 | 15 | 25 |
| ViewerC | Negative | 10 | 20 | 9 | 0 | 0 |
Discordant Results of OXY Strip
| Viewer | Sample Number | GC/MS Result | Strip Viewer Results |
|---|---|---|---|
| Viewer A | 638805 | 96 | Positive |
| Viewer A | 757887 | 102 | Negative |
| Viewer B | 638805 | 96 | Positive |
| Viewer C | 638805 | 96 | Positive |
{16}------------------------------------------------
| PanelDip | 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 | 15 | 25 |
| Negative | 10 | 20 | 9 | 0 | 0 | |
| ViewerB | Positive | 0 | 0 | 0 | 14 | 25 |
| Negative | 10 | 20 | 10 | 1 | 0 | |
| ViewerC | Positive | 0 | 0 | 1 | 15 | 25 |
| Negative | 10 | 20 | 9 | 0 | 0 |
Discordant Results of OXY Panel Dip
| Viewer | Sample Number | GC/MS Result | Panel DipViewer Results |
|---|---|---|---|
| Viewer A | 603216 | 90 | Positive |
| Viewer C | 638805 | 96 | Positive |
| Viewer B | 757887 | 102 | Negative |
| Turn-KeySplit Cup | Negative | Low Negative byGC/MS(less than -50%) | Near Cutoff Negative byGC/MS(Between -50% andcutoff) | Near Cutoff Positive byGC/MS(Between the cutoff and+50%) | High Positiveby GC/MS(greater than +50%) | |
|---|---|---|---|---|---|---|
| ViewerA | Positive | 0 | 0 | 1 | 14 | 25 |
| Negative | 1 | 20 | 9 | 1 | 0 | |
| ViewerB | Positive | 0 | 0 | 1 | 15 | 25 |
| Negative | 1 | 20 | 9 | 0 | 0 | |
| ViewerC | Positive | 0 | 0 | 0 | 15 | 25 |
| Negative | 1 | 20 | 10 | 0 | 0 |
Discordant Results of OXY Turn-Key Split Cup
| Viewer | Sample Number | GC/MS Result | Split Cup Viewer Results |
|---|---|---|---|
| Viewer A | 638805 | 96 | Positive |
| Viewer A | 285248 | 110 | Negative |
| Viewer B | 638805 | 96 | Positive |
{17}------------------------------------------------
| QuickCup | 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 |
| Negative | 10 | 20 | 9 | 1 | 0 | |
| ViewerB | Positive | 0 | 0 | 0 | 14 | 25 |
| Negative | 10 | 20 | 10 | 1 | 0 | |
| ViewerC | Positive | 0 | 0 | 1 | 14 | 25 |
| Negative | 10 | 20 | 9 | 1 | 0 |
Discordant Results of OXY Quick Cup
| Viewer | Sample Number | GC/MS Result | Quick CupViewer Results |
|---|---|---|---|
| Viewer A | 638805 | 96 | Positive |
| Viewer C | 603216 | 90 | Positive |
| Viewer A | 757887 | 102 | Negative |
| Viewer B | 508044 | 116 | Negative |
| Viewer C | 285248 | 110 | Negative |
Lay-user study
A lay user study was performed at three intended user sites with 1060 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 Secobarbital Strip
| % of Cutoff | Number of samples | SecobarbitalConcentration by GC/MS(ng/mL) | Lay person results | Thepercentage ofcorrect results(%) | |
|---|---|---|---|---|---|
| -100% Cutoff | 20 | 0 | No. ofPositive | No. ofNegative | 100 |
| -75% Cutoff | 20 | 73 | 0 | 20 | 100 |
| -50% Cutoff | 20 | 149 | 0 | 20 | 100 |
| -25% Cutoff | 20 | 228 | 2 | 18 | 90 |
| +25% Cutoff | 20 | 369 | 20 | 0 | 100 |
| +50% Cutoff | 20 | 455 | 20 | 0 | 100 |
| +75% Cutoff | 20 | 530 | 20 | 0 | 100 |
{18}------------------------------------------------
| Number | Oxycodone Concentration | Lay person results | The | ||
|---|---|---|---|---|---|
| % of Cutoff | ofsamples | by GC/MS (ng/mL) | No. ofPositive | No. ofNegative | percentage ofcorrect results(%) |
| -100% Cutoff | 20 | 0 | 0 | 20 | 100 |
| -75% Cutoff | 20 | 22 | 0 | 20 | 100 |
| -50% Cutoff | 20 | 48 | 0 | 20 | 100 |
| -25% Cutoff | 20 | 80 | 1 | 19 | 95 |
| +25% Cutoff | 20 | 127 | 19 | 1 | 95 |
| +50% Cutoff | 20 | 158 | 20 | 0 | 100 |
| +75% Cutoff | 20 | 176 | 20 | 0 | 100 |
Comparison between GC/MS and Lay Person Results for OXY Strip
Comparison between GC/MS and Lay Person Results for BAR/OXY Panel DipCard
| % Cutoff | No ofsamples | Concentration byGC/MS(ng/mL) | Lay personresults | Correct Results(%) | |||
|---|---|---|---|---|---|---|---|
| Secobarbital | Oxycodone | BAR | OXY | BAR | OXY | ||
| -100% | 20 | 0 | 0 | 0+/20- | 0+/20- | 100 | 100 |
| -75% | 20 | 73 | 22 | 0+/20- | 0+/20- | 100 | 100 |
| -50% | 20 | 149 | 48 | 0+/20- | 0+/20- | 100 | 100 |
| -25% | 20 | 228 | 80 | 1+/19- | 1+/19- | 95 | 95 |
| +25% | 20 | 369 | 127 | 19+/1- | 18+/2- | 95 | 90 |
| +50% | 20 | 455 | 158 | 20+/0- | 20+/0- | 100 | 100 |
| +75% | 20 | 530 | 176 | 20+/0- | 20+/0- | 100 | 100 |
Comparison between GC/MS and Lay Person Results for BAR/OXY Turn-Key Split Cup
| % Cutoff | No ofsamples | Concentration byGC/MS(ng/mL) | Lay personresults | Correct Results(%) | |||
|---|---|---|---|---|---|---|---|
| Secobarbital | Oxycodone | BAR | OXY | BAR | OXY | ||
| -100% | 20 | 0 | 0 | 0+/20- | 0+/20- | 100 | 100 |
| -75% | 20 | 73 | 22 | 0+/20- | 0+/20- | 100 | 100 |
| -50% | 20 | 149 | 48 | 0+/20- | 0+/20- | 100 | 100 |
| -25% | 20 | 228 | 80 | 2+/18- | 1+/19- | 90 | 95 |
| +25% | 20 | 369 | 127 | 20+/0- | 19+/1- | 100 | 95 |
| +50% | 20 | 455 | 158 | 20+/0- | 20+/0- | 100 | 100 |
| +75% | 20 | 530 | 176 | 20+/0- | 20+/0- | 100 | 100 |
Comparison between GC/MS and Lay Person Results for BAR/OXY Quick Cup
| % Cutoff | No ofsamples | Concentration byGC/MS(ng/mL) | Lay person results | Correct Results(%) | |||
|---|---|---|---|---|---|---|---|
| Secobarbital | Oxycodone | BAR | OXY | BAR | OXY | ||
| -100% | 20 | 0 | 0 | 0+/20- | 0+/20- | 100 | 100 |
| -75% | 20 | 73 | 22 | 0+/20- | 0+/20- | 100 | 100 |
| -50% | 20 | 149 | 48 | 0+/20- | 0+/20- | 100 | 100 |
| -25% | 20 | 228 | 80 | 1+/19- | 1+/19- | 95 | 95 |
{19}------------------------------------------------
| +25% | 20 | ૩૯તે રાજ્યના ઉત્તર પ્રદેશના પાકની ખેતી કરવવામાં આવે છે. આ ગામમાં પ્રાથમિક શાળા, પંચાયતઘર, આંગણવાડી તેમ જ દૂધની ડેરી જેવી સવલતો પ્રાપ્ય થયેલી છે. આ ગામનાં લોકોનો મુખ્ય વ્યવસ | 127 | 20+/0- | 20+/0- | 100 | 100 |
|---|---|---|---|---|---|---|---|
| +50% | 20 | 455 | 158 | 20+/0- | 20+/0- | 100 | 100 |
| +75% | 20 | 530 | 176 | 20+/0- | 20+/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 Secobarbital Strip, AssureTech Oxycodone the AssureTech Strip, AssureTech Secobarbital/Oxycodone Panel Dip, AssureTech Secobarbital/Oxycodone Quick Cup and AssureTech Secobarbial/Oxycodone Turn Key-Split Cup are substantially equivalent to the predicate.
§ 862.3150 Barbiturate test system.
(a)
Identification. A barbiturate test system is a device intended to measure barbiturates, a class of hypnotic and sedative drugs, in serum, urine, and gastric contents. Measurements obtained by this device are used in the diagnosis and treatment of barbiturate use or overdose and in monitoring levels of barbiturate to ensure appropriate therapy.(b)
Classification. Class II (special controls). A barbiturate 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).