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The AssureTech Quick Cup Tests are competitive binding, lateral flow immunochromatographic assays for qualitative and simultaneous detection of Amphetamine, Secobarbital, Buprenorphine, Oxazepam, Cocaine, EDDP, Fentanyl, Ecstasy, Propoxyphene, Morphine, Methadone, Phencyclidine, Oxycodone, Norfentanyl, Methamphetamine, Nortriptyline, 6-Monoacetylmorphine, Tramadol and Marijuana in human urine at the cutoff concentrations of:

Configuration of the AssureTech Quick Cup Tests can consist of any combination of the above listed drug analytes. The test may yield positive results for the prescription drugs above 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 exercised with any drug of abuse test result, particularly when the preliminary result is positive. 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 or LC/MS is the preferred confirmatory method.

For in vitro diagnostic use only.

The AssureTech Multi-drug Urine Test Cup are competitive binding, lateral flow immunochromatographic assays for qualitative and simultaneous detection of Amphetamine, Secobarbital, Buprenorphine, Oxazepam, Cocaine, EDDP, Fentanyl, Ecstasy, Propoxyphene, Morphine, Methadone, Phencyclidine, Oxycodone, Norfentanyl, Methamphetamine, Nortriptyline, 6-Monoacetylmorphine, Tramadol and Marijuana in human urine at the cutoff concentrations of:

Configuration of the AssureTech Multi-drug Urine Test Cup can consist of any combination of the above listed drug analytes. It is for in vitro diagnostic use only.

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 or LC/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 AssureTech Quick Cup Tests are immunochromatographic assays that use a lateral flow system for the qualitative detection of Amphetamine, Secobarbital, Buprenorphine, Oxazepam, Cocaine, EDDP, Fentanyl, Ecstasy, Propoxyphene, Morphine, Methadone, Phencyclidine, Oxycodone, Norfentanyl, Methamphetamine, Nortriptyline, 6-Monoacetylmorphine, Tramadol and Marijuana (target analytes) in human urine. The products are single-use in vitro diagnostic devices. Each test kit contains a Test Device and a package insert. Each test device is sealed with a desiccant in an aluminum pouch.

The provided FDA 510(k) Clearance Letter details the performance of the AssureTech Quick Cup Tests and AssureTech Multi-drug Urine Test Cup for qualitative and simultaneous detection of various drugs in human urine.

Here's an analysis of the acceptance criteria and the study proving the device meets those criteria:

1. Acceptance Criteria and Reported Device Performance

For in vitro diagnostic devices like these, acceptance criteria are typically related to the accuracy of the qualitative detection (positive vs. negative) compared to a gold standard, particularly around the established cutoff concentrations. The performance is assessed through analytical studies (precision, specificity, interference) and comparison studies with a confirmatory method.

Here's a table summarizing the implicit acceptance criteria based on the precision and lay-user studies, and the reported device performance. The acceptance criterion is inferred as the ideal performance for these types of tests, where results near or above the cutoff should be positive, and results significantly below should be negative. The performance data below is extracted from the "Precision" and "Lay-user study" sections.

Table of Acceptance Criteria and Reported Device Performance

Note: The precision study for AMP300, MET300, and TML100 used 3 lots, with "50-/0+" meaning 50 negative results and 0 positive results, and "50+/0-" meaning 50 positive results and 0 negative results. For the 'Cutoff' concentration, it shows a mix of positive and negative results, which is expected due to the nature of qualitative assays around the threshold.

2. Sample Sizes and Data Provenance

• Precision Study:

  • For AMP300, MET300, and TML100: Each drug had 8 concentrations (spanning -100% to +100% of cutoff, plus the cutoff). For each concentration, tests were performed two runs per day for 25 days, for 3 different lots.
    • This means 50 observations per concentration per lot (2 runs/day * 25 days/run).
    • Total observations per drug for all 3 lots: 8 concentrations * 50 observations/concentration * 3 lots = 1200 observations per drug.
  • Data for other drugs refer to previous 510(k) clearances (K243996, K201630, K181768, K180349, K170049, K161044, K153465, K152025, K151211).
  • Data Provenance: Retrospective, as samples were "prepared by spiking drug in negative samples" and confirmed by LC/MS. No specific country of origin is mentioned, but typically for FDA submissions, studies are conducted under GLP (Good Laboratory Practice) guidelines, often in the US or by international labs adhering to comparable standards.

• Comparison Studies (Clinical Samples):

  • For AMP300, MET300, and TML100: The tables show data broken down by "Negative" (presumably drug-free), "Low Negative" ( +50%). The sum of the positive and negative results across these categories for each operator represents the number of clinical samples tested for that drug.
    • AMP300: 5 (Negative) + 15 (LN) + 19 (NCN) + 24 (NCP) + 16 (HP) = 79 samples per operator. (Operator 1)
    • MET300: 4 (Negative) + 13 (LN) + 23 (NCN) + 20 (NCP) + 20 (HP) = 80 samples per operator. (Operator 1)
    • TML100: 2 (Negative) + 18 (LN) + 18 (NCN) + 19 (NCP) + 20 (HP) = 77 samples per operator. (Operator 1)
    • Total (approximate, as numbers vary slightly between operators): ~79+80+77 = ~236 clinical samples for AMP300, MET300, TML100 combined.
  • Data for other drugs refer to previous 510(k) clearances.
  • Data Provenance: Retrospective, using "unaltered clinical samples." No specific country of origin is mentioned.

• Lay-User Study:

  • Sample Size: 280 lay persons tested the device.
    • Configuration 1: 66 male + 74 female = 140 lay persons.
    • Configuration 2: 87 male + 53 female = 140 lay persons.
  • Data Provenance: Retrospective, samples were "prepared at the following concentrations; negative, +/-75%, +/-50%, +/-25% of the cutoff by spiking drugs into drug free-pooled urine specimens." Confirmed by LC/MS. Conducted "at three intended user sites." No specific country of origin is mentioned.

3. Number of Experts and Qualifications for Ground Truth (Clinical Samples)

• Ground Truth Establishment for Clinical Samples: LC/MS (Liquid Chromatography/Mass Spectrometry) is stated as the preferred confirmatory method and was used to confirm the concentrations of the samples. This is an objective chemical method, considered the gold standard for drug detection and quantification in urine.
• Experts: The comparison studies were performed "in-house with three laboratory assistants." While these individuals are performing the rapid tests, the ultimate ground truth is established by the LC/MS results. The "laboratory assistants" are not explicitly designated as "experts" in establishing ground truth, but rather as trained users of the device whose results are compared to the LC/MS gold standard.

4. Adjudication Method for the Test Set (Clinical Samples)

• The document states that "Operators ran unaltered clinical samples for each drug. The samples were blind labeled and compared to LC/MS results."
• There were three operators. The "Discordant Results" tables show discrepancies between the rapid test results and the LC/MS results, sometimes across multiple operators for the same sample.
• No explicit adjudication method (e.g., 2+1, 3+1) for the rapid test results themselves is described. The comparison seems to be a direct comparison of each operator's rapid test result against the LC/MS ground truth, and then discrepancies are noted. The LC/MS data serves as the final, objective ground truth.

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

• This document describes performance characteristics of an in-vitro diagnostic device (a qualitative urine drug test cup).
• No MRMC comparative effectiveness study was performed in the context of comparing human readers (e.g., radiologists interpreting images) with and without AI assistance. This type of study design is specific to AI/CADe (Computer-Assisted Detection) or CADx (Computer-Assisted Diagnosis) devices in imaging, which is not applicable to a lateral flow immunoassay like the AssureTech Quick Cup Tests.

6. Standalone (Algorithm Only Without Human-in-the-Loop Performance) Study

• Given this is a physical immunoassay test cup, the concept of a "standalone (algorithm only without human-in-the-loop performance)" study does not directly apply in the same way it would for a software-based AI device.
• The "Comparison Studies" with laboratory assistants and the "Lay-user study" assess the device's performance when interpreted by human users. The device itself, by producing a visual result (line/no line), is the "algorithm." Its performance is inherently tied to human interpretation of that visual output. The precision and specificity studies represent the analytical performance of the device itself.

7. Type of Ground Truth Used

• Analytical Performance Studies (Precision, Specificity, pH/SG Effect): The ground truth was established by spiking known concentrations of drugs into negative urine samples, with concentrations confirmed by LC/MS.
• Comparison Studies (Clinical Samples): The ground truth was established by LC/MS results on unaltered clinical urine samples. LC/MS is a highly accurate chemical analytical method.
• Lay-User Study: Ground truth was established by spiking known concentrations of drugs into drug-free pooled urine specimens, confirmed by LC/MS.

8. Sample Size for the Training Set

• This document describes a 510(k) submission for a traditional in-vitro diagnostic device (immunoassay). It does not mention any artificial intelligence (AI) or machine learning (ML) components that would typically require a "training set" in the computational sense.
• The terms "training set" and "test set" are common in AI/ML validation. For a traditional medical device, the studies described (precision, interference, specificity, comparison, lay-user) serve as the "validation set" against pre-defined performance criteria.
• Therefore, N/A for "training set" in the context of AI/ML.

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

• N/A (as above, no "training set" in the AI/ML context).
• However, if we consider how the device itself was developed, the ground truth for optimizing its performance (e.g., antibody binding, membrane characteristics) would have relied on highly controlled experiments with known concentrations of analytes, likely confirmed by advanced analytical chemistry methods like LC/MS. This process is part of the extensive R&D and quality control that precedes a 510(k) submission.

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FaStep Pregnancy Rapid Test Cassette is used for qualitative detection of Human Chorionic Gonadotropin (HCG) in human urine. This test is intended for use as an aid in the early detection of pregnancy. For over-the-counter use.

The Fastep HCG Rapid Test Cassette is a rapid visual immunoassay for the qualitative detection of Human Chorionic Gonadotropin (HCG) in human urine. This test is intended for use as an aid in the early detection of pregnancy. The test kits are for health care professionals use including professionals at physician's office labs (POLs).

The FaStep Pregnancy Rapid Test Cassette and the Fastep HCG Rapid Test Cassette are the same device with the first intended for over-the counter use and the second for prescription use. The devices contain individually wrapped pouches containing the device, instructions for use, and pipette droppers.

The devices utilize a combination of antibodies to detect hCG in urine as well as to serve as a run control. The result is displayed to the user in the test window as two lines for a 'Pregnant' positive result and one line for a 'Not Pregnant' negative result.

Here's an analysis of the acceptance criteria and study details for the FaStep Pregnancy Rapid Test Cassette and Fastep HCG Rapid Test Cassette, based on the provided document:

Acceptance Criteria and Device Performance

The document doesn't explicitly state "acceptance criteria" for all performance aspects in a separate table. However, the reported device performance implicitly defines the criteria that were met for substantial equivalence. The key performance indicators for a qualitative pregnancy test are its sensitivity (ability to detect low levels of hCG), specificity (absence of false positives), and agreement with a predicate device/professional results.

1. Table of Acceptance Criteria and Reported Device Performance

2. Sample Sizes and Data Provenance

• Analytical Performance (Precision/Reproducibility/Sensitivity):
  • Test Set Size: 9 hCG concentrations (0, 10, 12.5, 15, 17.5, 20, 50, 100, 200 mIU/mL) x 10 replicates/day for 5 days x 3 device lots x 3 operators = 1350 data points (for positive/negative determination).
  • Data Provenance: Not explicitly stated, but typically these studies are conducted in a controlled lab environment. No country of origin is mentioned, and it's a prospective lab study.
• Hook Effect Test:
  • Test Set Size: 7 hCG concentrations (25000 to 2000000 mIU/mL) x 5 replicates x 3 lots x 3 operators = 315 data points.
  • Data Provenance: Prospective lab study.
• Interfering Substances:
  • Test Set Size: 3 hCG concentrations (0, 10, 20 mIU/mL) x 3 replicates x 3 lots x 3 operators x 32 substances = 864 data points.
  • Data Provenance: Prospective lab study.
• Cross-reactivity:
  • Test Set Size: 3 hCG concentrations (0, 10, 20 mIU/mL) x 3 replicates x 3 lots x 3 operators x 3 cross-reactants = 81 data points.
  • Data Provenance: Prospective lab study.
• hCG ß-core fragment:
  • Test Set Size: 4 hCG concentrations (0, 10, 20, 20000 mIU/mL) x 3 replicates x 3 lots x 3 operators x 4 hCGBcf concentrations = 108 data points.
  • Data Provenance: Prospective lab study.
• Urine pH:
  • Test Set Size: 3 hCG concentrations (0, 10, 20 mIU/mL) x 3 replicates x 3 lots x 3 operators x 6 pH values = 162 data points.
  • Data Provenance: Prospective lab study.
• Urine Density:
  • Test Set Size: 3 hCG concentrations (0, 10, 20 mIU/mL) x 3 replicates x 3 lots x 3 operators x 8 density values = 216 data points.
  • Data Provenance: Prospective lab study.
• Method Comparison Study:
  • Test Set Size: 112 urine samples from women.
  • Data Provenance: Samples collected from 112 women aged 18 to 50 at "three clinical sites." Approximately half were early-stage pregnant. Implies prospective collection for this study, likely within the US given the FDA submission.
• Lay Person Study:
  • Test Set Size: 112 female subjects.
  • Data Provenance: Conducted at "three sites" with females aged 18-50. Implies prospective collection for this study, likely within the US.
• Specificity Study (False Positives):
  • Test Set Size: 300 urine samples from non-pregnant females (100 per age group: pre-menopausal, peri-menopausal, post-menopausal).
  • Data Provenance: Samples collected from non-pregnant females at "three sites." Implies prospective collection for this study, likely within the US.

3. Number of Experts and Qualifications for Ground Truth

• Analytical Performance Studies (Sensitivity, Hook Effect, Interfering Substances, etc.): Ground truth is established by the known, spiked concentrations of hCG or other substances. The "experts" performing the tests were "operators" (3 different operators for each study involving replicates across lots), but their specific qualifications are not detailed beyond "operator." These are typically trained lab personnel.
• Method Comparison Study: The ground truth for comparative purposes was established by the predicate device results, as read by a "separate professional" at each of the three test sites. Their specific qualifications are not detailed beyond "professional."
• Lay Person Study: The ground truth was established by professional testing of the same urine samples as used by the lay users. The specific qualifications of these "professionals" are not detailed.
• Specificity Study (False Positives): The ground truth (non-pregnant status) was based on the source of the samples (non-pregnant women across different age groups). The results were read by the device itself; no explicit external expert ground truthing beyond sample collection criteria is mentioned.

4. Adjudication Method for the Test Set

• Analytical Performance Studies: No formal adjudication method like 2+1 or 3+1 is mentioned. Each replicate/lot/operator result was recorded. Discrepancies (e.g., in the sensitivity study where partial positivity was seen) were simply reported as the percentage of positive/negative readings.
• Method Comparison Study: Three professional operators read the candidate device, with a different operator at each of the three test sites. A separate professional tested samples using the predicate. It's unclear if there was any adjudication process if different professionals at the same site (if there were multiple for one device) read differently, or if discrepancies between devices were adjudicated. The results table shows perfect agreement, suggesting either no discrepancies or an unstated adjudication process.
• Lay Person Study: Lay user results were compared to "professional test results." The agreement was 100%, implying robust ground truth or an unstated adjudication process if disagreements occurred.
• Specificity Study (False Positives): No false positives were observed. Therefore, no adjudication was necessary.

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

• No MRMC comparative effectiveness study was explicitly performed to quantify human reader improvement with AI vs. without AI assistance. The device is a rapid visual immunoassay for qualitative detection of hCG and does not involve AI.
• The "Method Comparison Study" and "Lay Person Study" compare device performance to a predicate or to professional results, but not with an AI component or a quantifiable "improvement" of human readers with AI.

6. Standalone Performance

• Yes, standalone performance was extensively done. All analytical performance studies (sensitivity, hook effect, interfering substances, cross-reactivity, pH, density) evaluate the device's inherent performance.
• The "Lay Person Study" also assesses the standalone performance of the device when used by the intended over-the-counter users.
• The device is designed for qualitative visual interpretation, so its standalone performance is its primary mode of operation.

7. Type of Ground Truth Used

• Analytical Performance Studies (Precision/Sensitivity, Hook Effect, Interfering Substances, Cross-reactivity, hCG ß-core fragment, pH, Density): Ground truth was established using spiked samples with known concentrations of hCG or other substances, traceable to WHO International Standard.
• Method Comparison Study: Ground truth for comparison was the results of the predicate device.
• Lay Person Study: Ground truth was the results of professional testing of the same urine samples.
• Specificity Study (False Positives): Ground truth was the known non-pregnant status of the study participants.

8. Sample Size for the Training Set

• The document describes performance studies, which are analogous to a "test set" for demonstrating effectiveness.
• The document does not provide details about a "training set" for the device itself. This is a qualitative immunoassay, not a machine learning or AI-driven device that requires a training set in the typical sense. The manufacturing process and quality control would be "trained" or optimized during development, but this is not typically disclosed in a 510(k) summary as a "training set."

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

• Since there is no explicit "training set" identified for an AI/ML context, this question is not applicable to the information provided in the document. The device's underlying chemistry and biology are its "training" or design principles.

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The AssureTech Panel Dip Tests are competitive binding, lateral flow immunochromatographic assays for qualitative and simultaneous detection of Amphetamine, Oxazepam, Cocaine, Methamphetamine, Fentanyl, Norfentany], Morphine, Oxycodone, Secobarbital, Buprenorphine, Methylenedioxy-methamphetamine, Phencyclidine, Methadone, EDDP, Nortriptyline and d-Propoxyphene in human urine at the cutoff concentrations listed. The single or multi-test panels can consist of up to seventeen (17) of the above listed analytes in any combination. Clinical consideration and professional judgment should be exercised with any drug of abuse test result, particularly when the preliminary result is positive. 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. For in vitro diagnostic use only.

The AssureTech Quick Cup Tests are competitive binding, lateral flow immunochromatographic assays for qualitative and simultaneous detection of Amphetamine, Oxazepam, Cocaine, Methamphetamine, Fentanyl, Norfentany], Morphine, Oxycodone, Secobarbital, Buprenorphine, Methylenedioxy-methamphetamine, Phencyclidine, Methadone, EDDP, Nortriptyline and d-Propoxyphene in human urine at the cutoff concentrations listed. The single or multi-test panels can consist of up to seventeen (17) of the above listed analytes in any combination. Clinical consideration and professional judgment should be exercised with any drug of abuse test result, particularly when the preliminary result is positive. 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. For in vitro diagnostic use only.

The AssureTech Multi-drug Urine Test Panel are competitive binding, lateral flow immunochromatographic assays for qualitative and simultaneous detection of Amphetamine, Cocaine, Marijuana, Methamphetamine, Morphine, Fentanyl, Norfentanyl, Oxycodone, Secobarbital, Buprenorphine, Methylenedioxy-methamphetamine, Phencyclidine, Methadone, EDDP, Nortriptyline, d-Propoxyphene and adulterants in human urine at the cutoff concentrations listed. The single or multi-test panel can consist of up to seventeen (17) of the above listed analytes in any combination. It is for in vitro diagnostic use only. The test provides only preliminary test results. A more specific alternative chemical 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.

The AssureTech Multi-drug Urine Test Cup are competitive binding, lateral flow immunochromatographic assays for qualitative and simultaneous detection of Amphetamine, Oxazepam, Marijuana, Methamphetamine, Morphine, Fentanyl, Norfentanyl, Oxycodone, Secobarbital, Buprenorphine, Methylenedioxy-methamphetamine, Phencyclidine, Methadone, EDDP, Nortriptyline, d-Propoxyphene and adulterants in human urine at the cutoff concentrations listed. The single or multi-test cups can consist of up to seventeen (17) of the above listed analytes in any combination. It is for in vitro diagnostic use only. 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.

The AssureTech Panel Dip Tests and AssureTech Quick Cup Tests are immunochromatographic assays that use a lateral flow system for the qualitative detection of Amphetamine, Oxazepam, Cocaine, Marijuana, Methamphetamine, Fentanyl, Morphine, Oxycodone, Secobarbital, Buprenorphine, Methylenedioxy-methamphetamine, Phencyclidine, Methadone, EDDP. Nortriptyline and Propoxyphene (target analytes) in human urine. The products are single use in vitro diagnostic devices, which come in the formats of Panel Dip Cards or Cups. Each test kit contains a Test Device (in one of the two formats), a package insert and a urine cup for sample collection. Each test device is sealed with a desiccant in an aluminum pouch.

The provided document describes the FDA 510(k) premarket notification for AssureTech Panel Dip Tests and Quick Cup Tests, which are in vitro diagnostic devices for qualitative and simultaneous detection of various drugs of abuse in human urine. The document focuses on demonstrating substantial equivalence to a predicate device (K181768).

Here's an analysis of the acceptance criteria and the study proving the device meets them, based on the provided text:

Acceptance Criteria and Reported Device Performance

The acceptance criteria for this type of device are primarily related to its analytical performance, specifically its ability to accurately detect the presence or absence of target drugs at specified cutoff concentrations. The device is a qualitative test, meaning it provides a "positive" or "negative" result, rather than a quantitative measurement.

The study demonstrates performance through:

• Precision: Consistency of results across multiple runs and lots, especially near the cutoff concentrations.
• Specificity: Ability to react only with the target drug/metabolite and not with other substances or structurally similar compounds.
• Interference: Lack of false positives/negatives due to common interfering substances in urine, or variations in urine specific gravity and pH.
• Method Comparison: Agreement of device results with a known, more precise reference method (LC/MS).
• Lay-user study: Evaluation of the device's performance when used by non-professionals, assessing ease of use and accuracy of interpretation.

Here is a table summarizing the reported device performance for Fentanyl (FYL), Norfentanyl (NFYL), and as an example for another drug, Amphetamine (AMP) from the "Lay-user study" data. The document does not explicitly state numerical "acceptance criteria" for each performance metric, but rather presents the results of the studies conducted to show sufficient performance for regulatory clearance. The implicit acceptance criterion for a qualitative test like this is generally very high accuracy, especially around the cutoff, and a low rate of false positives/negatives.

Table of Performance for Key Drugs (Fentanyl, Norfentanyl, Amphetamine)

Precision Study (Fentanyl - Panel Dip/Quick Cup, Norfentanyl - Panel Dip/Quick Cup):
The precision data is presented for three lots and various concentrations relative to the cutoff. The data shows very high consistency. For instance, for Fentanyl:

• At -100%, -75%, -50% cut off (negative range), all 50 tests across 3 lots consistently yielded negative results (50-/0+).
• At +25%, +50%, +75%, +100% cut off (positive range), all 50 tests consistently yielded positive results (50+/0-).
• At the cutoff concentration, the device shows variability, as expected for tests near the decision threshold. For Fentanyl Panel Dip, results were 28+/22-, 29+/23-, 28+/22- for Lot 1, 2, 3 respectively (meaning some tests were positive and some negative at the cutoff). This variability is inherent for qualitative tests around the cutoff and implies that some samples at the cutoff may read positive and others negative, which is acceptable performance for a qualitative test. Similar patterns are observed for Quick Cup Fentanyl, Panel Dip Norfentanyl, and Quick Cup Norfentanyl.

Method Comparison Study (Fentanyl - Panel Dip/Quick Cup, Norfentanyl - Panel Dip/Quick Cup):
This study compared the device results against LC/MS, the preferred confirmatory method. The results are presented in tables showing agreement across different concentration ranges (Negative, Low Negative, Near Cutoff Negative, Near Cutoff Positive, High Positive).

Example for FYL (Fentanyl) - Panel Dip, Operator 1:

• Negative (LC/MS 0): Device: 0 Positive, 1 Negative (1 discordant result here, sample 1484, LC/MS 0.78 ng/mL, Device: +)
• Low Negative (LC/MS +50%): Device: 20 Positive, 0 Negative

Lay-User Study (Selected data for AMP, FYL, NFYL):
This study evaluates the percentage of correct results when used by lay persons at various concentrations relative to the cutoff.

Example for AMP (Amphetamine):

• Negative (100% below cutoff): 100% correct (0 positive, 20 negative)
• Low Negative (-75% to -25% Cutoff): 100% correct negative for -75% and -50%, but 0 positive/20 negative for -25% cutoff.
• Positive (+25% to +75% Cutoff): Generally high correctness (95%-100%). For +25% cutoff, 95% correctness (19 positive, 1 negative).

Detailed Study Information:

1. Sample sizes used for the test set and the data provenance:

   • Precision Study: For Fentanyl and Norfentanyl, the reported data is for 3 lots, with 2 runs per day for 25 days, for 9 concentrations (e.g., -100% cutoff, -75% cutoff, etc.). This implies 50 tests per concentration per lot (2 runs * 25 days), leading to 450 tests per drug type per lot (9 concentrations * 50 tests), and 1350 tests per drug type across all 3 lots. The data provenance implies these samples were prepared by spiking known concentrations of drug into negative samples, indicating a controlled laboratory environment. Data for other analytes was "reported in K181768" (the predicate device documentation), so the exact sample sizes are not explicitly stated in this document but are assumed to be similar.
   • Method Comparison Study: For Fentanyl and Norfentanyl, 80 unaltered clinical samples (40 negative and 40 positive based on LC/MS results) were used per drug. Each sample was tested by three laboratory assistants for each device type (Panel Dip and Quick Cup). This means 80 samples * 3 operators = 240 tests per drug for each device type. The data provenance is "in-house" and "unaltered clinical samples." The document does not specify the country of origin, but given the FDA submission, it's likely US-based or compliant with US standards. The study appears to be retrospective, using already collected clinical samples for comparison.
   • Lay-user Study: 280 lay persons were used for each device format (Panel Dip and Quick Cup, though the results summarized apply to the overall device type). Urine samples were prepared at 7 different concentrations (negative, +/-25%, +/-50%, +/-75%, +/-100% of cutoff). Each participant received one blind-labeled sample and one device. Assuming each person tested one sample, this implies 280 samples were tested for each specific drug evaluated by lay-users on each format. The data provenance: "samples were prepared by spiking drugs into drug-free pooled urine specimens" and confirmed by LC/MS. This is a controlled experimental set-up rather than real-world patient samples.

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

   • Precision Study: Ground truth was established by spiking known concentrations of drugs into negative samples and confirmed by LC/MS. No human experts were involved in establishing the ground truth directly for this part.
   • Method Comparison Study: The ground truth was established by LC/MS (Liquid Chromatography-Mass Spectrometry), which is explicitly stated as the "preferred confirmatory method" and is considered a gold standard for drug detection and quantification in urine. No human expert readers established the ground truth; it was a laboratory instrument measurement. The study used three laboratory assistants to read the device results, but they were comparing their readings against the LC/MS truth, not establishing the truth themselves. Their qualifications are not specified beyond "laboratory assistants."
   • Lay-user Study: The ground truth was established by spiking known concentrations of drugs confirmed by LC/MS. No human experts established the ground truth of the samples. The study assessed the lay-users' ability to interpret the device results against this known truth.

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

   • Precision Study: No adjudication method mentioned as samples were prepared with known concentrations.
   • Method Comparison Study: No adjudication method was explicitly mentioned for the device results. Each of the three operators performed their own reads, and their individual results were compared to the LC/MS. Discordant results are noted for each operator.
   • Lay-user Study: No adjudication method was mentioned. Each lay user tested one sample against a pre-defined truth.

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:

   • No, a multi-reader multi-case (MRMC) comparative effectiveness study was not conducted in this report. This device is a rapid diagnostic test (lateral flow immunoassay), not an AI-assisted diagnostic tool for interpretation of medical images or other complex data. Therefore, the concept of "human readers improve with AI vs without AI assistance" is not applicable here.

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

   • This is a lateral flow immunoassay, which is a physical diagnostic device producing a visual result (colored lines). It does not involve an "algorithm" in the sense of a software-based AI or computational algorithm. The device itself is the "standalone" diagnostic. Its performance characteristics (precision, specificity, interference) are essentially its "algorithm only" performance. The method comparison study is akin to assessing the device's standalone performance against a gold standard. The lay-user study assesses human interpretation of the device's standalone output.

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

   • The primary ground truth for the analytical and method comparison studies was Liquid Chromatography-Mass Spectrometry (LC/MS), which is a highly accurate chemical method for detecting and quantifying substances.
   • For the precision and lay-user studies, the ground truth was based on spiked urine samples with known drug concentrations, which were then confirmed by LC/MS.

7. The sample size for the training set:

   • This document describes a 510(k) premarket notification for an in vitro diagnostic device (lateral flow immunoassay). Unlike AI/ML-driven devices that require extensive training data, such chemical-based devices are developed and optimized through chemical engineering and biological principles, not by "training" on datasets in the AI sense. Therefore, the concept of a "training set" with a statistical sample size as understood in machine learning is not applicable to this type of device. The development process involves chemical formulation and validation, not data training.

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

   • Since the concept of a "training set" as it pertains to AI/ML devices is not applicable, the establishment of ground truth for a training set is also not relevant in this context. The "ground truth" for the performance evaluation of the device relied on LC/MS results and carefully prepared spiked samples with known drug concentrations.

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FaStep Early Pregnancy Rapid Test Strip is used for qualitative detection of Human Chorionic Gonadotropin (HCG) in human urine. This test is intended for use as an aid in early detection of pregnancy, in some cases as early as six (6) days before the day of the missed period, (i.e. as early as five (5) days before the day of the expected period). For over thecounter use.

FaStep Early Pregnancy Rapid Test Cassette is used for qualitative detection of Human Chorionic Gonadotropin (HCG) in human urine. This test is intended for use as an aid in early detection of pregnancy, in some cases as early as six (6) days before the day of the missed period, (i.e. as early as five (5) days before the day of the expected period). For over thecounter use.

FaStep Early Pregnancy Rapid Test Midstream is used for qualitative detection of Human Chorionic Gonadotropin (HCG) in human urine. This test is intended for use as an aid in early detection of pregnancy, in some cases as early as six (6) days before the day of the missed period, (i.e. as early as five (5) days before the day of the expected period). For overthe-counter use.

FaStep Early Pregnancy Rapid Test will be sold in Strip, Cassette and Midstream format. The Strip format is a single test strip. The Cassette format consists of a single test strip assembled in a plastic housing. The Midstream format consists of a single test strip assembled in a plastic housing with an absorbent tip, and is designed to be tested in dip or midstream mode.

FaStep Early Pregnancy Rapid Test Strip, FaStep Early Pregnancy Rapid Test Cassette and FaStep Early Pregnancy Rapid Test Midstream each contains a pouch with the device and instructions, and in addition, cassette format is packaged with pipette dropper.

The devices utilize a combination of antibodies to detect hCG in urine as well as to serve as a run control. Each device contains mouse monoclonal anti-ß-hCG antibody colloidal gold conjugate pre-dried on the sample pad. Mouse monoclonal anti-a-hCG antibody (on the Test Line) and goat anti mouse IgG polyclonal antibody (on the Control Line) are coated and immobilized on a nitrocellulose membrane. The result is displayed to the user in the test window as two lines for a 'Pregnant' positive result and one line for a 'Not Pregnant' negative result.

The provided document describes the performance and acceptance criteria for the FaStep Early Pregnancy Rapid Test Strip, Cassette, and Midstream devices.

Here's an analysis of the acceptance criteria and the study proving the device meets them:

1. Acceptance Criteria and Reported Device Performance

The acceptance criteria are implicitly derived from the performance claims made for the device and the comparison to the predicate device. The primary performance metrics revolve around sensitivity (detection limit for hCG) and accuracy (agreement with professional testing and predicate devices, and lack of interference/cross-reactivity).

2. Sample Size and Data Provenance

• Test Set Sample Sizes:

  • Analytical Sensitivity (Precision/Reproducibility): For each format (Strip, Cassette, Midstream), 9 hCG concentrations tested. Each concentration had 10 replicates per day for 5 days, across 3 device lots, with 3 different operators. This sums to (9 concentrations * 10 replicates * 5 days * 3 lots * 3 operators = 1350 tests per format and per method for Midstream). More simply, the tables show 150 total results for each concentration level (50 per operator/lot). So, 9 concentrations * 150 results = 1350 tests per format.
  • Hook Effect: Multiple hCG concentrations (6,250 to 200,000 mIU/mL). Specific number of replicates not stated, but results demonstrated.
  • Interfering Substances: 3 hCG concentrations (0, 5, 10 mIU/mL) spiked with 25 substances. Number of replicates per substance not stated.
  • Cross-reactivity: 3 hCG concentrations (0, 5, 10 mIU/mL) spiked with 3 cross-reactants. Number of replicates per cross-reactant not stated.
  • hCG ß-core fragment effect: 4 hCG concentrations (0, 5, 10, 20,000 mIU/mL) spiked with 4 hCGBcf concentrations.
  • Urine pH effects: 3 hCG concentrations (0, 5, 10 mIU/mL) tested at 6 pH values.
  • Urine Density effects: 3 hCG concentrations (0, 5, 10 mIU/mL) tested at 8 density values.
  • Method Comparison: 321 urine samples collected from women.
    • Strip format: 110 samples.
    • Cassette format: 105 samples.
    • Midstream format (dip): 106 samples.
    • Midstream format (in-stream): 106 samples.
  • Lay Person Study (First Study - direct comparison): Total of 321 females.
    • Strip format: 110 subjects.
    • Cassette format: 105 subjects.
    • Midstream format (dip): 53 subjects.
    • Midstream format (in-stream): 53 subjects.
  • Lay Person Study (Second Study - spiked samples): Total of 300 laypersons (100 per device format). Each tested 4 blind-labeled samples. So, 400 tests per format.
  • Early Pregnancy Detection Study: 68 pregnant women provided 680 early pregnancy urine samples (from day -9 to 0 relative to expected period, presumably 10 samples per woman across these days). Each sample was tested with each format.
  • Specificity Study (False-Positive Rate): 900 urine samples collected from non-pregnant females. 300 participants per age group (pre-menopausal, peri-menopausal, post-menopausal). For each age group, 100 tested strip, 100 tested cassette, 100 tested midstream (method not specified, but likely implies dip or in-stream was representative, or it was split). Three batches of each format were used.

• Data Provenance:

  • Country of Origin: Not explicitly stated, but clinical studies were conducted at "three clinical sites," which typically implies the country where the manufacturer is located or seeking approval (likely USA given FDA submission).
  • Retrospective or Prospective:
    • Analytical studies (sensitivity, interference, etc.) are inherently prospective as they involve specific preparation and testing of samples.
    • Method comparison, lay person studies, early pregnancy detection study, and specificity study likely involved prospective collection of samples and testing as described (e.g., "Urine samples were collected from 321 women... at three clinical sites," "A lay user study was performed at three sites," "680 early pregnancy urine samples... were collected from 68 pregnant women," "900 urine samples were collected from non-pregnant females").

3. Number of Experts and Qualifications for Ground Truth

• Ground Truth for Analytical Studies (Sensitivity, Interfering substances, etc.): The ground truth for hCG concentration was established by spiking negative female urine with hCG standard traceable to the 5th WHO (World Health Organization) standard. This indicates a highly standardized and globally recognized reference. The "operators" who performed the tests are not explicitly described as "experts" in establishing ground truth, but rather trained personnel conducting the tests.
• Ground Truth for Method Comparison & Lay Person Studies (First Study): Ground truth was established by professional testing (laboratory professionals) and comparison to a predicate device. The document refers to "at least one professional at each site using the candidate device and by one professional at each site using the predicate device." Their specific qualifications are not detailed beyond "professional."
• Ground Truth for Lay Person Study (Second Study - Spiked Samples): The samples were blind labeled by the person who prepared the samples (and did not take part in testing). The ground truth for the spiked samples was their known hCG concentration. These spiked urine samples were also tested by professionals to generate professional results for comparison with layperson results.
• Ground Truth for Early Pregnancy Detection Study: The "positive results of B-ultrasound" (beta-ultrasound) served as the definitive ground truth for confirmed pregnancy at specific days relative to the expected menstrual period (EMP). This is a widely accepted clinical method for confirming pregnancy and gestational age.
• Ground Truth for Specificity Study: "Non-pregnant females" were tested. The ground truth for "non-pregnant" would inherently be established by clinical assessment, possibly including absence of a positive ultrasound and absence of HCG in other clinical tests at the time of study enrollment.

4. Adjudication Method for the Test Set

• No explicit "adjudication method" like 2+1 or 3+1 is mentioned for reconciling discordant results in the human studies.
• For the analytical studies (e.g., sensitivity), reproducibility involves comparing results across multiple operators and lots.
• For the method comparison and lay person studies, results are simply compared to the professional result or predicate device result. For the second lay person study, samples were "blind-labeled" with known concentrations, minimizing the need for adjudication of ground truth, but discrepancies between layperson and professional results are simply reported (e.g., "Percent Agreement").
• For the early pregnancy detection study, results were correlated with B-ultrasound findings, which serves as a definitive clinical ground truth, reducing the need for consensus-based adjudication of the test results themselves.

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

• No MRMC comparative effectiveness study was done. This device is a rapid diagnostic test (HCG test strip/cassette/midstream) for direct visual reading by a single user (professional or layperson), not an imaging device that would typically involve multiple readers interpreting complex images. Therefore, a study comparing human readers with and without AI assistance is not applicable.

6. Standalone (Algorithm Only) Performance

• This is not an AI/algorithm-based device. It is a visually read immunoassay. Therefore, a standalone performance study of an algorithm is not applicable. The device's performance is inherently tied to the user's visual interpretation, even for "professional" use. However, the "Analytical performance" section could be considered the "standalone" performance in the sense of the device's inherent capability under controlled conditions, demonstrating sensitivity and specificity based on the chemical reaction.

7. Type of Ground Truth Used

The types of ground truth used varied by study:

• Known hCG concentrations: For analytical sensitivity, hook effect, interfering substances, cross-reactivity, and effects of pH/density. These were generated in a lab setting by spiking negative urine samples with certified hCG standards.
• Results from a legally marketed predicate device: For the method comparison study.
• Professional testing/interpretation: For comparison in the lay person studies.
• B-ultrasound (beta-ultrasound): For the early pregnancy detection study, serving as the definitive clinical confirmation of pregnancy.
• Clinical status of "non-pregnant": For the specificity study, based on a cohort of non-pregnant females.

8. Sample Size for the Training Set

• This document describes a 510(k) premarket notification for an in vitro diagnostic (IVD) test kit, not an AI/ML software device. As such, there is no "training set" in the context of machine learning model development. The data presented here are for validation/testing of the device's performance against its claims to establish substantial equivalence.

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

• As explained in point 8, there is no "training set" for an AI/ML model for this type of IVD device. The various ground truths used for the validation studies are described in point 7.

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The FaStep™ Fentanyl Rapid Test Device (Urine) is a rapid visual immunoassay for the qualitative, presumptive detection of Fentanyl in human urine specimens at a cut-off concentration of 1.0 ng/mL. It is for in vitro diagnostic use only.

The tests provide only preliminary test results. A more specific alternative chemical method must be used in order to obtain a confirmed analytical result. GC/MS or LC/MS is the preferred confirmatory method.

The FaStep™ Rapid Fentanyl Urine Test (Urine) is a rapid visual immunoassay for the qualitative, presumptive detection of Fentanyl in human urine specimens at a cut-off concentration of 1.0 ng/mL. It is for in vitro diagnostic use only.

The tests provide only preliminary test results. A more specific alternative chemical method must be used in order to obtain a confirmed analytical result. GC/MS or LC/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 FaStep™ Fentanyl Tests are immunoassays intended for the qualitative detection of fentanyl in human urine. Each FaStep™ Fentanyl Test device consists of a Test Cassette, a Dropper and a package insert. Each Test Cassette is sealed with sachets of desiccant in an aluminum pouch.

The provided text is a 510(k) summary for the FaStep™ Fentanyl Rapid Test Device (Urine), an in vitro diagnostic device. It details the device's technical specifications and performance characteristics through analytical and lay-user studies. It does not describe a clinical study comparing human readers with and without AI assistance (MRMC study), nor does it involve the use of AI. Therefore, the information typically associated with acceptance criteria and studies for AI-powered devices, such as specific performance metrics like AUC, sensitivity, specificity for diagnostic accuracy in a clinical setting, or expert consensus and adjudication methods for ground truth, is not directly applicable or present in this document.

However, I can extract the relevant information from the document regarding the acceptance criteria and the study that proves the device meets the acceptance criteria, adapting to the context of a rapid diagnostic test.

Here’s the breakdown based on the provided text, focusing on the analytical and lay-user performance of the rapid immunoassay:

Acceptance Criteria and Device Performance (Adapted for a Rapid Diagnostic Test)

The primary performance evaluation in this document centers around the device's ability to accurately detect fentanyl in urine at a specific cut-off concentration (1.0 ng/mL) under various conditions. The "acceptance criteria" are implied by the desired accuracy rates at and around this cut-off, as demonstrated in the precision and lay-user studies.

1. Table of Acceptance Criteria (Implied) and Reported Device Performance:

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