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The Immunalysis Barbiturates Urine Enzyme Immunoassay is a homogeneous enzyme immunoassay with a cutoff of 200 ng/mL. The assay is intended for use in laboratories for the qualitative and semi-quantitative analysis of Barbiturates in human urine with automated clinical chemistry analyzers. This assay is calibrated against Secobarbital. This in vitro diagnostic device is for prescription use only.

The semi-quantitative mode is for purposes of enabling laboratories to determine an appropriate dilution of the specimen for confirmation by a confirmatory method such as Gas Chromatography/ Mass Spectrometry (GC-MS) or Liquid Chromatography/ Tandem Mass Spectrometry (LC-MS/MS) or permitting laboratories to establish quality control procedures.

The Immunalysis Barbiturates Urine Enzyme Immunoassay provides only a preliminary analytical test result. A more specific alternate chemical method must be used in order to obtain a confirmed analytical result. GC-MS or LC-MS/MS is the preferred confirmatory method. Clinical consideration and professional judgment should be applied to any drug of abuse test result, particularly when preliminary positive results are used.

Immunalysis Multi-Drug Calibrators:

The Immunalysis Multi-Drug Calibrators are intended for in vitro diagnostic use for the calibration of assays for the following analytes: Benzoylecgonine, Methamphetamine, Morphine, PCP, Secobarbital and Oxazepam. The calibrators are designed for prescription use with immunoassays.

The Immunalysis Barbiturates Urine Enzyme Immunoassay consists of antibody/ substrate reagent and enzyme conjugate reagent. The antibody/ substrate reagent includes a recombinant antibody to Secobarbital, a mouse monoclonal antibody to Secobarbital, glucose-6-phosphate (G6P) and nicotinamide adenine dinucleotide (NAD) in HEPES buffer with sodium azide as a preservative. The enzyme conjugate reagent includes Barbiturates labeled with glucose-6phosphate dehydrogenase (G6PDH) in HEPES buffer with sodium azide as a preservative.

Immunalysis Multi-Drug Calibrators are included as part of the test system and provided separately. The calibrator kit includes four levels of drugs and a negative calibrator in a ready-touse format. Automated clinical chemistry analyzers capable of maintaining a constant temperature, pipetting samples and reagents, mixing reagents, timing the reaction accurately and measuring enzymatic rates spectrophotometrically at 340nm can be used to perform the assay.

The Immunalysis Barbiturates Urine Enzyme Immunoassay uses barbiturates recombinant and monoclonal antibody. The assay is based on the competition of Barbiturates labeled enzyme glucose-6-phosphate dehydrogenase (G6PDH) and the free drug in the urine sample for the fixed amount of antibody binding sites. In the absence of the free drug in the sample, the antibody binds the drug enzyme conjugate and enzyme activity is inhibited. This creates a dose response relationship between drug concentration in the urine and enzyme activity. The enzyme G6PDH activity is determined at 340 nm spectrophotometrically by the conversion of NAD to NADH.

Here's a breakdown of the acceptance criteria and study information for the Immunalysis Barbiturates Urine Enzyme Immunoassay:

1. Table of Acceptance Criteria and Reported Device Performance

The acceptance criteria are not explicitly stated as distinct numerical targets within the provided text. However, the studies demonstrate the performance of the device in various metrics, and the conclusion states that the device is "substantially equivalent to the legally marketed predicate device for its intended use." This implies that the performance shown met the, albeit unstated, acceptance criteria for substantial equivalence to the predicate device.

For this analysis, I will infer the acceptance criteria from the context of how the results are presented, specifically the aim of demonstrating that the cutoff serves as a boundary between negative and positive interpretations, demonstrating appropriate cross-reactivity and non-interference, and showing high agreement with LC/MS-MS.

• 200 ng/mL (Cutoff): 33/80 Negative, 47/80 Positive
• 250-400 ng/mL: 80/80 Positive (100%) |
  | Semi-Quantitative Analysis (Precision/Cutoff Characterization) | Clear discrimination around the 200 ng/mL cutoff and mixed results at cutoff. | - 0-150 ng/mL: 80/80 Negative (100%)
• 200 ng/mL (Cutoff): 23/80 Negative, 57/80 Positive
• 250-400 ng/mL: 80/80 Positive (100%) |
  | Specificity and Cross-Reactivity (Structurally Related Compounds) | Detect target compound (Secobarbital) at cutoff with 100% cross-reactivity; minimal or varying cross-reactivity for other barbiturates, with higher concentrations needed for positive results; Negative results for Phenytoin. | - Secobarbital: 100% Cross-Reactivity
• Other Barbiturates: Cross-reactivity % varied from 0.3% (Hexobarbital, Mephobarbital) to 105.3% (Alphenal, Butobarbital)
• Phenytoin (100,000 ng/mL): Negative, 200 ng/mL and 200-300 ng/mL)
• Qualitative Negative: 100% Agreement (for 200 ng/mL and 200-300 ng/mL)
• Semi-Quantitative Negative: 100% Agreement (for

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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.

• 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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Healgen Secobarbital Test is an immunochromatographic assay for the qualitative determination of Secobarbital in human urine at a Cut-Off concentration of 300 ng/mL. The test is available in a Strip format, a Cassette format, a Dip Card format and a Cup format.

The test may yield preliminary positive results even when the prescription drug Secobarbital is ingescribed doses; it is not intended to distinguish between prescription use or abuse of this drug. There is no uniformly recognized cutoff concentration level 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. GC/MS 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. It is intended for prescription and for over-the-counter use.

Healgen Buprenorphine Test is an immunochromatographic assay for the qualitative determination of Buprenorplaine in human urine at a Cut-Off concentration of 10 ng/mL. The test is available in a Strip format, a Cassette format, a Dip Card format and a Cup format.

The test may yield preliminary positive results even when the prescription drug Burrenorphine is ingested, at prescribed doses; it is not intended to distinguish between prescription use or abuse of this drug. There is no uniformly recognized cutoff concentration level 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. GC/MS 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. It is intended for prescription and for over-the-counter use.

Healgen Methadone Test is an immunochromatographic assay for the qualitative determination of Methadone in human urine at a Cut-Off concentration of 300 ng/mL. The test is available in a Strip format, a Cassette format, a Dip Card format and a Cup format.

The test provides only preliminary test results. A more specific alternative chemical method must be used in order to obtain a confirmed analytical result. GC/MS 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. It is intended for prescription and for over-the-counter use.

Healgen Secobarbital Test. Healgen Buprenorphine Test and Healgen Methadone Test are immunochromatographic assays for Secobarbital, Buprenorphine and Methadone. Each assay test is a lateral flow system for the qualitative detection of Secobarbital, Buprenorphine and Methadone (target analyte) in human urine. The products are in vitro diagnostic devices, which come in the form of: Strips, Cassettes, DipCards, or Cups. Each product contains a Test Device (in one of the four formats), and a package insert. Each test device is sealed with a desiccant in an aluminum pouch.

Here's an analysis of the acceptance criteria and study findings for the Healgen Secobarbital, Buprenorphine, and Methadone Tests, structured as requested:

Acceptance Criteria and Device Performance

The provided document describes the analytical and comparison studies performed to demonstrate the substantial equivalence of the Healgen drug tests. The acceptance criteria are implied by the expected performance in these studies, particularly the accuracy relative to GC/MS at and around the cutoff concentrations.

Table of Acceptance Criteria (Implied) and Reported Device Performance

• 100% accuracy (50-/0+ or 50+/0-) at -100%, -75%, -50%, +50%, +75%, +100% of cutoff.
• Mixed results (e.g., 22-/28+, 25-/25+, 20-/30+) within the +/- 25% range of the cutoff, which is expected for qualitative tests at the decision point. |
  | Cut-off Verification | Ability to distinguish between drug concentrations at and around the cut-off | All samples at or above +25% cut-off should be positive; all samples at or below -25% cut-off should be negative. | For all three drugs, across three different device lots, and three different operators:
• All results were positive at and above +25% cut-off.
• All results were negative at and below -25% cut-off. |
  | Interference | Absence of interference from common urine substances | No interference at 100µg/mL for listed substances. | No differences observed across different formats for a comprehensive list of compounds at 100µg/mL for all three drugs. |
  | Specificity | Cross-reactivity with related compounds and non-reactivity with unrelated compounds. | Acceptable levels of cross-reactivity for structurally similar compounds and no detection for unrelated compounds (where applicable). | - Secobarbital: 100% cross-reactivity with Amobarbital; varying degrees with Alphenol (40%), Aprobarbital (120%), Butabarbital (12%), Butathal (12%), Butalbital (12%), Cyclopentobarbital (60%), Pentobarbital (12%), Phenobarbital (1%).
• Buprenorphine: 100% with Buprenorphine -3-D-Glucuronide; 50% with Norbuprenorphine and Norbuprenorphine-3-D-Glucuronide. No detection of Morphine, Oxymorphone, Hydromorphone at 100,000 ng/mL.
• Methadone: 6% cross-reactivity with Doxylamine. No detection of EDDP, EMDP, LAAM HCI, Alpha Methadol at 100,000 ng/mL. |
  | Effect of Urine Specific Gravity and pH | Consistent results across physiological ranges of specific gravity and pH. | All samples at or above +25% cut-off should be positive; all samples at or below -25% cut-off should be negative. | For all three drugs, across various specific gravity (1.000-1.035) and pH (4-9) levels:
• All results were positive for samples at and above +25% cut-off.
• All results were negative for samples at and below -25% cut-off. |
  | Method Comparison (Clinical Samples) | Agreement with GC/MS results for negative, low negative, near cutoff negative/positive, and high positive samples. | High agreement expected, especially for definitive negative and high positive samples. Discordant results are noted and acceptable near the cutoff. | Across all three drugs and all four formats, for each of three viewers:
• 100% agreement for negative, low negative, and high positive samples.
• Discordant results (some positives read as negative, or vice versa) observed mainly in the "Near Cutoff Negative" and "Near Cutoff Positive" categories, which is expected for qualitative tests near their decision point. Specific discordant sample numbers and GC/MS values (e.g., 302 ng/mL, 303 ng/mL for Secobarbital, 10.2 ng/mL for Buprenorphine with a 10 ng/mL cutoff) are provided, showing the device performs qualitatively as expected around the cutoff. |
  | Lay-User Study | High percentage of correct results by untrained users, ease of understanding instructions. | High accuracy across various concentrations, especially for definitive positive/negative samples. Instructions should be easily understood. | For all three drugs and all four formats, performed by over 1680 lay persons (560 per drug):
• 90-100% correct results for samples at -25% Cutoff, +25% Cutoff.
• 100% correct results for samples at -100%, -75%, -50% Cutoff, and +50%, +75% Cutoff.
• Package insert instructions were easily followed, and Flesch-Kincaid read-out at Grade Level 7. |

Study Details

1. Sample size used for the test set and the data provenance (e.g., country of origin of the data, retrospective or prospective)

   • Precision Studies:
     • For each of the three drugs (Secobarbital, Buprenorphine, Methadone) and each of the four device formats (Strip, Cassette, Dip Card, Cup): 9 drug concentrations (including the cutoff, +/-25%, +/-50%, +/-75%, +/-100%) were tested with 50 replicates per concentration per lot.
     • This means (9 concentrations * 50 replicates * 3 lots) = 1350 tests per format.
     • Total precision tests per drug: 1350 tests/format * 4 formats = 5400 tests.
     • Total precision tests for all three drugs: 5400 tests * 3 drugs = 16,200 individual tests.
     • Data Provenance: Not explicitly stated, but the study was "carried out for samples... prepared by spiking drug in negative samples." This suggests a controlled laboratory setting, likely prospective. The country of origin is not mentioned.
   • Cut-off Verification Studies:
     • For each drug: 150 samples (equally distributed across -50%, -25%, cut-off, +25%, +50% cut-off) per drug. These were tested using three different lots of each device by three different operators.
     • Total samples per drug: 150.
     • Total cut-off verification tests for all three drugs: 150 * 3 drugs = 450 samples.
     • Data Provenance: Controlled laboratory setting, prepared by spiking drugs into negative samples; likely prospective. Country of origin not mentioned.
   • Interference Studies:
     • Test Set Description: Drug-free urine and target drug urine (at 25% above cut-off) spiked with various potential interfering substances at 100 µg/mL.
     • Sample Size: Not explicitly stated as a number of individual samples, but tested "three batches of each device for all formats" against a comprehensive list of compounds.
     • Data Provenance: Controlled laboratory setting; likely prospective. Country of origin not mentioned.
   • Specificity Studies (Cross-Reactivity):
     • Test Set Description: Related drug metabolites and other components.
     • Sample Size: Not explicitly stated as a number of individual samples, but tested "three batches of each device for all formats."
     • Data Provenance: Controlled laboratory setting; likely prospective. Country of origin not mentioned.
   • Effect of Urine Specific Gravity and pH Studies:
     • Test Set Description: Urine samples with specific gravity of 1.000 to 1.035, or pH 4 to 9, spiked with target drugs at 25% below and 25% above cut-off levels.
     • Sample Size: Not explicitly stated but tested "three batches of each device for all formats."
     • Data Provenance: Controlled laboratory setting; likely prospective. Country of origin not mentioned.
   • Method Comparison (Clinical Samples):
     • For each of the three drugs and each of the four device formats: 80 unaltered clinical samples (40 negative and 40 positive).
     • Total clinical samples: 80 samples/format * 4 formats * 3 drugs = 960 samples.
     • Each sample was run by three different laboratory assistants.
     • Data Provenance: "unaltered clinical samples," blind labeled. The origin (country, retrospective/prospective) is not specified.
   • Lay-User Study:
     • Sample Size: 560 lay persons for each drug test (Secobarbital, Buprenorphine, Methadone). Total individuals performing the study: 1680.
     • For each drug, urine samples were prepared at 7 different concentrations per drug: negative, +/-25%, +/-50%, +/-75%, +/-100% of the cutoff. Each concentration had 20 samples. (7 concentrations * 20 samples = 140 samples per drug tested by lay users).
     • Data Provenance: Conducted at "three intended user sites." The demographic breakdown (age, gender, educational/professional backgrounds) is provided for the participants. Likely a prospective study. Country of origin not mentioned.

2. Number of experts used to establish the ground truth for the test set and the qualifications of those experts (e.g., radiologist with 10 years of experience)

   • The ground truth for all analytical and comparison studies was established by GC/MS (Gas Chromatography/Mass Spectrometry). This is a highly accurate and widely accepted "gold standard" analytical method for drug detection and quantification in urine.
   • The document implies that the GC/MS results themselves serve as the ground truth, rather than human experts interpreting the GC/MS. The qualifications of the individuals operating the GC/MS are not specified, but they would typically be trained laboratory technicians or chemists.

3. Adjudication method (e.g., 2+1, 3+1, none) for the test set

   • For the Method Comparison (Clinical Samples), the samples were "blind labeled and compared to GC/MS results." The results from the three "Viewer" (laboratory assistants) were individually recorded and compared to the GC/MS. There is no explicit "adjudication method" described where multiple human readers' opinions are combined to form a consensus before comparison to ground truth. Instead, individual human readings (referred to as "Viewer A, B, C") were directly compared to the GC/MS ground truth.
   • For the Lay-User Study, each participant interpreted their own test and results were compared to GC/MS. No adjudication method among lay users is mentioned.

4. If a multi reader multi case (MRMC) comparative effectiveness study was done, If so, what was the effect size of how much human readers improve with AI vs without AI assistance

   • This document describes the performance of immunochromatographic assay devices for drug detection, which are qualitative diagnostic tests, not AI-powered image analysis tools.
   • Therefore, an MRMC comparative effectiveness study comparing human readers with and without AI assistance was NOT performed or applicable for this device type. The "Viewers" mentioned in the method comparison are human operators reading a physical test strip/cassette/cup/dip card.

5. If a standalone (i.e. algorithm only without human-in-the loop performance) was done

   • This device is an immunochromatographic assay. It is a physical test that produces a visual result (colored lines) which is then interpreted by a human. There is no "algorithm only" performance component. The device's performance is intrinsically linked to human interpretation of its visual output.
   • The closest to "standalone" performance are the analytical studies (precision, cut-off, interference, specificity) where the chemical reaction and visual readout are evaluated, but even then, a human reads the result.

6. The type of ground truth used (expert consensus, pathology, outcomes data, etc)

   • The primary ground truth used for all performance evaluations (precision, cut-off, interference, specificity, method comparison, lay-user study) was GC/MS (Gas Chromatography/Mass Spectrometry). This is a highly accurate analytical measurement of drug concentration.

7. The sample size for the training set

   • This document describes the performance evaluation of a rapid diagnostic test (immunochromatographic assay). These types of tests are typically developed through chemical and biological engineering, not through machine learning models that require "training sets" in the computational sense.
   • Therefore, there is no "training set" sample size listed in this context.

8. How the ground truth for the training set was established

   • As there is no "training set" for a machine learning model, this question is not applicable to the described device.

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CR3 Keyless Split Sample Cup Secobarbital-Methadone is a rapid test for the qualitative detection of Secobarbital and Methadone in human urine at a cutoff concentration of 300ng/mL for each of the drugs.

The test may yield preliminary positive results when prescription drugs Secobarbital and Methadone are ingested, even at or above therapeutic doses. There are no uniformly recognized drug levels for Secobarbital and Methadone 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 CR3 Keyless Split Sample Cup Secobarbital - Methadone test uses immunochromatographic assays for secobarbital and methadone. The test is a lateral flow system for the qualitative detection of secobarbital and methadone in human urine. The test is 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.

Here's a breakdown of the acceptance criteria and study information for the CR3 Keyless Split Sample Cup Secobarbital-Methadone device, based on the provided text:

1. Table of Acceptance Criteria and Reported Device Performance

The document doesn't explicitly state "acceptance criteria" as a separate section with specific numerical targets. Instead, it describes performance characteristics that would be used to demonstrate substantial equivalence to a predicate device. For the purpose of this response, I've interpreted the demonstrated performance in the "Performance Characteristics" section as meeting assumed acceptance criteria for effective drug detection. The key performance indicators addressed are precision, cut-off values, interference, specificity, and comparison to GC/MS.

Since this is a qualitative test, metrics like sensitivity, specificity, and accuracy are inferred from the comparison study and precision data, rather than being explicitly stated as separate acceptance criteria with target percentages for positive/negative agreement.

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

• Precision Study:

  • For each concentration level (-100% cut-off, -75%, -50%, -25%, at cut-off, +25%, +50%, +75%, +100% cut-off): 50 tests (performed 2 runs/day by 3 operators for 25 days, which means 25 days * 2 runs/day * 1 test/run = 50 tests per operator for each concentration level. However, the tables show combined results for W12010501CU5, W12010502CU5, W12010503CU5, suggesting these are the operators, each performing 50 tests for each concentration).

• Cut-off Verification:

  • 125 Secobarbital samples and 125 Methadone samples.

• Interference Study:

  • Not specified as a number of samples, but target drugs were spiked into urine with potential interferents at 25% below and 25% above the cut-off.

• Specificity Study:

  • Not specified as a number of samples, but drug metabolites and related compounds were tested at different concentrations.

• Comparison Studies (Lab-based):

  • 80 unaltered clinical samples (40 negative and 40 positive) for Secobarbital.
  • 80 unaltered clinical samples (40 negative and 40 positive) for Methadone.

• Lay-User Study:

  • 260 lay persons.
  • 20 drug-free samples.
  • 120 Secobarbital samples (across different concentrations).
  • 120 Methadone samples (across different concentrations).

• Data Provenance: The document does not explicitly state the country of origin for the clinical samples. The precision and analytical studies appear to be "in-house" (performed by the manufacturer). The comparison study used "unaltered clinical samples." The lay-user study was performed "at three intended user sites." The data appears to be retrospective as samples were collected and then tested.

3. Number of Experts Used to Establish Ground Truth for the Test Set and Qualifications of Experts

• Ground Truth Establishment for Comparison Studies (Lab-based):
  • Method: Gas Chromatography/Mass Spectrometry (GC/MS).
  • Experts: The specific number and qualifications of experts performing the GC/MS analysis are not mentioned. GC/MS is an objective analytical method, so "experts" in the sense of clinical decision-makers might not be directly applicable for establishing the ground truth concentrations. However, skilled laboratory personnel are required to operate and interpret GC/MS results.
• Ground Truth Establishment for Lay-User Study:
  • Method: GC/MS was used to confirm the concentrations of the spiked urine samples.
  • Experts: Not explicitly stated, as above.

4. Adjudication Method for the Test Set

• Precision Study: "All sample aliquots were masked and randomized." Results were presented by operator but no explicit adjudication method (e.g., 2+1) is mentioned for discrepancies.
• Comparison Studies (Lab-based): "The samples were masked and randomized." The results of the device were compared to GC/MS. No explicit adjudication method is mentioned. The comparison study involved three "Viewer" operators (Viewer A, B, C) who manually read the device results. Their individual discordant results with GC/MS are listed, but there's no mention of a consensus or adjudication process among these viewers.
• Lay-User Study: Samples were "blind-labeled and randomized." There is no mention of an adjudication method for participant readings. The agreement is reported as a percentage with GC/MS.

5. Multi-Reader Multi-Case (MRMC) Comparative Effectiveness Study

• No MRMC comparative effectiveness study was explicitly done to assess how much human readers improve with AI vs. without AI assistance.
• The study involved multiple readers (three lab assistants in the comparison study, and 260 lay users in the lay-user study) and multiple cases. However, it was a standalone device performance study comparing the device output (read by humans) to a reference standard (GC/MS), not a comparative effectiveness study of human performance with vs. without AI. The device itself is a simple, qualitative rapid test, not an AI-assisted diagnostic tool.

6. Standalone (i.e., algorithm only without human-in-the-loop performance) Was Done

• Yes, in essence, the fundamental performance of the device itself (the "algorithm" in a chemical sense) was evaluated standalone. The precision, cut-off, interference, and specificity sections describe the inherent analytical performance of the test strips. The "viewers" in the comparison study are interpreting the visual lines on the device, rather than interacting with an algorithm that provides output. The device itself is a standalone qualitative test.

7. Type of Ground Truth Used

• Analytical Chemical Method (GC/MS): For both the internal performance characterization (precision, cut-off verification, interference, specificity) and the comparison studies, Gas Chromatography/Mass Spectrometry (GC/MS) was used as the reference standard to establish the ground truth concentrations of Secobarbital and Methadone.

8. Sample Size for the Training Set

• Not Applicable / Not Mentioned. This is a chemical assay (immunochromatographic), not a machine learning or AI-based device that typically requires a "training set." The development of such assays involves chemical optimization and validation, rather than a separate training phase with a distinct dataset.

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

• Not Applicable / Not Mentioned. As noted above, there isn't a "training set" in the context of this device type. The ground truth for analytical validation (e.g., precision, specificity, calibration) would be established by preparing samples with known concentrations using high-purity standards and analytical techniques like GC/MS.

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The Snap-Top Split Key Cup for use with the GenPrime Drugs of Abuse (DOA) Reader System is for in vitro diagnostic use and is intended for prescription use in laboratories, point-of-care and workplaces by trained users. The test is not intended for over-the-counter use. The test cannot be read visually and must be used with the GenPrime DOA Reader. The Snap-Top Split Key Cup qualitatively detects drug classes in human urine at the cutoff concentrations shown below:

• Test/ Calibrated to /Cutoff Amphetamines/ d-Amphetamine/ 500 ng/mL Barbiturates/ Secobarbital/ 300 ng/mL Benzodiazepines/ Oxazapam/ 300 ng/mL Cocaine/ Benzoylecgonine/ 150 ng/mL Methamphetamine/ d-Methamphetamine/ 500 ng/mL Methadone/ Methadone/ 300 ng/mL Morphine/ Morphine/ 300 ng/mL Morphine 2000/ Morphine/ 2000 ng/mL Oxycodone/ Oxycodone/ 100 ng/mL Phencyclidine/ Phencyclidine/ 25 ng/mL Marijuana/ Delta-9-THC-COOH/ 50 ng/mL
  Configurations of the Snap-Top Split Key Cup may consist of any combination of the above listed drug analytes. The Snap-Top Split Key Cup provides only a preliminary analytical result. A more specific alternate chemical method must be used in order to obtain a confirmed analytical result. Gas chromatography / mass spectrometry (GC/MS), high performance liquid chromatography (HPLC) or liquid chromatography/tandem mass spectrometry (LC/MS/MS) are the preferred confirmatory methods. Clinical consideration and professional judgment should be applied to any drug of abuse test result, particularly when preliminary positive results are obtained.

The GenPrime Drugs of Abuse (DOA) Reader System consists of a small, portable high resolution flatbed scanner, customized GenPrime DOA Reader Software, and lateral flow tests that are intended for use in the system. The scanner has a custom Scanner Lid with an opening for the test device, and a Scanner Stand, which places the scanner bed at the appropriate angle for running and reading the test devices. The System is intended for use with the Snap-Top Split Key Cup, which is a rapid, single use, disposable immunochromatographic test for the qualitative detection of drugs of abuse in human urine (K130082). This description is limited to the Snap-Top Split Key Cup (SK Cup), with 3 additional drugs being added, giving 11 total drugs.

The Snap-Top SK cup contains up to five (5) test strips embedded in a urine sample cup, containing a total of up to 11 drug test lines (between one and four drug test lines per test strip). Different drug configurations may be used. Each test strip has an internal control line to confirm validity of the test results.

The Snap-Top SK Cup Drugs of Abuse Test devices are run in the GenPrime DOA Reader System according to their specific instructions for use. At the conclusion of the test (5 minutes) an image is captured and the software algorithm determines whether the colored test lines for each analyte are above or below the threshold associated with a negative or positive result. The software also confirms the validity of the results by verifying the presence of control lines. The results are recorded and logged into a database along with an image of the test, patient and operator information and the time of image capture. The results can be viewed, printed, or sent to a recipient via email or other electronic method. The GenPrime DOA Reader is for in vitro diagnostic use and is intended for use in laboratories, point-of-care sites and workplaces by trained users. The test is not intended for over-the-counter use. The GenPrime DOA Reader System test devices cannot be read visually.

All analytes on the Snap-Top SK Cup for use with the GenPrime DOA Reader System were previously cleared (K130082) except for the drug tests for benzodiazepines, cocaine and barbiturates.

Here's a summary of the acceptance criteria and study details for the Snap-Top Split Key Cup, based on the provided text:

1. Table of Acceptance Criteria and Reported Device Performance

The acceptance criteria are implied by the precision studies, which show the percentage of correct classifications at various concentrations relative to the cutoff. For accuracy, the agreement with reference methods is presented.

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

• Test Set Sample Size (Precision Study):
  • For each drug (BAR, BZO, COC) at specific % of cutoff concentrations (0%, 25%, 50%, 75%, 125%, 150%, 175%, 200%), the number of tests (N) ranged from 45 to 50 samples.
  • For the "All Drugs" summary in the precision studies, the total N at each % of cutoff ranged from 135 to 142.
• Test Set Sample Size (Clinical Accuracy Study):
  • For each drug (BAR, BZO, COC), a minimum of 40 unaltered positive and 40 unaltered negative clinical samples were assessed.
• Data Provenance:
  • The precision studies were performed at three sites representative of laboratory, workplace, and point-of-care (POC) settings, suggesting prospective data collection in a controlled environment.
  • The clinical accuracy studies used "blind coded clinical urine samples," implying prospective or retrospectively collected clinical samples with unknown status to the test operators.
  • The country of origin is not explicitly stated, but the submission is to the U.S. FDA, suggesting the studies were likely conducted in the USA or adhering to international standards acceptable to the FDA.

3. Number of Experts Used to Establish the Ground Truth for the Test Set and Qualifications

• Precision Studies Ground Truth: The ground truth for the precision studies was established chemically. "GC/MS and/or LC/MS/MS were performed to confirm the concentration of calibrator drug in each test solution." No human experts were involved in establishing this ground truth directly.
• Clinical Accuracy Study Ground Truth: The ground truth for clinical samples was determined by "GC/MS or LC/MS/MS." Negative samples were initially screened by EIA, with 10% also confirmed by GC/MS or LC/MS/MS. Again, this points to instrumental analysis rather than human expert consensus for ground truth.

4. Adjudication Method for the Test Set

• No specific adjudication method by human experts (like 2+1 or 3+1) is mentioned in the document. The determination of "positive" or "negative" from the reference methods (GC/MS or LC/MS/MS) serves as the definitive ground truth for both precision and clinical studies. Discrepancies between the device and the reference standard were simply reported as "discordant results."

5. Multi-Reader Multi-Case (MRMC) Comparative Effectiveness Study

• No MRMC comparative effectiveness study was done to assess how much human readers improve with AI vs. without AI assistance. The device is for in vitro diagnostic use, and the "Reader System" refers to an automated instrument that interprets the results, not human readers.

6. Standalone Performance Study (Algorithm Only)

• Yes, a standalone performance study was done. The document explicitly states: "The test devices cannot be read visually." and "the software algorithm determines whether the colored test lines for each analyte are above or below the threshold associated with a negative or positive result." This indicates that the GenPrime DOA Reader System (which includes the software algorithm) operates as a standalone device to interpret the results without human interpretation of the test lines.

7. Type of Ground Truth Used

• Chemical/Instrumental Analysis (Gold Standard): The primary ground truth for both precision and clinical studies was established using highly accurate chemical analysis methods: Gas Chromatography / Mass Spectrometry (GC/MS) or Liquid Chromatography / Tandem Mass Spectrometry (LC/MS/MS). These are considered gold standard methods for drug concentration confirmation.

8. Sample Size for the Training Set

• The document does not specify a separate "training set" for the device's algorithm. The precision and clinical studies described appear to be validation studies rather than data used for initial algorithm development or training. Immunochromatographic tests typically rely on pre-defined thresholds and chemical reactions rather than machine learning algorithms that require explicit training sets. The "software algorithm" likely operates on fixed parameters derived from extensive research and development rather than a dynamic training process described for AI.

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

• As a training set is not explicitly mentioned or implied for a machine learning-based algorithm, how its ground truth was established is not detailed. For typical immunochromatographic tests with an automated reader, the 'training' process involves calibrating the reader to accurately detect the visual signal (colored lines) produced by known concentrations of analytes, which would have been established through controlled experimental protocols using chemically verified samples (similar to how the test set ground truth was established by GC/MS/LC/MS/MS).

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One Step Single/Multi-drug Test Cup and One Step Single/Multi-drug Test Dipcard are lateral flow chromatographic immunoassay designed to qualitatively detect the presence of drugs and drug metabolites in human urine at the following cut-off concentrations:

The tests contain two formats:1) Test Cup, 2) Test Dipcard, The test configuration comes with single drug screening test or any combinations of multiple drug screening tests. The test is intended for in vitro diagnostics use. They are intended for prescription use in clinical laboratories only and not for point-of-care use.

This assay provides only a preliminary analytical test result. Gas Chromatography/Mass spectrometry (GC/MS) is the preferred confirmatory method. Clinical consideration and professional judgment should be applied to any drug of abuse test result, particularly when preliminary positive results are indicated.

One Step Single/Multi-drug Test Cup and One Step Single/Multi-drug Test Dipcard are competitive binding, lateral flow immunochromatographic assays for qualitatively the detection of Barbiturates, Benzodiazepines, Methylenedioxymethamine, Methadone, Oxycodone, Phencyclidine and their metabolites at or above the cut-off levels as indicated. The tests can be performed without the use of an instrument.

The provided document describes the Co-Innovation Biotech Co.,Ltd. One Step Single/Multi-drug Test Cup and One Step Single/Multi-drug Test Dipcard for qualitative detection of drugs of abuse in human urine. Here's a breakdown of the acceptance criteria and study information:

1. Table of Acceptance Criteria and Reported Device Performance

The acceptance criteria for qualitative immunoassay tests like these are typically assessed by comparing the device's results (positive/negative) against a gold standard (GC/MS) especially around the cutoff concentration. While explicit numerical acceptance criteria (e.g., % agreement, sensitivity, specificity targets) are not explicitly stated as 'acceptance criteria' in the document, the performance data implicitly serves as the demonstration that the device performs acceptably. The study evaluates the device's ability to correctly identify drug-free, less than half cutoff, near cutoff negative, near cutoff positive, and high positive samples.

The tables below synthesize the reported device performance for both the Test Cup and Test Dipcard formats for single and multi-drug tests, against the GC/MS analysis. The "Total" column in the original tables sums up the sample distribution across concentration categories, not the total number of samples processed for each drug test condition. The key performance indicator here is the consistency of results, particularly for samples around the cutoff concentration.

Device Performance for One Step Single/Multi-drug Test Cup & Dipcard (Single Drug Test Example - All Drugs follow similar pattern)

| Drug Test | Co-Innovation Result | GC/MS Analysis (Drug-free) | GC/MS Analysis (1.5x Cutoff) | Total Samples |
|---|---|---|---|---|---|---|---|
| BAR | + | 0 | 0 | 0 | 6 | 34 | 80 |
| | - | 33 | 0 | 7 | 0 | 0 | 80 |
| BZO | + | 0 | 0 | 1 | 7 | 33 | 80 |
| | - | 31 | 0 | 8 | 0 | 0 | 80 |
| MDMA | + | 0 | 0 | 0 | 5 | 34 | 80 |
| | - | 32 | 3 | 5 | 1 | 0 | 80 |
| MTD | + | 0 | 0 | 1 | 5 | 35 | 80 |
| | - | 32 | 2 | 5 | 0 | 0 | 80 |
| OXY | + | 0 | 0 | 0 | 6 | 34 | 80 |
| | - | 35 | 0 | 5 | 0 | 0 | 80 |
| PCP | + | 0 | 0 | 1 | 5 | 35 | 80 |
| | - | 35 | 0 | 4 | 0 | 0 | 80 |

Analysis of Discordant Results (Example for Test Cup and Dipcard, Single and Multi-drug)

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

• Sample Size: 80 clinical urine specimens were used for each drug tested, for each device format (Single Drug Test Cup, Single Drug Test Dipcard, Multi-drug Test Cup, Multi-drug Test Dipcard). Therefore, for each drug, a total of 320 samples were analyzed (80 * 4). The samples were categorized into five groups based on concentration relative to the cutoff (drug-free, less than half the cutoff negative, near cutoff negative, near cutoff positive, and high positive).
• Data Provenance: The data is from "clinical urine specimens," implying human origin. However, the country of origin is not specified, and it is a retrospective analysis as the specimens were analyzed by GC/MS for comparison with the device.

3. Number of Experts Used to Establish the Ground Truth for the Test Set and Qualifications of Those Experts

• The ground truth was established by Gas Chromatography/Mass Spectrometry (GC/MS) analysis, which is considered the "preferred confirmatory method" for drug of abuse testing.
• No human "experts" are mentioned as having established the ground truth through consensus or individual reading of the device results for the purpose of the primary accuracy study. The device results were compared directly against the GC/MS findings.

4. Adjudication Method for the Test Set

• None in the traditional sense of multiple human readers adjudicating results. The device's qualitative results (positive/negative) were directly compared to the quantitative GC/MS results for each sample. Discordant results were individually listed with the GC/MS concentration.

5. If a Multi-Reader Multi-Case (MRMC) Comparative Effectiveness Study Was Done

• No, a MRMC comparative effectiveness study was not performed. The study's focus was on the standalone performance of the devices against a gold standard (GC/MS). Human readers' improvement with or without AI assistance is not relevant here as it's a diagnostic test that provides a clear positive/negative result, not an AI-assisted diagnostic imaging interpretation.

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

• Yes, this was a standalone performance study. The "One Step Single/Multi-drug Test Cup" and "One Step Single/Multi-drug Test Dipcard" are qualitative, lateral flow immunochromatographic assays designed to be read directly without an instrument or human interpretation loop beyond reading the presence or absence of test lines. The performance data presented directly reflects the device's output (positive/negative) compared to GC/MS.

7. The Type of Ground Truth Used

• The ground truth used was quantitative analytical data from Gas Chromatography/Mass Spectrometry (GC/MS), which is the preferred confirmatory method for drug of abuse testing. This is a highly objective and precise method for determining drug concentration.

8. The Sample Size for the Training Set

• This document describes a performance evaluation of a medical device, not an AI algorithm that requires a training set. Therefore, no training set for an algorithm is mentioned or applicable in this context. The devices are immunoassay tests, not machine learning algorithms.

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

• As mentioned above, there is no training set for an algorithm as the device is an immunoassay test.

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The Randox Laboratorles Ltd. barbiturates Assay is an in vitro diagnostic test for the qualitative and semi-quantitative detection of barbiturates in human urine on the Rx Imola and Rx Daytona. The cutoff for secobarbital is 200 ng/mL. This in vitro diagnostic device Is intended for prescription use only.

The semi-quantitative mode is for purpose of

• (1) enabling laboratories to determine an appropriate dilution of the specimen for
• confirmation by a confirmatory method such as GCMS.
• Or
• .. .. . ... . . . . . . (2) permilting laboratories to establish quality control procedures ... ... . . . . . .

This assay provides only a preliminary analytical result. A more specific alternative chemical method must be used in order to obtain a confirmed analytical result. Gas chromatograph/mass spectrometry (GC/MS) 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.

The Randox Multidrug Calibrator Set consists of liquid calibrators containing Secobarbital, Oxazepam and Methadone. There are 5 levels of calibrator. They have been developed for use in the calibration of Barbiturates, Benzodiazepines and Methadone assays for use on the JSC and analysers, which includes the a y to na" and the moss™. This in vitro diagnostic device is intended for prescription use only.

The Randox Multidrug Controls level 1 and 2 are liquid controls containing Secobarbital, Oxazepam and Methadone. There are 2 levels of controls. They have been developed for use in the quality control of Barbiturates, Benzodiazepines and Methadone assays for use on the I Kommanalysers, which includes the X day to na™ and the Anmone™. This in vitro diagnostic device is intended for prescription use only.

Not Found

The provided text is a 510(k) premarket notification letter for the Randox Barbiturates Assay, Randox Multidrug Calibrator Set, and Randox Multidrug Controls. It mentions the device's indications for use but does not contain information about acceptance criteria, analytical studies, or clinical studies that prove the device meets specific performance criteria.

Therefore, I cannot fully complete the requested table and answer all the questions based on the provided document. The document is primarily an FDA clearance letter, not a study report.

However, I can extract what little information is available regarding the device itself.

1. Table of acceptance criteria and the reported device performance:

This information is not provided in the given document. The document is a clearance letter, not a study report detailing performance data against acceptance criteria.

2. Sample size used for the test set and the data provenance:

This information is not provided in the given document.

3. Number of experts used to establish the ground truth for the test set and the qualifications of those experts:

This information is not provided in the given document.

4. Adjudication method for the test set:

This information is not provided in the given document.

5. If a multi reader multi case (MRMC) comparative effectiveness study was done, If so, what was the effect size of how much human readers improve with AI vs without AI assistance:

This is an in vitro diagnostic (IVD) assay for detecting barbiturates in urine. It is not an AI-driven device or an imaging device that would involve human readers or MRMC studies. Therefore, this question is not applicable to the device described.

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

This is an IVD assay, not an algorithm. The concept of "standalone performance" in the context of an algorithm is not applicable to this device.

7. The type of ground truth used:

This information is not explicitly provided in the given document. However, the "Indication for Use" section states: "A more specific alternative chemical method must be used in order to obtain a confirmed analytical result. Gas chromatograph/mass spectrometry (GC/MS) is the preferred confirmatory method." This strongly implies that GC/MS would be used as the ground truth for confirming preliminary analytical results of the assay.

8. The sample size for the training set:

This information is not provided in the given document.

9. How the ground truth for the training set was established:

This information is not provided in the given document. However, similar to item 7, it's highly probable that GC/MS would be the method for establishing ground truth for any calibration or validation samples.

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The UCP Drug Screening Test Cups are rapid, qualitative, competitive binding immunoassays for the detection the following drugs and their metabolites in human urine:

The test configuration comes with single drug screening test or any combinations of multiple drug screening tests. The test is intended for over-the-counter (OTC) users as the first step in a two step process to provide consumers, including but not limited to concerned parents, with information concerning the presence or absence of the above stated drugs or their metabolites in a urine sample. Information regarding confirmatory testing - the second step in the process, along with the materials for shipping the urine specimen to the laboratory, is provided. The test is also intended for health care professional users.

The tests will yield preliminary positive results when the prescription drugs Barbiturates, Oxycodone, Tricyclic Antidepressants are ingested, even at or above therapeutic doses. There are no uniformly recognized drug levels for Barbiturate, Benzodiazepines, Oxycodone, Tricyclic Antidepressant in urine. The tests only provide a preliminary analytical test result. A more specific alternate chemical method must be used in order to obtain a confirmed analytical result. Gas chromatography/mass spectrometry (GC/MS) is the preferred confirmatory method for most drugs (HPLC is the preferred confirmatory method for Tri-cyclic Antidepressants). Clinical consideration and professional judgment should be applied to any drug of abuse test result, particularly when preliminary positive results are indicated. The tests are not intended to be used in monitoring drug levels.

The UCP Drug Screening Test Cups are rapid, qualitative, competitive binding immunoassays for the detection the following drugs and their metabolites in human urine:

The test configuration comes with single drug screening test or any combinations of multiple drug screening tests. The test is intended for over-the-counter (OTC) users as the first step in a two step process to provide consumers, including but not limited to concerned parents, with information concerning the presence or absence of the above stated drugs or their metabolites in a urine sample. Information regarding confirmatory testing - the second step in the process, along with the materials for shipping the urine specimen to the laboratory, is provided. The test is also intended for health care professional users.

The tests will yield preliminary positive results when the prescription drugs Barbiturates, Oxycodone, Tricyclic Antidepressants are ingested, even at or above therapeutic doses. There are no uniformly recognized drug levels for Barbiturate, Benzodiazepines, Oxycodone, Tricyclic Antidepressant in urine. The tests only provide a preliminary analytical test result. A more specific alternate chemical method must be used in order to obtain a confirmed analytical result. Gas chromatography/mass spectrometry (GC/MS) is the preferred confirmatory method for most drugs (HPLC is the preferred confirmatory method for Tri-cyclic Antidepressants). Clinical consideration and professional judgment should be applied to any drug of abuse test result, particularly when preliminary positive results are indicated. The tests are not intended to be used in monitoring drug levels.

The document is a 510(k) premarket notification approval letter for the UCP Drug Screening Test Cups. It provides information about the device's intended use and lists the drugs it screens for, along with their calibrators and cut-off levels. However, it does not include details about acceptance criteria, device performance studies, sample sizes, ground truth establishment, or expert involvement in a study.

Therefore, I cannot provide the requested information from this document. The document is an FDA approval letter, not a study report.

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The QuickScreen™ Barbiturates Test is a rapid, qualitative immunoassay for the detection of Barbiturates in urine. The cutoff concentration for this test is 300 ngdomly This assay is intended for professional use.

QuickScreen Multi Drug Screening Test is a rapid, qualitative immunoassay for the detection of the target drugs/drug metabolites in urine. The cut-off concentrations of this test are as follows: Amphetamine; 1000 ng/ml Barbiturates: 300 nq/ml Benzodiazepines: 200 na/ml Cocaine; 300 ng/ml Methadone 300 nq/ml Methamphetamine; 1000 ng/ml Opiates: 2000 ng/ml. Phencyclidine (PCP) 25 ng/ml THC: 50 nq/ml This assay is intended to assist in the prevention of drug abuse

The QuickScreen Barbiturates Test is a qualitative in-vitro diagnostic screen that provides a preliminary result for the detection/presence of Barbiturates in urine. Tests for barbiturates cannot distinguish between abused drugs and certain prescribed medications. The cut-off concentration will be 300 ng/ml (secobarbital). It is intended for professional use only.

An invitro diagnostic test for the qualitative detection of amphetamine, cocaine, methamphetamine, opiates, PCP, Barbiturates, benzodiazepines, methadone and THC in urine. Tests for prescription drugs cannot distinguish between abused drugs and certain prescribed medications. Measurements obtained by this device are used in the diagnosis and treatment of drug abuse. It is intended for professional use only.

Immunoassay for the qualitative detection of Barbiturates in urine

Immunoassay for the qualitative detection, Amphetamine, THC, Cocaine, PCP, Barbiturates, Benzodiazepines, Methadone, Opiates and Methamphetamine in urine

The Phamatech QuickScreen™ Barbiturates Test (Models 9019, 9018) and the QuickScreen Multi Drug Screening Test (Models 9317T and 9187Z) are qualitative immunoassays for the detection of drugs/drug metabolites in urine. This summary addresses the performance of both devices as described in the provided 510(k) summaries.

Acceptance Criteria and Device Performance

The acceptance criteria for the QuickScreen™ Barbiturates Test and the QuickScreen Multi Drug Screening Test are implied through their claims of substantial equivalence to predicate devices and established laboratory methodologies. The performance is assessed by correlation studies against these benchmarks.

For QuickScreen™ Barbiturates Test:

For QuickScreen Multi Drug Screening Test:

Study Details

The information provided covers both the QuickScreen™ Barbiturates Test and the QuickScreen Multi Drug Screening Test. The studies performed were clinical sample correlation studies and blind labeled spiked studies.

1. Sample Size and Data Provenance:

• QuickScreen™ Barbiturates Test: The number of clinical samples used for the correlation study is not specified, only that "clinical specimens" were used. The country of origin for the data is not explicitly stated, but the manufacturer is based in San Diego, California, USA. The studies appear to be retrospective as they involve evaluating existing samples or spiked samples.
• QuickScreen Multi Drug Screening Test: The number of clinical samples, urine samples, and the specific composition of the blinded spiked samples is not specified. Clinical studies were performed at two independent laboratories. The country of origin for the data is not explicitly stated, but the manufacturer is based in San Diego, California, USA. The studies appear to be retrospective as they involve evaluating existing samples or spiked samples.

2. Number of Experts and Qualifications:

• The 510(k) summaries do not specify the number of experts or their qualifications for establishing ground truth for the test sets. The tests are intended for "professional use," and the Multi Drug Screening Test exhibited "excellent overall accuracy (>97%) in the hands of professional users," implying that professionals (likely lab technicians or clinicians) performed the assessments for the device.

3. Adjudication Method:

• The 510(k) summaries do not describe an adjudication method. The clinical sample correlation studies compare the device's results directly against predicate devices (Barbiturates Test) or Behring EMIT II and GC/MS methodology (Multi Drug Screening Test). The "blind labeled spiked study" implies that the labels of the spiked samples were not known to the testers.

4. Multi-Reader Multi-Case (MRMC) Comparative Effectiveness Study:

• No MRMC comparative effectiveness study was explicitly mentioned. The studies focus on the device's performance against reference methods rather than comparing human reader performance with and without AI assistance. The devices are point-of-care immunoassay tests, not AI-assisted diagnostic tools requiring human interpretation.

5. Standalone Performance (Algorithm Only):

• Yes, performance was evaluated in a standalone manner. These are immunoassay devices that provide a qualitative result directly, without requiring human interpretation other than observing a visual color change. The reported correlations and accuracy reflect the device's direct output.

6. Type of Ground Truth Used:

• QuickScreen™ Barbiturates Test: The ground truth for the clinical sample correlation study was established by predicate devices (e.g., ABMC RapidOne BZD test). For the blind labeled spiked study, the ground truth was based on the known concentrations of barbiturates in the spiked samples.
• QuickScreen Multi Drug Screening Test: The ground truth for the clinical sample correlation study was established by Behring EMIT II and Gas Chromatography/Mass Spectrometry (GC/MS) methodology. For the blind labeled spiked study, the ground truth was based on the known concentrations of the target drugs/metabolites in the spiked samples. GC/MS is widely considered a gold standard for drug confirmation. Expert opinion is also subtly implied through the requirement for professional use and clinical consideration.

7. Sample Size for Training Set:

• The 510(k) summaries do not mention a specific training set or its sample size. These devices are immunoassay tests, not machine learning algorithms that typically require a distinct training set. The development and optimization of such tests usually involve laboratory experiments rather than data-driven training as understood in AI/ML contexts.

8. How Ground Truth for Training Set Was Established:

• As there's no mention of a traditional "training set" in the context of an AI/ML algorithm, this question is not directly applicable. The performance characteristics were evaluated through the clinical sample correlation and blind labeled spiked studies, which served to validate the device's accuracy against established methods and known concentrations.

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