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Intended for the in vitro quantitative measurement of acetaminophen in serum, lithium heparin plasma. Measurement of acetaminophen is used in the diagnosis and treatment of acetaminophen overdose toxicity.

The SEKURE Acetaminophen L3K assay is an enzymatic, spectrophotometric assay for the measurement of acetaminophen concentration in serum, lithium heparin plasma and sodium heparin plasma. The assay consists two working reagents, an enzyme reagent and a color reagent. The enzyme reagent contains acyl amidohydrolase, which cleaves the amide bond of the acetaminophen, forming p-aminophenol which then reacts with the 2,5- dimethylphenol (contained the color reagent) in the presence of manganese. The product of that reaction causes increased absorbance at 605 nm which is directly proportional to the acetaminophen concentration in the sample. Testing is performed on open system clinical chemistry analyzers, such as the Hitachi 717 (K872494) in conjunction with a calibrator (510(k) exempt) which is included and controls which are provided separately.

The provided document is a 510(k) Pre-market Notification for a medical device called the "SEKURE Acetaminophen L3K Assay." This document describes the analytical studies conducted to demonstrate the device's performance and substantial equivalence to a predicate device, rather than a study involving human readers or AI assistance in image interpretation. Therefore, many of the requested points related to AI, human reader performance, expert consensus, and MRMC studies are not applicable to this type of device submission.

Here's an analysis based on the available information:

Device Type: In vitro diagnostic device (IVD) for quantitative measurement of acetaminophen in biological samples.

Focus of the Document: Analytical performance studies (precision, analytical sensitivity, linearity, interference, method comparison, matrix comparison) to demonstrate the assay's accuracy and reliability.

Information NOT Applicable to this Document Type:

• Sample sized used for the test set and the data provenance (e.g. country of origin of the data, retrospective or prospective) - Data provenance is typically not detailed for IVD analytical studies in this manner; samples are clinical specimens or prepared materials.
• Number of experts used to establish the ground truth for the test set and the qualifications of those experts (e.g. radiologist with 10 years of experience) - Ground truth for IVDs is established by reference methods or gravimetric preparation, not expert review of images.
• Adjudication method (e.g. 2+1, 3+1, none) for the test set - Not applicable for IVD analytical studies.
• 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-assisted diagnostic imaging device.
• If a standalone (i.e. algorithm only without human-in-the-loop performance) was done - Not applicable; this is not an AI algorithm.
• The type of ground truth used (expert consensus, pathology, outcomes data, etc) - Ground truth is established by reference methods, gravimetric preparation, or theoretical values.
• The sample size for the training set - Not applicable; this device does not use an AI training set.
• How the ground truth for the training set was established - Not applicable.

Acceptance Criteria and Reported Device Performance

The device is an in vitro diagnostic assay, and its performance is evaluated through various analytical studies. The acceptance criteria are therefore analytical performance specifications, not clinical outcomes directly.

Here's a table summarizing the acceptance criteria and a selection of reported performance data from the document:

Table of Acceptance Criteria and Reported Device Performance

Study that Proves the Device Meets the Acceptance Criteria

The study that proves the device meets the acceptance criteria is a series of Non-Clinical Performance Data studies, as detailed in the "510(k) Summary" document. These are analytical studies, typically following CLSI (Clinical and Laboratory Standards Institute) guidelines, to characterize the performance of the in vitro diagnostic assay.

1. Sample Sized Used for the Test Set and Data Provenance:

• Precision: 80 measurements per sample/control per lot (assayed in duplicate twice a day for 20 days). This included two unaltered patient serum samples, two spiked patient serum samples, and three levels of controls. Data is likely from laboratory samples, not specified by country.
• Analytical Sensitivity (LoB/LoD): 60 measurements per lot (five blank samples and five low concentration samples in quadruplicate over three operating days).
• Analytical Sensitivity (LoQ): 40 replicates per low concentration sample per lot (five low concentration samples tested in 40 replicates over five runs across three operating days).
• Linearity/Assay Reportable Range: 4 replicates per sample per lot (nine internally prepared samples across the measuring range).
• Analytical Specificity (Interference): 5 replicates per interferent concentration per acetaminophen concentration (tested at 3-4 acetaminophen concentrations).
• Method Comparison: 105 patient specimens, tested in duplicate, over seven operating days. Samples were distributed evenly throughout the assay range.
• Matrix Comparison: 40 matched sets of patient specimens.

Data Provenance: The document does not explicitly state the country of origin for patient samples or whether they were retrospective or prospective. However, for analytical performance, samples are typically collected from a pool of patient samples or are internally prepared clinical matrix materials.

2. Number of Experts and Qualifications:

• Not applicable. This device is an analytical chemistry assay, not one that relies on human experts for interpretation or ground truth establishment. The performance is assessed against quantitative analytical standards and a predicate device.

3. Adjudication Method:

• None. Not applicable for analytical performance studies of an IVD assay.

4. MRMC Comparative Effectiveness Study:

• No. Not applicable as this is not an imaging device or an AI-assisted diagnostic device.

5. Standalone Performance:

• Yes (in the context of an IVD). The performance data presented (e.g., precision, analytical sensitivity, linearity, interference) represent the standalone performance of the SEKURE Acetaminophen L3K Assay itself, without a "human-in-the-loop" in the artificial intelligence sense. The assay quantitatively measures acetaminophen concentration.

6. Type of Ground Truth Used:

• Reference Methods / Gravimetric Preparation / Theoretical Values / Predicate Device Comparison.
  • Precision: Relative to the mean of repeat measurements.
  • Analytical Sensitivity: Derived statistically from blank and low-level samples.
  • Linearity: Compared to theoretical concentrations of gravimetrically prepared standards.
  • Interference: Compared to control samples without interferent.
  • Method Comparison: Compared to measurements obtained using a legally marketed predicate device (SEKURE Acetaminophen L3K Assay, K081938). This is a common form of "ground truth" for demonstrating substantial equivalence for IVDs.
  • Matrix Comparison: Compared to serum samples (considered the reference matrix).

7. Sample Size for the Training Set:

• Not applicable. This device is an in vitro diagnostic assay, not an AI algorithm that requires a training set.

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

• Not applicable. See above.

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The SEKURE HbA1c assay is used to measure the percent concentration of hemoglobin A1c (NGSP) or the HbA1c fraction mmol/mol (IFCC) in human venous whole blood and hemolysate on the SK500 Clinical Chemistry System. Measurement of HbA 1c is used as an aid in the diagnosis of diabetes mellitus, as an aid in the identification of patients at risk for development of diabetes mellitus, and for the monitoring of long-term blood glucose with diabetes mellitus. For In Vitro Diagnostic Use Only.

The SEKURE HbA1c assay is an enzymatic assay for the measurement of the percent hemoglobin A1c concentration. The assay consists of a pre-treatment hemolyzing buffer solution and two working reagents. Testing is performed on the SK500 K103531in conjunction with calibrators and controls which will be provided separately.

The SEKURE HbA1c Assay is an in vitro diagnostic device used to measure the percentage concentration of hemoglobin A1c (HbA1c) in human venous whole blood and hemolysate. It's intended to aid in the diagnosis and monitoring of diabetes mellitus. The device's performance was evaluated through various non-clinical studies to demonstrate its substantial equivalence to a predicate device.

1. Acceptance Criteria and Reported Device Performance

Precision (NGSP Units, Whole Blood)

2. Sample Size and Data Provenance

• Precision:
  • 2 levels of controls and 4 levels of human whole blood pools.
  • Each assayed in 2 replicates at 2 separate times per day for 20 different days.
• Analytical Sensitivity (LoB and LoD):
  • 5 blank samples and 5 low concentration samples.
  • Analyzed in quadruplicate for 3 days (total of 60 measurements per level).
  • Low concentration samples were dilutions of dipotassium EDTA venous whole blood.
• Linearity/Reportable Range:
  • 11 levels configured as a dilution series by mixing high and low HbA1c dipotassium EDTA venous whole blood samples.
  • Samples run in quadruplicate.
• Analytical Specificity (Interference):
  • All interferents and potential drug interferents tested at ~6.5% and 8.0% HbA1c concentrations in replicates of ten.
• Hemoglobin Variants:
  • HbA2: 36 samples (4.1% - 6.2% abnormal variant, 4.06% - 10.0% HbA1c)
  • HbC: 14 samples (27.4% - 38.4% abnormal variant, 4.81% - 10.46% HbA1c)
  • HbD: 25 samples (19.6% - 40.0% abnormal variant, 4.79% - 12.62% HbA1c)
  • HbE: 22 samples (24.0% - 28.0% abnormal variant, 5.2% - 10.0% HbA1c)
  • HbF: 25 samples (4.4% - 29.3% abnormal variant, 5.1% - 12.8% HbA1c)
  • HbS: 15 samples (28.2% - 37.5% abnormal variant, 4.45% - 12.31% HbA1c)
• Method Comparison with Predicate Device:
  • 130 dipotassium EDTA whole blood specimens.
  • Assayed over 5 operating days in duplicate.
• Matrix Comparison:
  • 41 matched patient specimens.
  • Analyzed in duplicate.
• Reference Range Verification:
  • 20 fresh blood samples from clinically healthy patients.
  • Tested in singlicate.

Data Provenance: The document does not explicitly state the country of origin for the patient data used in these studies. The studies are non-clinical performance evaluations, conducted to support the device's substantial equivalence. The nature of the studies indicates a prospective collection for the purpose of device validation.

3. Number of Experts and Qualifications for Ground Truth

• Precision, Analytical Sensitivity, Linearity, Interferents, Matrix Comparison, Reference Range Verification: The ground truth for these studies is established by the methods, instrumentation, and protocols themselves (e.g., control values, dilution series, analytical measurements). No human experts are explicitly mentioned for establishing ground truth in these specific sections.
• Hemoglobin Variants (Comparative Method): The HbA1c values for samples containing hemoglobin variants were compared to a "comparative method" which serves as the ground truth. The specific nature and qualifications of experts associated with this comparative method are not detailed.
• Method Comparison (NGSP Secondary Reference Laboratory Method): The device's performance was compared to an "NGSP secondary reference laboratory method." The NGSP (National Glycohemoglobin Standardization Program) provides standardization and certification for HbA1c methods, implying that the reference lab adheres to established standards. However, the number of experts or their specific qualifications at this reference laboratory are not provided.

4. Adjudication Method

The document does not describe an adjudication method for a test set in the context of expert review. The studies are primarily analytical performance evaluations where results are compared against established analytical standards, reference methods, or statistical criteria.

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

No MRMC comparative effectiveness study is mentioned. This device is an in vitro diagnostic assay, meaning its performance is evaluated based on its analytical accuracy and precision in measuring a biomarker, not on human reader interpretation of images or other subjective data. Therefore, the concept of "human readers improve with AI vs without AI assistance" is not applicable.

6. Standalone (Algorithm Only) Performance

Yes, the studies described are essentially a standalone evaluation of the SEKURE HbA1c Assay. The performance metrics (precision, linearity, bias, interference, method comparison) quantify the analytical capability of the assay system (reagents plus SK500 analyzer) independent of human interpretation of the results beyond the technical execution of the test.

7. Type of Ground Truth Used

• Precision: Internal control values and human whole blood pools with calculated means.
• Analytical Sensitivity (LoB and LoD): Based on statistical analysis of blank and low-concentration measurements to determine the lowest detectable limit.
• Linearity/Reportable Range: Based on theoretical expected values of a dilution series.
• Traceability: Traceable to the International Federation of Clinical Chemistry (IFCC) reference calibrators and NGSP certification.
• Analytical Specificity (Interference): Established by comparing results in the presence of interferents to control samples (without interferents).
• Hemoglobin Variants: A "comparative method" for HbA1c measurement.
• Method Comparison: An "NGSP secondary reference laboratory method" for HbA1c.
• Matrix Comparison: Dipotassium EDTA whole blood (control tube) serves as the reference for comparison against other anticoagulants.
• Reference Range Verification: A published "Reference Range for Adults" (Source: ROCHE - Reference Ranges for Adults, Pre-Analytical Considerations - 2008).

8. Sample Size for the Training Set

The document describes performance studies for the SEKURE HbA1c Assay, not the development or training of an AI algorithm. Therefore, there is no "training set" in the context of machine learning. The data presented are for validation of the assay's analytical performance.

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

As there is no AI algorithm being trained, the concept of establishing ground truth for a training set is not applicable to this document. The ground truth for the validation studies is established as described in section 7.

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