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For in vitro diagnostic use only. VITROS® Chemistry Products HCY 2 Reagent is used on VITROS® Systems to quantitatively measure total homocysteine concentration in human serum and plasma. Serum and plasma homocysteine levels can assist in the diagnosis and treatment of patients suspected of having hyperhomocysteinemia and homocystinuria.
For in vitro diagnostic use only. VITROS® Chemistry Products HCY 2 Performance Verifiers are assayed controls used to monitor performance of VITROS® Chemistry Products HCY and VITROS® Chemistry Products HCY 2 Reagents on VITROS® Systems.

The VITROS® Chemistry Products HCY 2 Reagent is used in conjunction with the VITROS® Chemistry Products Calibrator Kit 27 and VITROS® Chemistry Products FS Diluent Pack 2 (BSA/Saline) on VITROS® 5.1 FS Chemistry Systems, VITROS® 4600 Chemistry Systems, and the VITROS® 5600 Integrated Systems to quantitatively measure total homocysteine concentration in human serum and plasma.
The VITROS® Chemistry Products HCY 2 Reagent consists of one dual chambered reagent pack containing two ready-to-use liquid reagents, one in each chamber. Disulfide linked homocysteine (oxidized forms) in the sample is reduced by Tris (2-Carboxyethyl) Phosphine hydrochloride (TCEP) to form reduced homocysteine. Reduced homocysteine reacts with serine in the presence of cystathionine ß-synthase (CBS) to form Lcystathionine. L-cystathionine is broken down by cystathionine ß-lyase (CBL) to produce homocysteine, pyruvate and ammonia. Pyruvate is reduced to lactate by lactate dehydrogenase (LDH) using NADH as coenzyme. The concentration of homocysteine is directly proportional to the amount of NADH converted to NAD and is measured spectrophotometrically at 340 nm.
The VITROS® Chemistry Products Calibrator Kit 27 is prepared from an aqueous solution containing amino acids and inorganic acid. These standards are used to calibrate the VITROS® 5.1 FS Chemistry Systems, VITROS® 4600 Chemistry Systems, and VITROS® 5600 Integrated Systems for the quantitative measurement of homocysteine.
The VITROS® Chemistry Products HCY 2 Performance Verifiers I, II and III are prepared from processed human serum to which amino acid and preservative have been added. These are assayed controls used to monitor performance of VITROS® Chemistry Products HCY and VITROS® Chemistry Products HCY 2 Reagents on VITROS® Systems.
The VITROS® Chemistry Products FS Diluent Pack 2 (Saline/BSA) is a common reagent that is used by multiple assays on VITROS® Systems. This is a dual chambered package containing two ready-to-use liquid diluents. Diluent 1 is prepared from processed water to which inorganic salt has been added. Diluent 2 is prepared from processed water to which bovine serum albumin, inorganic salts and preservatives have been added.

Here's a breakdown of the acceptance criteria and study information for the VITROS® Chemistry Products HCY 2 Reagent and Performance Verifiers, based on the provided text:

1. Table of Acceptance Criteria and Reported Device Performance

The provided 510(k) summary focuses on demonstrating substantial equivalence to a predicate device rather than explicitly listing hard-coded "acceptance criteria" in the traditional sense (e.g., a specific sensitivity or specificity threshold that must be met). Instead, the performance is evaluated through correlation studies and various bench testing parameters, compared against the predicate device.

The primary "acceptance criterion" for this type of submission is demonstrating substantial equivalence to the predicate device, which is concluded based on the presented data. The study compares the new device's performance to the predicate device.

For the VITROS® Chemistry Products HCY 2 Performance Verifiers I, II & III, the acceptance criteria relate to their function as assayed controls and their equivalence to the predicate verifiers.

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

• Test Set Sample Sizes:
  • VITROS® 5.1 FS Chemistry System: n = 110
  • VITROS® 4600 Chemistry System: n = 123
  • VITROS® 5600 Integrated System: n = 111
• Data Provenance: The data refers to "patient samples." The country of origin is not specified but is implicitly from a clinical setting, given the nature of the device. The data is retrospective, as it compares the new device to an already commercially available predicate device using these samples.

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

This type of immunoassay device submission does not typically involve human expert interpretation for "ground truth" establishment in the same way an imaging AI device would. The "ground truth" for the test set is effectively the quantitative measurement of total homocysteine concentration obtained by the predicate device (VITROS® Chemistry Products HCY Assay). Therefore, the concept of "number of experts" and "qualifications of those experts" does not directly apply here in the context of human reviewers.

4. Adjudication Method for the Test Set

Not applicable. As described above, the ground truth is established by the predicate device's quantitative measurements, not through expert adjudication of qualitative findings.

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 device is an in vitro diagnostic (IVD) assay for quantitative measurement of homocysteine, not an imaging or AI interpretation device designed to assist human readers. Therefore, the concept of "human readers improve with AI" is not relevant to this submission.

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

Yes, the studies presented are standalone performance studies of the device (reagent and verifiers) itself. It's an automated chemistry assay system, meaning it operates without continuous human intervention during the measurement process. The results are quantitative measurements directly produced by the system.

7. The Type of Ground Truth Used

The ground truth used for the comparative effectiveness study (correlation studies) was the quantitative measurement of total homocysteine concentration obtained by the predicate device (VITROS® Chemistry Products HCY Assay). This serves as the reference standard against which the new device's measurements are compared.

8. The Sample Size for the Training Set

The document does not explicitly mention a "training set" in the context of an algorithm or machine learning model. This is a traditional IVD submission for a chemistry assay, not an AI/ML-based device. The development process would involve internal optimization and validation studies, but these are not typically referred to as "training sets" in the AI sense within such a 510(k) summary.

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

As noted in point 8, the concept of a "training set" with established ground truth as understood in AI/ML is not directly applicable here. The development of the assay would involve standard chemical and analytical methodologies to ensure accuracy and precision, with reference to known standards and controls, rather than human-curated ground truth for training an algorithm.

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Diazyme's HCY POC Test Kit is intended to be used with the SMART analyzer in a Point-of-Care setting for the in vitro quantitative determination of total L-homocysteine in serum or plasma. The assay can assist in the diagnosis and treatment of patients suspected of having hyperhomocysteinemia and homocystinuria. For in vitro diagnostic use only.

Diazyme HCY POC Test Kit contains reagents intended for use with the SMART analyzer for the quantitative determination of Homocysteine (HCY) in human serum or plasma. Diazyme HCY POC Test is based on a novel enzyme cycling method as published in the Journal of Clinical Chemistry. In this assay, oxidized HCY is first reduced to free HCY which then reacts with a co-substrate, S-adenosylmethionine (SAM) catalyzed by a HCY S-methyltransferase to form methionine (Met) and S-adenosylhomocysteine (SAH). SAH is assessed by coupled enzyme reactions including SAH hydrolase, adenosine (Ado) deaminase and glutamate dehydrogenase, wherein SAH is hydrolyzed into adenosine (Ado) and HCY by SAH hydrolase. The formed HCY that is originated from the co-substrate SAM is cycled into the HCY conversion reaction by HCY S-methyltransferase. This forms a co-substrate conversion product-based enzyme cycling reaction system with signification of detection signals. The formed Ado is immediately hydrolyzed into inosine and ammonia which reacts with glutamate dehydrogenase with concomitant conversion of NADH to NAD+. The concentration of HCY in the sample is indirectly proportional to the amount of NADH converted to NAD+ (ΔA340mm).

The Diazyme HCY POC Test system thus consists of the following:

• HCY POC Test Kit. Reagents are provided in prefilled tubes, cuvettes and . cuvette caps. The DRS cuvette and cuvette caps can only work with the SMART analyzer.
• HCY POC Test Control Kit. Controls are provided for quality control of the . HCY POC Test.

Here’s an analysis of the acceptance criteria and study data for the Diazyme HCY POC Test, based on the provided document:

Acceptance Criteria and Device Performance for Diazyme HCY POC Test

1. Table of Acceptance Criteria and Reported Device Performance

• 7.5 µmol/L HCY: 3.2%
• 11.8 µmol/L HCY: 1.8%
• 29.0 µmol/L HCY: 2.8%
  Total CV%:
• 7.5 µmol/L HCY: 3.4%
• 11.8 µmol/L HCY: 3.5%
• 29.0 µmol/L HCY: 3.3% |
  | Precision (POL sites - 1) | "The results indicated good precision..." (Implied generally low CV%) | POL 1 (Sample 1): Within CV% 3.1%, Total CV% 5.2%
  POL 1 (Sample 2): Within CV% 2.8%, Total CV% 3.7%
  POL 1 (Sample 3): Within CV% 2.8%, Total CV% 4.1%
  POL 1 (Sample 4): Within CV% 3.5%, Total CV% 6.0%
  POL 1 (Sample 5): Within CV% 2.6%, Total CV% 3.2% |
  | Precision (POL sites - 2) | "a CV% of less than 8% was obtained at the three POL sites." for 9 serum samples ranging from 10.26 µmol/L to 42.73 µmol/L. | Site 1:
• Sample 1: Total CV 7.0%
• Sample 2: Total CV 5.3%
• Sample 3: Total CV 6.4%
  Site 2:
• Sample 1: Total CV 6.6%
• Sample 2: Total CV% 5.5%
• Sample 3: Total CV% 4.4%
  Site 3:
• Sample 1: Total CV% 6.0%
• Sample 2: Total CV% 6.8%
• Sample 3: Total CV% 5.5% |
  | Linearity/Reportable Range | Implied acceptable linearity and range. Based on R2, often >0.99 for diagnostic assays. | Linear from 3 - 50 µmol/L.
  Regression equation: Recovered HCY = 0.9749 * Expected HCY + 0.751
  Correlation coefficient (R2): 0.9992 |
  | Traceability | Traceable to a higher-order standard. | HCY POC Test calibration is traceable to the higher order NIST SRM 1955. |
  | Stability | Implied acceptable stability duration. | Real-time data showed stability for at least 10 months at 2-8℃ storage. (Testing is ongoing). |
  | LoB, LoD, LoQ | Distinct, measurable limits. | LoB = 0.06 µmol/L
  LoD = 0.32 µmol/L
  LoQ = 3.00 µmol/L |
  | Interference | "produced less than 10% deviation" for common endogenous substances at specified concentrations. | All listed endogenous substances (Ascorbic Acid, Bilirubin, Hemoglobin, Triglyceride, Glutathione, Methionine, Cysteine, Pyruvate, Cystathionine, Hydroxylamine, Carbamezapine, Methotrexate, Phenytoin, 6-azauridine triacetate, S-adenosyl-methionine, Carbamezapine-10, 11-epoxide, Ethosuximide, Primidone, Valporic Acid, Sodium Nitrate) produced less than 10% deviation at the specified concentrations. |
  | Method Comparison (Internal) | Strong correlation and agreement with predicate device (Diazyme HCY Two Reagent Enzymatic Assay on Olympus AU400). Implied R > 0.95. | n: 74
  Slope: 0.9612
  Intercept: 0.5246
  Correlation coefficient (R): 0.9696
  Range of values: 4.17-49.50 µmol/L |
  | Method Comparison (External) | Strong correlation and agreement with predicate device at POL sites. Implied R2 > 0.95. | All 120 samples combined:
  Slope: 1.0552
  Intercept: -0.8860
  R2: 0.9765
  Range: 3.88-49.86 µmol/L (across sites)
• Site 1: Slope 1.0890, Intercept -0.7438, R2 0.9830
• Site 2: Slope 1.0041, Intercept -0.6251, R2 0.9645
• Site 3: Slope 1.0600, Intercept -1.1564, R2 0.9819 |
  | Matrix Comparison | No significant matrix effect between serum, EDTA plasma, and Li Heparin plasma. | EDTA plasma: Slope = 1.0197, R = 0.9889
  Li Heparin plasma: Slope = 0.9632, R = 0.99
  Conclusion: No matrix effect between serum, EDTA plasma and Li Heparin Plasma. |

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

• Precision (Manufacture site): 40 points per HCY level (3 levels). Data provenance is internal (manufacturer site). Prospective data collection for this internal study.
• Precision (POL sites - 1): 20 points for each of 5 samples. Data provenance is external (three Physician Office Laboratories - POLs). Prospective data collection for this external study.
• Precision (POL sites - 2): 20 points for each of 3 samples per site, across 3 sites. Data provenance is external (three POLs with multiple users). Prospective data collection for this external study.
• Linearity/Assay Reportable Range: Ten levels of linearity set, tested in triplicate. Data provenance is internal (manufacturer site). Prospective data collection.
• Interference: 12μM and 29μM HCY serum samples spiked with various concentrations of interferents. Data provenance is internal (manufacturer site). Prospective data collection.
• Method Comparison (Internal): 74 individual serum samples. Data provenance is internal (manufacturer site). Likely prospective/retrospective (spiked samples indicate some manipulation).
• Method Comparison (External): 120 serum specimens total (40 samples at each of three POL sites). Data provenance is external (three POL sites). Prospective data collection.
• Matrix Comparison: 40 sample sets (serum/EDTA plasma/Li Heparin). Data provenance is internal (manufacturer site). Prospective data collection.

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

This type of device (a quantitative in-vitro diagnostic assay) does not typically use human experts to establish "ground truth" for the test set in the way an imaging AI algorithm would. Instead, the "ground truth" for the test samples is established by:

• Reference Methods: The predicate device itself (Diazyme HCY Two Reagent Enzymatic Assay on Olympus AU400 cleared under K071971) serves as the reference method for comparison studies, implicitly providing the "ground truth" values for patient samples. The predicate device itself would have been validated against a higher standard.
• Known Concentrations: For studies like linearity, LoB/LoD/LoQ, and interference, samples with precisely known concentrations of HCY or interfering substances are prepared according to recognized laboratory standards (e.g., CLSI guidelines).
• NIST SRM 1955: For calibrator traceability, the device is linked to a National Institute of Standards and Technology (NIST) Standard Reference Material, which represents a highly accurate and reliable "ground truth" for homocysteine concentration.

Therefore, no information on the number or qualifications of experts establishing ground truth in the context of clinical interpretation or annotations is applicable or provided.

4. Adjudication Method for the Test Set

Not applicable. As a quantitative in-vitro diagnostic test, "adjudication" in the sense of resolving conflicting interpretations (like in imaging studies) is not performed. The results are numerical values that are compared against a reference method or known concentrations.

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 in-vitro diagnostic device for quantitative bodily fluid analysis, not an imaging AI or decision-support tool for human interpretation. Therefore, MRMC studies and "human readers improving with AI assistance" are not relevant to this device.

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

Yes, the studies presented are essentially "standalone" performance evaluations of the device (HCY POC Test Kit + SMART analyzer). The device provides a quantitative result directly, without requiring human interpretation of raw data or human modification of the algorithm's output for its primary function. The users (nurses, office assistants) described in the POL precision studies are operating the device, but their "performance" isn't being measured in terms of their diagnostic accuracy, but rather their ability to correctly perform the test yielding consistent results.

7. The Type of Ground Truth Used

The ground truth used depends on the specific performance characteristic being evaluated:

• For Precision, Linearity, LoB/LoD/LoQ: Samples with precisely known concentrations of HCY, prepared in the laboratory or from certified reference materials (like NIST SRM 1955 for traceability).
• For Method Comparison: The values obtained from the predicate device (Diazyme HCY Two Reagent Enzymatic Assay on an Olympus AU400, K071971) were used as the reference "ground truth" for comparison.
• For Interference: Samples with known HCY concentrations spiked with known concentrations of suspected interfering substances.

8. The Sample Size for the Training Set

This document describes a premarket approval (510(k)) submission for an in-vitro diagnostic assay kit. Such submissions typically detail validation studies for the finished product, not the development or training of an algorithm in the machine learning sense. The "SMART analyzer" uses an RFID card with a preprogrammed calibration curve, which is derived from testing 5 levels of calibrators with the reagents.

• The training set for the calibration curve programming on the RFID card involves testing "5 levels of calibrators used in the predicate device (K071971)" with the Diazyme HCY POC Test reagents on SMART analyzers. The exact number of replicates or runs during this programming phase is not specified beyond "mean of absorbance change."

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

The "ground truth" for establishing the calibration curve (which is the "training set" in a functional sense for this IVD) is established by using:

• Reference Diazyme Homocysteine calibrator values (K071971): These calibrators themselves would have assigned values traceable to higher-order standards.
• NIST SRM 1955: The overall calibration is tied to this higher-order standard.

The process involves testing these known calibrators on the SMART analyzer to obtain absorbance changes, and then programming a curve that correlates these absorbance changes to the known HCY concentrations, which constitutes the "ground truth" for the device's measurement function.

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Reagents: ST AIA-PACK Homocysteine is designed for IN VITRO DIAGNOSTIC USE ONLY for the quantitative measurement of homocysteine in human serum, heparinized plasma or EDTA plasma using a Tosoh AlA System Analyzer. Homocysteine measurements are used in the diagnosis and treatment of hyperhomocysteinemia or homocystinuria. Calibrators: ST AIA-PACK Homocysteine Calibrator Set is intended for IN VITRO DIAGNOSTIC USE ONLY for the callbration of the ST AIA PACK Homocysteine assay using a Tosoh AIA System Analyzer. Controls: The AIA-PACK Homocysteine Control Set is intended for IN VITRO DIAGNOSTIC USE ONLY for performing quality control procedures with the ST AIA-PACK Homocysteine Assay.

The ST AIA-PACK Homocysteine is a competitive enzyme immunoassay which, after sample pretreatment, is performed entirely in the ST AIA-PACK Homocysteine test cups. Oxidized homocysteine is reduced by tris (2-carboxyethyl) phosphine (TCEP) to the free form and converted to S-adenosyl-L-homocysteine (SAH) by the SAH hydrolase and excess adenosine prior to the immunoassay. SAH present in the pretreated sample competes with immobilized SAH on magnetic beads for binding sites of the enzyme-labeled anti-SAH mouse monoclonal antibody. The magnetic beads are washed to remove unbound anti-SAH mouse monoclonal antibody and are then incubated with a fluorogenic substrate, 4-methylumbelliferyl phosphate (4MUP). The rate of fluorescence produced by the enzyme reaction indicates the amount of enzyme-labeled anti-SAH mouse monoclonal antibody. The amount of antibody that binds to the beads is inversely proportional to the homocysteine concentration in the test sample. A standard curve is constructed, and unknown sample concentrations are calculated using this curve.

Here's a breakdown of the acceptance criteria and study information for the ST AIA-PACK Homocysteine device, based on the provided text:

Acceptance Criteria and Device Performance

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The Homocysteine Enzymatic Assay is an in vitro test for the quantitative determination of total L-homocysteine in human serum and plasma on Roche/Hitachi cobas c systems. The assay can assist in the diagnosis of patients suspected of having hyperhomocysteinemia or homocystinuria.

The Homocysteine Calibrator Kit is intended for use in the calibration of quantitative Roche methods on Roche clinical chemistry analyzers as specified in the value sheets.

The Homocysteine Control Kit is intended for use in quality control by monitoring accuracy and precision for the quantitative methods as specified in the value sheets.

Assay: The Homocysteine Enzymatic Assay is based on an enzyme cycling assay principle that assesses the co-substrate conversion product. In this assay, oxidized homocysteine (Hcy) is first reduced to free Hcy which then reacts with a co-substrate, S-adenosylmethionine, to form methionine and S-adenosylhomocysteine (SAH), catalyzed by a Hcy S-methyltransferase. SAH is assessed by coupled enzyme reactions where SAH is hydrolyzed into adenosine (Ado) and Hcy by SAH hydrolase, and Hcy is cycled into the Hcy conversion reaction to form a reaction cycle that amplifies the detection signal. The formed Ado is immediately hydrolyzed into inosine and ammonia which reacts with glutamate dehydrogenase with concomitant conversions of NADH to NAD*. The concentration of Hcy in the sample is indirectly proportional to the amount of NADH converted to NAD which is measured spectrophotometrically at 340 nm.

Calibrator: The Homocysteine Calibrator Kit is a liquid, ready-for-use calibrator based on human serum. It is a single level calibrator with lot specific values and diluted on board the analyzer to create a 5-point calibration curve.

Control: The Homocysteine Control Kit consists of two ready-for-use controls based on human serum. The adjusted concentrations of the control components are in the low range for Control 1 and in the elevated range for Control 2.

This response summarizes the provided 510(k) Summary for the Homocysteine Enzymatic Assay, Calibrator Kit, and Control Kit. The document primarily focuses on demonstrating substantial equivalence to predicate devices rather than detailing a specific study to prove the device meets acceptance criteria. Therefore, some requested information, particularly regarding ground truth establishment, expert qualifications, adjudication methods, and MRMC studies, is not present in the provided text.

Here's the breakdown of the available information:

1. Table of Acceptance Criteria and Reported Device Performance

The 510(k) Summary presents a comparison of the draft device's features, including performance characteristics, against a predicate device. This comparison implicitly serves as a form of acceptance criteria, where the new device's performance is deemed acceptable if it is substantially equivalent to the cleared predicate.

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

The document does not explicitly state the sample size for a "test set" in the context of a clinical validation study. The precision data provided refers to "Hcy Control 1," "Hcy Control 2," and "Human serum 1, 2, 3, 4." The number of samples for each of these categories is not specified.

The data provenance (country of origin, retrospective/prospective) is not mentioned in the provided text.

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

This information is not available in the provided 510(k) summary. The document focuses on analytical performance characteristics rather than clinical diagnostic accuracy requiring ground truth established by experts.

4. Adjudication Method for the Test Set

This information is not provided.

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

An MRMC study is typically associated with imaging devices or diagnostic tests where human interpretation is a critical component. This device is an in vitro diagnostic (IVD) assay for quantitative determination of a biomarker. Therefore, an MRMC comparative effectiveness study involving human readers would not be applicable or expected for this type of device, and no such study is mentioned.

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

The provided data pertains to the analytical performance of the automated Homocysteine Enzymatic Assay on Roche/Hitachi cobas c systems. This inherently represents standalone (algorithm only/instrument only) performance, as it measures the assay's ability to precisely and accurately quantify Homocysteine in biological samples. The reported precision and interference studies demonstrate this standalone performance.

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

For the analytical performance studies (e.g., precision, measuring range, interference), the "ground truth" is established by:

• Known concentrations: For controls and calibrators, the concentrations are precisely manufactured and known.
• Reference methods or accepted analytical techniques: For validation of accuracy and linearity, comparison to established reference methods or highly accurate laboratory methods would typically be employed, although specific details are not provided in this summary.
• Spiked samples: Interference studies often involve spiking samples with known interferents to assess their effect.

There is no mention of expert consensus, pathology, or outcomes data as a ground truth for the performance claims presented in this analytical device summary.

8. The Sample Size for the Training Set

This information is not available in the provided 510(k) summary. The document describes an enzymatic assay, not an AI or machine learning algorithm that typically requires a distinct training set. The "training" in this context would likely refer to method development and optimization, for which specific sample sizes might not be explicitly documented in a 510(k) summary focused on substantial equivalence.

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

As noted above, this information is not available as the context for a "training set" in an AI/ML sense is not relevant here. For the development and optimization of the enzymatic assay, the "ground truth" would be established through a combination of chemical principles, known substrate/product concentrations, and potentially comparison with established methods during the R&D phase.

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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 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

• Intercept: 0.3165 (95% Confidence interval 0.031 to 0.290)
• r-value: 1.00 (95% Confidence interval 1.00 to 1.00)
• Average Percent Bias: 0.01% (95% Confidence interval -0.10 to 0.07%) |

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 A/C Portable Enzymatic Homocysteine Assay on the A/C Diagnostics Reader (HyTek-205) is intended for the quantitative determination of total homocysteine (tHCY) in human plasma or serum. The device can assist in the diagnosis and treatment of patients suspected of having hyperhomocysteinemia. The A/C Enzymatic Homocysteine Assay is for in vitro diagnostic use.

The A/C Portable Enzymatic Homocysteine Assay is calibrated with A/C Enzymatic Homocysteine Assay Calibrators. A/C Enzymatic Homocysteine Assay Controls are assayed for the verification of the accuracy and precision of the A/C Portable Enzymatic Homocysteine Assay.

The A/C Enzymatic Homocysteine Assay measures tHCY. The principle of the assay is that after reduction, tHCY is depleted by Homocysteinase (rHCYase) and produces hydrogen sulfide (H2S), which is determined using N.N-dibutyl phenylene diamine (DBPDA), the combination of which forms a chromophore, the fluorescence is measured by the A/C Diagnostics Reader (HyTek-205).

The A/C Portable Enzymatic Homocysteine Assay is a three-steps reaction, which runs at room temperature. The total assay takes 80 minutes, and the A/C Diagnostics Reader is the only equipment needed.

Here's an analysis of the provided text regarding the A/C Portable Enzymatic Homocysteine Assay, focusing on acceptance criteria and the supporting study:

The provided document is a 510(k) summary for a medical device seeking substantial equivalence to a predicate device. It focuses on demonstrating that the new device performs as well as, or better than, the predicate. Therefore, the "acceptance criteria" are implicitly established by the performance of the predicate device. The study aims to show that the new device's performance aligns closely with that of the predicate.

Acceptance Criteria and Reported Device Performance

The acceptance criteria are not explicitly stated as numerical thresholds in this summary. Instead, they are implied by the reported performance of the predicate device, which the new device aims to match or closely approximate. The primary performance metric for comparison is the correlation and mean difference between the new device and the predicate.

Study Details

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

   • Sample Size: 50 plasma samples.
   • Data Provenance: Not explicitly stated regarding country of origin or specific demographics. The samples are referred to as "fifty plasma samples," implying they were clinical samples. The study is retrospective, as it compares the new device's results on these samples against those obtained from an existing, already cleared predicate device (the A/C Automatic Enzymatic HCY Assay on Hitachi 912).

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

   • This is not applicable to this type of device and study. The "ground truth" for a quantitative assay like this is typically established by comparison to a reference method or a substantially equivalent predicate device, not by expert consensus on qualitative interpretation. The predicate device itself (A/C Automatic Enzymatic HCY Assay on Hitachi 912) served as the reference for comparison.

3. Adjudication method for the test set:

   • Not applicable. This is a quantitative assay comparison, not a diagnostic imaging or expert interpretation study 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 MRMC study was done. This is a comparison of two in vitro diagnostic devices, not an AI-assisted diagnostic tool involving human readers.

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

   • This is partially applicable, as the "A/C Portable Enzymatic Homocysteine Assay on the A/C Diagnostics Reader" is a standalone system in the sense that it performs the measurement without human subjective interpretation of results, beyond the operator running the test. The study is comparing the performance of this standalone system against another standalone system (the predicate device). The performance metrics (correlation, regression, mean difference, precision) are all "algorithm only" or "device only" metrics.

6. The type of ground truth used:

   • The "ground truth" for this study was the results obtained from the predicate device, the A/C Automatic Enzymatic HCY Assay on Hitachi 912 (K030754). This is a common approach for demonstrating substantial equivalence for in vitro diagnostic devices.

7. The sample size for the training set:

   • The document does not explicitly mention a "training set" in the context of device development or machine learning. For in vitro diagnostic assays, performance characteristics are typically established through analytical studies (e.g., precision, linearity, interference) and clinical comparison studies (like this one) using patient samples, rather than a machine learning training paradigm.

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

   • Not applicable, as a "training set" in the machine learning sense is not described. The predicate device's performance was already established through its prior 510(k) clearance (K030754).

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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 IMMULITE® 2500 High Sensitivity C-Reactive Protein Immunoassay is intended for use as follows: For in vitro diagnostic use with the IMMULITE 2500 Analyzer -- for the quantitative measurement of C-Reactive protein (CRP) in serum or plasma as an aid in the detection and evaluation of infection, tissue injury and inflammatory disorders and associated diseases. Measurements may also be used as an aid in the identification of individuals at risk for future cardiovascular disease. High sensitivity CRP (hsCRP) measurements, when used in conjunction with traditional clinical laboratory evaluation of acute noronary syndrome, may be useful as an independent marker for recurrent events in patients with stable coronary disease or acute coronary syndrome.

The IMMULITE 2500 High Sensitivity C-Reactive Protein Immunoassav is a solid-phase, two-site, chemiluminescent immunometric assay for use with the IMMULITE 2500 Automated Analyzer,

The provided text is a 510(k) summary for the IMMULITE® 2500 High Sensitivity C-Reactive Protein Immunoassay. It describes the device, its intended use, and its substantial equivalence to a predicate device. However, it does not contain the detailed study information needed to fill out all requested sections about acceptance criteria, device performance, ground truth establishment, or sample sizes for testing and training.

Therefore, I can only provide limited information based on the text provided.

Acceptance Criteria and Device Performance

The provided document does not explicitly state specific acceptance criteria in terms of precision, accuracy, or correlation coefficients, nor does it present detailed study results proving the device meets particular thresholds. It asserts substantial equivalence to a predicate device, which inherently means its performance should align with the predicate's established performance for the intended uses. Without specific study data from the document, I cannot create a table of acceptance criteria and reported device performance.

Study Information Based on Provided Text:

Here's what can be inferred or explicitly stated from the given text:

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

   • Acceptance Criteria: Not explicitly stated in the provided document. The 510(k) process relies on demonstrating substantial equivalence to a legally marketed predicate device rather than meeting specific performance thresholds presented in the summary.
   • Reported Device Performance: Not detailed in the provided document. The document describes the device and its intended use but does not present the results of performance studies (e.g., accuracy, precision, linearity).

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

   • Sample Size for Test Set: Not specified in the provided document.
   • Data Provenance: Not specified in the provided document.

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):

   • Number of Experts: Not applicable or specified. This device is an in vitro diagnostic (IVD) immunoassay. The "ground truth" for such devices typically refers to a reference method or validated standard, not expert consensus as in imaging studies.
   • Qualifications of Experts: Not applicable or specified.

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

   • Adjudication Method: Not applicable or specified. This is relevant for studies involving human interpretation (e.g., radiology), not typically for automated immunoassay performance evaluation.

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:

   • MRMC Comparative Effectiveness Study: Not applicable. This device is an automated immunoassay for quantitative measurement of C-reactive protein, not an AI-assisted diagnostic tool for human interpretation.

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

   • Standalone Performance: The IMMULITE® 2500 High Sensitivity C-Reactive Protein Immunoassay is an automated, standalone diagnostic test. Its performance is evaluated intrinsically through analytical studies (e.g., precision, accuracy, linearity) against reference methods, rather than in conjunction with human-in-the-loop scenarios. The summary does not provide details of these studies or their results.

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

   • Type of Ground Truth: For an immunoassay, the "ground truth" for performance studies would typically be established using a reference method, a comparative method deemed accurate, or certified reference materials/calibrators with known concentrations of C-reactive protein. The specific method used is not detailed in this summary.

8. The sample size for the training set:

   • Sample Size for Training Set: Not applicable or specified. This device is a traditional immunoassay, not a machine learning or AI algorithm that requires a "training set" in the computational sense. Its reagents and calibration curves are developed and optimized through laboratory procedures, not by training on a dataset.

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

   • Ground Truth for Training Set: Not applicable. As explained above, this is not an AI/ML device that uses a training set with established ground truth labels in the typical sense. Reagent and assay development involves standard chemical and biological validation processes.

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Teco Enzymatic Homocysteine Assay is in vitro quantitative determination of total homocysteine in serum and plasma. Homocysteine measurements are used in the diagnostics and treatment of hyperhomocysteinemia.

Not Found

I am sorry, but the provided text does not contain the information required to answer your request. The document discusses regulatory approval for a medical device (Teco Enzymatic Homocysteine Assay) but does not include details about acceptance criteria, specific study designs, sample sizes, expert qualifications, or ground truth establishment. It is a letter of substantial equivalence from the FDA, not a study report.

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