Search Results

The Deepblue Multi-Drug Urine Test Cup is a rapid lateral flow immunoassay for the qualitative detection of 6-Monoacetylmorphine, d-Amphetamine, Benzoylecgonine, Buprenorphine, EDDP, fentanyl, Methadone, d-Methamphetamine, d/l-Methylenedioxymethamphetamine, Morphine, Nortriptyline, Oxazepam, Oxycodone, Phencyclidine, d-Propoxyphene, Secobarbital, and THC-COOH in human urine. The test cut-off concentrations and the compounds the tests are calibrated to are as follows:

The single or multi-test cups can consist of up to seventeen (17) of the above listed analytes in any combination with or without on-board adulteration/specimen validity tests (SVT).

The tests provide only a preliminary result. A more specific alternative chemical method must be used to obtain a confirmed presumptive positive result. Gas Chromatography-Mass Spectrometry (GC-MS), Liquid Chromatography-Mass Spectrometry (LC-MS), and their tandem mass-spectrometer versions are the preferred confirmatory methods. Careful consideration and judgment should be applied to any drugs of abuse screen test result, particularly when evaluating preliminary positive results.

The Deepblue Home Multi-Drug Urine Test Cup is a rapid qualitative immunoassay. The device provides preliminary results for the detection of one or more of the following drugs.

This drug test cup may contain any combination of the drug tests listed in the table above.

This test provides only preliminary result. A more specific alternative chemical method must be used to obtain a confirmed presumptive positive result. Gas Chromatography-Mass Spectrometry (GC-MS), Liquid Chromatography-Mass Spectrometry (LC-MS), and their tandem mass-spectrometer versions are the preferred confirmatory methods. Careful consideration and judgment should be applied to any drugs of abuse screen test result, particularly when evaluating preliminary positive results.

Deepblue Home Muti-Drug Urine Test Cup and Deepblue Muti-Drug Urine Test Cup are immunochromatographic assays that use a lateral flow system for the qualitative detection of single or multiple drugs in human urine.

The device is a cup format. Each test device is sealed with two sachets of desiccant in an aluminum pouch. The device is in a ready-to-use format and no longer requires assembly before use.

The provided FDA 510(k) clearance letter details the performance characteristics of the Deepblue Multi-Drug Urine Test Cup and Deepblue Home Multi-Drug Urine Test Cup. This information allows us to describe the acceptance criteria and the study that proves the device meets these criteria.

It's important to note that this device is a qualitative lateral flow immunoassay for initial drug screening, not a diagnostic imaging AI, so the criteria and study methodology differ significantly from those for an AI-powered diagnostic tool. Specifically, there are no references to AI assistance, human readers, or image adjudication, as these are not relevant to this type of device.

Acceptance Criteria and Device Performance for Deepblue Multi-Drug Urine Test Cups

The acceptance criteria for this type of qualitative immunoassay are primarily based on its analytical performance, specifically its ability to correctly identify the presence or absence of target drugs at specified cutoff concentrations. This is demonstrated through precision/reproducibility studies, analytical specificity (cross-reactivity and interference), and method comparison studies against a gold standard (LC-MS/MS).

1. Table of Acceptance Criteria and Reported Device Performance

The acceptance criteria are implicitly derived from the successful demonstration of performance in the analytical and method comparison studies. The goal is to achieve high agreement rates with the confirmatory method (LC-MS/MS) and consistent results at and around the cutoff concentrations.

Ask a specific question about this device

Dochek® Multi-Drug Urine Test Cup is an immunoassay for the qualitative determination of single or multiple drugs in human urine at the following cutoff concentrations.
Dochek® Multi-Drug Urine Test Cup offers any combinations from 1 to 17 drugs but only one cutoff concentration under same drug condition will be included per device.
It is intended for over-the-counter (OTC) use. For in vitro diagnostic use only.
The test provides only preliminary results. Clinical consideration and professional judgment should be applied to any drug of abuse test result, particularly in evaluating a postive result. To obtain a confirmed analytical result, a more specific alternate chemical method is needed. GC/MS or LC/MS is the recommended confirmatory method.
Dochek® Multi-Drug Urine Test Cup Pro is an immunoassay for the qualitative determination of single or multiple drugs in human urine at the following cutoff concentrations.
Dochek® Multi-Drug Urine Test Cup Pro offers any combinations from 1 to 17 drugs but only one cutoff concentration under same drug condition will be included per device.
For in vitro diagnostic use only.
The test provides only preliminary results. Clinical consideration and professional judgment should be applied to any drug of abuse test result, particularly in evaluating a preliminary positive result. To obtain a confirmed analytical result, a more specific alternate chemical method is needed. GC/MS or LC/MS is the recommended confirmatory method.

Dochek® Multi-Drug Urine Test Cup Pro and Dochek® Multi-Drug Urine Test Cup are immunochromatographic assays that use a lateral flow system for the qualitative detection of single or multiple drugs in human urine at or above the cut-off levels as indicated. The products are single use in vitro diagnostic medical devices.
This device is a cup format, with the test strips integrated into the plastic cup provided, and the urine sample is collected directly into the cup containing the strips. Each cup device is sealed in an aluminum foil pouch with two sachets of desiccant. The device is in a ready-to-use format and no longer requires assembly before use.

The provided text describes the Dochek® Multi-Drug Urine Test Cup and Dochek® Multi-Drug Urine Test Cup Pro, which are immunoassays for the qualitative determination of single or multiple drugs in human urine. The acceptance criteria and the studies performed to demonstrate performance are detailed below. It is important to note that the acceptance criteria are implied by the reported performance, as explicit criteria are not stated in terms of thresholds for sensitivity/specificity. Instead, the studies demonstrate accuracy and agreement against a reference method and other concentrations.

1. Table of Acceptance Criteria and Reported Device Performance

The acceptance criteria are implicitly defined by the goal of demonstrating substantial equivalence to a predicate device and achieving certain performance levels in precision, accuracy against a reference method, and lay user comprehension.

Notes on the tables below:

• "Cutoff" refers to the specified ng/mL for each drug.
• "+" indicates a preliminary positive result (drug detected).
• "-" indicates a negative result (drug not detected).
• LC-MS/MS is the reference method for confirming drug concentrations.
• The "Percentage of correct results (%)" in the Lay User Study is derived from the reported counts of negative and positive results compared to the expected outcome given the drug concentration relative to the cutoff. For example, a sample at -100% cutoff should be negative, and a sample at +100% cutoff should be positive.

1.1. Precision/Reproducibility Study (Fentanyl (FTY) Example)

1.2. Method Comparison Study (Fentanyl (FTY) Example)

This study compares the device's results to LC-MS/MS, a highly accurate confirmatory method. The "Discordant results" highlight where the device deviated from the LC-MS/MS findings.

Summary of Discordant Fentanyl Results (FTY 1 ng/mL):

1.3. Lay Person Study (Configuration 1 & 2 - Example for AMP, BAR, BUP, BZO, COC, EDDP, MDMA, MET, OPI, MTD, OXY, PCP, PPX, TCA, THC, 6-MAM, FTY)

This study evaluates the device's performance when used by non-professionals. Results are generally expected to be 100% correct for samples at -100% and +100% of the cutoff, and high percentages for other concentrations (e.g., ≥90-95% for +/-25% of cutoff).

2. Sample Size and Data Provenance

Precision Study:

• Sample Size (Test Set): For Fentanyl, 50 tests were performed at each of the 9 concentration levels (+/-100%, +/-75%, +/-50%, +/-25% of cutoff, and cutoff) across 3 lots, for a total of 9 concentrations * 50 measurements * 3 lots = 1350 tests.
• Data Provenance: Samples were prepared by spiking target drug in drug-free urine samples. The source of the drug-free urine or spiked drugs is not explicitly stated in terms of country of origin. This was a prospective study, with samples specifically prepared for the testing.

Method Comparison Study:

• Sample Size (Test Set): 80 unaltered clinical urine samples were used for each drug (40 negative and 40 positive). For Fentanyl, this means 80 samples were tested.
• Data Provenance: Unaltered clinical urine samples. The country of origin of these clinical samples is not specified. This appears to be a retrospective study using existing clinical samples.

Lay Person Study:

• Sample Size (Test Set): 280 lay users participated.
  • Configuration 1: 140 users (68 male, 72 female).
  • Configuration 2: 138 users (74 male, 64 female).
  • Across 7 concentration levels (+/-100%, +/-75%, +/-50%, +/-25% of cutoff, and cutoff), with 20 samples per concentration level for each drug. This means for each drug, 7 * 20 = 140 results were generated by lay users.
• Data Provenance: Urine samples were prepared by spiking drug(s) into drug-free pooled urine specimens. The source of the drug-free pooled urine or spiked drugs is not explicitly stated in terms of country of origin. This was a prospective study.

3. Number of Experts and Qualifications for Ground Truth

• Precision Study: Ground truth for sample concentrations was confirmed by LC-MS/MS. This method is a highly qualified and generally accepted gold standard for drug concentration determination, not relying on human expert interpretation of the test result itself.
• Method Comparison Study: Ground truth was established by LC-MS/MS results. The operators in this study were "three operators" (presumably laboratory personnel or technicians, but their specific qualifications are not detailed). These operators read the device results, which were then compared to the LC-MS/MS ground truth.
• Lay Person Study: Ground truth for sample concentrations was confirmed by LC-MS/MS. The lay users themselves provided the device readings, and the percentage of correct results was calculated against the LC-MS/MS confirmed concentrations.

4. Adjudication Method for the Test Set

• Precision Study: The results are quantitative (counts of positive/negative) based on pre-defined concentrations. No adjudication method is explicitly described for subjective interpretation as the test is qualitative and the results are directly read as positive or negative by trained personnel (implied).
• Method Comparison Study: "Three operators" read the device results. The individual results for each viewer (A, B, C) are presented. There is no explicit adjudication method (e.g., 2-out-of-3 consensus) mentioned to derive a single device result per sample if the operators disagreed. The discordant results table shows instances where operators disagreed, or where the device result from an individual operator disagreed with LC-MS/MS.
• Lay Person Study: Lay users performed the tests independently. There is no mention of an adjudication process among lay users for their readings. Each participant provided a single result for their assigned sample/device.

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

No Multi-Reader Multi-Case (MRMC) comparative effectiveness study was mentioned to quantify the improvement of human readers with AI assistance versus without AI assistance. The device is a lateral flow immunoassay, not an AI-powered diagnostic for image interpretation or similar tasks often associated with MRMC studies.

6. Standalone Performance Study

Yes, standalone performance was conducted for the device.

• Precision Study: The device's inherent precision was evaluated across different drug concentrations and lots, independent of human interpretation variability (though human reading is still involved for the qualitative result).
• Method Comparison Study: The device's performance against the gold standard (LC-MS/MS) was evaluated by three operators independently, representing a standalone assessment of the device's accuracy in a laboratory setting.
• Lay Person Study: This study specifically assessed the standalone performance of the device when used by the intended lay users, including their ability to follow instructions and interpret results correctly.

7. Type of Ground Truth Used

The primary ground truth used for evaluating the device's accuracy in all relevant studies (Precision, Method Comparison, Lay Person) was:

• LC-MS/MS (Liquid Chromatography-Mass Spectrometry/Mass Spectrometry): This is a highly sensitive and specific analytical chemistry technique used to precisely confirm the presence and concentration of drugs and their metabolites in urine samples. This serves as the objective, quantitative ground truth for drug concentrations.

8. Sample Size for the Training Set

The provided document describes performance studies (precision, method comparison, lay person study) for the Dochek® Multi-Drug Urine Test Cup devices. These are immunoassay devices, not machine learning or AI-based devices that typically have "training sets" in the computational sense. The document does not describe any such training set for an algorithm. The development of the immunoassay itself relies on chemical and biological principles rather than algorithm training.

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

Since there is no "training set" in the context of a machine learning algorithm for this immunoassay device, this question is not applicable. The device's performance characteristics are inherent to its biochemical design.

Ask a specific question about this device

Dochek® Fentanyl Urine Test Strip Plus is a competitive binding, lateral flow immunochromatographic assay for the qualitative detection of Fentanyl (FTY) in human urine at the cut-off concentration of 1 ng/mL.

For in vitro diagnostic use only.

The test provides only preliminary results. To obtain a confirmed analytical result, a more specific alternative chemical method must be used. GC/MS or LC/MS is the preferred confirmatory method. Clinical consideration and professional judgment should be applied to any drug of abuse test result, particularly when the preliminary result is positive.

Dochek® Fentany] Urine Test Card Plus is a competitive binding, lateral flow immunochromatographic assay for the qualitative detection of Fentanyl (FTY) in human urine at the cut-off concentration of 1 ng/mL. For in vitro diagnostic use only.

The test provides only preliminary results. To obtain a confirmed analytical result, a more specific alternative chemical method must be used. GC/MS or LC/MS is the preferred confirmatory method. Clinical consideration and professional judgment should be applied to any drug of abuse test result, particularly when the preliminary result is positive.

Dochek® Fentanyl Urine Test Cup Plus is a competitive binding, lateral flow immunochromatographic assay for the qualitative detection of Fentanyl (FTY) in human urine at the cut-off concentration of 1 ng/mL.

For in vitro diagnostic use only.

The test provides only preliminary results. To obtain a confirmed analytical result, a more specific alternative chemical method must be used. GC/MS or LC/MS is the preferred confirmatory method. Clinical consideration and professional judgment should be applied to any drug of abuse test result, particularly when the preliminary result is positive.

Dochek® Fentanyl Urine Test Strip is a competitive binding, lateral flow immunochromatographic assay for the qualitative detection of Fentanyl (FTY) in human urine at the cut-off concentration of 1 ng/mL.

It is intended for over-the-counter (OTC) use. For in vitro diagnostic use only.

The test provides only preliminary results. To obtain a confirmed analytical result, a more specific alternative chemical method must be used. GC/MS or LC/MS is the preferred confirmatory method. Clinical consideration and professional judgment should be applied to any drug of abuse test result, particularly when the preliminary result is positive.

Dochek® Fentanyl Urine Test Card is a competitive binding, lateral flow immunochromatographic assay for the qualitative detection of Fentanyl (FTY) in human urine at the cut-off concentration of 1 ng/mL.

It is intended for over-the-counter (OTC) use. For in vitro diagnostic use only.

The test provides only preliminary results. To obtain a confirmed analytical result, a more specific alternative chemical method must be used. GC/MS or LC/MS is the preferred confirmatory method. Clinical consideration and professional judgment should be applied to any drug of abuse test result, particularly when the preliminary result is positive.

Dochek® Fentanyl Urine Test Cup is a competitive binding, lateral flow immunochromatographic assay for the qualitative detection of Fentanyl (FTY) in human urine at the cut-off concentration of 1 ng/mL.

It is intended for over-the-counter (OTC) use. For in vitro diagnostic use only.

The test provides only preliminary results. To obtain a confirmed analytical result, a more specific alternative chemical method must be used. GC/MS or LC/MS is the preferred confirmatory method. Clinical consideration and professional judgment should be applied to any drug of abuse test result, particularly when the preliminary result is positive.

Dochek® Fentanyl Urine Test Strip, Dochek® Fentanyl Urine Test Strip Plus, Dochek® Fentany1 Urine Test Card, Dochek® Fentany] Urine Test Card Plus, Dochek® Fentanyl Urine Test Cup and Dochek® Fentanyl Urine Test Cup Plus are immunochromatographic assays that use a lateral flow system for the qualitative detection of fentanyl in human urine.

Test Strip, Test Card and Test Cup use identical test strips made with same chemical formulation and manufacturing procedures.

The provided document is a 510(k) summary for the Dochek® Fentanyl Urine Test System. It describes the device's performance through various studies.

Here's an analysis of the acceptance criteria and study details:

Device: Dochek® Fentanyl Urine Test Strip, Dochek® Fentanyl Urine Test Strip Plus, Dochek® Fentanyl Urine Test Card, Dochek® Fentanyl Urine Test Card Plus, Dochek® Fentanyl Urine Test Cup, Dochek® Fentanyl Urine Test Cup Plus

Intended Use: Qualitative detection of Fentanyl (FTY) in human urine at a cut-off concentration of 1 ng/mL for in vitro diagnostic (OTC) use.

1. Table of Acceptance Criteria and Reported Device Performance:

The document doesn't explicitly state "acceptance criteria" as a separate, pre-defined set of thresholds. Instead, it presents performance data from various studies. For the purpose of this response, I will consider a general expectation for such devices to perform accurately around the cutoff.

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

• Precision/Reproducibility Study:
  • Test Set Size: For each concentration (0ng/mL, 0.25ng/mL, 0.75ng/mL, 1ng/mL, 1.25ng/mL, 1.5ng/mL, 1.75ng/mL, and 2ng/mL), 60 determinations were made per lot, with two operators independently reading results, leading to 60 results per concentration per lot. With 3 lots, this is 180 determinations per concentration, or 360 individual readings (across two operators).
  • Data Provenance: The specimens were "drug-free specimens spiked with Fentanyl." No specific country of origin is mentioned, but the study was conducted over 10 non-consecutive days using three different lots of the device. This appears to be a prospective study using prepared samples.
• Method Comparison Study:
  • Test Set Size: 80 clinical urine specimens were used. These were analyzed by LC/MS and by 3 lots of each Dochek® Fentanyl Urine Test product (Strip, Card, Cup). Therefore, for each device type, 80 samples were tested 3 times (once per lot/operator).
  • Data Provenance: "Clinical urine specimens." No specific country of origin is mentioned. This appears to be a retrospective study using existing clinical samples.
• Lay Person Study:
  • Test Set Size: 980 lay persons participated. For each concentration (0ng/mL, 0.25 ng/mL, 0.75ng/mL, 1.25ng/mL, 1.5ng/mL, 1.5ng/mL, 1.75ng/mL), the number of determinations per lot was 40 for the Strip and Cup, and 30 for the Card (cassette and dipcard). Each participant tested one blind-labeled sample.
  • Data Provenance: The urine samples were "prepared at the following concentrations... by spiking target drug fentanyl into drug free urine specimens." This indicates samples were prepared for the study. No specific country of origin is mentioned for the lay persons, but the study was conducted at "three intended user sites." This appears to be a prospective study using artificially prepared samples.

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

• Precision/Reproducibility Study: The ground truth for concentrations (0ng/mL, 0.25ng/mL, etc.) was established by LC-MS/MS. The document does not specify the number or qualifications of experts operating the LC-MS/MS. Device results were read in duplicate by "two different operators," but these are device operators, not ground truth experts.
• Method Comparison Study: The ground truth was established by LC/MS. The document does not specify the number or qualifications of experts operating the LC/MS. The study was conducted by "3 laboratory professionals at the manufacturer site" who performed the Dochek® tests.
• Lay Person Study: The ground truth for sample concentrations was confirmed by LC/MS. The document does not specify the number or qualifications of experts operating the LC/MS.

4. Adjudication Method for the Test Set:

• Precision/Reproducibility Study: Results for the Dochek device were "read in duplicate by two different operators." It doesn't explicitly state an adjudication method (e.g., 2+1, 3+1). It seems individual operator readings were recorded per sample.
• Method Comparison Study: The document lists results for "Lot 1, operator 1," "Lot 2, operator 2," and "Lot 3, operator 3" separately. This suggests that each operator's reading for each lot was compared directly to the LC/MS benchmark, rather than an adjudication among the operators' readings for a single sample.
• Lay Person Study: Each participant was given one device and one blind-labeled sample. The "Layer user Results" are presented as total positive/negative counts. There's no mention of adjudication among lay users' interpretations for the same sample.

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 MRMC comparative effectiveness study was mentioned. The device is a qualitative lateral flow immunoassay, not an AI-assisted diagnostic. Thus, questions regarding human reader improvement with AI assistance are not applicable.

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

The device itself is a standalone, read by a human. There is no algorithm component described that would operate without human-in-the-loop for reading the results. The studies assess the performance of the device as it is intended to be used (i.e., with human interpretation).

7. The Type of Ground Truth Used:

The primary ground truth method used across all studies (precision, method comparison, and lay person) was LC/MS or LC-MS/MS (Liquid Chromatography-Mass Spectrometry/Mass Spectrometry). This is a highly accurate and precise analytical chemistry method for identifying and quantifying substances.

8. The Sample Size for the Training Set:

The document describes performance studies for premarket notification. It does not mention a "training set" in the context of machine learning or AI. The product is a diagnostic device, and the data presented are for validation and verification, not for training an algorithm.

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

As there is no mention of a "training set" for an algorithm, this question is not applicable. The ground truth for the various performance evaluation samples (spiked samples, clinical samples) was established through LC/MS or LC-MS/MS.

Ask a specific question about this device

The Healgen® Accurate Multi-Drug Urine Screening Cup is a rapid lateral flow immunoassay for the qualitative detection of 6-Monoacetylmorphine, d-Amphetamine, Benzoylecgonine, Buprenorphine, EDDP, Norfentanyl, Methadone, d-Methamphetamine, d/l-Methylenedioxymethamine, Mortriptyline, Oxazepam, Oxycodone, Phencyclidine, d-Propoxyphene, Secobarbital, THC-COOH and Tramadol in human urine. The test cut-off concentrations and the compounds the tests are calibrated to are as follows:

The single or multi-test cups can consist of up to eighteen (18) of the above listed analytes in any combination with or without on-board adulteration/specimen validity tests (SVT).

The tests provide only a preliminary result. A more specific alternative chemical must be used to obtain a confirmed positive result. Gas Chromatography-Mass Spectrometry (GC-MS), Liquid Chromatography-Mass Spectrometry (LC-MS), and their tandem mass-spectrometer versions are the preferred confirmatory methods. Careful consideration and judgment should be applied to any drugs of abuse screen test result, particularly when evaluating preliminary positive results.

The Healgen® Accurate Home Multi-Drug Urine Test Cup is a rapid qualitative immunoassay. The device provides preliminary results for the detection of one or more of the following drugs

This drug test cup may contain any combination of the drug tests listed in the table above.

This test provides only preliminary result. A more specific alternative chemical must be used to obtain a confirmed positive result. Gas Chromatography-Mass Spectrometry (GC-MS), Liquid Chromatography-Mass Spectrometry (LC-MS), and their tandem mass-spectrometer versions are the preferred confirmatory methods. Careful consideration and judgment should be applied to any drugs of abuse screen test result, particularly when evaluating preliminary positive results.

Healgen® Accurate Home Muti-Drug Urine Test Cup and Healgen® Accurate Muti-Drug Urine Drug Screen Cup are immunochromatographic assays that use a lateral flow system for the qualitative detection of single or multiple drugs in human urine.

The device is a cup format. Each test device is sealed with two sachets of desiccant in an aluminum pouch. The device is in a ready-to-use format and no longer requires assembly before use.

Acceptance Criteria and Device Performance for Healgen® Accurate Multi-Drug Urine Drug Screen Cup

This document outlines the acceptance criteria and the evidence provided to demonstrate that the Healgen® Accurate Multi-Drug Urine Drug Screen Cup meets these criteria. The information is extracted from the provided FDA 510(k) summary (K243365).

1. Table of Acceptance Criteria and Reported Device Performance

The acceptance criteria for this qualitative immunoassay are primarily demonstrated through a combination of precision, analytical specificity/interference, and a method comparison study. The precision study evaluates the device's ability to consistently produce correct results at various concentrations relative to the cutoff, while the method comparison study assesses its agreement with a gold standard (LC-MS/MS) using clinical samples. The layperson study demonstrates ease of use for over-the-counter applications.

• 100% agreement for concentrations at -100%, -75%, -50%, +50%, +75%, and +100% cutoff (e.g., 0-/50+ or 50-/0+ indicating no false negatives or positives respectively).
• At the cutoff concentration, results consistently showed a mix of positive and negative interpretations, typically near 50%/50% (e.g., 23-/27+, 25-/25+), demonstrating sensitivity around the cutoff.
• At -25% cutoff, the device predominantly showed negative results (e.g., 50-/0+ or 49-/1+), with a few false positives.
• At +25% cutoff, the device predominantly showed positive results (e.g., 0-/50+ or 1-/49+), with a few false negatives.
  This indicates good precision around the cutoff with expected variability at borderline concentrations. |
  | Analytical Specificity | No significant cross-reactivity with commonly encountered substances (drug metabolites, prescription medications, endogenous compounds) at relevant concentrations, and no interference from variations in pH and specific gravity within a physiological range. | Diverse lists of compounds were tested for cross-reactivity. The results show that:
• Many cross-reacting compounds are identified with their minimum concentration needed to yield a positive result and their % Cross-Reactivity (e.g., Hydroxyamphetamine with AMP 1000, Amobarbital with BAR 300).
• Numerous compounds showed no detection or were negative at high concentrations (e.g., 100,000 ng/mL), indicating no cross-reactivity for those substances.
• pH levels of 4 to 9 and specific gravity levels of 1.000 to 1.035 were demonstrated to not affect the assay results. |
  | Method Comparison | A high degree of concordance between the device's qualitative results and confirmatory Gas Chromatography-Mass Spectrometry (GC-MS) or Liquid Chromatography-Mass Spectrometry (LC-MS) results for clinical urine samples, particularly for samples at or near the cutoff. | For each drug and its cutoff configuration:
• 100% agreement was observed for drug-free samples and "low negative" samples (less than -50% of cutoff).
• 100% agreement was primarily observed for "high positive" samples (greater than +50% of cutoff).
• For "near cutoff negative" (between -50% and cutoff) and "near cutoff positive" (between cutoff and +50%) samples, there was expected variability, with some samples interpreted differently by the device compared to LC-MS/MS, indicating the device's expected performance around the cutoff. The discordant results table details specific samples where device results differed from LC-MS/MS. Generally, the majority of samples near the cutoff were correctly identified by the device. |
  | Lay Person Usability | The device should be easy to understand and use by laypersons as indicated by a high agreement in understanding instructions and performance on prepared samples across different drug classes. A reading level analysis of the instructions for use should demonstrate appropriate readability. | A study with 280 laypersons (mix of male/female, aged 21 to >50, diverse backgrounds) demonstrated:
• 100% agreement for interpretation of drug-free and concentrations at -100%, -75%, -50% below cutoff.
• 100% agreement for concentrations at +50% and +75% above cutoff.
• Expected variability in agreement around the -25% and +25% cutoff concentrations, mostly ranging from 90% to 95%.
• All participants indicated the instructions were easy to understand and follow.
• The Flesch-Kincaid reading analysis yielded a Grade Level of 7, which is suitable for layperson use. |
  | Stability | The device should maintain its performance characteristics for a specified duration under defined storage conditions. | The device is stable at 2-30°C for 36 months based on real-time stability studies. |

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

Precision/Reproducibility Study:

• Sample Size: For each drug and each concentration level (total 9 levels per drug), 50 individual tests were performed (2 runs per day for 25 days). Given there are 17 distinct drug analytes, this amounts to 17 drugs * 9 concentrations * 50 tests/concentration = 7,650 tests.
• Data Provenance: Samples were prepared by spiking target drugs into drug-free urine samples. These samples were likely prepared in a laboratory setting, making the data provenance prospective and controlled. The document does not specify a country of origin for the samples/urine, but the study was conducted "in-house."

Method Comparison Study:

• Sample Size: For each drug, 80 unaltered urine clinical samples were used. This consisted of 40 negative and 40 positive samples. Given there are 17 distinct drug analytes, this amounts to 17 drugs * 80 samples/drug = 1,360 total clinical samples tested across all drugs.
• Data Provenance: Unaltered clinical urine samples. The document does not specify the country of origin but states the study was performed "in-house." The nature of "unaltered clinical samples" suggests these were collected from patients, and their retrospective or prospective nature is not explicitly stated, though being "blind labeled" for comparison suggests they were handled specifically for this study.

Lay Person Study:

• Sample Size: 280 lay persons participated. Urine samples were prepared at 7 concentration levels (-100%, +/-75%, +/-50%, +/-25% of cutoff). Each participant tested 1 blind labeled sample. While it states urine samples were prepared at 7 concentrations, the agreement tables show 7 concentrations and 20 tests per concentration for each drug. If we assume each of the 280 participants tested one sample for one drug, the sample sizes per concentration shown in the table (20 tests) indicate that multiple participants contributed data for each drug and concentration, but a single participant did not test all drugs or all concentrations.
• Data Provenance: Urine samples were prepared by spiking drugs into drug-free pooled urine specimens. The samples were prepared in a laboratory environment, indicating prospective and controlled data provenance. The lay persons were recruited for the study, making their involvement prospective. The study was performed at "three intended user sites."

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

Precision/Reproducibility Study:

• Ground Truth: The "ground truth" for the spiked samples was established by the known concentrations of the spiked drugs, which were confirmed by LC-MS/MS.
• Experts/Qualifications: The document states that "Each drug concentration was confirmed by LC-MS/MS." LC-MS/MS is a highly accurate analytical method, and while specific "experts" (e.g., toxicologists, clinical chemists) are not explicitly named, the use of this method implies analysis by qualified laboratory personnel specializing in mass spectrometry. "One operator per lot" (for 3 lots) performed the tests on the device, but the LC-MS/MS confirmation implies separate, expert analysis for ground truth.

Method Comparison Study:

• Ground Truth: The ground truth for the clinical samples was established by LC-MS/MS results.
• Experts/Qualifications: Similar to the precision study, the ground truth was determined by LC-MS/MS, implying analysis by qualified laboratory professionals. No specific number or qualification of "experts" is provided beyond the analytical method itself.

Lay Person Study:

• Ground Truth: The "ground truth" for the spiked samples was established by the known concentrations of the spiked drugs, which were confirmed by LC-MS/MS.
• Experts/Qualifications: As above, the ground truth was derived from LC-MS/MS analysis, indicating reliance on qualified laboratory personnel.

4. Adjudication Method for the Test Set

Precision/Reproducibility Study:

• Adjudication Method: Not applicable in the traditional sense of expert consensus. The ground truth was based on the quantitative LC-MS/MS results of the spiked samples. The device's qualitative results were compared against these known concentrations relative to the cutoff. Discrepancies were noted directly.

Method Comparison Study:

• Adjudication Method: Not applicable/Not explicitly stated as an adjudication process involving multiple human readers. The device results were directly compared to the LC-MS/MS results, which served as the definitive "true" value (ground truth). The tables show the device's output (positive/negative) versus the LC-MS/MS quantification, which then categorizes samples as drug-free, low negative, near cutoff negative, near cutoff positive, or high positive.

Lay Person Study:

• Adjudication Method: Not applicable in terms of expert consensus. The laypersons' interpretations of the device results were compared against the established ground truth (LC-MS/MS confirmed concentrations of spiked samples). The study aimed to assess if laypersons could correctly interpret the device results against this objective ground truth, not for them to establish ground truth or adjudicate.

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

No, an MRMC comparative effectiveness study was not done in the context of comparing human readers with and without AI assistance, as this is an in-vitro diagnostic device (a test cup) not an AI-powered diagnostic imaging or interpretation system. The "operators" in the method comparison study refer to individuals performing the device test, not medical interpreters assisted by AI. The "lay person study" evaluated if laypersons could correctly interpret the device, not an AI system.

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

This is an in-vitro diagnostic (IVD) device (a lateral flow immunoassay test cup), not an AI algorithm. Therefore, the concept of "standalone (algorithm only)" performance without human-in-the-loop is not applicable in the typical sense for AI/software devices. The device itself provides a visual qualitative result (lines appearing or not appearing), which then requires human observation and interpretation. The performance characteristics described (precision, specificity, method comparison) are inherently "standalone" in that they assess the device's ability to produce correct visual results, which a human then reads. The layperson study specifically evaluates the human (layperson) interpretation of these visual results.

7. The Type of Ground Truth Used

The primary type of ground truth used across all analytical performance studies (Precision, Analytical Specificity, Method Comparison, and Lay Person Study where applicable) is Gas Chromatography-Mass Spectrometry (GC-MS) and Liquid Chromatography-Mass Spectrometry (LC-MS) and their tandem mass-spectrometer versions (LC-MS/MS).

These are considered confirmatory analytical methods and are widely accepted as the gold standard for quantitative drug detection in toxicology.

8. The Sample Size for the Training Set

As this device is a lateral flow immunoassay (a chemical/biological test kit), and not an AI/machine learning algorithm, there is no "training set" in the computational sense. The device's performance is based on its inherent physical and chemical properties and reagent formulations, which are developed and optimized through laboratory research and development, rather than machine learning training.

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

Since there is no "training set" for this type of device, this question is not applicable. The development and optimization of the immunoassay undoubtedly involved extensive experimentation with samples of known drug concentrations, likely confirmed by GC-MS/LC-MS, but this is part of the product's research and development process, not analogous to establishing ground truth for a machine learning training set.

Ask a specific question about this device

The ETERBIO Fentany]Norfentary] Rapid Test (Colloidal Gold) is an immunoassay intended for the qualitative detection of Fentanyl (FTY) /Norfentanyl (NFTY) in human urine:

The test is available as a single panel for FYL, or as a dual panel combining both FYL and NFYL. It provides a preliminary screening result only. For a confirmed analytical outcome, a more specific chemical is required. GC/MS or LC/MS is the preferred confirmatory method.

The ETERBIO Fentanyl Norfentanyl Home Test is an immunoassay intended for the qualitative detection of Fentanyl (FTY) /Norfentanyl (NFTY) in human urine:

The test is available as a single panel for FYL, or as a dual panel combining both FYL and NFYL. This test provides only preliminary results. For a confirmed analytical outcome, a more specific chemical method is required. GC/MS or LC/MS is the preferred confirmatory method.

Rapid Test ETERBIO Fentanyl/Norfentanyl Gold) and ETERBIO The Fentanyl/Norfentanyl Home Test are immunoassays intended for the qualitative detection of fentanyl and norfentanyl in human urine. Each ETERBIO fentanyl/norfentanyl 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 of the ETERBIO Fentanyl/Norfentanyl Rapid Test (Colloidal Gold) and ETERBIO Fentanyl/Norfentanyl Home Test, which are immunoassay devices for qualitative detection of Fentanyl and Norfentanyl in human urine.

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

Acceptance Criteria for Performance (Implicit)

The document primarily details the analytical performance and comparison studies without explicitly stating numeric "acceptance criteria" for precision, specificity, or comparison study concordance rates. However, the reported results demonstrate that the device performs as expected for a qualitative drug test around the specified cutoff levels. For the Lay-User Study, the implicit acceptance criterion is a high percentage of correct results and ease of understanding for lay users.

1. Table of Acceptance Criteria and Reported Device Performance

• -25% cut off: Lot 1: 60-/0+, Lot 2: 59-/1+, Lot 3: 60-/0+.
• Custom Cutoff Concentration (not explicitly stated): Lot 1: 27+/33-, Lot 2: 26+/34-, Lot 3: 26+/34-.
• +25% to +100% cut off: 60+/0- (100% positive) across 3 lots. | * -100% to -50% cut off: 60-/0+ (100% negative) across 3 lots.
• -25% cut off: Lot 1: 58-/2+, Lot 2: 58-/2+, Lot 3: 59-/1+.
• Custom Cutoff Concentration (not explicitly stated): Lot 1: 27+/33-, Lot 2: 26+/34-, Lot 3: 26+/34-.
• +25% to +100% cut off: 60+/0- (100% positive) across 3 lots. |
  | Stability | Device remains stable and functional for a specified shelf life. | 24 months at 36-86°F based on real stability study. | 24 months at 36-86°F based on real stability study. |
  | Interference | No interference from common physiological/pathological substances or specified concentrations of other compounds. | No interference observed from a comprehensive list of 60+ compounds at specified concentrations (e.g., Acetaminophen, Ethanol, Albumin, Glucose, etc.) | No interference observed from a comprehensive list of 60+ compounds at specified concentrations (e.g., Acetaminophen, Ethanol, Albumin, Glucose, etc.) |
  | Specificity (Cross-Reactivity) | Minimal to no cross-reactivity with structurally similar but non-target compounds, and non-opioid compounds. Appropriate cross-reactivity with relevant metabolites. | Fentanyl: 100% cross-reactivity with Fentanyl at 1 ng/mL. Cross-reactivity observed with several fentanyl analogues (e.g., Acetyl fentanyl (83.3%), Acrylfentanyl (83.3%), Butyryl fentanyl (62.5%), Furanyl fentanyl (57.1%), Isobutyryl fentanyl (66.7%), Ocfentanil (66.7%), Para-fluoro fentanyl (33.3%), Para-fluorobutyryl fentanyl (33.3%), Valeryl fentanyl (40%)). Low/no cross-reactivity with others. | Norfentanyl: 100% cross-reactivity with Norfentanyl at 5 ng/mL. Cross-reactivity observed with several fentanyl analogues (e.g., (+)-3-cis-methyl fentanyl (50%), Acetyl fentanyl (50%), Acrylfentanyl (50%), Butyryl fentanyl (50%), Furanyl fentanyl (55.6%), Isobutyryl fentanyl (62.5%), Para-fluoro fentanyl (100%)). Low/no cross-reactivity with others. |
  | Effect of Urine Specific Gravity & pH | Consistent results across a range of urine specific gravity and pH levels. | All samples at and above +50% Cut-Offs were positive; all samples at and below -50% Cut-Offs were negative, for specific gravity 1.000-1.035 and pH 4-9. | All samples at and above +50% Cut-Offs were positive; all samples at and below -50% Cut-Offs were negative, for specific gravity 1.000-1.035 and pH 4-9. |
  | Method Comparison (Concordance with LC/MS) | High concordance with results from LC/MS (Liquid Chromatography-Mass Spectrometry), especially for samples far from the cutoff. Some discordance expected near cutoff. | Fentanyl:

• High agreement for Low Negative and High Positive samples (100% for most operators).
• Discordant results mainly near cutoff (e.g., some LC/MS negatives read as positive, some LC/MS positives read as negative). For example, Operator 1 had 1 negative result with LC/MS result (1.01 ng/mL) and 2 positive results with LC/MS results (0.986 ng/mL, 0.937 ng/mL). | Norfentanyl:
• High agreement for Low Negative and High Positive samples (100% for most operators).
• Discordant results mainly near cutoff. For example, Operator 1 had 1 negative result with LC/MS result (5.2 ng/mL) and 1 positive result (4.85 ng/mL). |
  | Lay-User Study (Accuracy) | High percentage of correct results by lay users, demonstrating ease of use and interpretability. | Fentanyl: 100% correct for samples at -100%, -75%, -50% cutoff, and +25%, +50%, +75% cutoff. 95% correct at -25% cutoff.
  Norfentanyl: 100% correct for samples at -100%, -75%, -50%, -25% cutoff, and +25%, +50%, +75% cutoff. | Fentanyl: 100% correct for samples at -100%, -75%, -50% cutoff, and +25%, +50%, +75% cutoff. 95% correct at -25% cutoff.
  Norfentanyl: 100% correct for samples at -100%, -75%, -50%, -25% cutoff, and +25%, +50%, +75% cutoff. |
  | Lay-User Study (Usability) | Instructions are easily understood and followed by lay users. | All lay users indicated that the device instructions can be easily followed. Flesch-Kincaid reading grade level

Ask a specific question about this device

The CLUNGENE Fentanyl Home Test Cassette is competitive binding, lateral flow immunochromatographic assay for the qualitative detection of Fentany] in human urine at the cut off concentration of 1.0 ng/mL. This test provides only a preliminary result. A more specific alternative chemical method must be used to obtain a confirmed analytical result. Gas Chromatography-Mass Spectrometry (GC-MS) or Liquid Chromatography-Mass Spectrometry (LC-MS) is the preferred confirmatory method. Evaluate preliminary positive results carefully. For in vitro diagnostic use only.

The CLUNGENE Fentanyl Test Cassette is competitive binding, lateral flow immunochromatographic assay for the qualitative detection of Fentanyl in human urine at the cut off concentration of 1.0 ng/mL.

This test provides only a preliminary result. A more specific alternative chemical must be used to obtain a confirmed presumptive positive result. Gas Chromatography-Mass Spectrometry (GC-MS). Liquid Chromatography-Mass Spectrometry (LC-MS), and their tandem mass-spectrometer versions are the preferred confirmatory methods. Careful consideration and judgment should be applied to any drugs of abuse screen test result, particularly when evaluating preliminary positive results. For in vitro diagnostic use only.

The CLUNGENE Fentanyl Tests are immunoassays intended for the qualitative detection of fentanyl in human urine. Each CLUNGENE 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.

Here's a breakdown of the acceptance criteria and study information for the CLUNGENE Fentanyl Home Test Cassette and CLUNGENE Fentanyl Test Cassette, based on the provided FDA 510(k) summary:

1. Table of Acceptance Criteria and Reported Device Performance

The document doesn't explicitly list "acceptance criteria" in a structured table. However, based on the performance characteristics presented, we can infer the criteria considered for demonstrating substantial equivalence. The reported performance is presented in the context of these implied criteria.

For qualitative detection of Fentanyl in human urine at a cut-off concentration of 1.0 ng/mL, the key performance characteristics evaluated were:

Lot 2:
-100%, -75%, -50%, -25% cut off: 100% negative (60-/0+)
Cut off: 43.3% negative, 56.7% positive (26-/34+)
+25%, +50%, +75%, +100% cut off: 100% positive (60+/0-)

Lot 3:
-100%, -75%, -50% cut off: 100% negative (60-/0+)
-25% cut off: 96.7% negative (58-/2+)
Cut off: 53.3% negative, 46.7% positive (32-/28+)
+25%, +50%, +75%, +100% cut off: 100% positive (60+/0-) |
| Stability | Stable at 39-86º F for 24 months (based on accelerated stability study). |
| Interference (no impact from common substances) | No interference observed at 100µg/mL (or specified concentrations) for a wide range of physiological, pathological, and common drug substances listed. This includes substances like Acetone (1000 mg/dL), Ethanol (1%), Glucose (3000 mg/dL), Ibuprofen, Caffeine, etc. |
| Specificity (cross-reactivity with similar compounds) | Demonstrated defined cross-reactivity profiles for Fentanyl analogs and related substances (e.g., Acetyl fentanyl (100%), Isobutyryl fentanyl (40%), Carfentanil (2%), Sufentanil (4%)). No cross-reactivity for a list of 27 other opioid compounds tested at 100 µg/mL. |
| Effect of Urine Specific Gravity and pH (robustness to urine variability) | All samples at and above +50% Cut-Off were positive; all samples at and below -50% Cut-Off were negative for urine specific gravities from 1.000 to 1.035 and pH from 4 to 9. |
| Method Comparison (agreement with confirmatory method) | Overall agreement near cutoff: For samples near the cutoff (between -50% and +50% of cutoff), there were a few discordant results, indicating expected variability around the cutoff.

• Example: 1 positive result for a true negative sample (0.953 ng/mL) by Operator 1.
• Example: 2 negative results for true positive samples (1.073 ng/mL, 1.083 ng/mL) by Operator 1 and 2.
  Key finding: Generally high agreement for samples significantly below or above the cutoff. |
  | Lay-User Performance (ease of use and accuracy by target users) | - 100% correct results for -100%, -75%, -50%, +25%, +50%, +75% of cutoff concentrations.
• 95% correct results for -25% of cutoff (1 positive result out of 20 samples).
• All lay users indicated the instructions were easy to follow.
• Package insert has a Flesch-Kincaid reading grade level less than 7. |

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

• Precision Study: For each of 9 fentanyl concentrations (-100% to +100% cut off), 60 tests were performed per lot (2 tests/day/operator for 10 days, across 3 lots).
• Interference Study: Urine samples were prepared with various interfering substances, with target fentanyl at 50% below and 50% above Cut-Off levels. Tested using three batches of each device. Specific sample sizes per substance are not given, but refers to "compounds that showed no interference at a concentration of 100µg/mL or specified concentrations".
• Specificity Study: Drug metabolites and other components were tested. Not explicitly stated as "test set" samples, but these are part of the analytical validation.
• Effect of Urine Specific Gravity and pH: Urine samples with varying specific gravity and pH were spiked with fentanyl at 50% below and 50% above cut-off levels. Tested using three lots of devices.
• Method Comparison Studies (Clinical Samples): 80 unaltered clinical urine samples (40 negative and 40 positive) were used.
• Lay-user Study: 140 lay persons tested samples. 20 samples were prepared per concentration level spanning -100% to +75% of the cutoff.

Data Provenance:
The document does not explicitly state the country of origin for the clinical samples or for the samples used in the precision and lay-user studies. The method comparison study used "unaltered clinical samples." The precision and lay-user studies used "spiked fentanyl in negative samples" or "spiked fentanyl into drug free-pooled urine specimens," which implies these were lab-prepared samples. The overall study appears to be retrospective in terms of sample collection for clinical samples, but the testing itself would be prospective for evaluating the device.

3. Number of Experts and Qualifications for Ground Truth for Test Set

• Method Comparison Studies (Clinical Samples): The ground truth was established by LC/MS (Liquid Chromatography-Mass Spectrometry). This is a highly accurate analytical method and is stated as the "preferred confirmatory method" in the Indications for Use. No human experts are listed for establishing this ground truth, as it is an instrumental analysis.
• Precision Study, Lay-user Study, Interference, Specificity, Effect of Urine Specific Gravity and pH: The fentanyl concentrations in spiked samples were "confirmed by LC/MS". Again, LC/MS served as the ground truth.

4. Adjudication Method for the Test Set

• Method Comparison Studies (Clinical Samples): Samples were "blind labeled" and compared to LC/MS results. This suggests a direct comparison method. Discrepancies (discordant results) were noted, but there's no mention of an adjudication process by human experts to resolve these. The LC/MS result is considered the definitive truth.
• Precision, Interference, Specificity, Effect of Urine Specific Gravity and pH, Lay-user Study: The ground truth was based on the known spiked concentrations confirmed by LC/MS. No human adjudication method is described or necessary for these types of analytical validation studies.

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

No MRMC comparative effectiveness study was done. The study compares the device's performance against LC/MS (a gold standard analytical method) and evaluates lay-user performance, but not in a comparative effectiveness study with human readers with and without AI assistance. This device is a rapid diagnostic test cassette, not an AI-assisted diagnostic tool.

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

Yes, this is essentially a standalone (device-only) performance assessment. The "CLUNGENE Fentanyl Test Cassette" is a lateral flow immunoassay. Its performance is read visually from the lines on the cassette. While human interpretation is involved in reading the result, the core "performance" (sensitivity, specificity, precision, etc.) is inherent to the chemical reactions and design of the device itself. The lay-user study evaluates the human interpretation aspect too.

7. Type of Ground Truth Used

The ground truth used throughout the studies was analytical confirmation by LC/MS (Liquid Chromatography-Mass Spectrometry). This is considered a highly reliable and quantitative method for determining the presence and concentration of fentanyl.

8. Sample Size for the Training Set

The document does not describe a "training set" in the context of machine learning or AI. This is a traditional immunoassay device, which typically does not involve machine learning models that require training sets. The studies described are for analytical and clinical validation of the device's inherent performance characteristics.

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

As there is no mention of a "training set" for a machine learning algorithm, this question is not applicable to the provided document.

Ask a specific question about this device

BioSieve™ Fentanyl FIA Home Test Kit is a fluorescence immunoassay (FIA) for the qualitative determination of fentanyl in human urine at a cutoff concentration of 1.0 ng/mL. The assay is intended for use with BioSieve™ Toxismart Reader.

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.

BioSieve™ Fentanyl FIA Pro Test Kit is a fluorescence immunoassay (FIA) for the qualitative determination of fentanyl in human urine at a cutoff concentration of 1.0 ng/mL. The assay is intended for use with BioSieve™ Toxismart Reader. It is for in vitro diagnostic use only.

The tests provide only preliminary results. A more specific alternative chemical must be used in order to obtain a confirmed analytical result. Gas Chromatography/Mass Spectrometry (GC/MS) or Liquid Chromatography/Tandem Mass Spectrometry (LC/MS-MS) is the preferred confirmatory method.

Clinical consideration and professional judgment should be exercised with any drug test result, particularly when the preliminary test result is positive.

BioSieve™ Toxismart Reader is a portable fluorescence instrument for in vitro diagnostic use only. The Reader is designed to perform in vitro diagnostic tests on urine specimens. This Reader is intended for OTC use.

BioSieve™ Fentanyl FIA Home Test Kit and BioSieve™ Fentanyl FIA Pro Test Kit are immunoassays intended for the qualitative detection of fentanyl in human urine. These candidate test kits are the same physical devices as the predicate device cleared in K240124. Each BioSieve™ Fentanyl Test Kit consists of a test cassette and a package insert. Each test cassette is sealed with sachets of desiccant in an aluminum pouch.

BioSieve™ Toxismart Reader is a portable fluorescence instrument that is intended for use with the BioSieve™ Fentanyl FIA Home Test Kit and BioSieve™ Fentany] Pro Test Kit. The Reader scans the test cassettes included in the Test Kits and displays the results.

The provided FDA 510(k) summary (K241869) describes the BioSieve™ Fentanyl FIA Home Test Kit, BioSieve™ Fentanyl FIA Pro Test Kit, and BioSieve™ Toxismart Reader. The document focuses on demonstrating substantial equivalence to a predicate device (K240124) and includes details of a lay-user study.

Here's an analysis of the acceptance criteria and study information:

1. Table of Acceptance Criteria and Reported Device Performance

The document does not explicitly state formal "acceptance criteria" for performance in the typical sense of numerical thresholds for sensitivity, specificity, accuracy, etc., that the device must meet for clearance. Instead, the performance is demonstrated through a lay-user study, and the implied acceptance is 100% correct results for all tested samples across various concentrations relative to the cutoff.

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

• Sample Size for Test Set: 140 lay persons (participants). Each participant was provided with 1 blind-labeled sample. The total number of individual urine samples prepared for the study across all concentration levels was $20 \times 7 = 140$ samples.
• Data Provenance: The document states "Urine samples were prepared... by spiking fentanyl into drug free-pooled urine specimens." This indicates the samples were laboratory-prepared (spiked) rather than naturally occurring clinical samples. The country of origin for the data is not specified, but the submitter is VivaChek Biotech (Hangzhou) Co., Ltd. from China. The study appears to be prospective in nature, as it involved lay users actively interacting with the device and samples.

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

• Number of Experts: Not explicitly stated as a panel of experts.
• Qualifications of Experts: The ground truth for the fentanyl concentrations in the prepared urine samples was established by LC/MS (Liquid Chromatography/Mass Spectrometry). This is a highly accurate analytical method for quantifying substances, and its operation would typically be performed by trained laboratory personnel/chemists rather than medical experts like radiologists. The document does not specify the qualifications of the individuals who performed the LC/MS analysis. The reference method is considered the "ground truth."

4. Adjudication Method for the Test Set

The document does not describe an explicit adjudication method involving multiple human readers or a consensus process for the results of the device tests. The lay users performed the tests, and their readings (positive/negative) were compared directly against the LC/MS confirmed concentrations of the spiked samples.

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

No, a multi-reader multi-case (MRMC) comparative effectiveness study was not done. The study described is a lay-user study evaluating the device's performance when used by intended lay users, not a comparison of human readers with and without AI assistance, nor does the device itself involve AI assistance for interpretation beyond the Toxismart Reader's automated reporting.

6. Standalone (Algorithm Only) Performance

Yes, a form of standalone performance was implicitly evaluated. The "lay-user study" assessed the BioSieve™ Fentanyl FIA Home Test Kit and BioSieve™ Toxismart Reader system (which includes interpretation by the reader) in an "algorithm only without human-in-the-loop performance" sense, as the lay users were simply operating the device and reading its output. The reader itself performs the detection and displays the result.

7. Type of Ground Truth Used

The ground truth used was analytical confirmation by LC/MS. This is an objective quantitative method considered highly accurate for determining the precise concentration of fentanyl in the spiked urine samples.

8. Sample Size for the Training Set

The document states: "1. Analytical Performance: See analytical performance in predicate K240124. 2. Comparison Studies: See studies in predicate K240124". This implies that the training (or development/optimization) data for the device's analytical performance and the reader's algorithm were part of the predicate device's submission (K240124) and are not detailed in this 510(k) summary. Therefore, the sample size for the training set is not provided in the current document.

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

Similar to the above, the methods for establishing ground truth for any training set related to the development of the device or reader would be found in the predicate device's documentation (K240124) and are not detailed in this summary. It can be inferred that for a diagnostic device like this, ground truth would likely involve a combination of spiked samples with known concentrations and potentially confirmed clinical samples using a reference method like GC/MS or LC/MS.

Ask a specific question about this device

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.

Ask a specific question about this device

The SAFElife™ Fentanyl Urine Home Test (Cassette) is a competitive binding, lateral flow immunochromatographic assay for qualitative detection of Fentanyl in human urine at cutoff concentration of 1 ng/mL.

For in vitro diagnostic use. For Over The Counter (OTC) use.

The test provides only preliminary test results. To obtain a confirmed analytical result, a more specific alternate chemical method must be used. Chromatography/Mass Spectrometry (GC/MS) or Liquid Chromatography/Tandem Mass Spectrometry (LC/MS-MS) is the recommended confirmatory method.

The SAFElife™ Fentanyl (FTY) Urine Test Cassette is a competitive binding, lateral flow immunochromatoqraphic assay for qualitative detection of Fentanyl (FTY) in human urine at cutoff concentration of 1 ng/mL.

For in vitro diagnostic use.

lt is not intended to distinquish between prescription drug or abuse of the drug. Clinical consideration and professional judgment should be applied to the drug of abuse test result, particularly in evaluating a preliminary positive result.

The test provides only preliminary test results. To obtain a confirmed analytical result, a more specific alternate chemical method must be used. Chromatography/Mass Spectrometry (GC/MS) or Liquid Chromatography/Tandem Mass Spectrometry (LC/MS-MS) is the recommended confirmatory method.

The SAFElife™ T-Dip Fentanyl Urine Home Test (Dip Card) is a competitive binding, lateral flow immunochromatographic assay for qualitative detection of Fentanyl in human urine at cutoff concentration of 1 ng/mL.

For in vitro diagnostic use. For Over The Counter (OTC) use.

The test provides only preliminary test results. To obtain a confirmed analytical result, a more specific alternate chemical method must be used. Chromatography/Mass Spectrometry (GC/MS) or Liquid Chromatography/Tandem Mass Spectrometry (LC/MS-MS) is the recommended confirmatory method.

The SAFElife™ T-Dip Fentanyl (FTY) Urine Test Panel is a competitive binding, lateral flow immunochromatographic assay for qualitative detection of Fentanyl (FTY) in human urine at cutoff concentration of 1 ng/mL.

For in vitro diagnostic use.

It is not intended to distinguish between prescription drug or abuse of the drug. Clinical consideration and professional judgment should be applied to the drug of abuse test result, particularly in evaluating a preliminary positive result. The test provides only preliminary test results. To obtain a confirmed analytical result, a more specific alternate chemical must be used. Chromatography/Mass Spectrometry (GC/ MS) or Liquid Chromatography/Tandem Mass Spectrometry (LC/MS-MS) is the recommended confirmatory method.

The Wondfo SAFElife™ Fentanyl Tests are immunoassays intended for the qualitative detection of fentanyl in human urine. Each Wondfo SAFElife™ Fentanyl Test consists of a Test Device in format of Cassette or Dip Card, and a package insert. Each Test Device is sealed with sachets of desiccant in an aluminum pouch.

Acceptance Criteria & Study Analysis for SAFElife™ Fentanyl Urine Home Test

The SAFElife™ Fentanyl Urine Home Test (and its variants) are competitive binding, lateral flow immunochromatographic assays for qualitative detection of Fentanyl in human urine at a cutoff concentration of 1 ng/mL. The device provides preliminary test results, with confirmation requiring a more specific alternate chemical method like GC/MS or LC/MS-MS.

1. Acceptance Criteria and Reported Device Performance

The provided documentation does not explicitly state formal acceptance criteria in the typical "pass/fail" format for each performance characteristic. However, the study results implicitly demonstrate the device's acceptable performance based on standard expectations for qualitative drug screening tests.

Given the information, we can infer the acceptance criteria and compare them to the reported performance:

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

• Precision Studies Test Set:

  • For each of the 9 concentration levels, 50 tests were performed for each of the 3 device lots.
  • Total tests for Precision (Cassette): 9 concentrations * 50 tests/concentration * 3 lots = 1350 tests.
  • Total tests for Precision (Dip Card): 9 concentrations * 50 tests/concentration * 3 lots = 1350 tests.
  • Data Provenance: The samples were "prepared by spiking fentanyl in negative samples." The document does not specify the country of origin but implies laboratory-prepared controlled samples. The study is prospective in nature as samples were prepared for the purpose of the study.

• Interference Test Set: Not explicitly stated as a single "test set" size. "These urine samples were tested using three batches of each device." The number of samples for each interferent tested at specific concentrations (drug-free and fentanyl-spiked) is not quantified.

  • Data Provenance: Laboratory-prepared controlled samples with spiked substances. Most likely retrospective analysis of prepared samples.

• Specificity (Cross-Reactivity) Test Set: Similar to interference, not a single "test set" size. "drug metabolites and other components that are likely to interfere in urine samples were tested using three batches of device." The number of individual compounds tested is large (dozens of fentanyl analogs and many other opioids/non-opioids).

  • Data Provenance: Laboratory-prepared controlled samples with spiked substances. Most likely retrospective analysis of prepared samples.

• Effect of Urine Specific Gravity and pH Test Set: Not explicitly stated as a single "test set" size. "These samples were tested using three lots of device." Samples were prepared by spiking target fentanyl at -50% and +50% Cut-Off levels across specific gravity and pH ranges.

  • Data Provenance: Laboratory-prepared controlled samples. Most likely retrospective analysis of prepared samples.

• Method Comparison Studies Test Set:

  • Cassette: 84 "unaltered clinical samples."
  • Dip Card: 84 "unaltered clinical samples." (It's unclear if these are the same 84 samples for both formats or separate sets of 84).
  • Data Provenance: "unaltered clinical samples." The country of origin is not specified, but the clinical nature suggests they were collected from human subjects. The study appears to be retrospective as these samples were "blind labeled" and then tested.

• Lay-user Study Test Set:

  • For each device format (Cassette and Dip Card), 7 different concentration levels were tested, with 20 samples per concentration.
  • Total samples per device format: 7 concentrations * 20 samples/concentration = 140 samples.
  • Total samples overall: 140 samples (Cassette) + 140 samples (Dip Card) = 280 samples.
  • Data Provenance: Samples were "prepared at the following concentrations by spiking fentanyl into drug free-pooled urine specimens." The samples were then blind-labeled and randomized. The study is prospective since samples were prepared for the study.

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

• Precision, Interference, Specificity, Effect of SG/pH, Lay-user Studies: The "ground truth" (actual fentanyl concentration or absence) was established by LC/MS (Liquid Chromatography/Mass Spectrometry) for all spiked samples. This is a highly accurate analytical method, and human experts are not directly establishing the ground truth in terms of visual interpretation for these studies. The LC/MS results are considered the definitive quantitative measurement.
• Method Comparison Studies: The ground truth for the 84 "unaltered clinical samples" was established by LC/MS. The document states, "The samples were blind labeled and compared to LC/MS results." No human experts (e.g., pathologists, radiologists) were involved in establishing the ground truth for these quantitative drug levels.

4. Adjudication Method for the Test Set

The concept of "adjudication" (e.g., 2+1, 3+1) typically applies to situations where multiple human readers are interpreting results and their agreement/disagreement needs to be resolved. In this case, the device output is a qualitative (positive/negative) result based on a visual line, and the ground truth is established by a quantitative analytical method (LC/MS).

• For the Precision studies, the results are quantitative counts of "positive" or "negative" for each lot and concentration, implying a direct read of the test.
• For the Method Comparison Studies, the rapid test results from the operators were directly compared to the LC/MS results. Discordant results are simply listed. No adjudication process is described for resolving discrepancies in the rapid test readings themselves among different operators, but rather the discrepancy is noted between the rapid test result and the LC/MS ground truth.
• For the Lay-user study, each participant (lay person) used one device and provided their result. The comparison was then made between the lay person's result and the LC/MS confirmed concentration. The study report only mentions "Lay person results" (No. of Positive / No. of Negative) implying their individual readings were collected and analyzed for correctness.

Therefore, an adjudication method in the traditional sense (e.g., expert panel review to resolve conflicting interpretations) was not applied, as the output is a qualitative visual reading compared to an analytical gold standard.

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 done.

An MRMC study typically compares the performance of multiple human readers on multiple cases, often with and without AI assistance, to determine if the AI improves human reader performance (e.g., sensitivity, specificity, efficiency). The studies presented here focus on the standalone performance of the device itself (precision, analytical performance, and comparison to LC/MS) and a lay-user study for ease of use. There is no mention of human readers being compared with and without AI assistance.

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

Yes, the primary studies presented are essentially standalone performance studies for the device.

The SAFElife™ Fentanyl Urine Home Test is a qualitative lateral flow immunoassay. Its "algorithm" is the biochemical reaction that produces a visual line. The precision studies, interference studies, specificity studies, effect of SG/pH studies, and method comparison studies all evaluate the device's ability to correctly classify samples as positive or negative based on its inherent properties, without human interpretation being the primary variable of interest for method comparison against LC/MS.

While the "reading" of the line is ultimately done by a human (either a trained operator in the method comparison or a lay-user in that specific study), the performance characteristics described (e.g., sensitivity at cutoff, cross-reactivity) are intrinsic to the device's chemical and physical design, functioning as an "algorithm-only" or "device-only" performance evaluation against a gold standard. The lay-user study specifically tests the human-in-the-loop aspect for OTC use, but the core analytical performance is evaluated as standalone.

7. The Type of Ground Truth Used

The primary ground truth used across all analytical performance studies (Precision, Interference, Specificity, Effect of SG/pH, and Method Comparison) and the Lay-user study was Liquid Chromatography/Mass Spectrometry (LC/MS).

LC/MS is a highly sensitive and specific analytical technique used to identify and quantify substances in complex mixtures, making it a robust "gold standard" for determining precise drug concentrations in urine samples.

8. The Sample Size for the Training Set

The document does not describe a "training set" in the context of an algorithm that learns from data. This device is a biochemical immunoassay, not a software-based AI algorithm that requires a training phase. Its performance is determined by its physical and chemical design, not by learning from a dataset.

Therefore, the concept of a "training set" is not applicable to this device.

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

As noted above, a "training set" is not applicable because this is a biochemical immunoassay, not a machine learning algorithm.

Ask a specific question about this device

Rapid Urine Fentanyl (FYL) Test Strip is a rapid, screening test for the qualitative detection of Fentanyl (FYL) in human urine at the cut-off concentration of 1 ng/mL. For in vitro diagnostic use only. This assay provides only a preliminary analytical test result. To obtain a confirmed analytical result, a more specific alternative chemical method must be used. GC/MS or LC/MS is the preferred confirmatory method. Rapid Urine Fentanyl (FYL) Test Dipcard is a rapid, screening test for the qualitative detection of Fentanyl (FYL) in human urine at the cut-off concentration of 1 ng/mL. For in vitro diagnostic use only. This assay provides only a preliminary analytical test result. To obtain a confirmed analytical result, a more specific alternative chemical method must be used. GC/MS is the preferred confirmatory method.

Rapid Urine Fentanyl (FYL) Test Strip and Rapid Urine Fentanyl (FYL) Test Dipcard are competitive binding, lateral flow immunochromatographic assays for qualitatively the detection of fentanyl at or above the cut-off concentration of 1 ng/mL. The tests can be performed without the use of an instrument. Test Strip and Test Dipcard use identical test strips made with same chemical formulation and manufacturing procedures.

The provided text describes a 510(k) premarket notification for a Rapid Urine Fentanyl (FYL) Test Strip and Dipcard. The device is a rapid screening test for the qualitative detection of Fentanyl in human urine at a cut-off concentration of 1 ng/mL. The approval is an addition of an OTC (Over-The-Counter) claim to a previously cleared prescription device (K231904).

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

1. A table of acceptance criteria and the reported device performance

The document doesn't explicitly state "acceptance criteria" as a separate table. However, the performance is demonstrated through a lay user study, with the implicit acceptance being a high agreement with the confirmed sample concentrations.

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

• Test Set Sample Size: The lay user study used 360 lay persons. For each device (Test Strip and Test Dipcard) and each concentration level, 30 determinations were made.
• Data Provenance: The text does not explicitly state the country of origin. The study was conducted at "three intended user sites." The study design indicates it was a prospective study where participants tested blinded, randomized samples.

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

The text states: "The concentrations of samples were confirmed by LC/MS." It does not specify the number of experts or their qualifications for this confirmation. LC/MS (Liquid Chromatography-Mass Spectrometry) is an analytical chemistry technique, and its use implies that the ground truth was established through a laboratory method, likely performed by trained laboratory personnel.

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

The text does not mention an adjudication method for the lay user results. Each participant's interpretation of their test result was recorded, and the "Agreement (%)" was calculated based on these individual interpretations compared to the known sample concentration.

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 section is not applicable as the device is a rapid, screening test for drug detection and does not involve AI or human reader interpretation in the context of image analysis or diagnostic assistance. The "readers" in this case are the lay users interpreting the test strip/dipcard result.

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

This section is not applicable as the device is a manual, rapid test. The "standalone" performance is essentially what the lay users demonstrated in their interpretation of the test results themselves. There is no algorithm or automated reading discussed.

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

The ground truth for the test set samples was established by LC/MS (Liquid Chromatography-Mass Spectrometry), which is a highly specific and sensitive analytical chemical method for confirming the concentration of substances. The text explicitly states: "The concentrations of samples were confirmed by LC/MS."

8. The sample size for the training set

The document does not provide information about a "training set" for the device itself because it is an immunochromatographic assay, not an AI/machine learning device. The performance characteristics are inherent to the chemical formulation and manufacturing procedures. The 510(k) summary references "analytical performance in predicate K231904" and "studies in predicate K231904," which would include the foundational analytical performance data.

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

As there is no "training set" in the context of AI/machine learning, this question is not applicable. The analytical performance and design of this type of device are established through various laboratory studies (e.g., specificity, sensitivity, precision, cross-reactivity) using reference standards and confirmed samples, as would have been documented for the predicate device (K231904).

Ask a specific question about this device