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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).

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The Rapid 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.

The tests is intended for in vitro diagnostics use. It is intended for prescription use including point of care sites. This assay provides only a preliminary analytical test result. To obtain a confirmed analytical result, a more specific alternative chemical method must be used. Gas Chromatography/ Mass spectrometry (GC/MS) or Liquid chromatography/Mass spectrometry (LC/MS) is the preferred confirmatory method. Clinical consideration and professional judgment should be applied to any drug of abuse test result, particularly when preliminary positive results are indicated.

The Rapid 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.

The tests is intended for in vitro diagnostics use. It is intended for prescription use including point of care sites. This assay provides only a preliminary analytical test result. To obtain a confirmed analytical result, a more specific alternative chemical method must be used. Gas Chromatography/ Mass spectrometry (GC/MS) or Liquid chromatography/Mass spectrometry (LC/MS) is the preferred confirmatory method. Clinical consideration and professional judgment should be applied to any drug of abuse test result, particularly when preliminary positive results are indicated.

Rapid Fentanyl (FYL) Test Strip and Rapid 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 document describes the Co-Innovation Biotech Co.,Ltd. Rapid Fentanyl (FYL) Test Strip and Rapid Fentanyl (FYL) Test Dipcard, which are rapid screening tests for the qualitative detection of Fentanyl (FYL) in human urine at a cut-off concentration of 1 ng/mL. The document includes performance data to demonstrate substantial equivalence to a predicate device (K220046 Superbio Fentanyl Urine Detection Kit).

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

1. Table of Acceptance Criteria and Reported Device Performance:

The document doesn't explicitly state "acceptance criteria" with numerical targets for accuracy, sensitivity, or specificity. However, the precision study and accuracy study demonstrate performance relative to the cut-off concentration. The implied acceptance criteria are that the device should accurately detect fentanyl around the 1 ng/mL cut-off and exhibit minimal interference and cross-reactivity. The precision study illustrates the device's ability to classify samples correctly relative to the cut-off, and the accuracy study compares device results to LC/MS reference results.

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

• Precision Study (Test Set):
  • Sample Size: 1620 observations in total (3 lots x 9 concentrations x 60 determinations/lot for each device type). Each concentration tested in 3 replicates daily for 10 non-consecutive days with 3 aliquots per location (2 operators per location, 3 locations).
  • Data Provenance: Drug-free human urine spiked with target fentanyl at various concentrations. The document does not specify the country of origin but implies laboratory-controlled samples, not patient data. Retrospective, as urine samples were collected and then spiked.
• Accuracy Study (Test Set):
  • Sample Size: 80 clinical urine specimens.
  • Data Provenance: Clinical urine specimens. The country of origin is not specified. Retrospective.

3. Number of Experts (or Reference Method) and Qualifications to Establish Ground Truth for the Test Set:

• Precision Study: Ground truth was established by precise spiking of fentanyl into drug-free urine at known concentrations, confirmed by LC/MS. No human experts were involved in establishing the ground truth for these spiked samples, as the concentration was analytically determined.
• Accuracy Study: Ground truth was established by LC/MS (Gas Chromatography/ Mass spectrometry or Liquid chromatography/Mass spectrometry) analysis of the clinical urine specimens. LC/MS is the "preferred confirmatory method" and considered the gold standard for quantitative drug testing. The qualifications of the LC/MS operators or analysts are not specified.

4. Adjudication Method for the Test Set:

Not applicable in the conventional sense of expert adjudication.

• In the precision study, known concentrations (LC/MS confirmed) served as the reference.
• In the accuracy study, LC/MS served as the reference method. Discordant results were analyzed by comparing the device's reading to the objective LC/MS concentration around the cutoff.

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

• No MRMC comparative effectiveness study was done in the context of human readers improving with AI vs. without AI assistance. This device is a rapid, screening test (immunochromatographic assay) and is not an AI-powered diagnostic imaging or interpretative device that augments human reader performance.
• However, the precision study did involve multiple operators (6 operators at 3 Point-of-Care sites) reading the results, although it wasn't designed as a comparative effectiveness study of human reader improvement. Each operator independently read the samples.

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

• Yes, this device is a standalone test. The "Rapid Fentanyl (FYL) Test Strip and Rapid Fentanyl (FYL) Test Dipcard are competitive binding, lateral flow immunochromatographic assays for qualitatively the detection of fentanyl... The tests can be performed without the use of an instrument." The results are visually interpreted by a human operator, but the device itself does not involve an algorithm or AI. It functions as a direct chemical/immunological reaction.

7. Type of Ground Truth Used:

• Precision Study: Known concentrations of Fentanyl in urine, confirmed by LC/MS.
• Accuracy Study: Quantitative results from LC/MS analysis of clinical urine specimens.

8. Sample Size for the Training Set:

This information is typically not applicable or explicitly stated for rapid, immunoassay-based tests like the one described. These devices are developed through chemical and biological formulation and optimization rather than machine learning training on a "training set" of data. The document describes analytical validation studies, which are performance evaluations, not algorithm training.

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

Not applicable, as there is no "training set" in the context of an AI/ML algorithm for this type of immunochromatographic device. The development process would involve optimizing reagent concentrations, membrane properties, and other manufacturing parameters to achieve the desired sensitivity and specificity, typically guided by analytical testing against known standards.

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The Co-Innovation One Step Human Chorionic Gonadotropin (HCG) Test Strip is an in vitro diagnostic visual qualitative immunochromatographic assay designed for the rapid determination of human chorionic gonadotropin (hCG) in urine to aid in the early detection of pregnancy. It is intended for over-the-counter (OTC) use.

The Co-Innovation One Step Human Chorionic Gonadotropin (HCG) Test Cassette is an in vitro diagnostic visual qualitative immunochromatographic assay designed for the rapid determination of human chorionic gonadotropin (hCG) in urine to aid in the early detection of pregnancy. It is intended for over-the-counter (OTC) use.

The Co-Innovation One Step Human Chorionic Gonadotropin (HCG) Test Midstream is an in vitro diagnostic visual qualitative immunochromatographic assay designed for the rapid determination of human chorionic gonadotropin (hCG) in urine to aid in the early detection of pregnancy. It is intended for over-the-counter (OTC) use.

The subject device One Step Human Chorionic Gonadotropin (HCG) Test is identical to the previous cleared version of the device with the same name (K132085). The purpose of this special 510(k) submission is to expand shelf-life from 2 years to 3 years, the device itself has not changed.

Co-Innovation One Step Human Chorionic Gonadotropin (HCG) Test is a rapid sandwich immunoassay device designed for the qualitative determination of human chorionic gonadotropin (hCG) concentration in human urine samples, as an aid in the early detection of pregnancy. The test devices are in three different formats: Strip,Cassette and Midstream . Three test formats use identical strips and each test strip in the device consists of:

1. A conjugate pad contains colloidal gold conjugated with mouse monoclonal anti-β -HCG antibody specific to the beta subunit of hCG.

2. A nitrocellulose membrane which is striped with the mouse monoclonal anti-α -HCG antibody in the test line (T line) and goat anti-mouse IgG polyclonal antibody in the control line (C line).

The Cassette format has the same performance specifications as the Test Strip format. The difference is that the urine sample is dispensed by dropper onto the sample well on the cassette.

The Midstream format has the same performance specifications as the Test Strip format. The difference is that the device is placed into the urine stream or dipped into the urine collection cup for 5 seconds.

This document describes the acceptance criteria and the study conducted to prove that the device meets those criteria.

1. Table of Acceptance Criteria and Reported Device Performance

The provided document describes a "Special 510(k) submission" where the primary purpose is to expand the shelf-life from 2 years to 3 years for the Co-Innovation One Step Human Chorionic Gonadotropin (HCG) Test devices. The device itself has not changed from its previously cleared version (K132085). Therefore, the acceptance criteria are focused on demonstrating that the device maintains its performance characteristics over the extended shelf-life.

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

• Test Set Description: The study described is a stability study designed to demonstrate the extended shelf-life of the device. It is not a clinical effectiveness study in the typical sense of testing patient samples against a ground truth for diagnostic accuracy.
• Sample Size: The study used 9 lots of HCG tests. The specific lot numbers are: 101180302, 101180303, 101180301C, 101180302C, 101180303C, 101180301M, 101180302M, 101180303M.
• Data Provenance: The study was conducted by the manufacturer, Co-Innovation Biotech Co., Ltd. in Guangzhou, China. It is a prospective study in the sense that the devices were placed under specific storage conditions for a defined duration (42 months) to assess stability over time. The "test set" here refers to the actual devices being tested, rather than a set of patient clinical samples.

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

• This question is not directly applicable in the context of this stability study. The "ground truth" for a device's performance in a stability study typically refers to its performance at time zero or its established performance characteristics (e.g., sensitivity, positive/negative conformity based on internal reference panels) as measured by the manufacturer's validated quality control procedures. The study mentions "manufacturer inner Reference Panel," which would serve as the basis for evaluating positive and negative conformity, sensitivity, and precision. No external experts are mentioned for establishing this ground truth.

4. Adjudication Method for the Test Set

• This question is not applicable. Adjudication methods (like 2+1 or 3+1) are typically used in clinical studies where human interpretation of results or images is involved and consensus among experts is needed to establish a definitive diagnosis or ground truth. In this device stability study, the performance parameters (physical testing, conformity rates, sensitivity, precision) would be assessed against predefined specifications using internal reference panels and quantitative measurements, not through expert adjudication of individual test results.

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 question is not applicable. The device is a qualitative immunochromatographic assay (a rapid test strip for HCG detection), not an AI-powered diagnostic imaging or interpretation tool. Therefore, an MRMC study or assessment of AI assistance is not relevant.

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

• This question is not applicable. The device is an in vitro diagnostic (IVD) test kit, not an algorithm or AI system. Its performance is inherent to the chemical and physical properties of the test strip/cassette/midstream, read visually by a human user.

7. The Type of Ground Truth Used

• For the stability study, the ground truth was established by the manufacturer's internal Reference Panel for assessing positive reference conformity rate, negative reference conformity rate, sensitivity, and precision. This panel represents known concentrations or characteristics used to validate the device's performance over time. The primary clinical cut-off for the device itself is 25mIU/mL of hCG in urine, traceable to WHO 3rd IS.

8. The Sample Size for the Training Set

• This question is not applicable to this type of device and study. "Training set" refers to data used to train machine learning models. This is a traditional IVD device, not an AI/ML product. The development of the device's components and design would typically involve extensive R&D and validation, but not in the context of a "training set" as understood in AI/ML.

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

• This question is not applicable for the reasons stated in point 8.

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

There are two formats: 1) Test Cup, 2) Test Dipcard. Each format may have from 1 to 5 drugs in any combination. The assays are intended for in vitro diagnostic use. They are intended for prescription use including point of care sites and over-the-counter use.

The tests may yield preliminary positive results even when prescription drugs including Buprenorphine, or Tricyclic Antidepressants are ingested, at prescribed to distinguish between prescription use or abuse of these drugs. There are no uniformly recognized cutoff concentration levels for Buprenorphine, or Tricyclic Antidepressants in urine.

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

One Step Single/Multi-drug Test Cup and One Step Single/Multi-drug Test Dipcard are competitive binding , lateral flow immunochromatographic assays for qualitatively the detection of Buprenorphine, 2-ethylidene-1, 5-dimethyl-3, 3-diphenylpyrrolidine, Morphine, Propoxyphene, Tri-cyclic Antidepressants and their metabolites at or above the cut-off levels as indicated. The tests can be performed without the use of an instrument.

Test Cup and Test Dipcard use identical test strips made with same chemical formulation and manufacturing procedures.

Here's a breakdown of the acceptance criteria and study details for the One Step Single/Multi-drug Test Cup and Dipcard, based on the provided document:

1. Table of Acceptance Criteria and Reported Device Performance

The document does not explicitly state "acceptance criteria" in a quantitative manner for overall device performance (e.g., global sensitivity/specificity targets). Instead, the performance data is presented against the established cutoff concentrations for each drug. The implicitly accepted performance is demonstrated by the agreement between the device's results and the confirmatory methods (GC/MS or HPLC) across different concentration ranges.

The tables below synthesize the performance of the device (both Cup and Dipcard formats, for Single and Multi-drug tests) by showing how results align with concentrations relative to the cutoff. The provided data focuses on the distribution of results across different concentration categories rather than overall accuracy metrics like sensitivity or specificity. However, we can infer performance by observing the agreement rates within each category.

Inferred Acceptance Criteria:
The device is expected to:

• Consistently produce negative results for drug-free samples.
• Consistently produce negative results for samples significantly below the cutoff concentration (less than half the cutoff).
• Demonstrate appropriate discrimination around the cutoff, with increasing positive results as concentrations approach and exceed the cutoff.
• Show agreement with confirmatory methods (GC/MS or HPLC) for samples within and outside the cutoff ranges.

Reported Device Performance (Sample Summary for BUP from 'Single drug Test' and 'Multi-drug Test' for both Cup and Dipcard):

Since the results are identical across all provided tables for BUP, EDDP, MOP, PPX, and TCA for both Single/Multi-drug Test Cup and Dipcard, a representative row is used.

Buprenorphine (BUP) Performance (Representative Example):

• Calibrator: Buprenorphine
• Cutoff Level: 10 ng/mL

Discordant Results (Representative Example for BUP):

• BUP Test: Positive result at 7.8 ng/mL (below 10 ng/mL cutoff). This is a false positive based on the cutoff but within the expected variability around the cutoff.
• TCA Test: Negative result at 1138 ng/mL (above 1000 ng/mL cutoff). This is a false negative.

(Similar tables and discordant results exist for EDDP, MOP, PPX, and TCA, exhibiting comparable patterns.)

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

• Sample Size: 80 clinical urine specimens were used for each drug (BUP, EDDP, MOP, PPX, TCA) for each device type (Single drug Test Cup, Single drug Test Dipcard, Multi-drug Test Cup, Multi-drug Test Dipcard). This means:
  • Single drug Test Cup: 5 drugs * 80 specimens = 400 specimens
  • Single drug Test Dipcard: 5 drugs * 80 specimens = 400 specimens
  • Multi-drug Test Cup: 5 drugs * 80 specimens = 400 specimens
  • Multi-drug Test Dipcard: 5 drugs * 80 specimens = 400 specimens
  • Total specimens analyzed across all tests and drugs: 1600 individual drug/specimen analyses.
• Data Provenance: The document states "80 clinical urine specimens". It does not specify the country of origin of the data or whether the study was retrospective or prospective.

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

The ground truth was established by analytical methods, not human experts.

• Number of Experts: Not applicable, as ground truth was not established by human experts.
• Qualifications of Experts: Not applicable.

4. Adjudication Method for the Test Set

The ground truth was established by definitive analytical methods, not through an adjudication process involving human interpretation of the device results.

• Adjudication Method: Not applicable. The reference method (GC/MS or HPLC) served as the definitive ground truth.

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

• MRMC Study: No, an MRMC comparative effectiveness study was not explicitly described or performed. This device is an in-vitro diagnostic assay for qualitative drug detection in urine, primarily evaluated against gold-standard analytical methods rather than against human readers or human readers with AI assistance.

6. If a Standalone (Algorithm Only Without Human-in-the-Loop Performance) Was Done

• Standalone Performance: Yes, the performance data presented is for the device's standalone performance. The "Co-Innovation Result" recorded for each specimen is directly from the device (visual interpretation of the test line on the Cup/Dipcard), without human intervention in interpreting the results. The comparison is made against laboratory-confirmed concentrations, representing the device's intrinsic analytical performance.

7. The Type of Ground Truth Used

• Type of Ground Truth: Analytical confirmation methods:
  • Gas Chromatography/Mass Spectrometry (GC/MS)
  • High-Performance Liquid Chromatography (HPLC)

8. The Sample Size for the Training Set

The document describes performance studies (accuracy, precision, sensitivity, specificity/cross-reactivity, interference, stability, and home-use consumer study), but it does not specify a separate "training set" or "training data" used for algorithm development, as this device appears to be a lateral flow immunoassay, not a machine learning-based device.

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. For quality control during manufacturing and development, external controls and reference materials are typically used, but these are not equivalent to an algorithm's training set in the context of AI/ML.

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