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The Axis-Shield Active-B12 (Holotranscobalamin) assay is an enzyme-immunoassay (EIA) for the quantitative determination of holotranscobalamin (HoloTC) in human serum. HoloTC (vitamin B12 bound to transcobalamin) is used as an aid in the diagnosis and treatment of vitamin B12 deficiency.

The Axis-Shield Active-B12 (Holotranscobalamin) device contains the following components: a microtitre plate with 8 x 12-well breakapart strips coated with a anti-holotranscobalamin murine monoclonal antibody, in a resealable foil pack with desiccant; ready-to-use calibrators, low and high controls (phosphate buffer containing protein (bovine) stabiliser and sodium azide preservative with or without recombinant HoloTC); ready-to-use pre-treatment solution; murine anti-human transcobalamin alkaline phosphatase conjugate; para-NitroPhenyl Phosphate (pNPP) substrate; wash buffer (8x); ready-to-use stop solution.

Here is a breakdown of the acceptance criteria and study information for the Axis-Shield Active-B12 (Holotranscobalamin) device, based on the provided 510(k) summary:

1. Table of Acceptance Criteria and Reported Device Performance

Note: The acceptance criteria are largely derived from the performance claims of the predicate device, as the submission aims to demonstrate substantial equivalence to it. Where specific numerical "acceptance criteria" are not listed for the predicate, the comparison is made to the predicate's reported performance or general principles of equivalence. For interference, the "≤ 10% deviation" acts as an acceptance criterion for the subject device.

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

• Dilution Linearity: Not explicitly stated as a sample size, but linearity was demonstrated "across the measuring range of the assay from 5.3 to 156.0 pmol/L." This typically involves a series of dilutions of a high-concentration sample. Data provenance not specified but likely derived from lab studies.
• Analytical limits at low levels (Limit of Blank, Detection, Quantitation): No specific sample size provided, stated as "a representative study." Data provenance not specified, likely lab-generated.
• High Dose Hook: No sample size provided, determined by testing up to 2236 pmol/L Holotranscobalamin. Data provenance not specified, likely lab-generated.
• Cross-reactivity: No specific sample size provided, determined by testing in the presence of 500 pmol/L apotranscobalamin or 5000 pmol/L haptocorrin. Data provenance not specified, likely lab-generated.
• Interference: No specific sample size provided, determined by testing in the presence of various interfering compounds at specific concentrations. Data provenance not specified, likely lab-generated.
• Precision: 8 human serum samples were used, each assayed 80 times across 3 lots, 2 operators, and 5 days. This sums to 640 individual measurements (8 samples * 80 replicates) for the human serum samples, plus 80 replicates each for a low and a high control. Data provenance not specified, but the use of "human serum samples" suggests clinical samples, likely retrospective.
• Matrix Comparison: > 36 specimens were used for the correlation study comparing serum (clot) and serum separator (SST) tubes. Data provenance not specified, likely retrospective from a clinical setting.
• Method Comparison: 111 specimens from apparently healthy adults were used. Data provenance not specified, but the description "apparently healthy adults" suggests prospective collection or selection from a healthy cohort.

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

This device is an in-vitro diagnostic assay for quantitative determination of a biomarker (Holotranscobalamin). The ground truth for such assays is typically established through:

• Reference Methods: Comparison to established, clinically validated methods (like the predicate device) or gold standard analytical techniques.
• Known Concentrations: Use of samples with known, spiked concentrations for analytical performance validation (e.g., linearity, detection limits).
• Clinical Diagnosis: Correlating assay results with clinical diagnosis of B12 deficiency (though a direct study for this is not detailed for the subject device beyond the general "aid in diagnosis").

Thus, the ground truth is established through laboratory measurements and comparison to a legally marketed predicate device, rather than through expert consensus on diagnostic images or interpretations. Therefore, there were no human experts establishing the ground truth in the way described (e.g., radiologists interpreting images).

4. Adjudication method for the test set

Not applicable, as this is a quantitative diagnostic assay. Adjudication methods like 2+1 or 3+1 are typically used for qualitative or interpretive tasks, often in imaging, where human experts might disagree.

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 an immunoassay device, not an AI-assisted diagnostic tool that aids human readers.

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

Yes, this device is a standalone (algorithm only) device if you consider the "algorithm" to be the immunoassay protocol and the detector quantifying the colored end-product. There is no human-in-the-loop for the final quantitative result generation from the assay. The intent is for the device to provide a direct quantitative holotranscobalamin level.

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

The ground truth used for demonstrating substantial equivalence and performance was primarily based on:

• Comparison to the predicate device: The ARCHITECT Active-B12 (Holotranscobalamin) assay served as the reference standard for the method comparison study. This implies the predicate's results were considered the "ground truth" for comparative purposes.
• Analytical validation standards: For metrics like linearity, detection limits, cross-reactivity, and interference, the ground truth is established by carefully prepared samples with known concentrations or compositions, following established analytical chemistry principles.
• Internal reference materials/controls: For precision studies, characterized control samples with established mean values are used.

8. The sample size for the training set

This device is a traditional immunoassay, not a machine learning or AI algorithm in the modern sense that requires a "training set" for model development. Therefore, there is no explicit training set as would be understood in AI/ML validation. The development and optimization of the assay would have involved various experimental batches and iterative improvements, but these do not constitute a formal "training set" in the context of AI regulatory submissions.

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

Not applicable, as there is no formal "training set" in the AI/ML sense. The development of the assay involved standard biochemical and immunological research and development processes.

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Reagents: The ARCHITECT HbA1c assay is a chemiluminescent microparticle immunoassay (CMIA) for the quantitative determination of percent hemoglobin A1c (HbA1c) in human whole blood on the ARCHITECT i System. Percent HbA1c measurements are used for monitoring long term glycemic control in diabetic patients. Calibrators: The ARCHITECT HbA1c Calibrators are for the calibration of the ARCHITECT i System when used for the quantitative determination of percent haemoglobin A1c (HbA1c) in human whole blood.

The ARCHITECT HbA1c assay is a two-step pre-treatment immunoassay for the quantitative determination of percent haemoglobin A1c (% HbA1c) in human whole blood using CMIA technology, with flexible assay protocols, referred to as Chemiflex. Sample is incubated with pre-treatment reagent to lyse the red blood cells. Pre-treated sample is the incubated with magnetic microparticles with a silica surface. Hemaglobin and HbA1c in the sample bind to the silica surface of the microparticles. Following a wash cvcle, anti-HbA1c acridinium-labeled conjugate is added to create a reaction mixture. Following another wash cycle, pre-trigger and trigger solutions are added to the reaction mixture. The resulting chemiluminescent reaction is measured as relative light units (RLUs). The haemoglobin and HbA1c that are bound to the surface of the microparticles represents the total percentage present in the sample however, only the HbA1c result is required to determine the % HbA1c in the sample. A direct relationship exists between the amount of HbA1c in the sample and the RLUs detected by the ARCHITECT i System optics.

The information provided describes the ARCHITECT HbA1c Reagents and ARCHITECT HbA1c Calibrators, an in-vitro diagnostic device. Here's a breakdown of the requested information:

1. Table of Acceptance Criteria and Reported Device Performance

The submission focuses on establishing substantial equivalence to a predicate device (AxSYM HbA1c). Therefore, the "acceptance criteria" are implied to be performance comparable to the predicate device, demonstrated through specific statistical metrics.

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

• Sample Size: 127 samples.
• Data Provenance: The document does not explicitly state the country of origin. It indicates the study was a "method comparison study" and does not specify if it was retrospective or prospective.

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

This information is not provided in the document. For in-vitro diagnostic devices, the "ground truth" is typically established by comparative analysis against a recognized reference method or a legally marketed predicate device, rather than by human expert review of images or clinical cases.

4. Adjudication Method for the Test Set

This information is not applicable and not provided for this type of device and study. Adjudication methods like 2+1 or 3+1 are typically used in studies involving expert interpretation (e.g., radiology studies) to establish a consensus ground truth. Here, the comparison is between two quantitative assays.

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. This type of study involves multiple human readers interpreting cases, often with and without AI assistance, and is relevant for devices that aid human interpretation (e.g., in medical imaging). This submission is for an in-vitro diagnostic assay that provides a direct quantitative measurement.

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

Yes, the performance described is a standalone (algorithm only) performance. The ARCHITECT HbA1c assay is an automated chemiluminescent microparticle immunoassay (CMIA) run on the ARCHITECT i System. The performance metrics presented (slope, intercept, correlation) compare the results obtained directly from this automated system against results from the predicate automated system, without any human-in-the-loop interpretation being evaluated.

7. The Type of Ground Truth Used

The "ground truth" in this context is the results obtained from the legally marketed predicate device (AxSYM HbA1c assay). The study is a method comparison, aiming to show that the new device produces results comparable to an already accepted method.

8. The Sample Size for the Training Set

The document does not specify a separate "training set" or its sample size. For an in-vitro diagnostic assay like the ARCHITECT HbA1c, the development process likely involves internal validation and optimization, but the submission primarily details the performance evaluation study against the predicate device.

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

Since a dedicated "training set" with established ground truth as typically understood in AI/ML contexts is not explicitly mentioned, this information is not provided. The development of the assay itself would have involved establishing accurate calibrators and quality control materials, which form the basis for accurate measurement, but this is distinct from a "ground truth" used for training an AI algorithm.

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The 3-Reagent Homocysteine Assay for Beckman Coulter SYNCHRON® and UniCel® systems is intended for in vitro quantitative determination of total homocysteine in human serum and plasma. The device can assist in the diagnosis and treatment of patients suspected of having hyperhomocysteinemia and homocystinuria.

Bound or dimerised homocysteine (oxidised form) is reduced to free homocysteine, which then reacts with serine catalysed by cystathionine beta-synthase (CBS) to form cystathionine. Cystathionine in turn is broken down by cystathionine beta-lyase (CBL) to form homocysteine, pyruvate and ammonia. Pyruvate is then converted by lactate dehydrogenase (LDH) to lactate with nicotinamide adenine dinucleotide (NADH) as coenzyme. The rate of NADH conversion to NAD+ is directly proportional to the concentration of homocysteine (delta A340 nm).

Here's a breakdown of the acceptance criteria and study details for the 3-Reagent Homocysteine Assay, based on the provided text:

1. Acceptance Criteria and Reported Device Performance

The submission focuses on establishing substantial equivalence to a predicate device. The acceptance criteria are implicitly defined by the performance of the predicate device (Axis-Shield Liquid Stable (LS) 2-Part Homocysteine Reagent) and demonstrated through method comparison metrics.

2. Sample Size and Data Provenance (Test Set)

• Sample Size: 100 samples
• Data Provenance: The text does not explicitly state the country of origin or whether the data was retrospective or prospective. It only mentions "human serum and plasma" samples.

3. Number and Qualifications of Experts for Ground Truth (Test Set)

The concept of "experts" and "ground truth" as typically applied in AI/imaging device studies (e.g., radiologists) is not applicable to this type of chemical assay. For this device, the comparison is against a legally marketed predicate device, where the "ground truth" is essentially the established performance of that predicate using accepted laboratory methods (e.g., a "reference" assay or the predicate itself).

4. Adjudication Method (Test Set)

Not applicable. This is a quantitative chemical assay, not an interpretative task requiring human adjudication of results in the way an imaging study would. The comparison is statistical (Passing & Bablock method comparison and Pearson correlation analysis) between the new device and the predicate.

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

No. This type of study is not relevant for a quantitative chemical assay like a homocysteine test. MRMC studies are used to assess the impact of a device on decision-making or diagnostic accuracy when human interpretation is involved.

6. Standalone (Algorithm Only) Performance Study

Yes, in a sense. The described "method comparison study" implicitly evaluates the standalone performance of the 3-Reagent Homocysteine Assay against the already established performance of the legally marketed predicate device (Axis-Shield Liquid Stable (LS) 2-Part Homocysteine Reagent) when run on different analyzer platforms. There is no human-in-the-loop component for these quantitative results.

7. Type of Ground Truth Used (Test Set)

The "ground truth" for the test set is the results obtained from the legally marketed predicate device (Axis-Shield Liquid Stable (LS) 2-Part Homocysteine Reagent) when tested on the Olympus AU400 analyzer. The study design is a method comparison, where the new device's results are compared to the predicate's results for the same samples.

8. Sample Size for the Training Set

Not applicable. This is a reagent-based assay, not a machine learning or AI algorithm that requires a "training set" in the traditional sense. The device's performance is inherent to its chemical reactions and physical characteristics.

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

Not applicable. As stated above, there is no "training set" for this type of device. The development and optimization of the reagent formulations would involve various internal validation steps (e.g., verifying chemical reactions, stability, sensitivity) rather than establishing "ground truth" through a dataset that directly trains an algorithm.

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The ARCHITECT Active-B12 (Holotranscobalamin) assay is a chemiluminescent microparticle immunoassay (CMIA) the for quantitative determination of Holotranscobalamin in human serum on the ARCHITECT i System. Active-B12 (Holotranscobalamin) is used as an aid in the diagnosis and treatment of vitamin B12 deficiency:

The ARCHITECT Active-B12 (Holotranscobalamin) assay is a two-step immunoassay for the quantitative determination of Holotranscobalamin in human serum using CMIA technology, with flexible assay protocols, referred to as Chemiflex.

In the first step, sample and anti-holotranscobalamin coated paramagnetic microparticles are combined. Holotranscobalamin present in the sample binds to the antiholotranscobalamin coated microparticles. After washing, anti-transcobalamin acridinium-labeled conjugate is added-to create a reaction mixture in the second step. Following another wash cycle, pretrigger and trigger solutions are added to the reaction mixture. The resulting chemiluminescent reaction is measured as relative light units (RLUs). A direct relationship exists between the amount of Holotranscobalamin in the sample and the RLUs detected by the ARCHITECT i System optics.

Here's a breakdown of the acceptance criteria and study information for the ARCHITECT Active-B12 device, based on the provided text:

Acceptance Criteria and Device Performance

Note: The acceptance criteria are largely implicit in the context of a 510(k) submission seeking "substantial equivalence." The device aims to perform as well as the predicate device (AxSYM Active-B12) across these performance characteristics.

Study Details

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

   • Sample Size: 125 samples
   • Data Provenance: Not explicitly stated (e.g., country of origin). The document indicates "human serum" samples. It's a non-clinical/clinical performance study comparing the new device to a predicate, not a study to establish clinical utility from a population. This type of study is retrospective, as existing samples are used to compare the new device to an established one.

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

   • Not applicable. This is a method comparison study between two quantitative laboratory assays. "Ground truth" is established by the reading of the predicate device (AxSYM Active-B12 (HoloTC) Immunoassay), not by expert opinion.

3. Adjudication Method for the Test Set:

   • Not applicable. Adjudication methods (like 2+1, 3+1) are typically used for qualitative or imaging studies where expert consensus is needed to define ground truth. For quantitative assays like this, the result from the predicate device serves as the comparator.

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

   • No. This is a comparison between two automated laboratory diagnostic devices, not a study involving human readers.

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

   • Yes, this is implicitly a standalone study. The ARCHITECT Active-B12 assay is an automated immunoassay. Its performance is evaluated independently against another automated immunoassay (AxSYM Active-B12). There is no "human-in-the-loop" component for the measurement itself, only for operating the instruments and interpreting the quantitative results.

6. The Type of Ground Truth Used:

   • Comparator (reference) Method: The AxSYM Active-B12 (HoloTC) Immunoassay served as the "ground truth" or reference method for comparison. The study aimed to show substantial equivalence between the new device and this legally marketed predicate device.

7. The Sample Size for the Training Set:

   • Not applicable. This 510(k) summary describes a performance study for a diagnostic assay, not a machine learning algorithm that requires a "training set." The ARCHITECT Active-B12 is a chemistry-based immunoassay.

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

   • Not applicable, as there is no training set mentioned or implied for a device of this type.

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The Axis-Shield Anti-CCP test is a semi-quantitative/qualitative enzyme-linked immunosorbent assay (ELISA) for the detection of the IgG class of autoantibodies specific to cyclic citrullinated peptide (CCP) in human serum (including Serum Separator Tubes) or plasma (EDTA, lithium heparin, or sodium citrate). Detection of anti-CCP antibodies is used as an aid in the diagnosis of Rheumatoid Arthritis (RA), and should be used in conjunction with other clinical information. Autoantibody levels represent one parameter in a multi-criterion diagnostic process, encompassing both clinical and laboratory-based assessments. For in vitro diagnostic use.

The Axis-Shield Anti-CCP device contains the following components: a microtitre plate with 8 x 12-well breakapart strips coated with purified synthetic cyclic citrullinated peptide, in a resealable foil pack with desiccant; ready to use calibrators (diluent with or without IqG antibodies against CCP2); positive and negative assay controls (human plasma with or without IgG antibodies against CCP); ready-to-use reference control; goat anti-human IgG horseradish peroxidase conjugate: TMB substrate; sample diluent (5x) wash buffer (10x); ready-to-use stop solution.

Here's an analysis of the provided text, extracting the requested information about acceptance criteria and the supporting study:

The provided text describes a 510(k) submission for the Axis-Shield Anti-CCP device, claiming substantial equivalence to the DIASTAT™ Anti-CCP Assay. The primary study presented is a method comparison and concordance analysis between the two devices.

1. Table of Acceptance Criteria and Reported Device Performance

The document does not explicitly state pre-defined acceptance criteria in terms of specific numeric thresholds (e.g., "concordance must be >95%"). Instead, it presents the achieved performance and implies that this level of performance was considered "substantially equivalent" to the predicate.

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

• Sample Size for Test Set: 514 samples.
• Data Provenance: Not explicitly stated (e.g., country of origin, demographics of participants). The document only mentions using "human serum (including Serum Separator Tubes) or plasma (EDTA, lithium heparin, or sodium citrate)." It's a clinical performance study comparing two assays, implying human samples. The study appears to be retrospective as it involves running existing banked samples on both devices for comparison.

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

The ground truth in this study is based on the results of the predicate device (DIASTAT™ Anti-CCP Assay). This is a comparison study, not a study aiming to establish the accuracy against a gold standard for Rheumatoid Arthritis diagnosis directly. Therefore, there were no human experts establishing a separate ground truth for the test set beyond the predicate device's results.

4. Adjudication Method for the Test Set

The concept of an adjudication method (like 2+1 or 3+1) is typically relevant when establishing a ground truth based on multiple expert opinions. Since the ground truth for comparison was the predicate device's results, no expert adjudication method was used for the test set. The devices were likely run independently and their results compared.

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. This device is an in-vitro diagnostic (ELISA assay), not an imaging-based AI system that requires human interpretation. Therefore, there is no "human readers improve with AI vs. without AI assistance" effect size to report.

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

• Yes, the study primarily demonstrates the standalone performance of the Axis-Shield Anti-CCP device by comparing its output (antibody levels) directly to the predicate device's output. ELISA assays are inherently standalone tests; human involvement is in performing the lab procedure, not in interpreting the raw results in a way that would classify it as "human-in-the-loop" for the algorithm itself.

7. The Type of Ground Truth Used

The "ground truth" for the comparison study was the results obtained from the legally marketed predicate device (DIASTAT™ Anti-CCP Assay). While the intended use notes the test is an "aid in the diagnosis of Rheumatoid Arthritis (RA) and should be used in conjunction with other clinical information," the study itself does not directly use a definitive RA diagnosis (e.g., pathology, long-term outcomes, or consensus clinical diagnosis) as its ground truth for evaluation. Instead, it assumes the predicate's results are acceptable and compares the new device's results to them.

8. The Sample Size for the Training Set

The document does not provide information on a training set for the Axis-Shield Anti-CCP device. ELISA assays are typically developed through biochemical optimization and validation, not through machine learning training on a 'training set' in the conventional AI sense. The "clinical performance" study described is a validation or test set study for the finished device.

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

As there is no mention of a training set in the context of an algorithm requiring ground truth, this information is not applicable and not provided in the document.

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The Liquid Stable (LS) 2-Part Homocysteine Reagent is intended for in vitro quantitative determination of total homocysteine in human serum and plasma. The device can assist in the diagnosis and treatment of patients suspected of having hyperhomocysteinemia and homocystinuria.

The Axis-Shield Liquid Stable (LS) 2-Part Homocysteine Reagent Test System includes two reagents and two calibrators.

The first reagent (Reag 1) includes Lactate dehydrogenase (LDH), Serine, nicotinamide adenine dinucleotide reduced di-sodium salt (NADH), tris [2-carboxyethyl] phosphine (TCEP) reductant, with buffers and stabilizers (Trizma Base and Trizma Hydrochloride), and preservative (Sodium Azide).

The second reagent (Reag2) includes Cystathionine beta-Synthase (CBS) and Cystathionine beta-Lvase (CBL) cvcling enzymes with preservative (sodium azide).

The Axis-Shield Liquid Stable (LS) 2-Part Homocysteine Reagent kit will also include two calibrators; Calibrator "0" (0 µmol/L) and Calibrator "28" (28 µmol/L).

Here's a breakdown of the acceptance criteria and the study details for the Axis-Shield Liquid Stable (LS) 2-Part HOMOCYSTEINE REAGENT, based on the provided 510(k) summary:

Acceptance Criteria and Reported Device Performance

Study Details

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

   • Sample Size: 94 plasma specimens.
   • Data Provenance: Not explicitly stated, but the submission is from Axis-Shield Diagnostics, Ltd. in the UK, suggesting potential European origin. It is a retrospective comparison study against an existing, legally marketed device.

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

   • This is a quantitative diagnostic assay. The "ground truth" for the test set is established by the predicate device (CATCH Incorporated Liquid Stable (LS) 2-Part Homocysteine Reagent assay) measurements rather than expert consensus on images or clinical diagnoses. Therefore, expert involvement for ground truth establishment as in image interpretation studies is not applicable here.

3. Adjudication Method for the Test Set:

   • Not applicable. The comparison is between two quantitative assays, not subjective interpretations requiring adjudication.

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. This is a study comparing the performance of a new quantitative laboratory assay against a predicate assay, not an AI-assisted diagnostic tool for human readers.

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

   • Yes, this is a standalone performance study. The Axis-Shield device is a reagent system for automated laboratory analysis, and its performance is evaluated directly without human interpretation in the loop impacting the result.

6. The Type of Ground Truth Used:

   • The "ground truth" in this context is the quantitative results obtained from the legally marketed predicate device, the CATCH Incorporated Liquid Stable (LS) 2-Part Homocysteine Reagent assay. The study aims to demonstrate that the new device produces results that are substantially equivalent to this established method.

7. The Sample Size for the Training Set:

   • Not applicable. This device is a biochemical reagent system, not a machine learning model that requires a dedicated "training set" in the computational sense. The "development" and "optimization" of the reagent would involve internal testing and validation, but not a formally segregated "training set" like in AI/ML contexts.

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

   • Not applicable, as there is no "training set" in the conventional AI/ML sense for this type of device.

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The ARCHITECT Homocysteine assay is a chemiluminescent microparticle immunoassay (CMIA) for the quantitative determination of total L-homocysteine in human serum or plasma on the ARCHITECT i System. Homocysteine values can assist in the diagnosis and treatment of patients suspected of having hyperhomocysteinemia and homocystinuria.

The ARCHITECT Homocysteine Calibrators are for the calibration of the ARCHITECT i System when used for the quantitative determination of total L-homocysteine in human serum or plasma.

The ARCHITECT Homocysteine Controls are for the estimation of test precision and the detection of systematic analytical deviations of the ARCHITECT i System (reagents, calibrators and instrument), when used for the quantitative determination of total L-homocysteine in human serum or plasma.

For in vitro diagnostic use.

The ARCHITECT Homocysteine assay is a one-step immunoassay for the quantitative determination of total L-homocysteine in human serum or plasma using CMIA technology, with flexible assay protocols, referred to as Chemiflex. Bound or dimerised homocysteine (oxidized form) is reduced by dithiothreitol (DTT) to free homocysteine, which is then converted to Sadenosyl homocysteine (SAH) by the action of the recombinant enzyme S-adenosyl homocysteine hydrolase (rSAHHase) in the presence of excess adenosine. The SAH then competes with acridinium-labeled S-adenosyl cysteine for particle-bound monoclonal antibody. Following a wash stage and magnetic separation, pre-trigger and trigger solutions are added to the reaction mixture and the resulting chemiluminescence is measured as relative light units (RLUs). An indirect relationship exists between the amount of homocysteine in the sample and the RLUs detected by the ARCHITECT i System optics.

The ARCHITECT Homocysteine assay is compared to the AxSYM Homocysteine assay. The acceptance criteria and the study results proving the device meets these criteria are as follows:

1. Table of Acceptance Criteria and Reported Device Performance:

Note: The acceptance criteria are implicit based on the statement of "substantially equivalent performance" and typical ranges for method comparison studies in clinical chemistry. The provided 510(k) summary does not explicitly state numerical acceptance criteria, but rather demonstrates equivalence to a predicate device.

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

   • Sample Size: 456 plasma samples.
   • Data Provenance: Not specified (country of origin, retrospective/prospective). Since it's a method comparison study for an in vitro diagnostic, it would typically involve clinical samples, likely prospective or a well-characterized retrospective cohort.

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

   • Not applicable. For an immunoassay, the "ground truth" is typically established by the reference method or comparative method, which in this case is the predicate device (AxSYM Homocysteine assay). The performance of the predicate device is assumed to be accurate.

4. Adjudication method for the test set:

   • Not applicable. This is a method comparison study for an in vitro diagnostic device, not an image-based diagnostic or clinical trial requiring expert adjudication of diagnoses. The predicate device's results serve as the comparison point.

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 for image interpretation or diagnosis by human readers. It is an in vitro diagnostic immunoassay.

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

   • Yes, the study performed is a standalone performance assessment of the ARCHITECT Homocysteine assay against a predicate device. The assay itself is automated and does not involve a human in the loop for its direct analytical performance once a sample is loaded.

7. The type of ground truth used:

   • Comparative data with a legally marketed predicate device: The AxSYM Homocysteine assay results were used as the comparison "ground truth" to establish substantial equivalence.

8. The sample size for the training set:

   • Not applicable. This device is an immunoassay, not a machine learning or AI algorithm that requires a separate training set. Its chemical and mechanical principles are fixed during development.

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

   • Not applicable (see point 8).

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The AxSYM HbA1c assay is an immunoassay for the quantitative determination of percent hemoglobin A1c (HbA1c) in whole blood samples on the AxSYM System. Percent HbA1c measurements are used in the clinical management of diabetes to assess the long-term efficacy of diabetic control.

The AxSYM HbA1c Standard Calibrators are for the standard calibration of the AxSYM System when used for the quantitative determination of percent HbA1c in whole blood samples.

The AxSYM HbA1c Controls are for the use in quality control to monitor the accuracy and precision of the AxSYM HbA1c assay when used for the quantitative determination of percent hemoglobin A1c (HbA1c) in whole blood samples on the AxSYM System.

For in vitro diagnostic use.

The AxSYM HbA1c assay is an immunoassay for the quantitative determination of percent hemoglobin A1c (HbA1c) in whole blood samples on the AxSYM System. Percent HbA1c measurements are used in the clinical management of diabetes to assess the long-term efficacy of diabetic control.

In the AxSYM HbA1c assay, whole blood sample is lysed, releasing hemoglobin and HbA1c analyte. Lysed sample is added to the glass fiber matrix that has been coated with Blocking Buffer in a previous step. Hemoglobin and HbA1c analyte are captured on the glass fiber matrix by the binding reaction that occurs between the analyte and the Blocking Buffer. HbA1c is quantified by measuring the amount of HbA1c analyte captured on the matrix cell, using a conjuqate of Anti-HbA1c and Alkaline Phosphatase as the signal-generating molecule, and the substrate, 4-Methylumbelliferyl Phosphate (MUP).

The AxSYM HbA1c reagents and sample are pipetted in the following sequence:

SAMPLING CENTER

• The whole blood samples can be processed from AxSYM sample . cups or from primary blood collection tubes (fluoride oxalate and fluoride EDTA). Potassium EDTA blood collection tubes that have undergone a single freeze-thaw cycle may also be processed from AxSYM sample cups or from the primary blood collection tube. Fresh (non-frozen) potassium EDTA primary whole blood collection tubes may be used if testing is performed in STAT mode and run in groups of eight tubes or less. For further instructions on use of potassium EDTA whole blood samples, refer to the SAMPLE COLLECTION AND PREPARATION FOR ANALYSIS section.

The sample and all AxSYM HbA1c reagents required for one test . are pipetted by the Sampling Probe into various wells of a Reaction Vessel (RV).

The RV is immediately transferred into the Processing Center. Further pipetting is done in the Processing Center by the Processing Probe.

PROCESSING CENTER

• The whole blood sample is combined with the Lysis Buffer and . incubated for 450 seconds.
• . The matrix cell is coated with Blocking Buffer.

The lysed sample is diluted with Sample Diluent and transferred to . the matrix cell. Hemoglobin and the HbA1c analyte are captured on the glass fiber matrix through interactions with the blocking buffer overcoat.

• . The matrix cell is washed to remove unbound materials.
• . The Anti-HbA1c:Alkaline Phosphatase Conjugate is dispensed onto the matrix cell and binds to the analyte, forming an antigen-antibody complex.
• . The matrix cell is washed to remove unbound materials.
• . The substrate, 4-Methylumbelliferyl Phosphate, is added to the matrix cell and the fluorescent product is measured by the MEIA optical assembly.

The concentration of HbA1c in the sample is determined using a previously generated calibration curve

Here's a breakdown of the acceptance criteria and the study details for the AxSYM HbA1c device, based on the provided text:

1. Table of Acceptance Criteria and Reported Device Performance:

The document doesn't explicitly state "acceptance criteria" in a numerical or categorical format for performance metrics. Instead, it demonstrates substantial equivalence to a predicate device ("G7 Automated Glycosylated Hemoglobin HPLC Analyzer") by comparing various performance characteristics. The implied acceptance criterion for the clinical performance, therefore, is substantial equivalence to the predicate device.

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

• Sample Size for Test Set: 300 samples were used for the method comparison study.
• Data Provenance: The document does not specify the country of origin of the data or whether it was retrospective or prospective.

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

This information is not provided in the given text. For a device like this (an immunoassay), the "ground truth" is typically established by the predicate device (the G7 Automated Glycosylated Hemoglobin HPLC Analyzer) rather than human expert interpretation of images or other subjective data. Therefore, the concept of "experts" to establish ground truth in the traditional sense for this type of device is not directly applicable.

4. Adjudication Method for the Test Set:

This information is not applicable as the ground truth is established by a reference method (the HPLC analyzer) and not by human experts whose discrepancies would need adjudication.

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. This type of study is relevant for diagnostic imaging devices where human readers interpret outputs, and the AI assists that interpretation. The AxSYM HbA1c is an automated immunoassay, and its performance is evaluated against a reference method directly. Therefore, there's no "human readers improve with AI vs without AI assistance" effect size to report.

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

Yes, the performance reported is a standalone (algorithm only) performance. The AxSYM HbA1c assay is an automated immunoassay system. The study compares its quantitative results directly against a predicate automated method (HPLC), without human involvement in the interpretation of the AxSYM HbA1c's output.

7. The Type of Ground Truth Used:

The ground truth used was the results obtained from the predicate device, the G7 Automated Glycosylated Hemoglobin HPLC Analyzer. This constitutes a "reference method" comparison.

8. The Sample Size for the Training Set:

The document does not specify the sample size for a training set. This is typical for an immunoassay that operates based on established chemical reactions and calibration curves, rather than a machine learning model that requires a dedicated training set. The calibration curve is generated using specific calibrators mentioned (AxSYM HbA1c Standard Calibrators), but the sample size for establishing these is not detailed in the summary.

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

This information is not explicitly detailed in the document. For an immunoassay, the "ground truth" for calibration (which is analogous to training in a machine learning context) is established through the known concentrations of the AxSYM HbA1c Standard Calibrators used to create the calibration curve. These calibrators would themselves have been precisely characterized, but the method for their characterization is not described in this summary.

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AxSYM® Anti-CCP is a Microparticle Enzyme Immunoassay (MEIA) for the semiquantitative determination of the IgG class of autoantibodies specific to cyclic citrullinated peptide (CCP) in human serum and plasma on the AxSYM System. Detection of anti-CCP antibodies is used as an aid in the diagnosis of Rheumatoid Arthritis (RA) and should be used in conjunction with other clinical information. Autoantibody levels represent one parameter in a multicriterion diagnostic process, encompassing both clinical and laboratory-based assessments.

The AxSYM® Anti-CCP Standard Calibrators are for the standard calibration of the AxSYM System when used for the semi-quantitative determination the IgG class of autoantibodies specific to cyclic citrullinated peptide (CCP) in human serum and plasma.

The AxSYM® Anti-CCP Controls are for the use in quality control to monitor the accuracy and precision of the AxSYM Anti-CCP assay when used for the semi-quantitative determination of the IgG class of autoantibodies specific to cyclic citrullinated peptide (CCP) in human serum and plasma on the AxSYM System.

For in vitro diagnostic use.

AxSYM Anti-CCP is based on Microparticle Enzyme Immunoassay (MEIA) technology. The AxSYM Anti-CCP reagents and sample are pipetted in the following sequence:

SAMPLING CENTER

• . Sample and all AxSYM Anti-CCP reagents required for one test are pipetted by the Sampling Probe into various wells of a Reaction Vessel (RV),
• AxSYM Line Diluent and sample are pipetted into the Incubation Well of the . RV.
• . The AxSYM Anti-CCP Sample Diluent and diluted sample are pipetted into the Sample Well of the RV.
• . The AxSYM Anti-CCP Matrix Cell Blocker is pipetted into the Buffer Well of the RV.
• . The AxSYM Anti-CCP Mouse Anti-Human IgG:Alkaline Phosphatase Conjugate is pipetted into Reagent Well 3 of the RV.
• . AxSYM Line Diluent and CCP-Coated Microparticles are pipetted into Reagent Well 2 of the RV.
• . A reaction mixture is formed by combining diluted sample and diluted microparticles coated with CCP in Reagent Well 1 of the RV.
• . When anti-CCP antibody is present in the sample, it binds to the CCP-Coated Microparticles, forming antigen-antibody complexes on the microparticles.

The RV is immediately transferred into the Processing Center. Further pipetting is done in the Processing Center by the Processing Probe.

PROCESSING CENTER

• . An aliquot of Matrix Cell Blocker is transferred to the Matrix Cell.
• . An aliquot of the reaction mixture, containing microparticles and bound antigen-antibody complex, is transferred to the Matrix Cell. The microparticles bind irreversibly to the glass fiber matrix.
• The Matrix Cell is washed to remove materials not bound to the . microparticles.
• The AxSYM Anti-CCP Mouse Anti-Human IgG:Alkaline Phosphatase . Conjugate is dispensed onto the Matrix Cell and it binds with the antigenantibody complexes.
• . The Matrix Cell is washed to remove conjugate not bound to the microparticles.
• . The substrate, 4-Methylumbelliferyl Phosphate, is added to the Matrix Cell. The alkaline phosphatase-labeled conjugate catalyzes the removal of a phosphate group from the substrate, yielding the fluorescent product, 4-Methylumbelliferone. This fluorescent product is measured by the MEIA optical assembly.

Here's an analysis of the provided text regarding the AxSYM® Anti-CCP device, focusing on acceptance criteria and supporting study details:

1. Table of Acceptance Criteria and Reported Device Performance

The acceptance criteria for this device are not explicitly stated in numerical thresholds within the provided text. Instead, the submission claims substantial equivalence to a predicate device (DIASTAT™ Anti-CCP Assay, K023285) based on comparable performance metrics.

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

• Sample Size: The document does not explicitly state the total number of samples used for the clinical performance comparison. It only mentions "all samples tested" for the method comparison with 97.3% concordance, but the raw count is not provided.
• Data Provenance: The document does not specify the country of origin of the data or whether it was retrospective or prospective.

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

This information is not provided in the document. The "ground truth" for evaluating the clinical performance of the AxSYM® Anti-CCP assay against the predicate device would typically involve a definitive diagnosis of Rheumatoid Arthritis (RA) or healthy controls, which should be established by qualified medical professionals. However, the document does not detail how this ground truth was established or the experts involved.

4. Adjudication Method for the Test Set

The document does not describe any adjudication method used for the test set.

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

• Was an MRMC study done? No, a Multi-Reader Multi-Case (MRMC) comparative effectiveness study was not done. This submission focuses on the performance of an in vitro diagnostic (IVD) assay, not a device requiring human interpretation of images or other data where reader variability would be a primary concern. The comparison is between two automated assays.
• Effect size of human readers with/without AI assistance: Not applicable, as this was not an MRMC study involving human readers and AI assistance.

6. Standalone Performance Study

Yes, a standalone performance study was implicitly done for the AxSYM® Anti-CCP assay. The "Summary of Clinical Performance" directly reports on the performance of the AxSYM® Anti-CCP assay (e.g., its ROC AUC of 0.875) and compares it to the predicate device. This evaluation of the device's accuracy in distinguishing between patient populations is a form of standalone performance assessment.

7. Type of Ground Truth Used

The ground truth used for evaluating the clinical performance of the AxSYM® Anti-CCP assay (and the predicate DIASTAT™ Anti-CCP assay) would be the clinical diagnosis of Rheumatoid Arthritis (RA) and non-RA status of the patient samples. While the document doesn't explicitly state "pathology" or "outcomes data," the intended use as "an aid in the diagnosis of Rheumatoid Arthritis" implies that the samples used for validation were from individuals with confirmed RA and appropriate control groups.

8. Sample Size for the Training Set

The document does not report the sample size used for the training set. This submission is for a manufactured diagnostic kit, and the specifics of its internal algorithm development (including training data for the assay's cut-off determination or internal calibration) are not detailed.

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

The document does not report how the ground truth for the training set was established, as details about the device's internal development process are not included in this 510(k) summary.

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