(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.
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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.
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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.
§ 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).