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The Acetaminophen assay is used for the quantitative determinophen in human serum or plasma on the ARCHITECT c Systems.

The Acetaminophen assay is to be used as an aid in the diagnosis and treatment of acetaminophen overdose toxicity.

The Acetaminophen assay is an enzymatic, spectrophotometric assay for the measurement of acetaminophen concentration in human serum and plasma. The assay consists two working reagents, an enzyme reagent and a color reagent.

The enzyme reagent contains aryl acylamidase, which cleaves the amide bond of 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 660 nm which is directly proportional to the acetaminophen concentration in the sample.

Testing is performed on the ARCHITECT c8000 clinical chemistry analyzers in conjunction with a calibrator (510(k) exempt) which is provided separately.

The provided text describes a 510(k) premarket notification for an Acetaminophen assay (K202644). The document details various performance studies conducted to demonstrate the device's substantial equivalence to a legally marketed predicate device.

Here's an analysis of the acceptance criteria and study details based on the provided text:

1. Table of Acceptance Criteria and Reported Device Performance

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

• Precision: 5 human serum panels and 3 control levels. Each assayed in a minimum of 2 replicates, twice per day on 20 days. N=120 for controls and panels.
• Reproducibility: 1 human serum panel and 3 control levels. Each assayed in a minimum of 3 replicates at 2 separate times per day on 5 different days. N=146-150 for controls and panel.
• Analytical Sensitivity (LoB, LoD, LoQ): Zero analyte samples and low analyte samples tested in replicates of 10.
• Linearity/Assay Reportable Range: One unique sample set, 13 sample levels, tested in a minimum of 2 replicates.
• Analytical Specificity (Interference): Test and reference samples tested in a minimum of 12 replicates.
• Method Comparison: 119 patient specimens (114 unaltered native samples, 5 contrived).
• Matrix Comparison: 78 matched specimen sets.
• Automated/Manual Dilution: 5 samples with high acetaminophen concentrations, tested in replicates of 42.

Data Provenance: The document does not explicitly state the country of origin of the data. The studies appear to be prospective as they were specifically designed and executed to evaluate the performance of the device for this submission (e.g., "A study was performed based on guidance...", "Testing was conducted according to CLSI EP05-A3...").

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

This type of information (number and qualifications of experts) is typically associated with studies involving subjective interpretation, such as imaging or pathology studies. For an in vitro diagnostic (IVD) like this Acetaminophen assay, the "ground truth" is generally established using reference methods or gravimetric preparation of standards, rather than expert consensus on patient data.

• For Value Assignment: The Acetaminophen Calibrator is prepared gravimetrically from USP grade reference acetaminophen material to a specific concentration, and verified against a master calibrator (internal reference standard). This is the analytical "ground truth" for calibration.
• For Method Comparison: The predicate device is considered the "reference" for comparison, not a "ground truth" established by experts.

Therefore, the concept of "experts establishing ground truth" as you've defined it (e.g., radiologists) is not applicable to this type of IVD device performance study.

4. Adjudication Method for the Test Set

Adjudication methods (e.g., 2+1, 3+1) are typically used in clinical studies where multiple readers or experts provide independent assessments, and discrepancies need to be resolved. Since this is an IVD device measuring an analyte quantitatively, and the "ground truth" is established analytically (gravimetric, reference methods, or predicate device results), an adjudication method in the traditional sense is not applicable. The studies involve quantitative measurements from instruments and comparisons to established analytical standards or methods.

5. If a Multi-Reader Multi-Case (MRMC) Comparative Effectiveness Study Was Done, If So, What Was the Effect Size of How Much Human Readers Improve with AI vs without AI Assistance

No, an MRMC comparative effectiveness study was not done. This is an in vitro diagnostic (IVD) device, specifically an assay for measuring acetaminophen levels, not an imaging or AI-assisted diagnostic tool that involves human readers. Therefore, the concept of "human readers improving with AI vs. without AI assistance" is not applicable.

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

The device itself (the Acetaminophen assay on the ARCHITECT c Systems) is a standalone system for quantitative measurement. The performance studies detailed (precision, linearity, method comparison, etc.) represent the standalone performance of the algorithm/reagent system as it processes samples on the automated platform without human intervention beyond sample loading and system operation. There is no "human-in-the-loop" component for interpretation of results in the direct sense; the device provides a quantitative number.

7. The Type of Ground Truth Used

The ground truth for the performance studies is established via:

• Gravimetric Preparation/Reference Standards: For analytical performance characteristics like calibrator value assignment, LoB, LoD, LoQ, and linearity. For example, calibrators are "prepared gravimetrically from USP grade reference acetaminophen material."
• Predicate Device Results: For the method comparison study, the results from the legally marketed predicate device (SEKURE Acetaminophen L3K Assay on Hitachi 717) serve as the comparative "reference" or "ground truth" against which the new device's performance is measured.
• Controlled Samples: For interference studies, samples with known concentrations of acetaminophen and specific interferents are used.

8. The Sample Size for the Training Set

The document does not mention a training set because this is not a machine learning or artificial intelligence (AI) device that requires extensive supervised learning. This is an enzymatic spectrophotometric assay, which relies on chemical reactions and optical measurement principles, not statistical pattern recognition trained on a dataset.

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

As there is no training set for this type of IVD device, this question is not applicable.

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For the in vitro quantitative measurement of creatine kinase activity in serum and plasma on the SK500 Clinical Chemistry System. Measurements of creatine kinase are used in the diagnosis and treatment of myocardial infarction and muscle diseases such as progressive, Duchenne-type muscular dystrophy.

The SEKURE Creatine Kinase Assay (CK Assay) is a spectrophotometric, coupled enzyme assay for the quantitative measurement of creatine kinase (CK) activity. The assay consists of two working reagents, a buffer solution (R1) and a substrate reagent (R2). The SEKURE CK Assay employs the reverse reaction of CK, to produce adenosine triphosphate (ATP). The reaction is coupled to hexokinase and G6PDH which consumes ATP to generate NADPH. The rate of NADPH formation is monitored at 340 nm and is directly proportional to CK activity. Testing is performed on the SK500 in conjunction with calibrator and controls which are provided separately.

The SK500 Analyzer is manufactured as Clinical Chemistry Analyzer Tokyo Boeki Medisys Inc. Biolis 50i Superior. "SK500" is the Sekisui Diagnostics labelled name for the Tokyo Boeki Medisys Inc. Biolis 50i Superior instrument.

This document describes the SEKURE Creatine Kinase Assay, an in vitro diagnostic device, and its performance study to demonstrate substantial equivalence to a predicate device.

1. Acceptance Criteria and Reported Device Performance

The device performance is evaluated against various analytical metrics. While explicit "acceptance criteria" for each study are not individually listed as pass/fail thresholds in a table, the document reports the results of these studies, implying that the observed performance met internal or regulatory expectations for demonstrating substantial equivalence. The predicate device's characteristics serve as an implicit benchmark for similarity.

Here's a table summarizing the reported device performance, with implied acceptance based on the submission being cleared:

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

• Precision:

  • Sample Size: 80 replicates per sample type (Serum Control 1, Serum Control 2, Serum High Pool, Plasma Low Pool, Plasma Med Pool, Plasma High Pool) for each of two reagent lots. Total of 480 measurements per lot.
  • Data Provenance: Not explicitly stated, but typical for in vitro diagnostic device studies would be laboratory-generated or purchased control materials and pooled human specimens. The study was conducted in-house by SEKISUI DIAGNOSTICS P.E.I. INC.
  • Retrospective/Prospective: Analytical studies like precision are typically prospective, performed under controlled laboratory conditions.

• Analytical Sensitivity (LoB, LoD):

  • Sample Size: 60 measurements for each level (low level samples, saline blanks, dilutions of pooled serum/plasma) for each reagent lot and matrix type.
  • Data Provenance: Not explicitly stated, but likely laboratory-generated materials.
  • Retrospective/Prospective: Prospective laboratory study.

• Limit of Quantitation (LoQ):

  • Sample Size: 40 replicates (8 linear serum samples, 8 linear plasma samples assayed in 5 runs over 3 days) for each reagent lot and matrix type.
  • Data Provenance: Not explicitly stated, but likely laboratory-generated materials.
  • Retrospective/Prospective: Prospective laboratory study.

• Linearity/Assay Reportable Range:

  • Sample Size:
    • Serum: 8 dilutions of pooled serum, tested in quadruplicate on two lots.
    • Plasma: 10 dilutions and admixtures of pooled plasma, tested in quadruplicate on two lots.
  • Data Provenance: Pooled serum and plasma likely from human donors, obtained through commercial biospecimen providers or internal collection (with ethics approval).
  • Retrospective/Prospective: Prospective laboratory study.

• Analytical Specificity (Interference):

  • Sample Size: Minimum of seven interferent concentrations in replicates of five on each of two reagent lots.
  • Data Provenance: Laboratory spiked samples using serum.
  • Retrospective/Prospective: Prospective laboratory study.

• Method Comparison with Predicate Device:

  • Sample Size: 112 serum specimens, tested in duplicate.
  • Data Provenance: Human serum specimens, source not further specified (e.g., country of origin).
  • Retrospective/Prospective: Likely prospective collection or use of banked retrospective samples under controlled laboratory conditions.

• Matrix Comparison (Serum vs. Lithium Heparin Plasma):

  • Sample Size: 75 matched serum and lithium heparin plasma specimens, assayed in duplicate.
  • Data Provenance: Matched human serum and plasma specimens, source not further specified.
  • Retrospective/Prospective: Likely prospective collection or use of banked retrospective samples under controlled laboratory conditions.

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

This type of in vitro diagnostic device (IVDD) for Creatine Kinase measurement, which measures a biochemical analyte, does not typically rely on "experts" in the same way an imaging AI device would. The "ground truth" for these studies is established through:

• Reference Methods: For value assignment (e.g., DC-Cal Multi-Analyte Calibrator traceable to an IFCC reference method).
• Highly Characterized Materials: Pooled serum/plasma, control materials with known target values.
• Statistical Analysis: CLSI guidelines (e.g., EP05-A3, EP17-A2, EP06-A, EP07-A2, EP09-A3) provide the statistical framework for defining performance metrics like precision, linearity, and limits of detection/quantitation.
• Comparison to Predicate: The predicate device's established performance serves as a comparative benchmark.

Therefore, there were no specific "experts" (like radiologists interpreting images) establishing ground truth for individual test cases in the context of this 510(k) submission.

4. Adjudication Method for the Test Set

Not applicable. As described above, the ground truth for this IVDD study is based on quantitative measurements against reference methods, characterized materials, and statistical analysis, not on subjective interpretations requiring adjudication by multiple readers or experts.

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

No, a Multi-Reader Multi-Case (MRMC) comparative effectiveness study was not done. MRMC studies are primarily relevant for imaging devices or AI tools where human interpretation of medical images is involved, and the AI's impact on reader performance is being evaluated. This 510(k) is for an in vitro diagnostic assay, which directly measures an analyte concentration.

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

Yes, the studies presented are all "standalone" in the sense that they evaluate the performance of the SEKURE Creatine Kinase Assay and the SK500 analyzer system based on their analytical capabilities to directly measure CK activity. There is no "human-in-the-loop" component in the direct measurement process or the evaluation of its analytical performance. The device provides a quantitative result without human interpretive input for the measurement itself.

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

The ground truth used here is primarily analytical ground truth based on:

• Reference Methods: Specifically, the CK activity value assignment for DC-Cal is traceable to an IFCC reference method.
• Characterized Materials: Pooled serum and plasma with known or expected CK activity levels derived from rigorous analytical testing.
• Statistical Models: Ground truth for linearity (theoretical values) and detection limits (through statistical calculation as per CLSI guidelines).
• Comparison to a Legally Marketed Predicate Device: The predicate device's performance (Creatine Kinase-SL Assay on a Hitachi 717 Analyzer) serves as a comparative ground truth for demonstrating substantial equivalence.

8. The sample size for the training set

This submission pertains to the performance validation of a diagnostic assay (reagents and analyzer), not a machine learning or AI algorithm in the traditional sense that requires distinct "training sets" and "test sets" for model development and validation. Therefore, there is no explicit separate "training set" described for an AI model.

The "training" of such a system involves the development and optimization of the assay chemistry and instrument parameters. The data presented here are part of the verification and validation (V&V) studies conducted on the final product to demonstrate its performance characteristics and substantial equivalence, akin to a "test set" for a traditional product.

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

As there isn't a "training set" in the context of an AI algorithm, the concept of establishing ground truth for it doesn't apply directly here. The development of the assay involves standard analytical chemistry principles, optimization of reagent concentrations, reaction conditions, and instrument calibration, with performance iteratively assessed against established analytical standards and clinical relevance. This is an engineering and chemistry development process rather than an AI model training process that relies on labeled datasets.

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For IN VITRO diagnostic use as a calibrator in clinical chemistry assays for UIBC (Unsaturated Iron Binding Capacity). DC-UIBC-CAL may be used to check the linearity over the reportable patient range of UIBC assays.

DC-UIBC-CAL is a human based, lyophilized serum intended for use as a calibrator with Sekisui Diagnostics UIBC Assays. The concentrations and activities of the UIBC (Unsaturated Iron Binding Capacity) is optimized for the calibration of clinical chemistry systems - Beckman Coulter AU® Systems, Roche/Hitachi® Beckman Coulter SYNCHRON® Systems, and Cobas Mira®.

The DC-UIBC-CAL kit consists of the following:

Six vials with 10mL of lyophilized serum.

Human serum was used in the manufacture of this product. The human serum in this product has been prepared exclusively from the blood of donors tested individually and shown by FDAapproved methods to be free from HBsAg and antibodies to HCV and HIV. However, as no test method can rule out the potential risk of infection with absolute certainty, the material should be treated just as carefully as a patient sample. In the event of exposure, the directives of the responsible Health Authorities should be followed.

The provided text describes a 510(k) submission for a medical device called DC-UIBC-CAL, a calibrator for clinical chemistry assays. The submission focuses on demonstrating substantial equivalence to a previously cleared predicate device, rather than a full de novo performance study. As such, many of the typical elements requested for software-based AI/ML device studies are not present.

Here's an analysis based on the provided text, indicating where information is present and where it is not applicable or not provided:

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

The document does not explicitly state quantitative "acceptance criteria" in the format typically seen for diagnostic performance metrics (e.g., sensitivity, specificity, AUC). Instead, the acceptance is based on demonstrating "substantial equivalence" to a predicate device.

The reported performance is primarily around stability and traceability/value assignment.

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

The document relates to a calibrator, not a diagnostic test for patient samples. Therefore, the concept of a "test set" for patient data, sample size, and data provenance (country, retrospective/prospective) as typically applied to diagnostic algorithms is not applicable here.

The stability studies would have involved multiple units of the calibrator product. The traceability and value assignment involved using two reagent lots on instruments. No specific sample sizes for these internal validation tests are provided.

The device itself is manufactured using human serum, and mentions that "Human serum was used in the manufacture of this product."

3. 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)

This information is not applicable. The device is a calibrator, not an interpretative AI/ML diagnostic device. Ground truth for a calibrator relates to its chemical composition and assigned values, which are established through metrological traceability to reference materials (like NIST SRM 937) and internal protocols, not through expert human review of diagnostic outputs.

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

Not applicable for a calibrator device.

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/ML diagnostic device for human interpretation.

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

Not applicable. This is a calibrator, a physical reagent device, not an algorithm.

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

The "ground truth" for the calibrator's UIBC concentration is established through metrological traceability to a reference material, specifically NIST SRM 937 (National Institute of Standards and Technology Standard Reference Material 937). Internal Sekisui protocols are also used for value assignment. This is a chemical/physical ground truth, not a clinical ground truth like pathology or patient outcomes.

8. The sample size for the training set

Not applicable. This is a calibrator, not an AI/ML algorithm requiring a training set.

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

Not applicable.

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The Sekisui Magnesium Assay is for the quantitative determination of magnesium in human serum and plasma (Lithium Heparin) on automated chemistry analyzers. Magnesium measurements are used in the diagnosis and treatment of hypomagnesemia (abnormally low levels of magnesium) and hypermagnesemia (abnormally high levels of magnesium). This device is intended for professional use and IN VITRO diagnostic use only.

The Sekisui Magnesium assay kit consists of the following: Magnesium Reagent: A solution containing buffer (pH 11.2 at 25°C), 0.14 mmol/L xylidy/ blue-1, 0.1 mmol/L EGTÅ, and a surfactant.

Here's a breakdown of the acceptance criteria and the study information for the Sekisui Magnesium Assay, based on the provided text:

Acceptance Criteria and Device Performance

Study Details

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

   • Precision: Not explicitly stated as a test set size for a single study, but samples (serum pools and control materials) were tested twice per day in duplicate for 20 days.
   • Linearity: 11 concentrations of magnesium (dilutions of a high concentration serum pool).
   • Detection Limit: 60 replicates of a zero magnesium sample and 60 replicates of a low concentration serum control (total 120 replicates).
   • Analytical Specificity: Three samples of human serum at different magnesium concentrations were tested in quadruplicate for each interfering substance.
   • Method Comparison: 100 serum samples.
   • Matrix Comparison: Not explicitly stated as a number, but refers to "fresh samples from non-fasting donors."
   • Reference Range Validation: 20 serum samples from apparently healthy donors.
   • Data Provenance: Not explicitly stated (e.g., country of origin). The studies appear to be retrospective as they use acquired samples.

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

   • Not applicable. This is an in vitro diagnostic device for quantitative chemical measurement. The "ground truth" for analytical performance tests (precision, linearity, detection limits, specificity, method comparison) relies on established reference methods, spiked samples, or known concentrations, rather than expert consensus on diagnostic images or interpretations.

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

   • Not applicable. This is an in vitro diagnostic device for quantitative chemical measurement. Adjudication methods are typically used for qualitative or interpretive assessments (e.g., in imaging studies) where human disagreement needs resolution.

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, a multi-reader, multi-case comparative effectiveness study was not done. This type of study is relevant for devices involving human interpretation (e.g., radiology AI), not for a quantitative chemical assay.

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

   • Yes, the performance characteristics described (precision, linearity, detection limit, analytical specificity) are standalone performance of the assay itself on an automated chemistry analyzer (Roche/Hitachi 717). The method comparison and matrix comparison also evaluate the device's performance against a predicate or different matrix, not human readers.

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

   • Precision: Internal controls and serum pools with target values.
   • Linearity: Serially diluted samples from a high concentration pool, where relative concentrations are known.
   • Detection Limit: Zero magnesium samples and low concentration serum control samples.
   • Analytical Specificity: Spiked samples with known concentrations of interfering substances, compared to unspiked controls.
   • Method Comparison: Comparison against the predicate device (Beckman Coulter Magnesium Reagent, K944407)
   • Matrix Comparison: Comparison between the candidate device run on serum vs. plasma samples.
   • Reference Range: Samples from "apparently healthy donors" (implying clinically normal magnesium levels).

7. The sample size for the training set:

   • Not applicable. This device is a chemical reagent and does not involve machine learning or AI that requires a "training set" in the conventional sense. Its performance is based on chemical reactions and assay optimization.

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

   • Not applicable, as there is no "training set" for this type of device.

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