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The Carolina Liquid Chemistries Cocaine Metabolite Enzyme Immunoassay (COCM) Test System is intended for the qualitative determination of benzoylecgonine (cocaine metabolite) in human urine at a cutoff value of 300 ng/mL. The assay is designed for professional use with a Carolina Liquid Chemistries CLC6410 automated clinical chemistry analyzer. For in vitro diagnostic use only. The assay provides a rapid screening procedure for determining the presence of benzoylecgonine in urine. The assay provides only a preliminary analytical result. A more specific alternative chemical method must be used to obtain a confirmed analytical result. Gas or Liquid Chromatography/Mass Spectrometry (GC/MS or LC/MS) is the preferred confirmatory method. Clinical considerations and professional judgment should be exercised with any drug of abuse test result, particularly when the preliminary test result is positive.

The Carolina Liquid Chemistries Cocaine and Cocaine Metabolite Enzyme Immunoassay (COCM) Test System is a ready-to-use, liquid reagent homogeneous enzyme immunoassay for qualitatively determining the presence of cocaine metabolite (benzoylecgonine) in human urine. The assay uses specific antibody that can detect benzoylecgonine in human urine with minimal cross-reactivity to various, common prescription drugs and abused drugs. The assay is based on competition between benzoylecgonine labeled with the enzyme glucose-6phosphate dehydrogenase (G6PDH) and free drug from the urine sample, for a fixed amount of antibody. In the absence of free drug from the urine sample, the specific antibody binds to the drug labeled with G6PDH causing a decrease in enzyme activity. The G6PDH enzyme activity is determined spectrophotometrically at 340 nm by measuring its ability to convert nicotinamide adenine dinucleotide (NAD+) to NADH.

Here's a breakdown 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

• 0 ng/mL, 75 ng/mL, 150 ng/mL, 225 ng/mL: 4/4 Negative results.
• 300 ng/mL (Cutoff): 3/1 Neg/Pos (3 Negative, 1 Positive).
• 375 ng/mL, 450 ng/mL, 525 ng/mL, 600 ng/mL: 4/4 Positive results.
  Run-to-Run:
• 0 ng/mL, 75 ng/mL, 150 ng/mL, 225 ng/mL: 88/88 Negative results.
• 300 ng/mL (Cutoff): 53/35 Neg/Pos (53 Negative, 35 Positive).
• 375 ng/mL, 450 ng/mL, 525 ng/mL: 88/88 Positive results. |
  | Specificity | Supported by cross-reactivity studies that supported the predicate device (K020763). (No specific numerical data provided in this document, but stated as acceptable by reference to predicate) |
  | Interference (pH) | No substantial interference noted.
• 225 ng/mL Target: All samples from pH 3.1 to 11.1 tested Negative.
• 375 ng/mL Target: All samples from pH 3.1 to 11.1 tested Positive. |
  | Interference (Specific Gravity) | No substantial interference noted.
• 225 ng/mL Target: All samples from SG 1.000 to 1.029 tested Negative.
• 375 ng/mL Target: All samples from SG 1.001 to 1.028 tested Positive. |
  | Carryover | No carryover was noted during testing with alternating high (1000 ng/mL) and low (0 ng/mL) samples. |
  | Method Comparison and Accuracy | Agreement among positives: 100% (40/40 samples correctly identified).
  Agreement among negatives: 100% (41/41 samples correctly identified).
  No discordant samples identified. |

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

• Precision:
  • Within Run: 4 replicates per concentration.
  • Run-to-Run: 88 replicates per concentration (2 samples/day for 22 non-consecutive days).
• Interference (pH): 18 real human urine samples (9 pH pools, each split and spiked at two concentrations).
• Interference (Specific Gravity): 20 real human urine samples (10 SG pools, each split and spiked at two concentrations).
• Carryover: 21 samples (10 "High" at 1000 ng/mL, 11 "Low" at 0 ng/mL).
• Method Comparison and Accuracy: 81 samples total.
  • 41 LC/MS Confirmed Negative Samples (20 drug-free, 21 between 0-300 ng/mL, with 8 between 150-300 ng/mL).
  • 40 LC/MS Confirmed Positive Samples (at least 8 between 300-450 ng/mL, remaining >450 ng/mL).

Data Provenance: The document states "real human urine samples" for interference testing, and for precision and accuracy, samples were "drug free urine" or "spiked with benzoylecgonine." The document does not specify the country of origin of the data or whether the data was retrospective or prospective. It implies a controlled laboratory setting (spiking, adjusting pH/SG).

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

The document does not mention the use of experts to establish a ground truth. The ground truth for the test set (Method Comparison and Accuracy, Precision) was established through instrumental analysis: LC/MS (Liquid Chromatography/Mass Spectrometry), which is explicitly called the "confirmatory method" and "reference method."

4. Adjudication Method for the Test Set

No adjudication method (e.g., 2+1, 3+1) is mentioned, as the ground truth was established by instrumental methods (LC/MS) rather than human experts requiring consensus.

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

No MRMC study was done, as this device is an in vitro diagnostic (IVD) assay for laboratory use, not an AI-assisted diagnostic tool for human readers. Therefore, there is no mention of effect size for human readers improving with or without AI assistance.

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

This device is a standalone algorithm/assay in the sense that it performs the qualitative determination of benzoylecgonine without a human-in-the-loop for the primary result interpretation. The "professional use" mentioned refers to laboratory professionals operating the automated analyzer and interpreting the results within a clinical context, not interacting with AI for improved diagnostic performance. The performance data presented (precision, accuracy, etc.) represents the standalone performance of the assay.

7. The Type of Ground Truth Used

The primary ground truth used for performance evaluation (especially for accuracy and precision) is Gas or Liquid Chromatography/Mass Spectrometry (GC/MS or LC/MS). For the precision study, it states: "All sample concentrations were verified by a confirmatory method (LCMS)." For method comparison and accuracy, it states: "Qualitative Mode Accuracy study with LC-MS/MS as reference method." This is an instrumental, objective laboratory method.

8. The Sample Size for the Training Set

The document describes performance studies for a developed immunoassay. It does not mention a "training set" in the context of machine learning, as this is a chemical assay, not an AI/ML algorithm that requires training data in that sense. The reagents and parameters are developed through R&D, not trained on a dataset like a deep learning model.

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

As no training set (in the ML sense) is relevant for this type of immunoassay, this question is not applicable. The assay's analytical characteristics are determined by its chemical and biological components and detection principles, which are optimized during development and validated through the studies described.

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The Alinity c Cocaine assay is a homogeneous enzyme immunoassay intended for the qualitative and/or semi-quantitative determination of benzoylecgonine (Cocaine Metabolite) in human urine at a cutoff concentration of either 150 ng/mL or 300 ng/mL on the Alinity c analyzer.

The semiquantitative application is for the purpose of enabling laboratories to determine an appropriate dilution of the specimen for confirmation by a confirmatory method such as Liquid Chromatography/Tandem Mass Spectrometry (LC-MS/MS) or permitting laboratories to establish quality control procedures.

The assay provides only a preliminary analytical test result. A more specific alternative chemical method must be used to obtain a confirmed analytical result. Gas Chromatography/Mass Spectrometry (GC/MS) or Liquid Chromatography/ Tandem Mass Spectrometry (LC-MS/MS) are the preferred confirmatory method. Tests for cocaine metabolite cannot distinguish between abused drugs and certain prescribed medications.

Clinical and professional judgment should be applied to any drug of abuse test result, particularly when preliminary results are used. For In Vitro Diagnostic Use Only.

The DRI Cocaine Metabolite Assay is a homogeneous enzyme immunoassay using ready-to-use liquid reagents. The assay uses a specific antibody, which can detect benzoylecgonine in urine. The assay is based on the competition of an enzyme glucose-6-phosphate dehydrogenase (G6PDH) labeled drug and the drug from the urine samplefor a fixed amount of specific antibody binding sites. In the presence of free drug fromthe sample, the free drug occupies the antibody binding sites, allowing the drug-labeled G6PDH to interact with the substrate, resulting in enzyme activity. In the absence of drug from the sample, the specific antibody binds to the drug labeled with G6PDH and the enzyme activity is inhibited. This phenomenon creates a direct relationship between the drug concentration in the urine and the enzyme activity. The enzyme G6PDH activity is determined spectrophotometrically at 340 nm by measuring its ability to convert nicotinamide adenine dinucleotide (NAD) to NADH.

The assay consists of reagents (A and E).

Reagent A: Contains mouse monoclonal anti-benzoylecgonine antibody, glucose-6- phosphate (G6P), and nicotinamide adenine dinucleotide (NAD) in Tris buffer with sodium azide as preservative.

Reagent E: Contains benzoylecgonine analog labeled with glucose-6-phosphate dehydrogenase (G6PDH) in HEPES buffer with sodium azide as preservative.

The provided text describes the analytical performance studies for the DRI Cocaine Metabolite Assay, an in vitro diagnostic device, rather than an AI-powered medical device requiring human-in-the-loop studies or expert consensus for ground truth. Therefore, many of the requested elements for AI/ML device studies (such as MRMC studies, number of experts for ground truth, adjudication methods, training set information) are not applicable to this submission.

However, I can extract information related to the acceptance criteria and performance of this in vitro diagnostic device.

Here's a breakdown based on the provided document:

Acceptance Criteria and Reported Device Performance

The acceptance criteria are implied by the results presented in the analytical performance studies. The device is expected to accurately categorize samples as negative or positive relative to defined cutoffs (150 ng/mL or 300 ng/mL) and demonstrate good precision, linearity, and minimal interference.

Table of Acceptance Criteria (Implied) and Reported Device Performance

• Below cutoff (-100% to -25%): 100% Negative (e.g., 120/0 or 119/0)
• Above cutoff (+25% to +100%): 100% Positive (0/120 or 0/119)
• At cutoff (150 ng/mL): Qualitative: 76/44 (N/P), Semi-Quantitative: 73/47 (N/P)
  300 ng/mL cutoff:
• Below cutoff (-100% to -25%): 100% Negative (e.g., 120/0 or 119/0)
• Above cutoff (+25% to +100%): 100% Positive (0/120)
• At cutoff (300 ng/mL): Qualitative: 44/76 (N/P), Semi-Quantitative: 42/77 (N/P) |
  | Spike Recovery | Samples spiked below cutoff should be negative; samples spiked above cutoff should be positive. | 150 ng/mL cutoff:
• 112.5 ng/mL (below C/O): 25/25 Negative
• 187.5 ng/mL (above C/O): 25/25 Positive
  300 ng/mL cutoff:
• 225 ng/mL (below C/O): 25/25 Negative
• 375 ng/mL (above C/O): 25/25 Positive |
  | Linearity | Observed concentrations should be within an acceptable recovery range of expected concentrations across the assay range. | Excellent linearity demonstrated over the range 0 to 1032.2 ng/mL. Percent recovery from 95.7% to 111.4%. |
  | Method Comparison (Accuracy) | High agreement (concordance) with the confirmatory method (LC-MS/MS). Discordant results should be minimal and explainable. | 150 ng/mL cutoff (Semi-Quantitative & Qualitative):
• Agreement among Positives: 100% (51/51)
• Agreement among Negative: 98% (49/50)
• 1 discordant result (Device: Positive, LC-MS/MS: 134 ng/mL, which is below 150 ng/mL cutoff)
  300 ng/mL cutoff (Semi-Quantitative & Qualitative):
• Agreement among Positives: 100% (50/50)
• Agreement among Negative: 96% (48/50)
• 2 discordant results (Device: Positive, LC-MS/MS: 268 ng/mL and 211 ng/mL, both below 300 ng/mL cutoff) |
  | Specificity (Cross-Reactivity) | Minimal cross-reactivity with structurally related or unrelated compounds at specified concentrations. | Cocaine and metabolites:
• Benzoylecgonine: 100%
• Cocaine: 0.6%
• Cocaethylene: 0.5%
• Ecgonine: 0.17-0.19%
• Ecgonine Methyl Ester:

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The Pointe Scientific Cocaine Metabolite Enzyme Immunoassay is intended for the qualitative determination of benzoylecgonine (a cocaine metabolite) in human urine at a cutoff value of 150 ng/mL. Rx only.

This assay provides only a preliminary analytical test result. A more specific alternative chemical must be used in order to obtain a confirmed analytical result. Gas or Liquid Chromatograph/Mass Spectrometry (GC/MS) are the preferred confirmatory methods. Clinical consideration and professional judgment should be exercised with any drug of abuse test result, particularly when the preliminary result is positive.

The Cocaine Metabolite Enzyme Immunoassay consists of ready-to-use liquid reagents:

• . Reagent 1 contains a mouse monoclonal anti-benzoylecgonine antibody, glucose-6-phosphate (G6P) nicotinamide adenine dinucleotide (NAD), stabilizers and sodium azide (0.09%) as a preservative.
• Reagent 2 contains glucose-6-phosphate dehydrogenase (G6PDH) labeled with . benzoylecgonine in buffer with sodium azide (0.09%) as a preservative.
  The assay is based on competition between drug in the sample and drug labeled with the enzyme glucose-6-phosphate dehydrogenase (G6PDH) for a fixed amount of antibody in the reagent. Enzyme activity decreases upon binding to the antibody, and the drug concentration in the sample is measured in terms of enzyme activity. In the absence of drug in the sample, benzoylecgonine-labeled G6PDH conjugate is bound to antibody, and the enzyme activity is inhibited. On the other hand, when drug is present in the sample, antibody binds to the free drug; the unbound benzovlecgonine-labeled G6PDH then exhibits its maximal enzyme activity. Active enzyme converts nicotinamide adenine dinucleotide (NAD) to NADH, resulting in an absorbance change that can be measured spectrophotometrically at a 340 nm primary wavelength.
  The assay has a cutoff of 150 ng/mL benzoylecqonine.

Here's an analysis of the provided text to extract the acceptance criteria and study information, formatted as requested:

1. Table of Acceptance Criteria and Reported Device Performance:

The document doesn't explicitly state "acceptance criteria" in a numerical or categorical format for overall device performance (e.g., "sensitivity must be >X%"). Instead, it presents performance data for several metrics that implicitly represent the device's ability to perform as intended and demonstrate substantial equivalence to the predicate device.

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

• Sample Size for Method Comparison: 114 unaltered clinical urine remnant samples.
• Data Provenance: The samples were obtained from a "third-party biorepository." The country of origin is not specified but is implied to be within the scope of the FDA's jurisdiction (likely the US). The data is retrospective as it uses remnant samples.
• Sample Size for Precision Studies: Drug-free urine was spiked at various concentrations (zero, -75%, -50%, -25% of cutoff, at cutoff, +25%, +50%, +75%, +100% of cutoff). For within-run studies, 20 observations were made for each concentration. For between-run studies, 80 observations were made for each concentration.
• Sample Size for Interference Studies: Specific numbers are not given for each interfering substance, but the study involved "various concentrations" for endogenous compounds, and urine samples at 9 different pH levels and 12 different specific gravity levels.
• Sample Size for Cross-Reactivity Studies: "Various concentrations" of structurally related and unrelated compounds were spiked into drug-free urine. Specific numbers of replicates are not provided, except for the referenced study which likely involved a larger set.

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

• The ground truth for the method comparison study was established by Agilent 6460 LC/MS. This is an analytical instrument, not human experts.
• For the precision, interference, and cross-reactivity studies, the ground truth was established by spiking known concentrations of benzoylecgonine or interfering substances into drug-free urine or using urine samples with known characteristics (e.g., pH, specific gravity). This is also an analytical assessment.
• Therefore, no human experts were used to establish the ground truth in the traditional sense of consensus or adjudication. The "ground truth" was determined by the highly precise and accurate analytical methods of LC/MS and controlled spiking.

4. Adjudication Method for the Test Set:

• None. The primary analytical reference method (LC/MS) is considered the gold standard for quantitative determination of benzoylecgonine in this context. The comparison is directly between the candidate device and this analytical gold standard. Discrepancies are reported as "discordant results" without further human adjudication in the provided summary.

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 an in vitro diagnostic (IVD) assay designed for qualitative determination of a cocaine metabolite in urine. It does not involve human "readers" in the context of image interpretation or subjective diagnostic assessment. Therefore, an MRMC study or AI assistance is not applicable to this type of device.

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

• Yes, this is essentially a standalone algorithm/device performance study. The Pointe Scientific Cocaine Metabolite Enzyme Immunoassay operates as an automated assay on clinical chemistry analyzers (Mindray BS-480 and BA-800M). Its performance is evaluated intrinsically against an analytical gold standard (LC/MS) and under controlled laboratory conditions (precision, interference, cross-reactivity). It does not involve a human in the loop for interpreting its primary result, which is a qualitative "positive" or "negative" determination based on a defined cutoff.

7. The Type of Ground Truth Used:

• Analytical Gold Standard / Spiked Samples:
  • For the method comparison, the ground truth was established by a fully validated and qualified Agilent 6460 LC/MS (Liquid Chromatograph/Mass Spectrometry), which is considered a highly accurate and precise reference method for quantitative drug analysis.
  • For precision, interference, and cross-reactivity studies, the ground truth was established by spiking known, confirmed concentrations of benzoylecgonine or other substances into drug-free urine, or by using urine samples with precisely measured characteristics (pH, specific gravity).

8. The Sample Size for the Training Set:

• The document describes a 510(k) submission for a diagnostic assay, not a machine learning or AI algorithm. Therefore, the concept of a "training set" for an algorithm to learn from does not apply in this context. The assay's performance is based on its chemical and enzymatic reactions, which are designed and validated, not "trained" on data.

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

• As explained above, there is no "training set" in the context of this chemical immunoassay. The device's operational characteristics are fixed by its chemical and biological components.

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The DRI Cocaine Metabolite Assay is a homogeneous enzyme immunoassay intended for the qualitative and/or semi- quantitative determination of benzoylecgonine (Cocaine Metabolite) in human urine at a cutoff concentration of either 150 ng/mL or 300 ng/mL.

The semi-quantitative mode is for the purpose of enabling laboratories to determine an appropriate dilution of the specimen for confirmation by a confirmatory method such as Liquid Chromatography/tandem mass spectrometry (LC- MS/MS) or permitting laboratories to establish quality control procedures.

The assay provides only a preliminary analytical test result. A more specific alternative chemical method must be used to obtain a confirmed analytical result. Gas chromatography / Mass spectrometry (GC/MS) or Liquid chromatography/ tandem mass spectrometry (LC-MS/MS) is the preferred confirmatory method. Tests for cocaine metabolite cannot distinguish between abused drugs and certain prescribed medications.

Clinical and professional judgment should be applied to any drug of abuse test result, particularly when preliminary results are used. For In Vitro Diagnostic Use Only.

The DRI Cocaine Metabolite Assay is a homogeneous enzyme immunoassay using ready-to-use liquid reagents. The assay uses a specific antibody, which can detect benzoylecgonine in urine. The assay is based on the competition of an enzyme glucose-6-phosphate dehydrogenase (G6PDH) labeled drug and the drug from the urine sample for a fixed amount of specific antibody binding sites. In the presence of free drug from the sample, the free drug occupies the antibody binding sites, allowing the drug-labeled G6PDH to interact with the substrate, resulting in enzyme activity. In the absence of drug from the sample, the specific antibody binds to the drug labeled with G6PDH and the enzyme activity is inhibited. This phenomenon creates a direct relationship between the drug concentration in the urine and the enzyme activity. The enzyme G6PDH activity is determined spectrophotometrically at 340 mm by measuring its ability to convert nicotinamide adenine dinucleotide (NAD) to NADH.

The assay consists of reagents (A and E).

Reagent A: Contains mouse monoclonal anti-benzoylecgonine antibody, glucose-6-phosphate (G6P), and nicotinamide adenine dinucleotide (NAD) in Tris buffer with sodium azide as preservative.

Reagent E: Contains benzoylecgonine analog labeled with glucose-6-phosphate dehydrogenase (G6PDH) in HEPES buffer with sodium azide as preservative.

The DRI Cocaine Metabolite Assay is a homogeneous enzyme immunoassay intended for the qualitative and/or semi-quantitative determination of benzoylecgonine (Cocaine Metabolite) in human urine at cutoff concentrations of either 150 ng/mL or 300 ng/mL. The study performed aims to demonstrate the analytical performance of the device and its substantial equivalence to the predicate device, Cocaine Metabolite Enzyme Immunoassay (K960187).

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

1. Table of Acceptance Criteria and Reported Device Performance

The document does not explicitly state pre-defined acceptance criteria values for agreement percentages (e.g., "must be >95%"). However, the reported performance demonstrates 100% agreement with the reference method (LC-MS/MS) for both positive and negative samples at both cutoff levels in the method comparison study. The precision studies also show consistent determination of positive and negative results at concentrations significantly above and below the cutoff, with expected mixed results at the cutoff itself.

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The Emit® II Plus Cocaine Metabolite Assay is a homogeneous enzyme immunoassay with a 150 ng/mL or 300 ng/mL cutoff. The assay is intended for use in the qualitative and semiquantitative analyses of benzoylecgonine (cocaine metabolite) in human urine. Emit® II Plus assays are designed for use with a number of chemistry analyzers.

The Emit® II Plus Cocaine Metabolite Assay provides only a preliminary analytical test result. A more specific alternative chemical method must be used to obtain a confirmed analytical result. Gas chromatography/mass spectrometry (GC/MS) is the preferred confirmatory method. Other chemical confirmation methods are available. Clinical consideration and professional judgment should be applied to any drug-of-abuse test result, particularly when preliminary positive results are used.

The Emit II Plus Cocaine Metabolite assay is a homogeneous enzyme immunoassay that qualitatively and semiquantitatively measures benzoylecgonine. The assay has cutoffs of 150 ng/mL and 300 ng/mL benzoylecgonine.

The assay is based on competition between drug in the specimen and drug labeled with the enzyme glucose-6-phosphate dehydrogenase (G6PDH) for antibody binding sites. Enzyme activity decreases upon binding to the antibody, so the drug concentration in the specimen can be measured in terms of enzyme activity. Active enzyme converts nicotinamide adenine dinucleotide (NAD) to NADH, resulting in an absorbance change that is measured spectrophotometrically at 340 nm.

The Emit II Plus Cocaine Metabolite Assay consists of two ready-to-use reagents:

Antibody/Substrate Reagent 1
Sheep polyclonal antibodies to benzoylecgonine (2.2 µg/mL), bovine serum albumin, G6P (15 mM), NAD (12 mM), preservatives, and stabilizers

Enzyme Reagent 2
Benzoylecgonine labeled with bacterial G6PDH (0.46 U/mL), HEPES buffer, bovine serum albumin, preservatives, and stabilizers

Here's a breakdown of the requested information based on the provided text:

1. Table of Acceptance Criteria and Reported Device Performance

The document does not explicitly state "acceptance criteria" for the method comparison studies. However, the reported "Result" for agreement percentages can be interpreted as the performance achieved. Similarly, for precision studies, "Results" indicate the number of negative/positive determinations. For linearity, it's % recovery.

Table 1: Acceptance Criteria and Reported Device Performance

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The Carolina Liquid Chemistries Cocaine and Cocaine Metabolite Test System (COCM) is for the qualitative determination of benzoylecgonine (cocaine metabolite) in human urine at a cutoff value of 300 ng/mL. The assay is designed for professional use with a clinical chemistry analyzer. For in vitro diagnostic use only.

This assay provides a rapid screening procedure for determining the presence of benzoylecgonine in urine. The assay provides only a preliminary analytical result. A more specific alternative chemical method must be used in order to obtain a confirmed analytical result. Gas or Liquid Chromatography/Mass Spectrometry (GC/MS or LC/MS) is the preferred confirmatory method. Clinical considerations and professional judgment should be exercised with any drug of abuse test result, particularly when the preliminary test result is positive.

Carolina Liquid Chemistries Cocaine Metabolite Test System (COCM) is a ready-to-use, liquid reagent, homogenous enzyme immunoassay. The assay uses a specific antibody that can detect benzoylecgonine (cocaine metabolite) in human urine with minimal cross-reactivity to various, common prescription drugs and abused drugs. The assay is based on competition between benzoylecgonine and glucose-6-phosphate dehydrogenase (G6PDH) enzyme, and free drug from the urine sample for a fixed amount of the specific antibody. In the absence of free drug from the urine sample the specific antibody binds to the drug labeled with G6PDH enzyme causing a decrease in enzyme activity. The G6PDH enzyme activity is determined spectrophotometrically and 340nm by measuring its ability to convert nicotinamide adenine dinucleotide (NAD) to NADH.

This document describes the validation of the Carolina Liquid Chemistries Cocaine and Cocaine Metabolite Test System (COCM), an enzyme immunoassay for the qualitative detection of benzoylecgonine (cocaine metabolite) in human urine at a cutoff value of 300 ng/mL. The study aims to demonstrate substantial equivalence to a legally marketed predicate device (Lin-Zhi International, Inc. Cocaine Metabolite Enzyme Immunoassay).

Based on the provided information, here's a breakdown of the acceptance criteria and the study that proves the device meets them:

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

The document implicitly uses the performance of the predicate device and LCMS/GCMS as the "acceptance criteria" for demonstrating substantial equivalence. The key performance characteristics evaluated for the candidate device are Accuracy, Interfering Substances/Cross-Reactivity, and Precision.

- Drug Free (0.00 ng/mL): 30 Negative (100% negative)
-  50 to  100 to  150% of cutoff (>= 450 ng/mL): 26 Positive (100% positive)
- Overall: All 100 samples matched LCMS results (100% agreement). |

| Interfering Substances/Cross-Reactivity/Specificity | Demonstrate a specific antibody that can detect benzoylecgonine with minimal cross-reactivity to various common prescription and abused drugs. pH (3-11) and specific gravity (1.000-1.030) should not interfere. | - Specific Gravity & pH: "Study results show that neither pH (range tested: 3-11), nor specific gravity conditions (range tested 1.000-1.030) will interfere with this assay."

• Specificity (Cross-Reactivity):
  • Structurally Related Cocaine Compounds showed cross-reactivity (e.g., Cocaine (30 µg/mL), Norcocaine (60 µg/mL), Ecgonine, Methyl Ester (350 µg/mL) were "Positive"). Benzoylecgonine (0.3 µg/mL) also positive, as expected.
  • Numerous other common drugs/substances (e.g., Acetaminophen, Amphetamine, Codeine, Morphine, Nicotine, etc.) tested up to 1000-2000 µg/mL showed "Negative" cross-reactivity. |
    | Precision | Consistent and reproducible results across runs and within runs, especially around the cutoff concentration. | - Within Run (Qualitative Analysis): 20 replicates of spiked human urine at 9 concentrations. At the 300 ng/mL cutoff, 15 Negative / 5 Positive results were obtained (implies some borderline results). All other concentrations (0-225 ng/mL and 375-600 ng/mL) showed 100% agreement with expected negative/positive results.
• Run-to-Run (Qualitative Analysis): 90 replicates of spiked human urine at 9 concentrations. At the 300 ng/mL cutoff, 84 Positive / 6 Negative results were obtained (implies some borderline results). All other concentrations (0-225 ng/mL and 375-600 ng/mL) showed 100% agreement with expected negative/positive results.
• Within/Run-to-Run (ΔmA/min): Provided mean, SD, %CV for different concentrations, indicating good precision (e.g., %CV

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The MP DOA-10 Panel Test Cup and the MP DOA-11 Panel Test Cup are immunochromatographic one-step in-vitro tests intended for the qualitative detection of up to ten or eleven different drug substances, respectively, in human urine at the following cut-off levels: amphetamine, 1000 ng/ml; barbiturate, 300 ng/ml; benzodiazepine, 300 ng/ml; buprenorphine, 10 ng/ml; cannabinoid, 50 ng/ml; cocaine, 300 ng/ml; methadone, 300 ng/ml; methamphetamine, 1000 ng/ml; opiates, 300/2000 ng/ml; oxycodone, 100 ng/ml and phencyclidine, 25 ng/ml. Only one cutoff concentration will be included per analyte per device.

The MP DOA-10 Panel Test Cup and the MP DOA-11 Panel Test Cup may be used in a point-of-care (POC) setting and will provide preliminary analytical test result. A more specific alternative chemical method must be used in order to obtain a confirmed analytical result. Gas chromatography/mass spectrometry (GC/MS) has been established as the preferred confirmatory method by the Substance Abuse Mental Health Services Administration (SAMSHA). Clinical consideration and professional judgment should be exercised with any drug of abuse test result, particularly when the preliminary result is positive.

The Rapid Diagnostics MP DOA-10 Panel Test Cup and MP DOA-11 Panel Test Cup are competitive binding, lateral flow immunochromatographic iv-vitro assays for the qualitative and simultaneous detection of amphetamines, barbiturates, benzodiazenines, buprenorphine, cocaine, methadone, methamphetamine, opiates, oxycodone and phencyclidine, in human urine samples. MP DOA-10 Panel Test Cup and MP DOA-11 Panel Test Cup detects each of the analytes on separate strips. A positive urine sample will not generate a colored line for the specific drug tested in the designated region. A negative urine sample containine, barbiturates, benzodiazepines, buprenorphine, cannabinoids, cocaine, methamphetamine, opiates, oxycodone or phencyclidine below the designated cutoff levels will generate a colored line in the designated test region for the drug. To serve as a procedural control, a colored line will always appear at the control region.

The provided document describes the MP DOA-10 Panel Test Cup and MP DOA-11 Panel Test Cup, which are in-vitro immunochromatographic assays for drug detection in human urine. Here's a breakdown of the acceptance criteria and the study details:

1. Acceptance Criteria and Reported Device Performance

The acceptance criteria for performance were based on a comparison study to verify that there is no performance difference between the DOA Test Strips and DOA Test Cups when exposed to a human urine specimen for 20 seconds vs. 5 minutes. The specific acceptance criteria are implied by the reported results:

Note: The document states "per the pre-defined study acceptance criteria" but does not explicitly list the criteria themselves. However, the 100% pass rate implies that the devices met the full performance expectations in this comparison study.

An additional study on interfering drug analytes also demonstrated no interference at 5 and 10 minutes following the addition of specimens at different concentrations.

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

Since this document describes a pre-market notification (510k), it refers to validation studies rather than external test sets in the typical AI/ML context.

• Comparison Study:

  • For each device format (DOA Test Strips, MP DOA-10 Panel Test Cup, MP DOA-11 Panel Test Cup), three lots of product were tested.
  • Each lot was tested over three drug cut-off concentration levels (-50%, +50%, +300%), including a negative specimen.
  • Total tests: 432 for DOA Test Strips, 360 for MP DOA-10 Panel Test Cups, and 396 for MP DOA-11 Panel Test Cups.
  • Data Provenance: The document does not explicitly state the country of origin or if the data was retrospective or prospective, but given it's a device for use with "human urine," it's prospective data collected from prepared samples for internal validation.

• Interfering Drug Analyte Study:

  • 198 MP DOA-11 Panel Test Cups (divided into 2 groups) were used.
  • 180 MP DOA-10 Panel Test Cups (divided into 2 groups) were used.
  • Tested over 3 lots of DOA Test Cups.
  • Cut-off concentrations (-50%, +50%, +300%) for each drug analyte were assessed.
  • Data Provenance: Similar to the comparison study, this would likely be prospective data collected from controlled laboratory settings.

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

This type of device (immunochromatographic in-vitro test) does not typically involve human experts in the way an AI diagnostic imaging device would. The "ground truth" for the test set (urine samples with specific drug concentrations) is established through precise laboratory preparation of known concentrations of drug substances and negative specimens.

4. Adjudication Method for the Test Set

Not applicable for this type of in-vitro diagnostic device. The results are based on a chemical reaction producing a visible line, not subjective interpretations requiring adjudication.

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

Not applicable. This is not an AI-based device that assists human readers. It's a standalone in-vitro diagnostic test.

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

Yes, the studies described are standalone performance evaluations of the device itself. The device (test cup) functions without continuous human intervention to interpret the chemical reaction. While a human reads the result (presence or absence of a line), the detection mechanism is entirely within the device.

7. The Type of Ground Truth Used (expert consensus, pathology, outcomes data, etc.)

The ground truth used is based on known, controlled concentrations of drug analytes in urine samples prepared in a laboratory setting. For example, samples were prepared at -50%, at cut-off, +50%, and +300% of the specified cut-off levels for each drug. Negative control samples were also used.

8. The Sample Size for the Training Set

This document describes a medical device, not an AI/ML algorithm that requires a "training set" in the conventional sense. The device's operational characteristics are determined by its chemical and physical design, which is developed and refined, but not "trained" with data like a machine learning model.

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

Not applicable. There is no training set as this is not an AI/ML device. The performance is based on the inherent chemical and immunological properties of the test strips and cups.

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The Quest Diagnostics HairCheck-DT (Cocaine) test system utilizes an Enzyme Linked Immunosorbent Assay (ELISA) for the qualitative detection of cocaine in head hair samples through the measurement of cocaine and cocaine metabolites for concentrations at or above 300 pg/mg hair. This test system has not been evaluated for use with hair specimens from locations other than the head. It is an in vitro diagnostic device intended exclusively for in-house professional use and is not intended for sale to anyone.

The HairCheck-DT (Cocaine) test system was evaluated in two distinct study populations; individuals known to be chronic drug abusers, and individuals proclaiming to be drug-free.

The Quest Diagnostics HairCheck-DT (Cocaine) test system provides only a preliminary analytical test result. To confirm a presumptive screen positive result, a more specific alternate chemical method, such as gas chromatography-mass spectrometry (GC-MS) or Liquid Chromatography-Tandem Mass Spectrometry (LC-MS/MS), must be used. Clinical consideration and professional judgment should be applied to any drug of abuse test result, particularly when preliminary positive results are obtained.

The Quest Diagnostics Hair Check-DT (Cocaine) test system utilizes an Enzyme Linked Immunosorbent Assay (ELISA) for the qualitative detection of cocaine in head hair samples through the measurement of cocaine and cocaine metabolites for concentrations at or above 300 pg/mg hair. This test system has not been evaluated for use with hair specimens from locations other than the head. It is an in vitro diagnostic device intended exclusively for in-house professional use and is not intended for sale to anyone.
The ELISA Cocaine Kit is based on the competition for a limited number of antibody sites by unlabeled cocaine/cocaine metabolites and enzyme-labeled drug. The two will bind to the antibody in proportion to their concentration in solution.
Once accessioned in the lab, the aluminum foil is opened and the specimen is cut at approxima 3.9 cm from the root end. This specimen is cut into smaller lengths and mixed to ens homogeneity. Ten milligrams of the specimen is weighed out and placed into a properly labeled test tube. The specimen is then washed with methanol, decanted, and then placed in hot methanol containing 0.5% (v/v) trifluoroacetic acid for one hour forty-five minutes. The extracted methanol solution is then transferred to a new tube and evaporated under nitrogen. The tubes are reconstituted with phosphate buffer and assayed using the Cocaine ELISA Kit. This kit is a solid-phase microtiter plate immunoassay in which the microwells are coated with a high affinity capture antibody to cocaine. A hair sample extract is added to the well, followed by the horseradish peroxidase (HRP) enzyme conjugate. During this initial phase, the enzyme conjugate competes with the analyte in the sample for binding sites on the antibody-coated microwells. A wash solution (Tween-20 in phosphate buffered saline solution) is then applied to remove any unbound materials such as excess conjugate and residual sample. Enzyme substrate solution containing 3, 3', 5, 5'-tetramethylbenzidine (TMB) is then added for the final color development process. The reaction is stopped with 1N sulfuric acid and the absorbance is read at 450 nm, with a reference wavelength of 620 nm, using a plate reader. Color intensity is inversely proportional to the amount of analyte present in the sample. Therefore, samples that contain drug or analyte will inhibit binding of the enzyme conjugate to the antibody, resulting in little substrate binding and less color development than in the negative calibrator. For the screening assay an absorbance less than or equal to the absorbance of the 300 pg cocaine/mg hair cutoff calibrator is indicative of the presence of cocaine/cocaine metabolites.

The Quest Diagnostics HairCheck-DT (Cocaine) test system is an in vitro diagnostic device that uses an Enzyme Linked Immunosorbent Assay (ELISA) for the qualitative detection of cocaine and cocaine metabolites in head hair samples at concentrations at or above 300 pg/mg hair. A positive result from this screening test requires confirmation using a more specific alternate chemical method, such as gas chromatography-mass spectrometry (GC/MS) or Liquid Chromatography-Tandem Mass Spectrometry (LC-MS/MS).

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

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Wondfo Amphetamine Urine Test AMP 500 Cup is an immunochromatographic assay for the qualitative determination of Amphetamine in human urine at a Cut-Off concentration of 500 ng/mL. This test is calibrated to d-Amphetamine (calibrator).

The test provides only preliminary test results. A more specific alternative chemical method must be used in order to obtain a confirmed analytical result. GC/MS is the preferred confirmatory method. Clinical consideration and professional judgment should be exercised with any drug of abuse test result, particularly when the preliminary result is positive. For in vitro diagnostic use only. This test is intended for over-the-counter (OTC) consumer use as the first step in a twostep process to provide consumers with information concerning the presence of the above stated drugs or their metabolites in a urine sample. Information regarding confirmatory testing- the second step in the process, is provided in the package labeling.

Wondfo Amphetamine Urine Test AMP 500 DipCard is an immunochromatographic assay for the qualitative determination of Amphetamine in human urine at a Cut-Off concentration of 500 ng/mL. This test is calibrated to d-Amphetamine (calibrator).

The test provides only preliminary test results. A more specific alternative chemical method must be used in order to obtain a confirmed analytical result. GC/MS is the preferred confirmatory method. Clinical consideration and professional judgment should be exercised with any drug of abuse test result, particularly when the preliminary result is positive. For in vitro diagnostic use only. This test is intended for over-the-counter (OTC) consumer use as the first step in a twostep process to provide consumers with information concerning the presence or absence of the above stated drugs or their metabolites in a urine sample. Information regarding confirmatory testing- the second step in the process, is provided in the package labeling.

Wondfo Cocaine Urine Test COC 150 Cup is an immunochromatographic assay for the qualitative determination of Benzoylecgonine in human urine at a Cut-Off concentration of 150 ng/mL. This test is callbrated to Benzoylecgonine (calibrator).

The test provides only preliminary test results. A more specific alternative chemical method must be used in order to obtain a confirmed analytical result. GC/MS is the preferred confirmatory method. Clinical consideration and professional judgment should be exercised with any drug of abuse test result, particularly when the preliminary result is positive. For in vitro diagnostic use only. This test is intended for over-the-counter (OTC) consumer use as the first step in a twostep process to provide consumers with information concerning the presence or absence of the above stated drugs or their metabolites in a urine sample. Information regarding confirmatory testing- the second step in the process, is provided in the package labeling.

Wondfo Cocaine Urine Test COC 150 DipCard is an immunochromatographic assay for the qualitative determination of Benzoylecgonine in human urine at a Cut-Off concentration of 150 ng/mL. This test is callbrated to Benzoylecgonine (calibrator).

The test provides only preliminary test results. A more specific alternative chemical method must be used in order to obtain a confirmed analytical result. GC/MS is the preferred confirmatory method. Clinical consideration and professional judgment should be exercised with any drug of abuse test result, particularly when the preliminary result is positive. For in vitro diagnostic use only. This test is intended for over-the-counter (OTC) consumer use as the first step in a twostep process to provide consumers with information concerning the presence of the above stated drugs or their metabolites in a urine sample. Information regarding confirmatory testing- the second step in the process, is provided in the package labeling.

Wondfo Methamphetamine Urine Test MET 500 Cup is an immunochromatographic assay for the qualitative determination of Methamphetamine in human urine at a Cut-Off concentration of 500 ng/mL. This test is calibrated to d-Methamphetamine (calibrator).

The test provides only preliminary test results. A more specific alternative chemical method must be used in order to obtain a confirmed analytical result. GC/MS is the preferred confirmatory method. Clinical consideration and professional judgment should be exercised with any drug of abuse test result, particularly when the preliminary result is positive. For in vitro diagnostic use only. This test is intended for over-the-counter (OTC) consumer use as the first step in a twostep process to provide consumers with information concerning the presence or absence of the above stated drugs or their metabolites in a urine sample. Information regarding confirmatory testing- the second step in the process, is provided in the package labeling.

Wondfo Amphetamine Urine Test MET 500 DipCard is an immunochromatographic assay for the qualitative determination of Methamphetamine in human urine at a Cut-Off concentration of 500 ng/mL. This test is calibrated to d-Methamphetamine (calibrator).

The test provides only preliminary test results. A more specific alternative chemical must be used in order to obtain a confirmed analytical result. GC/MS is the preferred confirmatory method. Clinical consideration and professional judgment should be exercised with any drug of abuse test result, particularly when the preliminary result is positive. For in vitro diagnostic use only. This test is intended for over-the-counter (OTC) consumer use as the first step in a twostep process to provide consumers with information concerning the presence or absence of the above stated drugs or their metabolites in a urine sample. Information regarding confirmatory testing- the second step in the process, is provided in the package labeling.

WONDFO Urine Test devices are immunochromatographic assays for cocaine, amphetamine and Methamphetamine. Each assay test is a lateral flow, one step system for the qualitative detection of Benzoylecgonine, or D-amphetamine or D-methamphetamine (target analyte) in human urine. The product is a single-use in vitro diagnostic device, which comes in the form of: DipCards, or Cups. It contains a Test Device (in one of the two formats), a package insert and a urine cup. Each test device is sealed with a desiccant in an aluminum pouch.

The document provides information on the acceptance criteria and performance of the Wondfo Amphetamine/Cocaine/Methamphetamine Urine Tests.

Here's the breakdown:

1. Table of Acceptance Criteria and Reported Device Performance

The document does not explicitly state "acceptance criteria" in a table format with a direct comparison to performance against those criteria. Instead, it presents performance characteristics (precision, cut-off verification, interference, specificity, effects of specific gravity and pH, agreement with GC/MS, and lay-user performance) which implicitly define the device's acceptable performance. The performance demonstrated is the acceptance criteria met.

Implicit Acceptance Criteria and Reported Device Performance (Summary derived from the text):

The study demonstrates that the Wondfo Urine Test devices perform as expected for qualitative drug detection around specified cut-off levels, show appropriate specificity, are not significantly affected by common interfering substances or urine properties, and can be used accurately by lay-users. This collective performance data indicates that the devices meet the implied acceptance criteria for their intended use as preliminary, over-the-counter drug screening tests.

Study Details:

2. Sample Size and Data Provenance

• Test Set Sample Size:

  • Precision Studies: For each drug concentration, three lots of devices were tested, with two runs per day for 25 days. The number of individual tests per concentration point for each lot is not explicitly stated as a single total, but 50 measurements (e.g., 50-/0+ or 50+/0-) are reported for each concentration for each lot. This implies 50 tests per concentration per lot for each of "Lot 1, Lot 2, Lot 3". Given 9 concentration points per drug, that's 9 * 50 = 450 tests per lot, and 3 lots means 1350 tests per drug for each device format (Cup/DipCard).
  • Cut-off Verification: 150 samples were used in total, equally distributed across 5 concentrations (-50%, -25%, cut-off, +25%, +50%). Tested using three different lots of each device by three different operators. (This means 150 samples * 3 lots * 3 operators = 1350 individual test results reported for this section across all drugs and device formats).
  • Interference & Specificity Studies: Not explicitly stated as a total N, but substances were added to drug-free urine and target-drug urine (25% above cut-off) and tested using "three batches of each device for all formats."
  • Method Comparison (Agreement with GC/MS): 80 unaltered clinical samples (40 negative, 40 positive) were used for each drug (Amphetamine, Cocaine, Methamphetamine) for each device format (Cup/DipCard).
  • Lay-user Study: 280 lay persons for Amphetamine devices, 280 for Cocaine devices, and 280 for Methamphetamine devices. Each lay person tested one blind-labeled sample. For each drug, 7 distinct concentration levels with 20 samples per level were used. This means 7 * 20 = 140 samples were prepared for each drug per device format (e.g., AMP Cup), and these samples were then distributed to the 280 lay users (presumably 140 for the Cup and 140 for the DipCard, but this is not explicitly stated for all, though AMP and COC show 140 samples in total distributed across the 7 concentrations for both Cup and DipCard results tables).

• Data Provenance:

  • Country of Origin: Wondfo Biotech Co., Ltd. is located in Guangzhou, P.R. China (page 4). The studies were likely conducted internally or by associated labs.
  • Retrospective or Prospective: Not explicitly stated, but the "clinical samples" for the method comparison were "unaltered," which often implies prospectively collected real-world samples. The precision and cut-off studies involved "spiking drug in negative samples" which are laboratory-prepared. The lay-user study used prepared samples and was a controlled prospective study.

3. Number of Experts and Qualifications for Ground Truth

• Method Comparison (Agreement with GC/MS):

  • The ground truth was established by GC/MS (Gas Chromatography/Mass Spectrometry), which is the preferred confirmatory method for drug testing, considered the "gold standard."
  • No human "experts" were listed as establishing ground truth for the test set; the GC/MS analytical results served as the objective gold standard.
  • Three "laboratory assistants" were involved in running the Wondfo devices, not in establishing the ground truth. Their qualifications are not provided.

• Precision, Cut-off, Interference, Specificity, Specific Gravity/pH: The ground truth for these studies was established by the precise preparation of samples with known drug concentrations (confirmed by GC/MS where relevant) and the analytical methods used to prepare and characterize the samples.

• Lay-user Study: The ground truth for the lay-user study was established by GC/MS for the prepared urine samples.

4. Adjudication Method for the Test Set

• Method Comparison: No formal "adjudication method" among human readers is described for the test sets. The Wondfo device results (read by the laboratory assistants/viewers) were directly compared to the GC/MS ground truth. Discordant results are noted individually for each viewer against the GC/MS result.
• Precision/Cut-off: Not applicable, as results were based on predefined expectations for concentrations.
• Lay-user Study: Not applicable, as each lay person read their assigned sample independently against the GC/MS-confirmed concentration.

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

• No MRMC comparative effectiveness study was explicitly performed or reported in this document to assess how much human readers improve with AI (or rather, with the device) versus without assistance.
• The studies were designed to evaluate the performance of the device itself and the ability of lay users to correctly interpret device results compared to a gold standard (GC/MS).
• The "Method Comparison" section involved three "viewers" (laboratory assistants) independently reading the device results and comparing them to GC/MS. This is a multi-reader study, but it's evaluating the device's accuracy when read by trained personnel, not necessarily the improvement of those readers.
• The "Lay-user study" is also a multi-reader study (280 lay persons), but it's assessing the device's ease of use and accuracy in untrained hands, not an improvement over unassisted human performance.

6. Standalone Performance Study

• Yes, a standalone performance study was done. The core of the document describes the standalone performance of the Wondfo Urine Test device itself.
  • The "Precision," "Cut-off," "Interference," and "Specificity" sections evaluate the analytical performance of the device in a laboratory setting when operated by laboratory personnel, without explicit human-in-the-loop decision-making beyond visual interpretation of a test line.
  • The "Method Comparison" study explicitly compares the device's qualitative results (interpreted visually by laboratory assistants) against the GC/MS gold standard. This is a direct measure of the device's standalone performance in a simulated clinical context.

7. Type of Ground Truth Used

• The primary ground truth used for all performance studies (precision, cut-off, interference, specificity, method comparison, lay-user study) for drug concentrations was GC/MS (Gas Chromatography/Mass Spectrometry). GC/MS is a highly accurate analytical chemistry technique considered the definitive "confirmatory method" for drug identification and quantification in urine.
• For the lay-user study, the ground truth for ease of use was collected via user surveys.

8. Sample Size for the Training Set

• Not Applicable. This device is an immunochromatographic assay (lateral flow immunoassay), not a machine learning or AI-based device that typically requires a "training set" in the computational sense. The device's performance is based on its chemical and biological design, not a trained algorithm.

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

• Not Applicable, as there is no "training set" for this type of device. The ground truth for the validation/test samples was established via GC/MS.

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SAFECARE Urine Test Amphetamine Cassette is a rapid test for the qualitative detection of Amphetamine in human urine at a cutoff concentration of 1000 ng/mL.

The tests provide only preliminary test results. A more specific alternative chemical method must be used in order to obtain a confirmed analytical result. GC/MS is the preferred confirmatory method. Clinical consideration and professional judgment should be exercised with any drug of abuse test result, particularly when the preliminary result is positive. For in vitro diagnostic use only. The tests are intended for over-the-counter and for prescription use.

SAFECARE Urine Test Amphetamine Cup is a rapid test for the qualitative detection of Amphetamine in human urine at a cutoff concentration of 1000 ng/mL.

The tests provide only preliminary test results. A more specific alternative chemical method must be used in order to obtain a confirmed analytical result. GC/MS is the preferred confirmatory method. Clinical consideration and professional judgment should be exercised with any drug of abuse test result, particularly when the preliminary result is positive. For in vitro diagnostic use only. The tests are intended for over-the-counter and for prescription use.

SAFECARE Urine Test Amphetamine DipCard is a rapid test for the qualitative detection of Amphetamine in human urine at a cutoff concentration of 1000 ng/mL.

The tests provide only preliminary test results. A more specific alternative chemical method must be used in order to obtain a confirmed analytical result. GC/MS is the preferred confirmatory method. Clinical consideration and professional judgment should be exercised with any drug of abuse test result, particularly when the preliminary result is positive. For in vitro diagnostic use only. The tests are intended for over-the-counter and for prescription use.

SAFECARE Urine Test Cocaine Cassette is a rapid test for the qualitative detection of Benzoylecgonine in human urine at a cutoff concentration of 300 ng/ml.

The tests provide only preliminary test results. A more specific alternative chemical method must be used in order to obtain a confirmed analytical result. GC/MS is the preferred confirmatory method. Clinical consideration and professional judgment should be exercised with any drug of abuse test result, particularly when the preliminary result is positive. For in vitro diagnostic use only. The tests are intended for over-the-counter and for prescription use.

SAFECARE Urine Test Cocaine Cup is a rapid test for the qualitative detection of Benzoylecgonine in human urine at a cutoff concentration of 300 ng/ml.

The tests provide only preliminary test results. A more specific alternative chemical method must be used in order to obtain a confirmed analytical result. GC/MS is the preferred confirmatory method. Clinical consideration and professional judgment should be exercised with any drug of abuse test result, particularly when the preliminary result is positive. For in vitro diagnostic use only. The tests are intended for over-the-counter and for prescription use.

SAFECARE Urine Test Cocaine DipCard is a rapid test for the qualitative detection of Benzoylecgonine in human urine at a cutoff concentration of 300 ng/ml.

The tests provide only preliminary test results. A more specific alternative chemical method must be used in order to obtain a confirmed analytical result. GC/MS is the preferred confirmatory method. Clinical consideration and professional judgment should be exercised with any drug of abuse test result, particularly when the preliminary result is positive. For in vitro diagnostic use only. The tests are intended for over-the-counter and for prescription use.

SAFECARE Urine Test Marijuana Cassette is a rapid test for the qualitative detection of Cannabinoids in human urine at a cutoff concentration of 50 ng/mL.

The tests provide only preliminary test results. A more specific alternative chemical method must be used in order to obtain a confirmed analytical result. GC/MS is the preferred confirmatory method. Clinical consideration and professional judgment should be exercised with any drug of abuse test result, particularly when the preliminary result is positive. For in vitro diagnostic use only. The tests are intended for over-the-counter and for prescription use.

SAFECARE Urine Test Marijuana Cup is a rapid test for the qualitative detection of Cannabinoids in human urine at a cutoff concentration of 50 ng/mL.

The tests provide only preliminary test results. A more specific alternative chemical must be used in order to obtain a confirmed analytical result. GC/MS is the preferred confirmatory method. Clinical consideration and professional judgment should be exercised with any drug of abuse test result, particularly when the preliminary result is positive. For in vitro diagnostic use only. The tests are intended for over-the-counter and for prescription use.

SAFECARE Urine Test Marijuana DipCard is a rapid test for the qualitative detection of Cannabinoids in human urine at a cutoff concentration of 50 ng/mL.

The tests provide only preliminary test results. A more specific alternative chemical must be used in order to obtain a confirmed analytical result. GC/MS is the preferred confirmatory method. Clinical consideration and professional judgment should be exercised with any drug of abuse test result, particularly when the preliminary result is positive. For in vitro diagnostic use only. The tests are intended for over-the-counter and for prescription use.

SAFECARE Urine Test devices are immunochromatographic assays for cocaine, amphetamine and marijuana. Each assay test is a lateral flow, one step system for the qualitative detection of Benzoylecgonine, or D-amphetamine or 11-nor-A9-THC-9 COOH (target analyte) in human urine. The product is a single-use in vitro diagnostic device, which comes in the form of: DipCards, or Cups or Cassettes. It contains a Test Device (in one of the three formats), a package insert and a urine cup. Each test device is sealed with a desiccant in an aluminum pouch.

The provided document describes the acceptance criteria and study results for the SAFECARE Urine Test Amphetamine, Cocaine, and Marijuana devices.

Here's an organized summary of the information requested:

Acceptance Criteria and Device Performance Study

The SAFECARE Urine Test devices are qualitative tests for the detection of Amphetamine, Cocaine (Benzoylecgonine), and Marijuana (Cannabinoids) in human urine at specific cutoff concentrations. The study aims to demonstrate the device's accuracy and reliability through analytical performance and comparison studies.

1. Acceptance Criteria and Reported Device Performance

The acceptance criteria are not explicitly stated as numerical targets (e.g., Sensitivity > X%, Specificity > Y%). However, the study design implicitly establishes acceptance criteria through its reported performance, which demonstrates consistent and accurate results around the cutoff concentrations. Given that this is a 510(k) submission and the conclusion states "acceptable performance characteristics" and "substantially equivalent to the predicate," the presented performance implicitly meets the FDA's requirements for substantial equivalence.

Interpreted Acceptance Criteria (Implicitly met by study results):

• Precision: Consistent results across different lots and repeated testing at various concentrations relative to the cutoff. For concentrations well below the cutoff (-100%, -75%, -50% cutoff), results should be consistently negative. For concentrations well above the cutoff (+50%, +75%, +100% cutoff), results should be consistently positive. At concentrations near the cutoff (-25%, cutoff, +25% cutoff), there should be an expected distribution of positive and negative results, demonstrating appropriate cutoff sensitivity.
• Cut-off Verification: All samples at and above +50% cut-off are positive, and all samples at and below -50% cut-off are negative.
• Interference/Specificity: No interference from common physiological substances or cross-reactivity from specified compounds at tested concentrations should lead to false positives/negatives at 25% above cutoff.
• Method Comparison: High agreement with GC/MS results for both negative and positive clinical samples. Low rates of discordant results, particularly for samples well below or well above the cutoff.
• Lay-user Performance: High percentages of correct results when performed by lay users, indicating ease of understanding and use. This is especially critical for over-the-counter devices.

Reported Device Performance (Excerpt for Amphetamine Dip Card - Precision Study):

Self-correction made: The table in the document uses "50-/0+" format where 50- means 50 negative results and 0+ means 0 positive results. This was separated into two rows for clarity as "Negative" and "Positive".

Lay-User Performance (Excerpt for Amphetamine Cup):

2. Sample Size for the Test Set and Data Provenance

All test sets (precision, cut-off, interference, specificity, method comparison, and lay-user studies) appear to use data that is retrospective in nature, as samples were "prepared by spiking drug in negative samples" or "unaltered clinical samples" were "blind labeled and compared to GC/MS results". The provenance of the data is not explicitly stated as a country of origin but implies laboratory-prepared or collected clinical samples, likely within China where the manufacturer is located, or a contract lab.

Sample Sizes for Test Sets:

• Precision Study:
  • For each drug (Amphetamine, Cocaine, Marijuana) and each format (Dip Card, Cup, Cassette):
    • 9 concentration levels (-100% to +100% of cut-off).
    • Each concentration tested 50 times (2 runs per day for 25 days) for each of 3 lots.
    • Total observations per drug/format: 9 concentrations * 50 tests/concentration * 3 lots = 1350 observations.
• Cut-off Verification Study:
  • For each drug (Amphetamine, Cocaine, Marijuana) and each format (Dip Card, Cup, Cassette):
    • 5 concentration levels (-50%, -25%, cut-off, +25%, +50% of cut-off).
    • Total samples: 150 samples (equally distributed across 5 concentrations, so 30 samples per concentration) tested using 3 different lots by 3 different operators.
• Interference/Specificity Studies:
  • Urine samples (drug-free and spiked at +25% cut-off) tested for each interfering substance/cross-reactant compound. Number of tests per substance (e.g., 3 batches of each device for all formats) is not explicitly listed per substance but implied to be sufficient.
• Method Comparison Studies:
  • For each drug (Amphetamine, Cocaine, Marijuana) and each format (Dip Card, Cup, Cassette):
    • 80 unaltered clinical samples (40 negative, 40 positive).
    • Total samples per drug/format tested by 3 viewers: 80 samples * 3 viewers = 240 observations.
• Lay-user Study:
  • For Amphetamine devices: 420 lay persons.
  • For Cocaine devices: 420 lay persons.
  • For Marijuana devices: 420 lay persons.
  • Each person tested one blind labeled sample and a device.
  • Sample concentrations used: 7 levels (-100% to +75% of cut-off), 20 samples per level. Total samples per drug: 7 concentrations * 20 samples/concentration = 140 samples.

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

• For Analytical Performance (Precision, Cut-off, Interference, Specificity): The ground truth for spiked samples (negative samples spiked with known concentrations of drug) was established by GC/MS (Gas Chromatography/Mass Spectrometry), which is the "preferred confirmatory method" and considered the gold standard for drug detection and quantification in toxicology. No "experts" in the sense of clinicians or radiologists were used. The document doesn't specify the qualifications of the personnel performing GC/MS.
• For Method Comparison Studies: The ground truth for the 80 unaltered clinical samples was established by GC/MS. These GC/MS results are the reference against which the device's performance was compared.
• For Lay-user Study: The ground truth for the prepared urine samples was confirmed by GC/MS.

4. Adjudication Method for the Test Set

• For Precision Studies: The testing was "performed two runs per day for 25 days" (total 50 tests per concentration per lot). The results are presented as counts of positive/negative. There is no mention of an adjudication method among multiple readers for these analytical studies.
• For Cut-off Verification Study: Testing was performed by "three different operators." There is no explicit adjudication method stated for these observations. The results are presented as all positive or all negative for certain concentration ranges, which implies agreement or a predefined interpretation across operators.
• For Method Comparison Studies: "Three different laboratory assistants" were the "operators" or "viewers" (referred to as Viewer A, B, C) who read the device results. The document lists discordant results individually for each viewer, indicating that results were compared viewer-by-viewer against GC/MS. There is no explicit multi-reader adjudication method (e.g., majority vote like 2+1 or 3+1) mentioned for reaching a consensus device result; rather, individual reader agreement with GC/MS is analyzed.
• For Lay-user Study: Lay persons independently read the results. The comparison is between the lay person's reading and the GC/MS ground truth. No adjudication among lay persons is described.

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

No MRMC comparative effectiveness study was mentioned. The study performed a method comparison where individual "viewers" (laboratory assistants) read the devices and their results were compared to GC/MS. There is no comparison of human readers' performance with AI assistance versus without AI assistance, as these are rapid qualitative test devices, not AI-powered diagnostic algorithms.

6. Standalone (Algorithm Only) Performance

The SAFECARE Urine Test devices are immunochromatographic assays, not software algorithms or AI-driven systems. Their performance is inherently standalone (device-only, interpreted by a human user). The reported precision, cut-off, interference, specificity, and method comparison data represent the standalone performance of these physical tests.

7. Type of Ground Truth Used

• GC/MS (Gas Chromatography/Mass Spectrometry): This is consistently stated as the ground truth method for confirming drug concentrations in all performance studies (precision, cut-off, interference, specificity, method comparison, and lay-user studies). GC/MS is a highly accurate analytical method considered the gold standard for drug testing.

8. Sample Size for the Training Set

These devices are immunochromatographic assays, not machine learning or AI models, therefore they do not have a "training set" in the computational sense. Their development typically involves chemical and biological optimization, with analytical and clinical validation serving as the equivalent of performance evaluation.

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

As noted above, these devices do not involve a training set as they are not AI/ML-based. The development of such diagnostic tests relies on established immunochemistry principles and rigorous analytical validation to ensure sensitivity, specificity, and accuracy against a gold standard like GC/MS.

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