Search Results

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

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

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

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

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

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

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

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

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

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

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

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

5. If a multi-reader multi-case (MRMC) comparative effectiveness study was done, If so, what was the effect size of how much human readers improve with AI vs without AI assistance

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

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

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

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

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

8. The sample size for the training set

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

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

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

Ask a specific question about this device

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.

• 0 ng/mL, 0.25 ng/mL, 0.5 ng/mL: 100% negative (60/60 for each lot).
• 0.75 ng/mL (-25% cutoff): 4/60 (Lot 1), 4/60 (Lot 2), 2/60 (Lot 3) positive results (majority negative).
• 1 ng/mL (cutoff): 34/60 (Lot 1), 34/60 (Lot 2), 36/60 (Lot 3) positive results (near 50% positive/negative as expected at cutoff).
• 1.25 ng/mL (+25% cutoff): 56/60 (Lot 1), 58/60 (Lot 2), 56/60 (Lot 3) positive results (majority positive).
• 1.5 ng/mL, 1.75 ng/mL, 2 ng/mL: 100% positive (60/60 for each lot).

Rapid Fentanyl (FYL) Test Dipcard:

• 0 ng/mL, 0.25 ng/mL, 0.5 ng/mL: 100% negative (60/60 for each lot).
• 0.75 ng/mL (-25% cutoff): 4/60 (Lot 1), 2/60 (Lot 2), 6/60 (Lot 3) positive results (majority negative).
• 1 ng/mL (cutoff): 36/60 (Lot 1), 34/60 (Lot 2), 32/60 (Lot 3) positive results (near 50% positive/negative as expected at cutoff).
• 1.25 ng/mL (+25% cutoff): 54/60 (Lot 1), 56/60 (Lot 2), 56/60 (Lot 3) positive results (majority positive).
• 1.5 ng/mL, 1.75 ng/mL, 2 ng/mL: 100% positive (60/60 for each lot). |
  | Accuracy (Agreement with Reference Method) | High agreement with a confirmed analytical method (LC/MS). | Rapid Fentanyl (FYL) Test Strip & Dipcard:
• Discordant results for both devices and all sites: One positive at 0.76 ng/mL (LC/MS result, below cutoff) and one negative at 1.04 ng/mL (LC/MS result, above cutoff).
• Drug-free: 27/27 negative calls by device.
• Less than half cutoff: 5/5 negative calls by device.
• Near Cutoff Negative (0.5-1 ng/mL): 7/8 negative calls by device, 1/8 positive call (at 0.76ng/mL).
• Near Cutoff Positive (1-1.5 ng/mL): 8/9 positive calls by device, 1/9 negative call (at 1.04ng/mL).
• High Positive (>1.5 ng/mL): 31/31 positive calls by device. |
  | Cross-reactivity | Minimal cross-reactivity with structurally similar compounds. | Fentanyl analogs showed varying degrees of cross-reactivity, some as low as 1.2 ng/mL (Acetyl fentanyl), while Norfentanyl and Acetyl norfentanyl showed very low (0.01%) cross-reactivity at 10,000 ng/mL. This indicates the device can detect some fentanyl analogs at relevant concentrations. |
  | Interference | No interference from common opioids, medications, or endogenous substances. | None of the tested opioids, commonly ingested medications, or substances (at specified concentrations) were shown to interfere with the test. |
  | Effect of urinary pH | Consistent results across a range of urinary pH. | Varying ranges of pH (3 to 9) did not interfere with performance. |
  | Effect of urinary specific gravity | Consistent results across a range of urinary specific gravity. | Varying ranges of urinary specific gravity (1.000 to 1.040) did not affect the test result. |

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.

Ask a specific question about this device

Rapid Marijuana (THC) Test Strip 20 and Rapid Marijuana (THC) Test Dipcard 20 is a rapid, screening test for the qualitative detection of Marijuana and their metabolites in human urine at the cut-off concentration of 20 ng/mL.

Rapid Marijuana (THC) Test Strip 50 and Rapid Marijuana (THC) Test Dipcard 50 is a rapid, screening test for the qualitative detection of Marijuana and their metabolites in human urine at the cut-off concentration of 50 ng/mL.

The tests contain two formats:1) Test Strip and 2) Test Dipcard. The tests are intended for in vitro diagnostics use. They are intended for over-the-counter use.

The tests provide only a preliminary 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 obtained.

Rapid Marijuana (THC) Test Strip 20 and Rapid Marijuana (THC) Test Dipcard 20 are competitive binding, lateral flow immunochromatographic assays for qualitatively the detection of Marijuana and their metabolites at or above the cut-off concentration of 20 ng/mL. The tests can be performed without the use of an instrument.

Rapid Marijuana (THC) Test Strip 50 and Rapid Marijuana (THC) Test Dipcard 50 are competitive binding, lateral flow immunochromatographic assays for qualitatively the detection of Marijuana and their metabolites at or above the cut-off concentration of 50 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.

This document describes the performance of the Rapid Marijuana (THC) Test Strip and Dipcard devices, available in 20 ng/mL and 50 ng/mL cutoff concentrations, for the qualitative detection of Marijuana and its metabolites in human urine.

Here's an analysis of the provided information:

1. Table of Acceptance Criteria and Reported Device Performance

The document does not explicitly state pre-defined acceptance criteria in terms of specific performance metrics (e.g., minimum sensitivity, specificity, or agreement percentages for accuracy studies). However, the performance data presented implies a standard of acceptable qualitative detection around the cutoff concentration. The precision and accuracy studies evaluate the device's ability to correctly identify positive and negative samples at various concentrations relative to the cutoff. The home-use study assesses user comprehension and ease of use.

Since no explicit numerical acceptance criteria are provided, I will present key performance indicators from the precision and accuracy studies. For the purpose of this table, I will infer that a high percentage of correct classifications at and around the cutoff, along with 100% correct classification for samples significantly above or below the cutoff, would be considered acceptable.

Inferred Performance Acceptance Criteria & Reported Device Performance for Cut-off 20 ng/mL:

• Neg. (drug free): 27 Negative
• Neg. (+50% cutoff): 31 Positive | Site 1,2,3 (Agreement with LC/MS categories):
• Neg. (drug free): 27 Negative
• Neg. (+50% cutoff): 31 Positive |
  | Home Use Consumer Study | Agreement at 0 ng/mL: 100% Negative | 100% Agreement (30 Negative) | 100% Agreement (30 Negative) |
  | | Agreement at -50% Cutoff (10 ng/mL): 100% Negative | 100% Agreement (30 Negative) | 100% Agreement (30 Negative) |
  | | Agreement at -25% Cutoff (15 ng/mL): High percentage of Negative (e.g.,>90%) | 93% Agreement (2 Positive, 28 Negative) | 90% Agreement (3 Positive, 27 Negative) |
  | | Agreement at +25% Cutoff (25 ng/mL): High percentage of Positive (e.g.,>90%) | 90% Agreement (27 Positive, 3 Negative) | 93% Agreement (28 Positive, 2 Negative) |
  | | Agreement at +50% Cutoff (30 ng/mL): 100% Positive | 100% Agreement (30 Positive) | 100% Agreement (30 Positive) |
  | | Agreement at +100% Cutoff (40 ng/mL): 100% Positive | 100% Agreement (30 Positive) | 100% Agreement (30 Positive) |

Inferred Performance Acceptance Criteria & Reported Device Performance for Cut-off 50 ng/mL:

• Neg. (drug free): 21 Negative
• Neg. (+50% cutoff): 30 Positive | Site 1,2,3 (Agreement with LC/MS categories):
• Neg. (drug free): 21 Negative
• Neg. (+50% cutoff): 30 Positive |
  | Home Use Consumer Study | Agreement at 0 ng/mL: 100% Negative | 100% Agreement (30 Negative) | 100% Agreement (30 Negative) |
  | | Agreement at -50% Cutoff (25 ng/mL): 100% Negative | 100% Agreement (30 Negative) | 100% Agreement (30 Negative) |
  | | Agreement at -25% Cutoff (37.5 ng/mL): High percentage of Negative (e.g.,>90%) | 97% Agreement (1 Positive, 29 Negative) | 93% Agreement (2 Positive, 28 Negative) |
  | | Agreement at +25% Cutoff (62.5 ng/mL): High percentage of Positive (e.g.,>90%) | 93% Agreement (28 Positive, 2 Negative) | 93% Agreement (28 Positive, 2 Negative) |
  | | Agreement at +50% Cutoff (75 ng/mL): 100% Positive | 100% Agreement (30 Positive) | 100% Agreement (30 Positive) |
  | | Agreement at +100% Cutoff (100 ng/mL): 100% Positive | 100% Agreement (30 Positive) | 100% Agreement (30 Positive) |

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

• Precision Study:
  • Sample Size: For each device type (Strip 20, Dipcard 20, Strip 50, Dipcard 50), 3 lots were tested. Each lot involved 60 determinations for each of 9 concentration levels, across 6 operators at 3 Point-of-Care sites over 10 non-consecutive days. This totals to 1620 observations per device type in the precision study.
  • Data Provenance: The document does not explicitly state the country of origin for the urine samples. The study involved spiking drug-free urine specimens. The study itself was conducted at 3 Point-of-Care sites, but their locations are not specified. It is a prospective study as samples were prepared and tested specifically for this evaluation.
• Accuracy Study:
  • Sample Size: 80 clinical urine specimens were used for each device type (Strip 20, Dipcard 20, Strip 50, Dipcard 50) and each operator site. Since there were 3 operator sites, this amounts to 80 * 3 = 240 tests (device results vs. LC/MS) for each specificity (20 ng/mL and 50 ng/mL).
  • Data Provenance: The samples were described as "clinical urine specimens," implying they were collected from human subjects. The country of origin is not specified, and it's unclear if they were retrospective or prospectively collected for the study.
• Home Use Consumer Study:
  • Sample Size: 180 lay users participated in the study. Each user performed 1 test on a provided specimen. The samples were prepared for the study. For each device type and concentration category, 30 determinations were made.
  • Data Provenance: The document does not specify the country of origin of the lay users or the urine samples used. It is a prospective study.

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

• Precision Study: The ground truth for the spiked samples was established by the precise concentration of "-)-11-nor-9-Carboxy-Δ⁹-THC" added to drug-free urine, confirmed with LC/MS. No human experts were involved in establishing this ground truth, as it was based on laboratory preparation and analytical confirmation.
• Accuracy Study: The ground truth for the clinical urine specimens was established by LC/MS (Gas Chromatography/Mass spectrometry or Liquid chromatography/Mass spectrometry). LC/MS is described as the "preferred confirmatory method." LC/MS is an analytical chemistry technique, not a human expert. Therefore, no human experts directly established the ground truth in this study; it was based on objective analytical measurement.
• Home Use Consumer Study: Similar to the precision study, the ground truth for samples was established by spiking drugs into urine with concentrations confirmed by LC/MS. No human experts were involved in establishing this ground truth.

4. Adjudication Method for the Test Set

• Precision Study: The results were read by operators comparing the test line intensity to the control line. There is no mention of an adjudication process for discrepancies in reading within the precision study; each determination (positive/negative) was recorded independently.
• Accuracy Study: The device results were compared directly to the LC/MS results. Discordant results are noted in tables (e.g., device positive when LC/MS was negative below cutoff, or device negative when LC/MS was positive above cutoff), but no formal adjudication method (like 2+1 reading) is described beyond this direct comparison.
• Home Use Consumer Study: The "Layer user Results" likely represent the interpretation of the test by the lay users themselves. No specific adjudication method is mentioned.

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

There was no MRMC comparative effectiveness study done. The device is a rapid, screening immunoassay test (similar to a pregnancy test) for qualitative detection of THC metabolites in urine, designed for Over-The-Counter use. It is interpreted visually by the user or an operator. There is no AI component in this device, nor is there a comparison of human readers with vs. without AI assistance.

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

This is not applicable as the device is a lateral flow immunochromatographic assay requiring human visual interpretation. It is not an algorithm-only device. The results are read visually.

7. The Type of Ground Truth Used

• Cross-reactivity and Interference Studies: Ground truth was established by precisely preparing samples with known concentrations of various compounds and expected drug-free or drug-spiked urine.
• Precision Study: Ground truth for the concentration levels of (-)-11-nor-9-Carboxy-Δ⁹-THC was confirmed using LC/MS.
• Accuracy Study: Ground truth for clinical urine specimens was established by LC/MS (Gas Chromatography/Mass spectrometry or Liquid chromatography/Mass spectrometry).
• Home Use Consumer Study: Ground truth for the spiked samples was confirmed using LC/MS.

In summary, the primary ground truth method for quantitative confirmation of drug concentrations in samples was LC/MS.

8. The Sample Size for the Training Set

This information is not applicable to this device. As a rapid, screening immunoassay test, it does not involve machine learning or AI models that require a "training set." Its performance is based on the chemical reactions and visual detection inherent in the lateral flow assay.

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

This is not applicable as there is no training set for this device type.

Ask a specific question about this device

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.

Ask a specific question about this device

Rapid Single/Multi-drug Test Cup and Rapid Single/Multi-drug Test Dipcard is a rapid drug screening test designed to qualitatively detect the presence of drugs and drug metabolites in human urine at the following cut-off concentrations:

The tests contain two formats:1) Test Cup and 2) Test Dipcard. The tests may be configured as single drug tests in any combination of the drug analytes listed in the table above up to a maximum of 15 analytes. Only one cutoff concentration will be included per analyte per device. The tests are intended for in vitro diagnostics use. They are intended for prescription use including point of care sites and over-the-counter use.

The tests will vield preliminary positive results when prescription drugs Barbiturates. Benzodiazenine, Methadone, Propoxyphene or Tricyclic Antidepressants are ingested, even at or above there are no unformly recognized drug levels for Barbiturates, Buprenorphine, Benzodiazepine, Propoxyphene and Tricyclic Antidepressants in urine.

This assay provides only a preliminary analytical test result. Gas Chromatography Mass spectrometry (GC/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 Single/Multi-drug Test Cup and Rapid Single/Multi-drug Test Dipcard are competitive binding, lateral flow immunochromatographic assays for qualitatively the detection of Amphetamine, Barbiturates, Buprenorphine, Benzodiazepines, Cocaines, 2-ethylidene-1, 5-dimethyl-3, 3-diphenylpyrrolidine, Methylenedioxymethamphetamine, Methamphetamine, Morphine300, Morphine2000, Methadone, Oxycodone, Phencyclidine, Propoxyphene, Tri-cyclic Antidepressants, Marijuana and their metabolites ( specifically THC ) 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 an analysis of the acceptance criteria and study findings for the "Rapid Single/Multi-drug Test Cup, Rapid Single/Multi-drug Test Dipcard" device, based solely on the provided text:

This document is a 510(k) Premarket Notification summary to the FDA, indicating that the device is seeking clearance based on substantial equivalence to a legally marketed predicate device, not necessarily showcasing comprehensive clinical trials for novel devices. Therefore, the "study" described focuses on demonstrating equivalence rather than proving novel clinical utility with large-scale, multi-reader, or outcomes-based studies.

Acceptance Criteria and Reported Device Performance

The core acceptance criteria are based on the ability to qualitatively detect specific drugs and their metabolites in human urine at predefined cut-off concentrations. The performance data demonstrates agreement with these cut-off concentrations, indicating the device meets the intended detection capability.

Table of Acceptance Criteria and Reported Device Performance (Specificity and Sensitivity implicitly)

For each drug, the acceptance criteria are to correctly identify negative samples and positive samples relative to the specified cut-off. The performance is reported in terms of the number of positive/negative results at various concentrations around these cut-offs during precision and accuracy studies.

Precision Study (Example for AMP, BAR, BUP, BZO, COC, EDDP, MDMA, MET, MOP300, MOP2000, MTD, OXY, PCP, PPX, TCA, THC)

The precision study aimed for accurate detection at concentrations:

• 0 ng/mL: All negative
• -75% cutoff: All negative or predominantly negative
• -50% cutoff: All negative or predominantly negative
• -25% cutoff: Mixture of positive and negative, demonstrating sensitivity around the cut-off
• Cutoff: Mixture of positive and negative, demonstrating sensitivity around the cut-off
• +25% cutoff: Mixture of positive and negative, demonstrating sensitivity around the cut-off
• +50% cutoff, +75% cutoff, +100% cutoff: All positive or predominantly positive

Observed Performance (Summarized from Precision Tables)

For all drugs tested (AMP, BAR, BUP, BZO, COC, EDDP, MDMA, MET, MOP300, MOP2000, MTD, OXY, PCP, PPX, TCA, THC) across three lots for both the Test Cup and Test Dipcard:

• At 0 ng/mL, -75% cutoff, and -50% cutoff: All (or overwhelmingly almost all) reported results were negative. This indicates good specificity below the cutoff.
• At +50% cutoff, +75% cutoff, and +100% cutoff: All (or overwhelmingly almost all) reported results were positive. This indicates good sensitivity above the cutoff.
• At -25% cutoff, cutoff, and +25% cutoff: A mixed distribution of positive and negative results was consistently observed, demonstrating the device's ability to differentiate samples around the cut-off concentration, as expected for a qualitative assay. For instance, at the exact cutoff, typically around 30-40 positive and 20-30 negative results were seen out of 60 determinations per lot, for most analytes.

Accuracy Study (Clinical Specimens - Example for AMP, BAR, BUP, BZO, COC, EDDP, MDMA, MET, MOP300, MOP2000, MTD, OXY, PCP, PPX, TCA, THC)

The accuracy study categorizes samples into five groups based on GC/MS or HPLC reference:

• Drug free
• Less than half the cutoff
• Near cutoff negative (between 50% below cutoff and cutoff)
• Near cutoff positive (between cutoff and 50% above cutoff)
• High positive (greater than 50% above cutoff)

The acceptance criteria here are that results from the Rapid Multi-drug Test Cup/Dipcard should align with the GC/MS or HPLC classifications.

Observed Performance (Summarized from Accuracy Tables)

For both the Test Cup and Test Dipcard:

• Drug-free, Less than half the cutoff, Near Cutoff Negative samples: Overwhelmingly resulted in negative reports from the device. A very small number of "false positives" (e.g., 1 or 2 positive results in the "Near Cutoff Negative" category for some drugs) were noted, and some "false negatives" for Buprenorphine, Morphine, Methadone, Oxycodone, TCA, and THC in the "Near Cutoff Negative" or "Near Cutoff Positive" categories when compared to the reference methods. The "Analysis of Discordant Results" section details these specific discrepancies.
• Near Cutoff Positive and High Positive samples: Overwhelmingly resulted in positive reports from the device. Similar to above, a very small number of discordant results (e.g., some "Near Cutoff Positive" samples were reported negative by the device) were observed, which are explicitly detailed in the "Analysis of Discordant Results" tables.

Overall Conclusion on Acceptance Criteria: The studies presented generally demonstrate that the device performs as expected for a qualitative immunoassay, showing good agreement with GC/MS/HPLC results for samples significantly above or below the cut-off. The mixed results near the cut-off are typical for such tests.

Study Details

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

   • Precision Study: For each drug, there were 9 concentrations tested. For each concentration, 60 determinations were made (3 lots x 3 runs/day x 10 days = 90 determinations per concentration, but the table indicates 60 determinations per lot for each concentration, which suggests (2 operators * 3 aliquots tested per lot per day = 6 determinations per lot per day) * 10 days leads to 60 determinations per lot). With 16 drugs, this means roughly 16 x 9 x 60 = 8,640 determinations for the precision study (excluding the implicit number of lots).
   • Accuracy Study (Clinical Samples): 80 clinical urine specimens per drug were used for both the Multi-drug Test Cup and Multi-drug Test Dipcard. With 16 drugs, this amounts to 16 x 80 = 1,280 samples per device format (Cup and Dipcard), so a total of 2,560 unique clinical specimens.
     • Data Provenance: The document does not specify the country of origin but states "Clinical urine specimens." It also states these were "retrospective" as they were analyzed by GC/MS/HPLC prior to testing with the device, and then retrospectively analyzed against the device results. The absence of details on where these clinical samples were collected typically means their origin is unknown or not considered relevant for this type of submission (often laboratory-sourced for drug testing evaluations).
   • Lay User Study: 1720 lay users participated. Each participant performed 1 test. Urine samples were prepared at 0, +/- 50% cutoff, +/- 25% cutoff, and +100% cutoff. This study does not explicitly state the number of unique urine samples used but rather the number of user interactions with a test sample. For each drug and each concentration, there were 10 or 30 or 360 determinations across two lots (one for Cup, one for Dipcard, it seems implied).
     • Data Provenance: Not specified, but involved "lay users" performing tests, implying a prospective collection for this specific study.
   • Interference Study: For each drug, 4 concentrations (0, -50% cutoff, +50% cutoff, +100% cutoff), 3 lots, and 15 determinations per lot per concentration. This amounts to 16 x 4 x 3 x 15 = 2,880 determinations.

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

   • Ground Truth Method: For the accuracy studies, the ground truth was established by Gas Chromatography/Mass Spectrometry (GC/MS) or High-Performance Liquid Chromatography (HPLC). These are analytical chemistry "gold-standard" methods, not expert human interpretation.
   • Number/Qualifications of Experts: Not applicable in the context of GC/MS or HPLC as ground truth. The results are based on analytical measurements, not human interpretation of images or observations.

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

   • No formal adjudication method is described for establishing ground truth, as the ground truth relies on quantitative analytical methods (GC/MS, HPLC) rather than subjective human assessment.
   • For the precision study, results were based on multiple determinations (e.g., 60 per lot per concentration), and for the lay user study, the "agreement" was calculated based on the collective results of the lay users against the known spiked concentrations. Discordant results in the accuracy study are individually listed, implying a comparison against the GC/MS/HPLC result without further adjudication panels described for the device's outcome.

4. If a multi reader multi case (MRMC) comparative effectiveness study was done, If so, what was the effect size of how much human readers improve with AI vs without AI assistance:

   • No MRMC comparative effectiveness study was performed or described. This device is a rapid diagnostic test (Test Cup/Dipcard) for drug screening, not an AI-assisted diagnostic imaging device. Therefore, the concept of "human readers improving with AI vs without AI assistance" does not apply to this specific device. The closest equivalent is the "Lay User Study," which assesses how well lay users can interpret the test independently using the provided instructions. Their agreement rates for correctly classifying samples are provided.

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

   • Yes, in essence, standalone performance was assessed in the "Precision" and "Accuracy" studies if "standalone" is interpreted as the device's intrinsic ability to detect drugs in controlled and clinical samples when read by trained operators. The device itself (the dipcard or cup) produces a visual qualitative result (lines appearing or not appearing), which is then read. The "precision study" and "accuracy study" data (Table 8.5, 8.6) represent this "algorithm only" (device only) performance when operated and interpreted by presumably trained personnel. The "Lay User Study" (Table 8.7) assesses reading by an untrained human-in-the-loop, demonstrating usability rather than optimal device performance.

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

   • The ground truth for the accuracy studies was established by analytical chemistry methods: Gas Chromatography/Mass Spectrometry (GC/MS) or High-Performance Liquid Chromatography (HPLC). These methods provide quantitative measurements of drug concentrations, which are considered the definitive "ground truth" for drug screening device validation. For spiked samples in precision, lay user, and interference studies, the ground truth was the known spiked concentration of the drug.

7. The sample size for the training set:

   • This document describes a 510(k) submission, which is for a traditional in-vitro diagnostic device (a rapid test cup/dipcard with reagent strips). There is no "training set" in the context of machine learning or AI models, as this device does not utilize such technologies. The studies described are for validation and performance assessment of the physical chemical assay.

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

   • As there is no "training set" in the AI/ML sense, this question is not applicable to the device described. The studies involve testing the device against samples with known drug concentrations (either spiked or determined by reference analytical methods) to evaluate its performance.

Ask a specific question about this device

Rapid Single/Multi-drug test Cup and Rapid 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:

The tests contain two formats: 1) Test Cup and 2) Test Dipcard. The tests may be configured as single drug tests or multiple drug tests in any combination of the drug analytes listed in the table above. These tests are intended for in vitro diagnostics use. They are intended for prescription use including point of care sites and over-the-counter use. The tests will yield preliminary positive results when prescription drugs Barbiturates, Benzodiazepine, and Methadone are ingested, even at or above therapeutic doses. There are no uniformly recognized drug levels for Barbiturates and Benzodiazepine in urine.

The assays provide only a preliminary analytical test result. Gas Chromatography/Mass spectrometry (GC/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 Single/Multi-drug Test Cup and Rapid Single/Multi-drug Test Dipcard are competitive binding, lateral flow immunochromatographic assays for the qualitative detection of Amphetamine, Cocaine, Marijuana, Methamphetamine, Barbiturates, Benzodiazepines, Methylenedioxymethamphetamine, Methadone, Oxycodone, Phencyclidine and their metabolites ( specifically THC ) at or above the cut-off levels as indicated. The tests are performed without the use of an instrument.

The test cup and test dipcard formats use identical test strips made with the same chemical formulation and manufacturing procedures.

Here's a breakdown of the acceptance criteria and study information for the Rapid 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" for precision or accuracy studies in a quantitative manner (e.g., "must achieve X% agreement"). However, given the nature of the data presented, the implied acceptance criterion for precision is that the device should reliably identify samples at or above the cutoff as positive, and samples significantly below the cutoff as negative, with a reasonable degree of accuracy for concentrations near the cutoff. For accuracy, the implied acceptance criterion is that the device should demonstrate high agreement with GC/MS analysis. For lay user readability, the implied criterion is high user comprehension.

Let's synthesize the data into a table based on these implied criteria.

Note on "Reported Device Performance": The document provides raw numbers of positive/negative results at different concentration levels for precision and individual count breakdowns for accuracy against GC/MS. To create a concise table, I will report the general trends and highlight key metrics. Specific percentages are primarily for the lay-user study.

• 0% false positives for negative samples
• 0% false negatives for high positive samples
• Consistent results at +/- 25% cutoff levels | Across all drugs and lots (single/multi-drug, cup/dipcard formats):
• Negative samples (0 ng/mL, -75% & -50% cutoff): Universally reported as 0 positive, 60 negative (100% accurate negative).
• High positive samples (+50%, +75%, +100% cutoff): Universally reported as 60 positive, 0 negative (100% accurate positive).
• Near Cutoff (-25% & +25% cutoff): Showed variability (e.g., AMP -25% cutoff ranged 4-10 positives out of 60, +25% cutoff ranged 50-58 positives out of 60). This variability near cutoff is expected for qualitative tests. |
  | Accuracy (vs. GC/MS) | High agreement between device result and GC/MS for all concentration categories. Minimal discordant results. | For clinical specimens:
• Drug free, less than half cutoff, and high positive: Generally 100% agreement with GC/MS.
• Near Cutoff Negative and Near Cutoff Positive: Showed some mixed results (expected for qualitative tests near cutoff).
• Discordant Results: A few specific cases reported where the device result (e.g., positive) did not match GC/MS (e.g., device positive for MET at 867ng/mL vs. 1000ng/mL cutoff, device negative for THC at 61ng/mL vs. 50ng/mL cutoff). These are mostly near the cutoff. |
  | Interference | No interference from common substances found in urine at 100µg/mL. | None of the tested compounds (listing many common drugs and substances) were shown to interfere with the device's performance when added to drug-free or drug-positive urine. |
  | pH Effect | Device performance unaffected by urinary pH range of 3 to 9. | The results demonstrated that varying ranges of pH (3 to 9 in 1 pH unit increments) do not interfere with the test's performance when spiked at 50% below and 50% above cutoff levels. |
  | Specific Gravity Effect | Device performance unaffected by urinary specific gravity range (1.002-1.040). | The results demonstrated that varying ranges of urinary specific gravity (1.002, 1.010, 1.020, 1.030, 1.040) do not affect the test result when spiked at 50% below and 50% above cutoff. |
  | Lay User Study | High agreement with expected results and high user comprehension for home use. | Agreement: For lay users, agreement percentages were high, generally 100% for clear negatives and clear positives, and ranging from 83% to 97% for samples near the +/- 25% cutoff for various drugs and test formats.
  Readability/Ease of Use: 100% of users felt the test was easy to use and the instructions were easy to understand. The labeling was assessed at a 6th-grade reading level. |

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

• Precision Study:
  • Sample Size: 60 determinations per lot per concentration (Total: 9 concentrations * 60 determinations/lot * 3 lots = 1620 observations for each drug type). This was for both single drug and multi-drug formats, and both cup and dipcard.
  • Data Provenance: Not explicitly stated, but based on the overall document, it is likely internal laboratory testing or conducted at the specified Point-of-Care sites, implying prospective. The "nonparticipant" blinding suggests a controlled, prospective design.
• Accuracy Study (Clinical Urine Specimens):
  • Sample Size: 80 clinical urine specimens for each drug type. These were divided into five categories (drug free, less than half cutoff, near cutoff negative, near cutoff positive, high positive).
  • Data Provenance: "Clinical urine specimens" suggests real-world samples. The study was conducted by nurses at two Point-of-Care sites, indicating prospective, real-world data collection using the device.
• Home Use Consumer Study:
  • Sample Size: 360 lay users. Urine samples were prepared at various concentrations (0, +/- 50% cutoff, +/- 25% cutoff, +100% cutoff). Each participant performed 1 test on a provided specimen.
  • Data Provenance: Prospective, controlled study with lay users using prepared samples.

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

• Precision Study: Ground truth was established by spiking known concentrations of drugs into drug-free urine. The concentrations were "confirmed with GC/MS." No human experts were used for ground truth directly for precision.
• Accuracy Study (Clinical Urine Specimens): The ground truth for the clinical urine specimens was established by Gas Chromatography/Mass Spectrometry (GC/MS) analysis. This is an analytical chemistry technique, not human expert interpretation.
• Home Use Consumer Study: Ground truth was established by spiking known concentrations of drugs into drug-free urine. The concentrations were "confirmed with GC/MS." No human experts were used for ground truth directly for the lay user study's analytical performance.

4. Adjudication Method for the Test Set

• Precision Study: The samples were "blindly labeled by a nonparticipant" and "randomized prior to testing." Results were qualitative (Positive/Negative) based on the device's output. No explicit multi-reader adjudication method (e.g., 2+1) is mentioned; it appears to be a direct comparison of the device's qualitative result to the known spiked concentration.
• Accuracy Study (Clinical Urine Specimens): "All samples were blindly labeled by a nonparticipant" and "randomized prior to testing." The device results were compared directly to the GC/MS analysis. No multi-reader adjudication is mentioned for the device's interpretation or the GC/MS results.
• Home Use Consumer Study: Each participant performed one test and filled out a questionnaire. The device's qualitative result (positive/negative) from the lay user was compared against the known spiked concentration. No explicit multi-reader adjudication is mentioned.

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. This device is a qualitative in-vitro diagnostic (drug test cup/dipcard) that provides a direct positive or negative result, read by an individual (either a healthcare professional or a lay user). It is not an imaging AI device that assists human readers in interpreting complex medical images. Therefore, an MRMC comparative effectiveness study involving AI-assisted human readers is not applicable and was not performed.

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

Yes, in essence. The device itself is a standalone qualitative test. Its performance (producing a positive or negative line) is inherent to the device's chemical assay. While a human physically observes the lines, the "algorithm" is the chemical reaction and visual indicator built into the device. The precision and accuracy studies directly reflect this standalone chemical "algorithm's" performance against known concentrations or GC/MS. The lay user study evaluated the human reading the standalone device.

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

The primary ground truth used for evaluating the performance of the device was known spiked concentrations of drugs (confirmed by GC/MS) for precision and lay user studies, and Gas Chromatography/Mass Spectrometry (GC/MS) analysis for clinical accuracy studies. GC/MS is a highly accurate analytical method considered a gold standard for confirming the presence and concentration of drugs in urine.

8. The sample size for the training set

The document describes performance studies, but it does not mention a "training set" in the context of machine learning or AI models. This device is a lateral flow immunoassay, which does not typically involve training data in the AI sense. The design and validation of this type of device rely on analytical and clinical performance studies, not machine learning model training.

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

As there is no mention of a "training set" for an AI or machine learning model, this question is not applicable to the information provided in the document. The ground truth for the performance evaluation (test sets) was established through spiking known drug concentrations into urine and confirmation via GC/MS, as detailed in point 7.

Ask a specific question about this device

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.

Ask a specific question about this device

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

The tests contain two formats:1) Test Cup, 2) Test Dipcard, The test configuration comes with single drug screening test or any combinations of multiple drug screening tests. The test is intended for in vitro diagnostics use. They are intended for prescription use in clinical laboratories only and not for point-of-care use.

This assay provides only a preliminary analytical test result. Gas Chromatography/Mass spectrometry (GC/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.

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 Barbiturates, Benzodiazepines, Methylenedioxymethamine, Methadone, Oxycodone, Phencyclidine and their metabolites at or above the cut-off levels as indicated. The tests can be performed without the use of an instrument.

The provided document describes the Co-Innovation Biotech Co.,Ltd. One Step Single/Multi-drug Test Cup and One Step Single/Multi-drug Test Dipcard for qualitative detection of drugs of abuse in human urine. Here's a breakdown of the acceptance criteria and study information:

1. Table of Acceptance Criteria and Reported Device Performance

The acceptance criteria for qualitative immunoassay tests like these are typically assessed by comparing the device's results (positive/negative) against a gold standard (GC/MS) especially around the cutoff concentration. While explicit numerical acceptance criteria (e.g., % agreement, sensitivity, specificity targets) are not explicitly stated as 'acceptance criteria' in the document, the performance data implicitly serves as the demonstration that the device performs acceptably. The study evaluates the device's ability to correctly identify drug-free, less than half cutoff, near cutoff negative, near cutoff positive, and high positive samples.

The tables below synthesize the reported device performance for both the Test Cup and Test Dipcard formats for single and multi-drug tests, against the GC/MS analysis. The "Total" column in the original tables sums up the sample distribution across concentration categories, not the total number of samples processed for each drug test condition. The key performance indicator here is the consistency of results, particularly for samples around the cutoff concentration.

Device Performance for One Step Single/Multi-drug Test Cup & Dipcard (Single Drug Test Example - All Drugs follow similar pattern)

| Drug Test | Co-Innovation Result | GC/MS Analysis (Drug-free) | GC/MS Analysis (1.5x Cutoff) | Total Samples |
|---|---|---|---|---|---|---|---|
| BAR | + | 0 | 0 | 0 | 6 | 34 | 80 |
| | - | 33 | 0 | 7 | 0 | 0 | 80 |
| BZO | + | 0 | 0 | 1 | 7 | 33 | 80 |
| | - | 31 | 0 | 8 | 0 | 0 | 80 |
| MDMA | + | 0 | 0 | 0 | 5 | 34 | 80 |
| | - | 32 | 3 | 5 | 1 | 0 | 80 |
| MTD | + | 0 | 0 | 1 | 5 | 35 | 80 |
| | - | 32 | 2 | 5 | 0 | 0 | 80 |
| OXY | + | 0 | 0 | 0 | 6 | 34 | 80 |
| | - | 35 | 0 | 5 | 0 | 0 | 80 |
| PCP | + | 0 | 0 | 1 | 5 | 35 | 80 |
| | - | 35 | 0 | 4 | 0 | 0 | 80 |

Analysis of Discordant Results (Example for Test Cup and Dipcard, Single and Multi-drug)

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

• Sample Size: 80 clinical urine specimens were used for each drug tested, for each device format (Single Drug Test Cup, Single Drug Test Dipcard, Multi-drug Test Cup, Multi-drug Test Dipcard). Therefore, for each drug, a total of 320 samples were analyzed (80 * 4). The samples were categorized into five groups based on concentration relative to the cutoff (drug-free, less than half the cutoff negative, near cutoff negative, near cutoff positive, and high positive).
• Data Provenance: The data is from "clinical urine specimens," implying human origin. However, the country of origin is not specified, and it is a retrospective analysis as the specimens were analyzed by GC/MS for comparison with the device.

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

• The ground truth was established by Gas Chromatography/Mass Spectrometry (GC/MS) analysis, which is considered the "preferred confirmatory method" for drug of abuse testing.
• No human "experts" are mentioned as having established the ground truth through consensus or individual reading of the device results for the purpose of the primary accuracy study. The device results were compared directly against the GC/MS findings.

4. Adjudication Method for the Test Set

• None in the traditional sense of multiple human readers adjudicating results. The device's qualitative results (positive/negative) were directly compared to the quantitative GC/MS results for each sample. Discordant results were individually listed with the GC/MS concentration.

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

• No, a MRMC comparative effectiveness study was not performed. The study's focus was on the standalone performance of the devices against a gold standard (GC/MS). Human readers' improvement with or without AI assistance is not relevant here as it's a diagnostic test that provides a clear positive/negative result, not an AI-assisted diagnostic imaging interpretation.

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

• Yes, this was a standalone performance study. The "One Step Single/Multi-drug Test Cup" and "One Step Single/Multi-drug Test Dipcard" are qualitative, lateral flow immunochromatographic assays designed to be read directly without an instrument or human interpretation loop beyond reading the presence or absence of test lines. The performance data presented directly reflects the device's output (positive/negative) compared to GC/MS.

7. The Type of Ground Truth Used

• The ground truth used was quantitative analytical data from Gas Chromatography/Mass Spectrometry (GC/MS), which is the preferred confirmatory method for drug of abuse testing. This is a highly objective and precise method for determining drug concentration.

8. The Sample Size for the Training Set

• This document describes a performance evaluation of a medical device, not an AI algorithm that requires a training set. Therefore, no training set for an algorithm is mentioned or applicable in this context. The devices are immunoassay tests, not machine learning algorithms.

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

• As mentioned above, there is no training set for an algorithm as the device is an immunoassay test.

Ask a specific question about this device

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

Marijuana (THC) Calibrato r · Delta-9-THC-COOH Cut-off level 50 ng/ml.
Cocaine (COC) Benzoylecgonine 300 ng/ml.
Amphetamine (AMP) D-Amphetamine 1000 ng/ml.
Methamphetamine (MET) D-Methamphetamine 1000 ng/mL
Morphine 2000 (MOP) Morphine 2000 ne/ml.

The tests contain two formats: 1) Test Cup, 2) Test Dipeard. The test configuration comes with single drug sereening test or any combinations of multiple drug screening tests. The test is intended for in vitro diagnostics use. They are intended for preseription use in clinical laboratories only and not for point-of-care use.

These esss provide only a prefininary analytical test result and are the first step in a two-step process for detecting drugs of abuse in urine. The second step is continuing the results in a certified laboratory. For a quantitative result or to confirm preliminary positive positive positive results obtained by the One Step Multi-drug Test Cup Insert or One Step Single/Multi-drug Test Dipeard Insert, a more specific alternaire method such as Gas Chromatography/Mass Spectomerry (GCMS) must be used. 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 Amphetamine, Cocaines, Marijuana, Methamphetamine,Morphine and their metabolites at or above the cut-off levels as indicated. The tests can be performed without the use of an instrument.

The provided document describes the performance of the Co-Innovation Biotech Co., Ltd. One Step Single/Multi-drug Test Cup and Dipcard for the qualitative detection of drugs and drug metabolites in human urine.

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

1. Table of Acceptance Criteria and Reported Device Performance

The document does not explicitly state "acceptance criteria" with numerical thresholds for performance metrics (like sensitivity, specificity, or agreement percentages). Instead, it presents the results of clinical studies (accuracy studies) designed to demonstrate the device's performance against a gold standard (GC/MS). The implied acceptance is that the device demonstrates a high level of agreement with GC/MS, especially near and above the cutoff concentrations.

For the purpose of this response, I infer the performance target is to achieve high agreement with GC/MS. The reported device performance is shown in the tables below, demonstrating the number of positive and negative results from the device compared to GC/MS at different concentration levels.

Performance Summary (based on provided data for both formats: Cup and Dipcard)

| Drug Test | Cut-off Level (ng/mL) | Device Format | Agreement with Drug Free (Negative Result) | Agreement with

Ask a specific question about this device

The Co-Innovation One Step 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 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 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.

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-B-HCG antibody specific to the beta subunit of hCG.

2. A nitrocellulose membrane which is striped with the mouse monoclonal anti-a-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.

Here's an analysis of the provided 510(k) summary, detailing the acceptance criteria and the studies conducted to demonstrate the device's performance:

1. Table of Acceptance Criteria and Reported Device Performance

The acceptance criteria are generally implied by the successful outcomes presented in the study results, particularly for precision and sensitivity, as no explicit numerical acceptance targets are stated (e.g., "sensitivity must be >99%"). However, the performance data clearly demonstrates that the device meets the implicit requirement for accurate qualitative detection of HCG at the clinical cut-off of 25mIU/mL.

• 0mIU/mL, 12.5mIU/mL, 18.75mIU/mL: 100% negative (30/30 for each LOT and concentration).
• 25mIU/mL, 50mIU/mL, 100mIU/mL: 100% positive (30/30 for each LOT and concentration). |
  | Sensitivity: Detect HCG at the clinical cut-off of 25mIU/mL. | Sensitivity: 25mIU/mL (derived from precision study, showing 100% detection at this concentration). |
  | Specificity: No cross-reactivity with common related hormones. | Specificity: No cross-reaction observed with LH at 500mIU/mL, FSH at 1000mIU/mL, and TSH at 1000uIU/ml in urine specimens containing 0 mIU/ml and 25mIU/ml HCG. |
  | Interference: No interference from common exogenous compounds. | Interference: No interferences observed from Acetaminophen, Aspirin, Ascorbic acid, Atropine, Caffeine (all at 20mg/dL), Glucose (2000mg/dL), Hemoglobin (500mg/dL), Tetracycline, Ampicillin (all at 20mg/dL), Albumin (2000mg/dL), Bilirubin (2mg/dL) for both negative and positive HCG samples. |
  | HCG ß-core fragment interference: No interference from high levels of HCG ß-core fragment. | HCG ß-core fragment interference: No interference was observed when spiked at 125,000, 250,000, 500,000, and 1,000,000 pmol/mL in urine samples containing 0 and 25 mlU/ml HCG. |
  | pH interference: Stable performance across a physiological pH range. | pH interference: Varying pH ranges (3 to 9 in 1 pH unit increments) did not interfere with test performance for 0mlU/ml and 25mlU/ml HCG samples. |
  | Specific gravity interference: Stable performance across a physiological range of specific gravity. | Specific gravity interference: No interference was observed when specific gravity was between 1.01-1.04 for purified water and 25mIU/mL HCG spiked specimens. |
  | Urinary system diseases interference: No interference from markers of urinary conditions. | Urinary system diseases interference: No interference observed from strongly positive white blood cells, urine occult blood, uric acid, and urine ketone in urine samples containing 0mlU/ml and 25mlU/ml HCG. |
  | Hook effect: Maintain positive results at high HCG concentrations. | Hook effect: Generated positive results for HCG concentrations from 62,500mIU/ml to 1,000,000mIU/ml. (Note: "T line get to light as the concentration above 125000mlU/ml" indicates the test still works, but potentially with reduced band intensity, which is acceptable for qualitative detection and does not lead to false negatives at very high concentrations). |
  | Method Comparison (Professional User): High agreement with predicate device results. | Professional Method Comparison (Strip, Cassette, Midstream - all methods): 100% agreement with the predicate device for all formats. (e.g., for Strip, Professional A: 38 Positive, 42 Negative; Professional B: 38 Positive, 42 Negative, all matching the predicate). |
  | Method Comparison (Lay User): High agreement with professional test results. | Lay User Method Comparison (Strip, Cassette, Midstream - all methods): 100% agreement with professional laboratory results using the candidate device for all formats. (e.g., for Strip, Lay Users: 38 Positive, 42 Negative, all matching the professional results). |
  | OTC User Performance: Untrained users can obtain correct results reliably. | OTC User Study:
• Strip: 29/30 correct positive (31.25mIU/ml), 30/30 correct negative (18.75mIU/ml).
• Cassette: 30/30 correct positive, 30/30 correct negative.
• Midstream (dip): 30/30 correct positive, 30/30 correct negative.
• Midstream (simulated midstream): 30/31 correct positive, 29/29 correct negative.
  Conclusion: Untrained operators can get correct results. |

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

• Precision Study: 30 clinical samples (normal, non-pregnant female urine) were spiked with HCG at 6 different concentrations (0mIU/ml, 12.5mIU/ml, 18.75mIU/ml, 25mIU/ml, 50mIU/ml, 100mIU/ml). Each concentration had 30 samples tested per LOT, across 3 lots, yielding 90 tests per concentration per format. The study was conducted over 10 days, 3 runs/day.
  • Provenance: Clinical samples from "normal, non-pregnant females." The document does not explicitly state the country of origin, but the submitter is from Guangzhou, China, and the OTC user study sites are in Guangzhou, Shanghai, and Wuhan, suggesting a Chinese origin. The study appears to be a prospective experimental study using spiked samples.
• Specificity Study: 60 urine specimens (containing 0 mIU/ml and 25mIU/ml HCG) were spiked with LH, FSH, and TSH. Tested across 3 lots.
  • Provenance: Not explicitly stated, likely similar to precision study. Prospective experimental study.
• Interfering Substances Study: Normal, non-pregnant female urine specimens (0 and 25 mIU/ml HCG) were spiked with 11 different compounds. 3 batches of each format were tested for each interferent.
  • Provenance: Not explicitly stated, likely similar to precision study. Prospective experimental study.
• HCG ß-core fragment Interference Study: Normal, non-pregnant female urine specimens (0 and 25 mlU/ml HCG) were spiked with 4 different concentrations of HCG ß-core fragment. 3 batches of each format were tested.
  • Provenance: Not explicitly stated, likely similar to precision study. Prospective experimental study.
• pH Interference Study: Aliquoted negative urine pool adjusted to pH 3-9, spiked with 0mlU/ml and 25mlU/ml HCG. 3 batches were tested repeatedly.
  • Provenance: Not explicitly stated, likely similar to precision study. Prospective experimental study.
• Specific Gravity Interference Study: Purified water and 25mlUml HCG spiked specimens formulated with specific gravity 1.01-1.04. 3 lots tested.
  • Provenance: Not explicitly stated, likely similar to precision study. Prospective experimental study.
• Urinary System Diseases Interference Study: Urine specimens with strongly positive markers (white blood cells, occult blood, uric acid, urine ketone) prepared with 0mlU/ml and 25mlU/ml HCG. 3 lots tested repeatedly.
  • Provenance: Not explicitly stated, likely clinical samples. Prospective experimental study.
• HOOK Effect Study: HCG free specimens spiked with 5 different very high HCG concentrations (62,500mIU/m1 to 1,000,000mIU/ml). Three lots tested.
  • Provenance: Not explicitly stated, likely similar to precision study. Prospective experimental study.
• Professional Method Comparison: 353 urine samples collected from women at a hospital laboratory. "Approximately half of the women were pregnant in the early stage of less than 5 weeks." Ages 18-45 years.
  • Provenance: Clinical samples from a hospital laboratory. Not explicitly stated, but likely China given other study locations. Retrospective (samples collected, then tested) or prospective (samples collected specifically for the study) clinical study.
• Lay User Method Comparison: The same 353 urine samples as the Professional Method Comparison.
  • Provenance: Clinical samples, likely China. Retrospective or prospective clinical study.
  • Specific breakdown for lay users: 80 using strip, 113 using cassette, 160 using midstream (actual + dip methods combined).
• OTC User Performance: 240 female subjects (untrained operators, ages 18-45) tested masked spiked urine samples (120 containers of 18.75mlU/ml and 120 of 31.25mlU/ml). Each subject performed 1 test on one format/method.
  • Provenance: Samples were spiked. Subjects from Guangzhou, Shanghai, and Wuhan, China. Prospective experimental study (simulated home use).

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

• Precision, Specificity, Interference, pH, Specific Gravity, Urinary System Diseases, HOOK Effect Studies: The ground truth (HCG concentration, presence/absence of interferents) was established by spiking known concentrations of HCG or interfering substances, traceable to WHO standards or determined by immunoassay (ELISA). This does not involve human experts establishing ground truth for individual test samples, but rather analytical methods.
• Professional Method Comparison: The "ground truth" for this study was the result obtained by the predicate device when tested by laboratory professionals. The exact number of professionals is not specified, but the study was conducted at "two laboratories (namely Professional A and Professional B)", implying at least two professionals. Their qualifications are stated as "laboratory professionals."
• Lay User Method Comparison: The "ground truth" for this study was the result obtained by laboratory professionals using the candidate device. The number of laboratory professionals is not specified, but it was conducted at "a laboratory." Their qualifications are "laboratory professionals."
• OTC User Performance: The "ground truth" for this study was established by masked spiked urine samples (known HCG concentrations) and independently verified by professional laboratory personnel at the manufacturer site. The number of professionals is not specified, and their exact qualifications are not detailed beyond "professional laboratory personnel."

4. Adjudication Method for the Test Set

• For the analytical performance studies (Precision, Specificity, Interference, etc.), adjudication generally involves comparing the device's output to the known, spiked concentration or condition. There's no human adjudication process described beyond analytical confirmation of spike levels.
• For the Professional Method Comparison and Lay User Method Comparison, the comparison is against the predicate device or professional results of the candidate device. The agreement is tabulated directly, implying no specific "adjudication" if disagreement occurred, as 100% agreement was reported.
• For the OTC User Performance study, the lay users' results were compared against the "masked spiked sample professional users" results (i.e., known spiked concentration verified by professionals). Again, no specific adjudication process for discrepancies is described, as the focus is on the agreement rate.

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

There was no MRMC comparative effectiveness study done, as this device is a qualitative diagnostic test (HCG pregnancy test) not an imaging device typically analyzed by human readers with or without AI assistance. The studies involve human users (professional or lay) interpreting the test results visually, but not in a context typically requiring MRMC analysis.

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

This device is a visual qualitative immunochromatographic assay. There is no "algorithm" in the sense of a software-based AI. The performance is inherently "standalone" in that it produces a visual result (a line) and the interpretation is human-in-the-loop (reading the line). The "performance" studies are effectively standalone because they evaluate the test's ability to produce the correct visual output given an HCG concentration. The OTC user study then evaluates the human (lay user) interpretation of this visual output.

7. The Type of Ground Truth Used

• Spiked Samples (Precision, Specificity, Interference, Hook Effect, pH, Specific Gravity, Urinary System Diseases, OTC User Study): The ground truth was established by laboratory control, adding known concentrations of HCG (traceable to WHO 3rd IS) or interfering substances to urine samples. This is a form of analytical or engineered ground truth.
• Professional Method Comparison: The ground truth was the result from the predicate device.
• Lay User Method Comparison: The ground truth was the result from professional users testing the candidate device.

8. The Sample Size for the Training Set

There is no explicit training set described in this 510(k) summary. This type of device (lateral flow immunoassay) typically does not involve a machine learning model that requires a distinct "training set." The development process for such a device relies on chemical and biological engineering principles, optimization of reagents, and initial analytical testing, rather than an iterative machine learning training process with labeled data.

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

As no explicit training set for a machine learning algorithm is mentioned, pertinent to the nature of this device, the question of how ground truth was established for a training set is not applicable. The ground truth for the performance evaluations (test sets) was established as described in section 7.

Ask a specific question about this device