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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.

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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.

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MissLan® Early Detection Pregnancy 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). It is intended for use by people who would like to find out whether they are pregnant in a home environment. Only for use outside the body. For over-the-counter use.

Important note regarding positive results:

Because this test detects low levels of hCG, it is possible that this test may give positive results even if you are not pregnant. All results should be confirmed by your healthcare provider, especially when making decisions about future medical care.

This device is intended for home-use only.

MissLan® Early Detection Pregnancy 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). It is intended for use by people who would like to find out whether they are pregnant in a home environment. Only for use outside the body. For over-the-counter use.

Important note regarding positive results:

Because this test detects low levels of hCG, it is possible that this test may give positive results even if you are not pregnant. All results should be confirmed by your healthcare provider, especially when making decisions about future medical care.

This device is intended for home-use only.

MissLan® Early Detection Pregnancy 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). It is intended for use by people who would like to find out whether they are pregnant in a home environment. Only for use outside the body. For over-the-counter use.

Important note regarding positive results:

Because this test detects low levels of hCG, it is possible that this test may give positive results even if you are not pregnant. All results should be confirmed by your healthcare provider, especially when making decisions about future medical care.

This device is intended for home-use only.

MissLan® Early Detection Pregnancy 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.

MissLan® Early Detection Pregnancy Test Strip. MissLan® Early Detection Pregnancy Test Cassette and MissLan® Early Detection Pregnancy Test Midstream each contains a pouch with the device and instructions, and in addition, cassette format is packaged with pipette dropper and urine collection cup.

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 FDA 510(k) summary describes the acceptance criteria and study results for the MissLan® Early Detection Pregnancy Test Strip, Cassette, and Midstream devices.

Here's a breakdown of the requested information:

1. Table of acceptance criteria and reported device performance

The document does not explicitly state "acceptance criteria" as a separate section with numerical targets for each performance metric. However, the performance characteristics studies demonstrate that the device meets the necessary performance for its intended use, implying that the observed results constitute the criteria it should achieve. The predicate device's performance often forms the implicit benchmark for substantial equivalence.

Based on the provided data, the implicit acceptance criteria and reported performance are as follows:

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

Analytical Performance (Precision/Reproducibility/Sensitivity):

• Sample Size: 3 lots x 3 operators x 10 replicates x 9 hCG concentrations = 810 tests per device format. Since there are 4 effective formats (strip, cassette, midstream in-stream, midstream dip), this would be 810 x 4 = 3240 individual test results for this section.
• Data Provenance: Retrospective. Negative female urine was spiked with hCG standard.

Method Comparison Study:

• Sample Size: 400 women. Samples were divided: 100 for strip, 100 for cassette, 100 for midstream (dip), 100 for midstream (in-stream).
• Data Provenance: Prospective, collected from women aged 18 to 51 at three clinical sites. Approximately half were early pregnant. Samples were collected randomly throughout the day. Country of origin not specified, but typically US or manufacturer's country due to regulatory context.

Lay Person Study (First Study - Clinical Samples):

• Sample Size: 400 females (100 for each device format/method).
• Data Provenance: Prospective, from "diverse educational and occupational backgrounds and ages ranging from 18 to 51 years old" at three sites. Country not specified.

Lay Person Study (Second Study - Spiked Samples):

• Sample Size: 300 laypersons (100 for each device format). Each tested 4 blind-labeled spiked samples, so 300 * 4 = 1200 tests.
• Data Provenance: Retrospective, using negative urine samples spiked with hCG. Country not specified.

Early Pregnancy Detection Study:

• Sample Size: 65 pregnant women, contributing 650 early pregnancy urine samples (from day -8 to day +1 relative to the day of expected menstrual period).
• Data Provenance: Prospective, collected from pregnant women. Country not specified.

Specificity Study (False-Positive Results Rate):

• Sample Size: 900 urine samples from non-pregnant females (300 pre-menopausal, 300 peri-menopausal, 300 post-menopausal). These were divided further by device format (e.g., for each age group, 100 for strip, 100 for cassette, 50 for midstream dip, 50 for midstream in-stream).
• Data Provenance: Clinical, collected from non-pregnant females at three sites. Country not specified.

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

• Analytical Performance (Precision/Reproducibility/Sensitivity): 3 operators performed the tests for the device, but the "ground truth" for hCG concentration was based on spiking with a standard traceable to the 5th WHO.
• Method Comparison Study: "Three professionals at each site" tested the candidate device, and "one professional at each site" tested the predicate device. Their specific qualifications are not detailed beyond "professional." It's implied they are trained laboratory personnel.
• Lay Person Study (First Study - Clinical Samples): "Professional" testing was used as ground truth for comparison with layperson results. The number of professionals is not specified, nor their detailed qualifications, but it implies a single assessment for ground truth by trained personnel.
• Lay Person Study (Second Study - Spiked Samples): "Professional" testing was used as ground truth, but the ultimate ground truth was the known hCG concentration of the spiked samples.
• Early Pregnancy Detection Study: The ground truth for pregnancy status was established by B-ultrasound and HCG levels for the 65 pregnant women/650 samples. This refers to established clinical diagnostic methods, implying expert medical interpretation of ultrasound and quantitative lab HCG results.
• Specificity Study: The samples were collected from "non-pregnant females," implying a clinical determination of non-pregnancy as ground truth.

4. Adjudication method for the test set

• The document does not explicitly describe an adjudication method (such as 2+1 or 3+1 consensus) for establishing ground truth from multiple experts.
• In studies involving comparisons (e.g., method comparison, layperson study), results from "professionals" or "known spiked concentrations" served as the reference standard (ground truth). For the early pregnancy detection study, B-ultrasound and HCG levels were the ground truth, which are typically conclusive diagnostic methods.

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, a multi-reader, multi-case (MRMC) comparative effectiveness study was not conducted, nor is this device an AI-assisted device. This device is a rapid in-vitro diagnostic (IVD) test for qualitative detection of HCG. The "readers" are either laypersons or professionals interpreting a visual line on a test strip.

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

• This question is not applicable as the device is a manual, visually interpreted rapid diagnostic test, not an algorithm or software. It is inherently human-in-the-loop (for reading the result).
• However, the analytical performance studies (e.g., precision, hook effect, interfering substances) could be considered "standalone" in the sense that they assess the device's chemical and physical characteristics independent of human interpretation variability, but still involve human technicians performing the tests.

7. The type of ground truth used

• Analytical Performance Studies (Precision/Reproducibility, Hook Effect, Interfering Substances, Cross-Reactivity, HCG ß-core fragment, pH, density): Ground truth was based on known spiked concentrations of hCG (traceable to WHO standard) or interfering substances into negative urine.
• Method Comparison Study: Ground truth was established by comparison to a legally marketed predicate device (Wondfo One Step HCG Urine Pregnancy Test) and/or potentially by clinical reference methods by professionals.
• Lay Person Study (First Study): Ground truth was established by professional testing results of the same clinical urine samples.
• Lay Person Study (Second Study): Ground truth was based on known spiked concentrations of hCG and confirmed by professional testing.
• Early Pregnancy Detection Study: Ground truth was established by clinical B-ultrasound and HCG levels to confirm pregnancy status and gestational age.
• Specificity Study: Ground truth was the clinical diagnosis of non-pregnant females.

8. The sample size for the training set

• The document does not specify a separate "training set" for the device. This is typical for traditional rapid diagnostic tests, which are validated against established performance metrics rather than trained via machine learning. The studies described are validation and verification studies.

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

• As there's no specified "training set" in the context of machine learning, this question is not directly applicable. The ground truth for validation/verification studies was established as described in point 7.

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Dochek® Multi-Drug Urine Test Dipcard Rx is an immunoassay for the qualitative determination of single or multiple drugs in human urine at the following cutoff concentrations:
Amphetamine (AMP) 1000 or 500 ng/mL
Secobarbital (BAR) 300 ng/mL
Buprenorphine (BUP) 10 ng/mL
Oxazepam (BZO) 300 ng/mL
Cocaine (COC) 300 or 150 ng/mL
2-ethylidene-1,5-dimethyl-3,3-diphenylpyrrolidine (EDDP) 300 ng/mL
Methylenedioxymethamphetamine (MDMA) 500 ng/mL
Methamphetamine (MET) 1000 or 500 ng/mL
Morphine (MOP/OPI) 300 or 2000 ng/mL
Methadone (MTD) 300 ng/mL
Oxycodone (OXY) 100 ng/mL
Phencyclidine (PCP) 25 ng/mL
Propoxyphene (PPX) 300 ng/mL
Nortriptyline (TCA) 1000 ng/mL
Cannabinoids (THC) 50 ng/mL
6-Monoacetylmorphine (6-MAM) 10 ng/mL
Dochek® Multi-Drug Urine Test Dipcard Rx offers any combinations from 1 to 16 drugs but only one cutoff concentration under same drug condition will be included per device. It is intended for prescription 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 preliminary positive result. To obtain a confirmed analytical result, a more specific alternate chemical method is needed. GC/MS is the recommended confirmatory method.

Dochek® Multi-Drug Urine Test Dipcard is an immunoassay for the qualitative determination of single or multiple drugs in human urine at the following cutoff concentrations:
Amphetamine (AMP) 1000 or 500 ng/mL
Secobarbital (BAR) 300 ng/mL
Buprenorphine (BUP) 10 ng/mL
Oxazepam (BZO) 300 ng/mL
Cocaine (COC) 300 or 150 ng/mL
2-ethylidene-1,5-dimethyl-3,3-diphenylpyrrolidine (EDDP) 300 ng/mL
Methylenedioxymethamphetamine (MDMA) 500 ng/mL
Methamphetamine (MET) 1000 or 500 ng/mL
Morphine (MOP/OPI) 300 or 2000 ng/mL
Methadone (MTD) 300 ng/mL
Oxycodone (OXY) 100 ng/mL
Phencyclidine (PCP) 25 ng/mL
Propoxyphene (PPX) 300 ng/mL
Nortriptyline (TCA) 1000 ng/mL
Cannabinoids (THC) 50 ng/mL
6-Monoacetylmorphine (6-MAM) 10 ng/mL
Dochek® Multi-Drug Urine Test Dipcard offers any combinations from 1 to 16 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 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 Dipcard Rx and Dochek® Multi-Drug Urine Test Dipcard 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 singleuse in vitro diagnostic devices.
This device is a dipcard format in which the test strips are integrated into the plastic dipcard. After removing the cap of the dipcard, the absorbent end of the test strips is exposed and can be in direct contact with the urine sample. The device is in a ready-to-use format and no longer requires assembly before use.

Here's a breakdown of the acceptance criteria and study details for the Dochek® Multi-Drug Urine Test Dipcard, based on the provided FDA 510(k) summary:

This device is an in-vitro diagnostic test, not an AI/ML device, so many of the requested criteria (e.g., number of experts, adjudication, MRMC study, training set) typically apply to AI/ML software. Therefore, I will adapt the response to describe the data provided for this type of diagnostic device.

Acceptance Criteria and Device Performance for Dochek® Multi-Drug Urine Test Dipcard

This device is a qualitative immunoassay for the detection of various drugs in human urine. The acceptance criteria and performance are primarily based on its analytical accuracy (precision, specificity, and comparison to a gold standard) and usability.

1. Table of Acceptance Criteria and Reported Device Performance

For this type of qualitative immunoassay, the primary acceptance criteria revolve around the device's ability to correctly classify samples as positive or negative at and around the specified cutoff concentrations. The "performance" is demonstrated through the observed concordance with confirmatory methods (LC-MS/MS) and its precision.

• AMP (1000 ng/mL): Lot I: 13-/37+, Lot II: 14-/36+, Lot III: 13-/37+ (out of 50 tests)
• BAR (300 ng/mL): Lot I: 14-/36+, Lot II: 12-/38+, Lot III: 14-/36+
• COC (300 ng/mL): Lot II: 13-/37+, Lot III: 12-/38+
• MDMA (500 ng/mL): Lot I: 10-/40+, Lot II: 10-/40+, Lot III: 11-/39+
  All samples ≥ +25% cutoff consistently showed "0-/50+" (0 negative, 50 positive). All samples ≤ -25% cutoff consistently showed "50-/0+" (50 negative, 0 positive). |
  | Analytical Specificity | Minimal or no cross-reactivity with structurally unrelated compounds at specified concentrations. Acceptable cross-reactivity with structurally related compounds. | Extensive cross-reactivity tables provided (pages 13-22 in original document) for all 16 drugs. Many structurally related compounds showed cross-reactivity, requiring careful interpretation of results (e.g., Amphetamine panel detects other amphetamine-like substances). Many non-structurally related compounds showed no interference at 100 µg/mL. |
  | Interference | Urinary pH (4-9) and Specific Gravity (1.000-1.035) should not affect results. Substances commonly found in urine should not interfere. | pH levels of 4-9 and specific gravity levels of 1.000-1.035 did not affect assay results. Over 100 non-structurally related compounds (e.g., acetaminophen, ibuprofen, glucose) showed no interference at 100 µg/mL. (Pages 22-23) |
  | Method Comparison (Accuracy) | High concordance with a confirmed analytical method (LC-MS/MS) for both negative and positive samples, especially around the cutoff concentrations. | High concordance with LC-MS/MS. For each drug, 80 clinical samples (40 negative, 40 positive) were tested. The detailed tables (pages 24-27) show the breakdown of positive/negative calls by the dipcard vs. LC-MS/MS concentrations (drug-free, low negative, near cutoff negative, near cutoff positive, high positive). While some discordant results (false positives/negatives near cutoff) were observed, they are typical for qualitative immunoassay screening tests designed to be highly sensitive around the cutoff. The device generally performed as expected for a qualitative screening test. |
  | Lay Person Usability | Lay users should be able to correctly interpret the device results and understand the instructions for use. | High (≥90%) correct result interpretation by lay users across various drug concentrations for the majority of tests. The "Percentage of correct results" for samples +/- 25% of cutoff varied (e.g., BAR 95%, BUP 90% for -25% cutoff; BUP 95% for +25% cutoff), indicating some variability by lay users near the cutoff, which is expected for visual interpretation of a qualitative test. All participants found the instructions easy to understand and follow, with a Flesch-Kincaid Grade Level of 7. (Pages 28-33) |
  | Stability | The device should demonstrate stability over its claimed shelf life. | Demonstrated stability at 2-30°C for 36 months based on real-time stability study. |

2. Sample Size and Data Provenance:

• Test Set Sample Sizes:
  • Precision/Reproducibility: For each drug and each of the three lots, 50 tests were performed at each of the 9 concentration levels around the cutoff (total of 450 tests per lot per drug for analytical precision). This was repeated for multiple lots.
  • Method Comparison: 80 clinical urine samples were used for each drug. These 80 samples consisted of 40 negative and 40 positive samples, further categorized by their concentration relative to the cutoff (drug-free, low negative, near cutoff negative, near cutoff positive, high positive).
  • Lay Person Study: 140 participants (79 male, 61 female for Configuration 1; 73 male, 67 female for Configuration 2). For each drug and concentration level, 20 samples were tested by lay users.
• Data Provenance: The document generally indicates "in-house" studies for method comparison and precision. The clinical samples for method comparison were "unaltered urine clinical samples." The lay person study used pooled urine specimens spiked with drugs, confirmed by LC-MS/MS. The country of origin for the data is implied to be China, given the manufacturer's address (Guangzhou, China). The studies appear to be prospective in nature as they involved preparing samples and testing them using the device under controlled conditions to evaluate performance.

3. Number of Experts and Qualifications for Ground Truth:

• This device is a qualitative immunoassay, not an AI/ML algorithm requiring expert interpretation of images. Therefore, the concept of "experts" to establish ground truth in the same way as for imaging AI is not directly applicable.
• The ground truth for the analytical studies was established by LC-MS/MS (Liquid Chromatography-Mass Spectrometry/Mass Spectrometry). This is a highly accurate chemical method considered the gold standard for quantitative drug identification and concentration determination in urine.
• For the method comparison study, "three operators" performed the tests. Their qualifications are not explicitly stated, but for a laboratory-based study of an immunoassay, these would typically be trained laboratory personnel or technicians.

4. Adjudication Method for the Test Set:

• Not applicable in the context of an immunoassay device. The results are physical readouts (presence/absence of a line).
• For the Method Comparison study, the device result (positive/negative) was compared directly to the quantitative LC-MS/MS result. Discordant results are individually listed (pages 27-28), showing which operators, if any, had differing readings from the LC-MS/MS ground truth. Since three operators independently read the same samples for the method comparison, consistency among them can be inferred, but formal "adjudication" is not described as they were simply recording what they observed.

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

• No, an MRMC comparative effectiveness study was not conducted for this device. This type of study is specifically designed for AI-assisted diagnostic tools (often in imaging) to compare human performance with and without AI assistance.
• This device is a standalone diagnostic test; it does not "assist" human readers in the interpretation of complex data (like medical images).

6. Standalone (Algorithm Only) Performance:

• Yes, in a sense. The "Performance Characteristics" section details the device's inherent analytical performance (precision, specificity, and method comparison against LC-MS/MS). These studies evaluate the device's ability to detect drugs independently of human interpretation nuances (though human "operators" did conduct the tests, the output is a visual line).
• The "Lay Person Study" then evaluates the human interpretation of the device's output.

7. Type of Ground Truth Used:

• The primary ground truth used throughout the studies (precision, method comparison) was GC/MS or LC/MS (Gas Chromatography/Mass Spectrometry or Liquid Chromatography/Mass Spectrometry) results. These are highly accurate, quantitative analytical chemistry methods considered definitive for drug presence and concentration.
• For the lay person study, the "ground truth" for the samples was also established by LC-MS/MS confirmation of spiked drug concentrations.

8. Sample Size for the Training Set:

• This device is a chemical immunoassay, not a machine learning model. Therefore, there is no "training set" in the context of algorithm development. The device's performance is inherent to its biochemical design.

9. How Ground Truth for Training Set was Established:

• As stated above, no training set for an algorithm exists for this type of device. The scientific and engineering principles of immunoassay design and manufacturing determine its performance, which is then validated through the analytical and clinical studies described.

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Dochek® Multi-Drug Urine Test Cup Rx is an immunoassay for the qualitative determination of single or multiple drugs in human urine at the cutoff concentrations of following table.
Dochek® Multi-Drug Urine Test Cup Rx offers any combinations from 1 to 16 drugs but only one cutoff concentration under same drug condition will be included per device .
It is intended for prescription 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 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 is an immunoassay for the qualitative determination of single or multiple drugs in human urine at the cutoff concentrations of following table.
Dochek® Multi-Drug Urine Test Cup offers any combinations from 1 to 16 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 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 Rx 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.
The device is a cup format. The test strips are integrated into the cup provided and the urine sample is collected directly into the cup containing the strips. Each cup 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 document describes the performance characteristics and studies for the Dochek® Multi-Drug Urine Test Cup Rx and Dochek® Multi-Drug Urine Test Cup, which are immunoassays for the qualitative determination of single or multiple drugs in human urine.

1. Table of Acceptance Criteria and Reported Device Performance

The acceptance criteria are not explicitly stated in a single table with numerical targets, but rather implied by the results of the performance studies. The overall acceptance criterion is that the device is "substantially equivalent" to predicate devices, based on various performance characteristics.

For semi-quantitative interpretation, such as precision studies, the acceptance typically involves a high percentage of correct results (e.g., ≥95% or 100%) for samples at certain concentrations relative to the cutoff. For samples at the cutoff, some variability is expected.

For qualitative comparisons with a reference method (LC-MS/MS), accuracy metrics like sensitivity and specificity (or agreement) are generally used, especially for samples near the cutoff.

Here's a summary of reported performance, correlating with typical acceptance considerations for such devices:

• AMP 1000: All drug-free, low negative, and most near cutoff negative samples were correctly identified as negative. All high positive samples were correctly identified as positive. Some near cutoff positive and negative samples showed discordant results, as expected due to the nature of qualitative cut-off assays (e.g., Viewer A for AMP 1000: 17 negative results for "Near Cutoff Negative" LC-MS/MS, and 3 positive results for "Near Cutoff Positive" LC-MS/MS, with 3 positive results for "Near Cutoff Negative" LC-MS/MS and 0 negative for "Near Cutoff Positive" LC-MS/MS). The discordant results detail section confirms that most discrepancies occurred very close to the cutoff (e.g., AMP 1000, 1014.625 ng/mL LC/MS/MS result but device read negative). This pattern was consistent across all drugs, demonstrating that the device performs as expected around the stated cutoffs. |
  | Lay Person Study | High percentage of correct results when used by laypersons, demonstrating ease of use and interpretability of instructions and results for OTC use. | For both configurations (OTC), a high percentage of correct results was observed across all drugs and drug concentrations (from -100% cutoff to +75% cutoff). For samples significantly above or below the cutoff (e.g., -100%, -75%, -50%, +50%, +75% cutoff), the correct identification rate was consistently 100%. For samples at -25% and +25% cutoff, the correct results ranged from 90% to 100% (e.g., AMP 1000 at -25% cutoff: 95% correct, at +25% cutoff: 100% correct). All participants found the instructions easy to understand and follow, corroborated by a Flesch-Kincaid reading Grade Level of 7 for the package insert. |

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

• Precision Study:

  • Test Set Size: For each drug and each concentration (-100%, -75%, -50%, -25%, cutoff, +25%, +50%, +75%, +100%), 50 tests were performed (2 runs per day for 25 days). Given there are 9 concentrations and multiple lots (3-6), this means hundreds of tests per drug. With 16 drugs, this amounts to a substantial number of individual tests.
  • Data Provenance: The study was "carried out for samples... by spiked target drug in drug-free urine samples." This indicates a prospective, controlled laboratory study using simulated clinical samples, likely conducted at the manufacturer's location in Guangzhou, China.

• Method Comparison Study:

  • Test Set Size: 80 "unaltered urine clinical samples" per drug (40 negative and 40 positive). With 16 drugs, this means 1280 clinical samples were tested.
  • Data Provenance: "in-house" study, using "unaltered urine clinical samples." The geographic origin of these clinical samples is not specified, but since the submitter is in Guangzhou, it's likely from China. It's a retrospective analysis of collected clinical samples, as they were "blind labeled" before testing.

• Lay Person Study:

  • Test Set Size:
    • Configuration 1: 78 male and 62 female participants (Total 140 participants). Each participant was given 1 blind-labeled sample. For each drug concentration (e.g., -100% cutoff to +75% cutoff), there were 20 samples tested (implying 20 participants per drug concentration level).
    • Configuration 2: 89 male and 51 female participants (Total 140 participants). Similar to Configuration 1, 20 samples were tested per drug concentration level.
  • Data Provenance: The study was conducted with participants from diverse educational and professional backgrounds, aged 21 to >50. The location is not explicitly stated but is implicitly tied to the manufacturer/clinical study site. The samples were "prepared at the following concentrations; -100%, +/-75%, +/-25% of the cutoff by spiking drug(s) into drug free-pooled urine specimens," then confirmed by LC-MS/MS and blind-labeled. This is a prospective study using simulated clinical samples.

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

• Ground Truth for Precision and Lay Person Studies: The ground truth was established by spiking known concentrations of target drugs into drug-free urine samples, and these concentrations were "confirmed by LC-MS/MS." This method uses an analytical standard as the ground truth. No human experts were used for establishing this type of ground truth, as it is based on precise laboratory measurements.

• Ground Truth for Method Comparison Study: The ground truth for the 80 "unaltered urine clinical samples" was established using LC-MS/MS results. LC-MS/MS (Liquid Chromatography-Mass Spectrometry/Mass Spectrometry) is a highly sensitive and specific analytical method and is considered the gold standard for confirmatory drug testing. Therefore, no human experts were needed to establish this ground truth; it's based on objective analytical data.

4. Adjudication Method for the Test Set

• Precision Study: No adjudication method mentioned as the results are quantitative counts of positive/negative for known concentrations.
• Method Comparison Study: The document lists results for three "Viewers" (A, B, C) who presumably interpreted the test cups. However, the final "Dochek Result" in the discordant table does not indicate an explicit adjudication between these viewers (e.g., 2 out of 3 agreement). Instead, it seems to imply the individual viewer's result that led to the discordance. For example, "Viewer A, B, C" indicates all three viewers had the same discordant result. "Viewer B, C" indicates these two had a discordant result, with Viewer A possibly having a concordant one. The data presented compares each viewer's result against the LC-MS/MS ground truth individually. There is no explicit mention of an adjudication process (e.g., 2+1, 3+1) for discrepant results among the viewers.
• Lay Person Study: Results are aggregated as counts of "Negative" and "Positive" for various concentrations. There's no mention of an adjudication method among laypersons for their individual interpretations, as each participant tested one blind-labeled sample. The study assesses the overall performance and ease of interpretation by individual lay users.

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 done. This device is a rapid immunoassay test cup, not an AI-powered diagnostic system requiring human interpretation with or without AI assistance. The "Viewers" in the method comparison study are likely laboratory personnel interpreting the test cup's visual lines, not "human readers" in the context of image interpretation with AI.

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

• Not applicable. This device is a manual immunoassay test cup, not an algorithm or software. It involves visual interpretation of control and test lines by a user.

7. The Type of Ground Truth Used

• For the precision studies and lay person studies, the ground truth was based on spiking known concentrations of drugs into drug-free urine samples, confirmed by LC-MS/MS. This is an analytical and laboratory-controlled ground truth.
• For the method comparison study, the ground truth was established by LC-MS/MS confirmation of "unaltered urine clinical samples." This is considered a gold standard analytical ground truth.

8. The Sample Size for the Training Set

• Not applicable. This device is an immunoassay test cup, not a machine learning or AI model that requires a training set.

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

• Not applicable, as this is not an AI/ML device requiring a training set.

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MissLan® Pregnancy Rapid Test (Strip) is used for qualitative detection of Human Chorionic Gonadotropin (HCG) in human urine, as an aid in early detection of pregnancy. It is intended for use by people who would like to find out whether they are pregnant in a home environment. Only for use outside the body. For over the counter use.

MissLan® Pregnancy Rapid Test (Midstream) is used for qualitative detection of Human Chorionic Gonadotropin (HCG) in human urine, as an aid in early detection of pregnancy. It is intended for use by people who would like to find out whether they are pregnant in a home environment. Only for use outside the body. For over the counter use.

MissLan® Pregnancy Rapid Test will be sold in Midstream and Strip format. 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. The Strip format is a single test strip. The Midstream format contains one Test Midstream sealed in a desiccated aluminum pouch and Instructions for Use. The Strip format contains one Test strip sealed in a desiccated aluminum pouch, Urine Collection Cup and Instructions for Use. The device is in a ready-to-use format and does not require assembly before use.

Here is a summary of the acceptance criteria and study details for the MissLan® Pregnancy Rapid Test (Strip) and MissLan® Pregnancy Rapid Test (Midstream), based on the provided FDA 510(k) summary:

1. Table of Acceptance Criteria and Reported Device Performance

2. Sample Size for Test Set and Data Provenance

• Analytical Performance (Precision/Reproducibility/Sensitivity):

  • For each hCG concentration (0, 12.5, 15, 18.75, 22.5, 25, 50, 100, 200 mIU/mL), 10 replicates were tested per day for 5 days for each of 3 device lots. This means 50 tests per operator/lot/concentration.
  • Total tests for Strip format: 9 concentrations * 50 replicates/operator * 3 operators = 1350 tests.
  • Total tests for Midstream format (in-stream): 9 concentrations * 50 replicates/operator * 3 operators = 1350 tests.
  • Total tests for Midstream format (dip): 9 concentrations * 50 replicates/operator * 3 operators = 1350 tests.
  • Total for Sensitivity: 4050 unique test interpretations.
  • Data Provenance: Not explicitly stated, but likely laboratory-prepared samples.

• Specificity (Cross-reactivity with non-pregnant samples):

  • Sample Size: 450 urine samples (150 from pre-menopausal, 150 from peri-menopausal, 150 from post-menopausal women).
  • Each age group had 50 participants tested with strip, 50 with midstream (dip), and 50 with midstream (in-stream).
  • Data Provenance: Not explicitly stated but implies prospective collection of urine from normal, non-pregnant females.

• Method Comparison Study:

  • Sample Size: 200 urine samples (approximately half suspected pregnant, most in early stage

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MissLan™ Digital Pregnancy Rapid Test is intended for the qualitative detection of human chorionic gonadotropin (hCG) in urine, as an aid in early detection of pregnancy. It is intended for use by people who would like to find out whether they are pregnant in a home environment.

Only for use outside the body. For over the counter use.

MissLan™ Digital Pregnancy Rapid Test is used for in vitro qualitative detection of Human Chorionic Gonadotropin (HCG) in human urine, and is designed to be tested in dip or midstream mode. The test device consists of a single test strip assembled in a plastic housing, with an absorbent tip. The device is in a ready-to-use format.

The provided document details the performance characteristics of the MissLan™ Digital Pregnancy Rapid Test, which is a qualitative test for human chorionic gonadotropin (hCG) in urine.

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

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

The document doesn't explicitly list "acceptance criteria" for each performance metric with quantitative targets. Instead, it presents the results of various analytical and clinical studies, implying that the observed performance meets the requirements for demonstrating substantial equivalence to the predicate device.

However, we can infer the key performance metrics and the achieved results from the "Performance Characteristics" section. For qualitative pregnancy tests, crucial performance indicators include sensitivity (detection limit), specificity (absence of false positives), reproducibility, absence of hook effect, and agreement with predicate devices/professional results.

Inferred Acceptance Criteria and Reported Device Performance:

• 0 mIU/mL hCG: 100% negative for both midstream and dip testing across all 3 operators and 3 lots (total 150 negative for each method, 300 total).
• 12.5 mIU/mL hCG: 100% negative for both midstream and dip testing across all 3 operators and 3 lots (total 150 negative for each method, 300 total).
• Overall Sensitivity (for both methods combined): Demonstrated to be 25 mIU/mL.
• Reproducibility: Exhibited reproducible results across operators and lots. |
  | Specificity | No false positive results should be observed from healthy non-pregnant individuals across various age groups. No significant cross-reactivity with structurally similar hormones (e.g., hLH, hFSH, hTSH) or hCG ß-core fragment. | - Non-pregnant healthy females: 300 urine samples from healthy, non-pregnant females across pre-menopausal, peri-menopausal, and post-menopausal groups (100 per group) showed no false positive results for both dip and midstream testing.
• Cross-reactivity: No cross-reactivity was observed with 500 mIU/mL hLH, 1000 mIU/mL hFSH, or 1000 uIU/mL hTSH.
• hCG ß-core fragment: Performance not affected by hCG ß-core fragment concentrations up to 500,000 pmol/L. |
  | Hook Effect | No false negative results at very high concentrations of hCG. | No hook effect observed at hCG concentrations up to 500,000 mIU/mL (all tested concentrations from 6,250 mIU/mL to 500,000 mIU/mL gave a positive result). |
  | Interference | Performance should not be affected by common interfering substances, urine pH, or urine density. | - Interfering substances: No interference effect observed for 25 listed substances (e.g., Glucose, Albumin, Hemoglobin, Acetaminophen, Aspirin, Ibuprofen, Ethanol, etc.) at specified concentrations.
• Urine pH: Performance not affected by urine pH values between 4 and 9.
• Urine Density: Performance not affected by urine density values between 1.000 and 1.035. |
  | Method Comparison | High conformity (ideally 100%) with a legally marketed predicate device. | - Midstream Method: 100% concordance (55 positive, 45 negative) with the predicate device (n=100).
• Dip Method: 100% concordance (47 positive, 53 negative) with the predicate device (n=100).
• Overall Conformity: 100% between MissLan™ and the predicate device. |
  | Lay Person Study | High agreement between lay user results and professional results. Easy to use and interpret. | - First Study (Self-Testing): 100% conformity (midstream: 55 positive, 45 negative; dip: 47 positive, 53 negative) between layperson results and professional results (for 200 women).
• Second Study (Spiked Samples): 100% correct results for 5 mIU/mL (100 negative) and 25 mIU/mL (100 positive) hCG samples tested by laypersons.
• Questionnaire: Consumers found the test easy to use and had no trouble understanding labeling and interpreting results. |

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

• Analytical Performance (Sensitivity/Reproducibility):

  • Sample Size: For each hCG concentration (0, 12.5, 15, 18.75, 22.5, 25, 50, 100, 200 mIU/mL):
    • 10 replicates per day for 5 days = 50 replicates per operator per lot.
    • 3 operators for each sample concentration.
    • 3 device lots.
    • Total tests per hCG concentration: 50 (replicates) * 3 (operators) * 3 (lots) = 450 tests.
    • Total tests for all concentrations: 450 * 9 = 4050 tests across all concentrations, operators, and lots.
  • Data Provenance: The document does not specify the country of origin of the data or whether it was retrospective or prospective. It implies a controlled laboratory setting (analytical performance).

• Specificity (Non-pregnant females):

  • Sample Size: 300 urine samples (100 from pre-menopausal, 100 peri-menopausal, 100 post-menopausal).
  • Data Provenance: Not specified regarding country or retrospective/prospective.

• Method Comparison Study:

  • Sample Size: 200 urine samples from women presenting to test for pregnancy (approximately half suspected pregnant, most in early stage

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