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Hightop® Home Use Fentanyl Urine Rapid Test Panel is a competitive binding, lateral flow immunochromatographic assay for qualitative detection of fentanyl, the major metabolite of fentaryl in human urine at the cut-off concentrations listed below:

The test is available in a single test of FYL or a Double panel of FYL and NFYL. It is intended for OTC use. The test provides only a preliminary test result. A more specific alternative chemical must be used in order to obtain a confirmed analytical result. GC/MS or LC/MS is the preferred confirmatory method.

Hightop® Fentanyl/Norfentany] Urine Rapid Test Panel is a competitive binding, lateral flow immunochromatographic assay for qualitative detection of fentanyl, the major metabolite of fentanyl in human urine at the cut-off concentrations listed below:

The test is available in a single test of FYL or NFYL or a Double panel of FYL and NFYL. The test panel provides only a preliminary test result. A more specific alternative chemical must be used in order to obtain a confirmed analytical result. GC/MS or LC/MS is the preferred confirmatory method.

The test panel is not intended to distinguish between prescription use or abuse of fentanyl. Clinical consideration and professional judgment should be applied to the test result, particularly in evaluating a preliminary positive result.

The Hightop® Home Use Fentanyl/Norfentanyl Urine Rapid Test Panel and Hightop® Fentanyl Norfentanyl Urine Rapid Test Panel are immunoassays intended for the qualitative detection of fentanyl and norfentany] in human urine. Each Hightop® fentanyl urine test device consists of a Test Panel and a package insert. Each Test Panel is sealed with sachets of desiccant in an aluminum pouch.

The provided text describes the performance characteristics and studies for the Hightop® Home Use Fentanyl/Norfentanyl Urine Rapid Test Panel and Hightop® Fentanyl/Norfentanyl Urine Rapid Test Panel. However, the document does not explicitly state "acceptance criteria" for precision or method comparison studies in a tabular format with corresponding performance results. Instead, it provides the raw data from these studies.

Based on the provided information, I will infer the acceptance criteria from the typical expectations for such tests (e.g., high correct result percentages for samples well below or above cutoff, and some variability near the cutoff) and present the performance.

1. Table of Acceptance Criteria and Reported Device Performance

Since explicit acceptance criteria are not stated, I will interpret the goal of these studies as demonstrating reliability and accuracy, especially concerning the defined cut-off levels. For precision, the acceptance criterion implicitly is that results should be consistently negative well below the cutoff and consistently positive well above the cutoff, with some expected variability around the cutoff. For method comparison, the acceptance is that the rapid test results should largely agree with the LC/MS reference method. For the lay-user study, the implied acceptance is a high percentage of correct results.

Fentanyl

Norfentanyl

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

• Precision Study:

  • Sample Size: For each analyte (Fentanyl, Norfentanyl) and each of the 9 concentration levels, 6 tests were performed per day for 10 days, across 3 device lots. This equates to 60 tests per concentration per lot.
    • Fentanyl: 9 concentrations * 60 tests/concentration * 3 lots = 1620 tests
    • Norfentanyl: 8 concentrations * 60 tests/concentration * 3 lots = 1440 tests
  • Data Provenance: Samples were prepared by spiking fentanyl/norfentanyl into negative urine samples. "Each fentanyl or norfentanyl concentration was confirmed by LC/MS." This indicates a prospective, controlled laboratory study. Country of origin not explicitly stated for study execution, but the manufacturer is based in China.

• Method Comparison Studies:

  • Sample Size: 80 clinical samples (40 negative and 40 positive) for each analyte (Fentanyl, Norfentanyl). These were tested by three different operators.
    • Fentanyl: 80 samples * 3 operators = 240 results
    • Norfentanyl: 80 samples * 3 operators = 240 results
  • Data Provenance: "unaltered clinical samples." The document does not specify the country of origin or whether they were retrospectively collected or prospectively collected for the study. They were "blind labeled."

• Lay-User Study:

  • Sample Size: 140 lay persons. "Urine samples were prepared at the following concentrations; -100%, +/-75%, +/-50%, +/-25% of the cut-offs by spiking drug(s) into drug free-pooled urine specimens." There are 7 concentration levels for each analyte. Assuming each lay person tested one sample, the total is 140 samples, evenly distributed across the concentration levels and across the three test sites (1 lot per site). This means 20 samples per concentration level for each analyte (Fentanyl and Norfentanyl data tables confirm 20 samples per concentration).
  • Data Provenance: Samples were prepared by spiking drugs into drug-free pooled urine specimens. Concentrations were confirmed by LC/MS. This is a prospective, controlled usability study. Test sites are not specified by country, but they likely involve the target user population for OTC use.

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

• Precision Study: Ground truth was established by preparation of spiked samples with known concentrations confirmed by LC/MS. No human expert interpretation was involved in establishing the ground truth for these samples beyond the analytical chemists confirming the concentrations.
• Method Comparison Studies: Ground truth was established by LC/MS results. "The samples were blind labeled and compared to LC/MS results." No human expert interpretation for ground truth.
• Lay-User Study: Ground truth was established by the known spiked concentrations of the samples, confirmed by LC/MS. No human expert interpretation for ground truth.

4. Adjudication Method for the Test Set

• Given that the ground truth for all studies was established by LC/MS (a quantitative analytical method) or known spiked concentrations, there was no need for human expert adjudication (e.g., 2+1, 3+1). The sample results were definitively positive or negative based on their concentration relative to the cut-off, as determined by LC/MS.

5. If a Multi-Reader Multi-Case (MRMC) Comparative Effectiveness Study Was Done, and Effect Size of Human Readers Improvement with AI vs. Without AI Assistance

• No, an MRMC comparative effectiveness study was not done. This device is a rapid diagnostic test panel (likely a lateral flow immunoassay), not an AI-assisted diagnostic device that would involve human readers interpreting images or data with or without AI assistance. The "operators" in the method comparison study directly read the test panel results, which are qualitative (positive/negative line presence).

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

• Not applicable in the typical sense of AI algorithms. This is a rapid diagnostic test kit. Its "performance" is its ability to correctly identify the presence or absence of the analyte at and around the defined cutoff. The instructions for use guide how a human reads the result (presence/absence of lines). There's no separate "algorithm" that generates a result independent of the physical test strip being read by a human. The precision, method comparison, and lay-user studies effectively evaluate the standalone performance of the device when used as directed.

7. The Type of Ground Truth Used

• Analytical Ground Truth (LC/MS and Spiked Concentrations): For all studies (precision, method comparison, and lay-user), the ground truth for the presence/absence of Fentanyl and Norfentanyl was established by quantitative analytical methods, specifically LC/MS (Liquid Chromatography-Mass Spectrometry), or by the precisely known concentrations of spiked samples. This is considered a highly objective and accurate method for determining the true concentration of substances in a sample.

8. The Sample Size for the Training Set

• Not applicable. This device is a biochemical rapid diagnostic test, not a machine learning or AI model that requires a "training set" in the computational sense. Its design and performance are based on chemical and immunological principles, not on learning from data.

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

• Not applicable, as there is no training set for this type of device.

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Hightop® Multi-Drug Urine Test Cup tests are competitive binding, lateral flow immunochromatographic assays for qualitative and simultaneous detection of Amphetamine, Buprenorphine, Secobarbital, Oxazepam, Cocaine, 2ethylidene-1,5-dimethy1-3,3-diphenylpyrrolidine, Methylenedioxymethamphetamine, Morphine, Methadone, Oxycodone, Phencyclidine, Propoxyphene, Nortriptyline and Cannabinoids in human urine at the cutoff concentrations of:

Hightop® Multi-Drug Urine Test Cup offers any combinations from 2 to 15 drugs of abuse tests but only one cutoff concentration under same drug condition will be included per device. It is for in vitro diagnostic use only. It is intended for OTC use.

The tests may vield positive results for the prescription drugs Buprenorphine, Oxazepam, Secobarbital, Propoxyphene, and Oxycodone when taken at or above prescribed doses. It is not intended to distinguish between prescription use or abuse of these drugs. Clinical consideration and professional judgment should be applied to any drug of abuse test result, particularly in evaluating a preliminary positive result.

The tests provide only preliminary results. To obtain a confirmed analytical result, a more specific alternate chemical method must be used. GC/MS or LC/MS is the recommended confirmatory method.

Hightop® Multi-Drug Urine Test Cup Rx tests are competitive binding. lateral flow immunochromatographic assavs for qualitative and simultaneous detection of Amphetamine, Secobarbital, Oxazepam, Cocaine, 2ethylidene-1,5-dimethyl-3,3-diphenylpyrrolidine, Methylenedioxymethamphetamine, Morphine, Methadone, Oxycodone, Phencyclidine, Propoxyphene, Nortriptyline and Cannabinoids in human urine at the cutoff concentrations of:

Hightop® Multi-Drug Urine Test Cup Rx offers any combinations from 2 to 15 drugs of abuse tests but only one cutoff concentration under same drug condition will be included per device. It is for in vitro diagnostic use only. It is intended for prescription use.

The tests may yield positive results for the prescription drugs Buprenorphine, Oxazepam, Secobarbital, Propoxyphene, and Oxycodone when taken at or above prescribed doses. It is not intended to distinguish between prescription use or abuse of these drugs. Clinical consideration and professional judgment should be applied to any drug of abuse test result, particularly in evaluating a preliminary positive result.

The tests provide only preliminary results. To obtain a confirmed analytical result, a more specific alternate chemical method must be used. GC/MS or LC/MS is the recommended confirmatory method.

The Hightop® Multi-Drug Urine Test Cup and Hightop® Multi-Drug Urine Test Cup Rx are rapid, single-use in vitro diagnostic devices. Each test kit contains a test device in one pouch. One pouch contains a test Hightop® Cup and two desiccants, and a package insert. The Hightop® Multi-Drug Urine Test Cup is intended for over-the-counter use and the Hightop® Multi-Drug Urine Test Cup Rx is intended for prescription use.

The provided document describes the performance characteristics and studies for the Hightop® Multi-Drug Urine Test Cup and Hightop® Multi-Drug Urine Test Cup Rx. This device is an in-vitro diagnostic test.

Here's a breakdown of the requested information:

1. Table of Acceptance Criteria and Reported Device Performance

For an in vitro diagnostic device like this multi-drug urine test cup, the "acceptance criteria" generally refers to the expected outcomes and performance targets for sensitivity and specificity around the defined cut-off concentrations, as demonstrated by the precision and method comparison studies. The reported device performance is indicated by the agreement of the device results with LC/MS (Liquid Chromatography/Mass Spectrometry) reference results.

The precision study results show the device performance across various concentrations relative to the cutoff, aiming for all negative results below the -25% cutoff and all positive results above the +25% cutoff. The "Near Cutoff Negative" and "Near Cutoff Positive" categories show deviations which are commonly observed for immunoassay devices operating close to the clinical cutoff.

A summarized table of the stated performance for each drug at various concentrations relative to the cutoff is presented in the original document (e.g., page 11). For the purpose of this summary, a general acceptance criterion for qualitative drug screening tests is typically high agreement with a reference method, especially for samples outside the +/- 25% cutoff range, and reasonable agreement within the +/- 25% cutoff range, as these regions represent the limits of detection and decision points for such assays. The acceptance is implicitly demonstrated by the results showing high concordance for samples sufficiently above or below the cutoff.

Here is a summary of the precision data for Buprenorphine (BUP 10) as an example. Similar tables exist for each drug on pages 11-15.

Acceptance Criteria (Implicitly based on performance expectations for qualitative drug screens) and Reported Device Performance (Precision Study for BUP 10)

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

• Sample Size for Analytical Studies (Precision, Specificity, Interference, pH/SG effect): For each drug and each concentration point (-100%, -75%, -50%, -25%, cutoff, +25%, +50%, +75%, +100% cutoff), tests were performed two runs per day for 20 days using three lots of test Cups. This means for each concentration point, there were 2 runs/day * 20 days * 3 lots = 120 tests. For each drug, across the 9 concentration points reported in the precision studies, there were 9 * 40 * 3 = 1080 tests (40 tests per lot). For interference and specificity: results are reported for relevant concentrations.
• Sample Size for Method Comparison Studies: For each drug, 80 unaltered urine samples were used (40 negative and 40 positive). These 80 samples were tested by three operators.
• Sample Size for Lay-User Study:
  • Configuration 1 (AMP 500, MET 500, MOP 300, COC 150): 140 participants (72 males, 68 females). Each participant presumably tested all drugs in this configuration. The results are presented for 20 samples per concentration level for each drug.
  • Configuration 2 (AMP 1000, MET 1000, OPI 2000, COC 300): 140 participants (71 males, 69 females). Each participant presumably tested all drugs in this configuration. The results are presented for 20 samples per concentration level for each drug.
• Data Provenance: The analytical and method comparison studies were performed "in-house" and involved spiking drugs into "drug-free urine samples" and "unaltered urine samples." The lay-user study involved recruitment from "three sites." The exact country of origin for the samples or study sites is not explicitly stated, but the manufacturer is Qingdao HIGHTOP Biotech Co., Ltd. in China, suggesting the studies likely took place in China or were managed by the Chinese manufacturer. The studies are retrospective in the sense that samples were prepared or collected and then blinded and tested.

3. Number of Experts and Qualifications for Ground Truth

• Analytical and Method Comparison Studies: LC/MS (Liquid Chromatography/Mass Spectrometry) was used to confirm the concentrations of drugs in the urine samples. This is an objective, highly accurate, and quantitative chemical method. The document does not specify the number of experts or their qualifications for performing the LC/MS analysis, but LC/MS is a standard laboratory method typically performed by trained laboratory technicians or chemists.

4. Adjudication Method for the Test Set

• Analytical and Method Comparison Studies: The ground truth for these studies was established by LC/MS results. There is no mention of human expert adjudication in the traditional sense (e.g., 2+1, 3+1 consensus). The device's qualitative results (positive/negative) were directly compared against the quantitative LC/MS results relative to the defined cutoff concentration.
• Lay-User Study: Outcomes were reported as percentage of correct results compared to the known spiked concentrations. No explicit human adjudication method beyond comparing the lay users' interpretations to the true spiked concentrations is mentioned.

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

• No, a multi-reader multi-case (MRMC) comparative effectiveness study was not explicitly described in the traditional sense of comparing human readers' performance with and without AI assistance for image analysis or similar tasks.
• The document describes a "Lay-user study" which involves multiple users (readers) interpreting the device results, but this is a study to assess the ease of use and interpretation by non-professional users. It compares device performance (as interpreted by lay users) to LC/MS ground truth, not the improvement of human readers with AI assistance.

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

• Yes, the device itself is a standalone qualitative immunoassay device. Its performance, as reported in the "Precision" and "Method Comparison" sections (pages 11-15 and 25-35), represents the algorithm's (test strip's) performance in detecting drugs in urine samples without human interpretive bias (beyond the operator physically performing the test and reading the line, which is standard for such devices). The "Discordant Results" tables (pages 25-35) directly compare the device's output against the LC/MS reference.

7. The Type of Ground Truth Used

• LC/MS or LC/MS: For all analytical performance and method comparison studies (precision, specificity, interference, pH/SG effect, and comparison with operators), the ground truth for drug concentration was established by Liquid Chromatography/Mass Spectrometry (LC/MS) or LC/MS. This is a highly accurate and quantitative analytical method used as the gold standard for confirming drug concentrations.
• Known Spiked Concentrations: For the lay-user study, the ground truth was based on urine samples prepared with known, spiked concentrations of drugs into drug-free urine, which were then confirmed by LC/MS.

8. The Sample Size for the Training Set

• The document does not explicitly mention a training set in the context of an algorithm or AI model development. This device is a lateral flow immunochromatographic assay, which is a biochemical test, not a software algorithm that requires a "training set" in the machine learning sense. The performance studies described (precision, specificity, method comparison, lay-user study) are all validation studies.

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

• As there is no mention of a traditional "training set" for an algorithm, this question is not directly applicable. The device's performance is based on its inherent biochemical properties and design, which are then validated through the studies described using LC/MS as the ground truth for drug concentrations.

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HIGHTOP Pregnancy Rapid Test Cassette is intended for the qualitative detection of human chorionic gonadotropin (hCG) in urine, as an aid in early detection of pregnancy.

HIGHTOP Pregnancy Rapid Test Strip is intended for the qualitative detection of human chorionic gonadotropin (hCG) in urine, as an aid in early detection of pregnancy.

HIGHTOP Pregnancy Rapid Test Midstream is intended for the qualitative detection of human chorionic gonadotropin (hCG) in urine, as an aid in early detection of pregnancy.

HIGHTOP Pregnancy Rapid Test measures the presence of the hormone Human Chorionic Gonadotrophin (HCG) in human urine for the detection of pregnancy. The test devices are in three different formats: Strip, Cassette and Midstream. Each test kit contains a test device sealed in a desiccated aluminum pouch and a package insert. The cassette format also contains a dropper.

Here's an analysis of the acceptance criteria and supporting studies for the HIGHTOP Pregnancy Rapid Test devices, based on the provided document:

Acceptance Criteria and Device Performance

• Strip: 57 positive, 0 false positive, 1 false negative, 62 true negative.
• Cassette: 56 positive, 0 false positive, 2 false negative, 62 true negative.
• Midstream: 57 positive, 0 false positive, 1 false negative, 62 true negative.) |
  | Lay Person Readability & Usability | 100% positive and negative conformity with professional results. (Lay person results showed 100% agreement with professional testing. Questionnaire results indicated consumers found the test easy to use and understood labeling/results.) |
  | Shelf-Life Stability | 24 months (Based on accelerated testing at 4-30°C in a sealed foil pouch. Real-time stability studies are ongoing.) |

Study Details

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

• Analytical Performance (Sensitivity):

  • Test Set Sample Size: For each hCG concentration level (0, 12.5, 18.75, 22.5, 25, 50, 100, 200 mIU/mL), 50 replicates per lot across 3 lots = 150 total tests per hCG concentration. This was performed for each of the three device formats (Strip, Cassette, Midstream).
  • Data Provenance: Negative urine was spiked with hCG standard. The specific origin of the negative urine or hCG standard is not explicitly stated beyond "traceable to the 5th WHO." This is an in-vitro study setup.

• Hook Effect Test:

  • Test Set Sample Size: Not explicitly stated as a count, but "Negative urine samples were spiked with varying hCG concentrations (3125, 6250, 62500, 125000, 250000, 500000, 1000000 and 2000000 mIU/mL)." Each concentration was tested to observe the effect.
  • Data Provenance: In-vitro study setup using spiked urine samples.

• Specificity and Cross-Reactivity:

  • Test Set Sample Size: "Negative and positive urine samples (10 mIU/mL and 25 mIU/mL) were spiked with various concentrations of glycoprotein hormones LH, FSH, TSH and hCG ß-core fragment." The number of replicates is not specified.
  • Data Provenance: In-vitro study setup using spiked urine samples.

• Interfering Substance Test:

  • Test Set Sample Size: "Urine samples containing 10 mIU/mL and 25 mIU/mL hCG were spiked with the interfering substance to obtain the desired test concentration" for a long list of substances, as well as pH and specific gravity variations. The number of replicates is not specified.
  • Data Provenance: In-vitro study setup using spiked urine samples.

• Method Comparison Study (with predicate device):

  • Test Set Sample Size: 120 urine samples from women ("approximately half... suspected to be pregnant and most of them are in the early stage of less than 5 weeks").
  • Data Provenance: Prospective collection from "women presenting to test for pregnancy at OB/GYN Physician's offices." The country of origin is not specified but implied to be where the offices are located. All samples were processed and tested after collection.

• Lay Person Study:

  • Test Set Sample Size: 300 women.
  • Data Provenance: Prospective collection. "Women with varying educational and occupational backgrounds from three sites were chosen for the study." The country of origin is not specified.

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

• Analytical Performance (Sensitivity): Ground truth was established by spiking known concentrations of hCG into negative urine. No human experts were involved in establishing this ground truth. However, "Tests were performed by three different operators" for reproducibility. Their qualifications are not specified.
• Hook Effect Test, Specificity, Interfering Substances: Ground truth was established by spiking known concentrations of substances into urine. No human experts were involved in establishing this ground truth.
• Method Comparison Study: Ground truth was established by the predicate device. "All samples were tested by ten different health professionals at the 3 OB/GYN Physician's offices with the proposed and the predicate devices." The qualifications of these "health professionals" are not specified beyond their title.
• Lay Person Study: Ground truth was established by "professional testing with the candidate device." It is implied that "professional" here refers to trained personnel, likely the "health professionals" mentioned in the method comparison study. The qualifications of these professionals are not specified.

4. Adjudication method for the test set

• Analytical Performance: The document describes "Total result" columns for '-' and '+' readings, implying a summation of results from different lots and operators. It doesn't describe an adjudication process for discordant results during the initial replicates, but the final % Negative / % Positive is presented as an aggregated outcome.
• Method Comparison Study: No explicit adjudication method (e.g., 2+1, 3+1) is mentioned for resolving discrepancies between the proposed and predicate devices, or among the ten health professionals. The results are presented as direct comparison counts between the proposed device and the predicate device.
• Lay Person Study: No explicit adjudication method is mentioned. Lay person results were compared to "professional testing with the candidate device," and a 100% conformity indicates no discrepancies needed adjudication, or any discrepancies were resolved outside of what is reported.

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

• No, an MRMC study was not done, and this device is not an AI/CAD device. The studies described are for an in vitro diagnostic (IVD) pregnancy rapid test, which is a chemical assay read visually. There is no AI assistance involved with this device.

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

• Yes, in essence, standalone performance was assessed though the term "standalone" is more common for AI algorithms. The analytical performance studies (sensitivity, hook effect, specificity, interfering substances) evaluate the device's inherent capability to detect/react to hCG under various conditions. The human role in these initial analytical tests is typically procedural (e.g., proper execution of the test, accurate reading of the results). The method comparison study and lay person study, while involving human readers (health professionals and lay users), assess the device's performance in the hands of users compared to another device or professional reading, rather than as an algorithm versus human.

7. The type of ground truth used

• Analytical Performance Studies (Sensitivity, Hook Effect, Specificity, Interfering Substances): Spiked samples with known concentrations. This is a highly controlled, synthetic ground truth established in a lab setting.
• Method Comparison Study: Ground truth was established by the predicate device (WONDFO One Step HCG Urine Pregnancy Test - K043443). This relies on the established accuracy of another legally marketed device.
• Lay Person Study: Ground truth was established by professional testing with the candidate device. This relies on the deemed accurate interpretation by trained professionals using the same device.

8. The sample size for the training set

• Not applicable. This device is a rapid diagnostic test based on immunochromatography, not an AI or machine learning model that requires a training set. The term "training set" is not relevant to the development and validation of this type of IVD.

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

• Not applicable. (See point 8 above).

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