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The Envoy® 500 HDL Cholesterol Reagent and Envoy® 500 HDL Calibrator are intended for use with the Envoy® 500 Chemistry System as a system for the quantitative determination of high density lipoprotein (HDL) cholesterol in serum and plasma. HDL cholesterol measurements are used in the diagnosis and treatment of lipid disorders (such as diabetes mellitus), atherosclerosis, and various liver and renal diseases, and for the assessment of the risk of developing cardiovascular disease.

The Envoy® 500 HDL Cholesterol Reagent is a two-part reagent that is calibrated with the Envoy® 500 HDL Calibrator for use with the Envoy® 500 Chemistry System. This reagent determines high density lipoprotein cholesterol through the accelerator selective detergent methodology. This procedure measures HDL-cholesterol in a two step reaction sequence. In the first step, non-HDL cholesterol is rendered non-reactive. In the second step, HDL cholesterol is solubilized using a selective detergent and reacts to produce a red chromogen.

Here's an analysis of the acceptance criteria and study detailed in the provided text for the Envoy® 500 HDL Cholesterol Reagent and Envoy® 500 HDL Calibrator:

1. Table of Acceptance Criteria and Reported Device Performance

The provided text focuses on demonstrating the performance of the device without explicitly stating pre-defined "acceptance criteria" in a structured table. However, we can infer the acceptance criteria based on the reported performance for each study.

• Linear regression: (Envoy Recoveries) = - 0.6 mg/dL + 19.284 x (Dilution Factor), r = 0.9998, syx = 1.11 mg/dL, n = 44, range = 0.1 to 173.5 mg/dL. |
  | Limit of Detection (LoD) | - LoD with proportions of false positives (a) less than 5% and false negatives (B) less than 5%. | - Limit of Blank (LoB): 0.29 mg/dL.
• Reported LoD: 0.46 mg/dL.
• Proportions of false positives (a) less than 5% and false negatives (B) less than 5%. |
  | Precision | - Precision to be demonstrated by replicate assay of control sera. | Level 1 (mean 36.8 mg/dL):
• Within Run: 1 SD = 0.52, %CV = 1.4%
• Total: 1 SD = 0.72, %CV = 2.0%
  Level 2 (mean 71.1 mg/dL):
• Within Run: 1 SD = 0.68, %CV = 1.0%
• Total: 1 SD = 1.25, %CV = 1.8% |
  | Correlation | - Comparison to a commercially available method using least squares linear regression and Passing-Bablok regression. | Least Squares Linear Regression:
• Envoy 500 = 0.7 mg/dL + 1.021 × Competitive Method
• r = 0.995
• S = 2.42 mg/dL
• 95% CI y-intercept: 0.07 to 1.38 mg/dL
• 95% CI slope: 1.010 to 1.032
  Passing-Bablok Regression:
• Envoy 500 = 0.7 mg/dL + 1.015 × Competitive Method
• 95% CI y-intercept: 0.2 to 2.0 mg/dL
• 95% CI slope: 1.000 to 1.029 |
  | Stability | - Statistical estimates of total imprecision to be less than 1.5 mg/dL over claimed stability periods (14-day onboard reagent, 7-day calibration). | - Total imprecision less than 1.5 mg/dL for 14-day onboard reagent stability and 7-day calibration stability. |

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

• Usable Range:

  • Sample Size: n = 44 (reference pools prepared by diluting human HDL cholesterol concentrate with stripped human serum pool).
  • Data Provenance: Not explicitly stated (e.g., country of origin). The samples are referred to as "human HDL cholesterol concentrate" and "stripped human serum pool," suggesting they are derived from human biological materials.
  • Retrospective/Prospective: Not specified.

• Limit of Detection:

  • Sample Size: 40 blank samples and 40 low-level samples.
  • Data Provenance: Not explicitly stated.
  • Retrospective/Prospective: Not specified.

• Precision:

  • Sample Size: Level 1: n = 45; Level 2: n = 48 (replicate assays of commercially available control sera).
  • Data Provenance: "Commercially available control sera." Not explicitly stated (e.g., country of origin).
  • Retrospective/Prospective: Not specified, but generally implies a prospective experimental setup for precision studies.

• Correlation:

  • Sample Size: n = 312 (mixed serum and plasma specimens).
  • Data Provenance: "Collected from adult patients." Not explicitly stated (e.g., country of origin).
  • Retrospective/Prospective: Not specified, but "collected from adult patients" often implies a retrospective collection or a prospective collection for this specific study.

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

This device is an in-vitro diagnostic (IVD) reagent for determining a biochemical analyte (HDL cholesterol). The ground truth for such devices is established through reference methods or by the intrinsic properties of reference materials, not typically by human experts making diagnoses or interpretations like in imaging studies.

• For Usable Range, ground truth is based on known dilution factors of a reference standard.
• For Limit of Detection, ground truth is based on blank samples and low-level samples, with expected very low or zero concentrations.
• For Precision, ground truth is the "true" concentration of the control sera, established by the manufacturer of the control sera or a reference lab, not individual experts.
• For Correlation, the ground truth is the measurement obtained by a "commercially available method" (the predicate or another established method), not human experts.

Therefore, the concept of "number of experts" and "qualifications of those experts" as typically applied in AI/ML performance evaluation (e.g., radiologists interpreting images) is not directly applicable here.

4. Adjudication Method for the Test Set

As explained in point 3, the ground truth for chemical analyte measurements is typically established by reference methods or material properties, not through expert adjudication in the classic sense. Therefore, no adjudication method (like 2+1 or 3+1 consensus) is described or applicable for this type of device.

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

No, an MRMC comparative effectiveness study was not done. This device is an in-vitro diagnostic (IVD) reagent, not an imaging or diagnostic AI tool that assists human readers. Its performance is evaluated biochemically against reference methods and statistical parameters.

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

Yes, the studies presented (Usable Range, Limit of Detection, Precision, Correlation, Stability) evaluate the performance of the Envoy® 500 HDL Cholesterol Reagent and Calibrator directly on serum/plasma samples using the Envoy® 500 Chemistry System. This represents a standalone performance evaluation of the assay system without human interpretation being a primary variable in the measurement outcome. The role of "human-in-the-loop" would be limited to operating the analyzer and interpreting the numerical results, not making subjective diagnoses from raw data.

7. The Type of Ground Truth Used

• Usable Range: The ground truth is based on the known concentrations of HDL cholesterol in reference pools prepared by diluting a human HDL cholesterol concentrate with stripped human serum. The dilution factors provide the expected "true" values.
• Limit of Detection: The ground truth is based on blank samples (expected zero concentration) and low-level samples with known, very low concentrations.
• Precision: The ground truth is the assigned value of commercially available control sera, which are typically established through rigorous inter-laboratory comparisons or against reference methods by the control manufacturer.
• Correlation: The ground truth is the measurement obtained by a "commercially available method" (the predicate device or another established method) used as a comparative standard.
• Stability: The ground truth is again the assigned value of serum controls.

In summary, the ground truth is established through a combination of:

• Reference materials with known concentrations.
• Established analytical methods.
• Commercially validated control materials.

8. The Sample Size for the Training Set

The provided summary describes performance evaluation studies. For an IVD reagent like this, the "training set" doesn't apply in the same way as it would for an AI/ML algorithm. Reagents and calibrators are developed through a formulation and optimization process that involves wet lab experimentation, but this experimental data is not typically referred to as a "training set" in the context of device submission. The studies detailed here are for validation of the finalized product.

Therefore, no specific sample size for a "training set" is mentioned because it's not a relevant concept for this type of device.

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

Given that the concept of a "training set" is not applicable here as for AI/ML algorithms, the establishment of ground truth for such a set is also not relevant or described. The performance data presented demonstrates the analytical characteristics of the final reagent and calibrator.

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The Nanopia Wide Range CRP Reagent is intended for the quantitative measurement of C-Reactive Protein (CRP) concentration in serum or plasma.

Measurement of CRP is useful for determining the existence of inflammatory lesions and to monitor treatment.

The Nanopia Wide Range CRP Calibrator is intended for the calibration of the Nanopia Wide Range CRP assay.

The Nanopia Wide Range CRP Reagent is intended for the quantitative measurement of C-Reactive Protein (CRP) in serum or plasma. The assay is intended for use in the evaluation of infection, tissue injury, and inflammatory disorders in combination with a complete clinical evaluation.

The Nanopia Wide Range CRP assay consists of two liquid reagents. Reagent 1 is a buffering solution and Reagent 2 contains latex beads coated with mouse monoclonal anti-human CRP antibodies. The assay is for use on general clinical chemistry analyzers.

Here's an analysis of the provided text regarding the Nanopia Wide Range CRP device, structured to answer your questions:

1. Table of Acceptance Criteria and Reported Device Performance

The document does not explicitly state "acceptance criteria" for each performance characteristic in a separate, dedicated section. However, the study results implicitly define what was considered acceptable by stating the findings and, in one instance (linearity), explicitly stating the criteria.

• Control 1 (0.886 mg/L): 1.83%
• Control 2 (6.71 mg/L): 0.76%
• Control 3 (38.88 mg/L): 0.61%
  Total % CV:
• Control 1 (0.886 mg/L): 2.46%
• Control 2 (6.71 mg/L): 1.31%
• Control 3 (38.88 mg/L): 1.11% |
  | Linearity | 100% ± 5% recovery | % Recovery from 0 to 400 mg/L: Ranged from 97.5% to 102.7% (e.g., at 40 mg/L: 99.4%, at 160 mg/L: 97.5%, at 360 mg/L: 102.7%). The document states, "The results above indicate that the assay is linear across the measuring range of the assay." |
  | Assay Reportable Range | Defined as the linear range | 0.10 - 400 mg/L (Limit of Quantification to the upper end of the linear range). |
  | Detection Limit | Lowest concentration at which the assay performs with +/- 2 SD | Functional sensitivity: 0.10 mg/L (derived by extrapolation). |
  | Analytical Specificity | No interference, defined as a result +/- 5% of the control | No interference was noted for hemoglobin (up to 500 mg/dL), ascorbic acid (up to 100 mg/dL), free bilirubin (up to 50 mg/dL), conjugated bilirubin (up to 50 mg/dl), lipid emulsion (up to 5000 turbidity), Rheumatoid factor (up to 500 IU/mL) on serum samples containing 3.7 mg/L nominal CRP. |
  | Method Comparison (vs. Predicate) | Presumably, a strong correlation (high R2 and slope close to 1, intercept close to 0) indicating substantial equivalence. | Serum Samples (n=98): Nanopia = 1.015(Predicate) - 0.0349; R² = 0.9992. This indicates a very high correlation and closeness to the predicate device. |
  | Matrix Comparison | No significant differences between sample types (serum/plasma, or spiked serum). | Paired samples of serum and EDTA plasma (n=50): Plasma = 0.994(Serum) + 0.03; r = 0.999.
  No significant differences observed with sodium citrate, sodium oxalate, EDTA, and sodium heparin spiked serum pools. |

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

• Precision Test Set: Triplicate measurements daily for 20 days on 3 spiked serum samples (Control 1, 2, and 3). So, 3 samples * 3 replicates * 20 days = 180 total measurements.
• Linearity Test Set: One sample with high CRP (400 mg/L) serially diluted into 10 concentrations, plus a zero concentration sample. Each run in duplicate. So, 11 concentrations * 2 replicates = 22 measurements.
• Detection Limit Test Set: A serum sample with 0.5 mg/L diluted to 0.0 mg/L, measured in 10 replicates.
• Analytical Specificity (Interference) Test Set: Serum samples containing a nominal CRP of 3.7 mg/L, tested with various interfering substances. The number of samples per substance or replicates is not specified.
• Method Comparison Test Set: 98 serum samples ranging from 0.0 to 293 mg/L.
• Matrix Comparison Test Set: 50 paired samples of serum and EDTA plasma from individuals, plus additional serum pools spiked with anticoagulants.

Data Provenance: The document does not explicitly state the country of origin for the patient samples or if they were retrospective or prospective. Given it's a 510(k) summary for a US submission, the studies were likely conducted to meet US regulatory requirements, but the origin of the samples themselves is not detailed. The samples used for precision, linearity, and detection limit were "spiked serum samples" or "serum pools," suggesting laboratory-prepared samples rather than directly from patients in some instances. The "98 serum samples" and "50 paired samples" used for comparison studies were likely patient samples.

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

Not applicable. This device is an in vitro diagnostic (IVD) for quantitative measurement of C-Reactive Protein (CRP). The "ground truth" for such devices is typically established by reference methods, traceable calibrators, or known concentrations, not by expert consensus on visual interpretation as might be the case for imaging devices.

For example:

• The calibrator is traceable to CRM470, which serves as a ground truth reference.
• For linearity, theoretical concentrations are the ground truth comparing to measured values.
• For method comparison, the predicate device's measurements serve as the reference for comparison, effectively a proxy for ground truth for demonstrating equivalence.

4. Adjudication Method for the Test Set

Not applicable. Adjudication methods (like 2+1, 3+1) are common in studies involving human interpretation (e.g., radiology reads). For quantitative IVD assays, the "truth" is determined by direct measurement against a standard or reference method, not by human interpretation that requires adjudication.

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

No, a Multi Reader Multi Case (MRMC) comparative effectiveness study was not done. This type of study typically involves multiple human readers evaluating cases, often with and without AI assistance, to assess the impact of AI on reader performance. For a quantitative IVD device like the Nanopia Wide Range CRP, which performs an automated measurement, MRMC studies are not relevant.

6. Standalone Performance Study

Yes, a standalone performance study was done. The entire "Performance Characteristics" section (K.1. Analytical performance) details the algorithm's performance independent of human input. This includes:

• Precision/Reproducibility
• Linearity/Assay Reportable Range
• Traceability
• Detection Limit
• Analytical Specificity
• Method Comparison with predicate device
• Matrix Comparison

All these evaluate the device's inherent analytical capability to accurately measure CRP concentration.

7. Type of Ground Truth Used

The ground truth for the analytical performance studies primarily relied on:

• Reference Materials/Standards: The calibrator is stated to be traceable to CRM470.
• Known Concentrations: For linearity, samples were prepared with theoretical (known) CRP concentrations. For detection limit, dilutions were made to specific concentrations. For analytical specificity, samples contained a "nominal concentration."
• Predicate Device Measurements: For method comparison, the measurements from the legally marketed predicate device (N-Geneous Wide Range CRP Reagent) served as the comparative "truth" to establish substantial equivalence.

8. Sample Size for the Training Set

The document does not provide information about a "training set" in the context of machine learning. The Nanopia Wide Range CRP is a turbidimetric immunoassay, which is a traditional chemical measurement system, not an AI/ML-based device that would require a training set in the typical sense. Its "training" involves calibration using standard calibrators (a set of 5 with targeted CRP concentrations).

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

As mentioned above, the device is not an AI/ML-based system with a "training set" in that context. The "training" for such an assay is the calibration process. The ground truth for the calibrators is established as:

• The calibrator is traceable to CRM470 (Certified Reference Material 470).
• A master calibrator is prepared, and its value is assigned by multiple measurements of multiple lots using the device.
• The sold calibrators are then traceable to this master calibrator and are value-assigned using the device.

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The Vitalab Iron Reagent Kit, which contains both reagent and calibrator, is intended for use with the Vitalab Selectra Analyzer as a system for the quantitative determination of total iron in serum and plasma. Iron results may be used for the diagnosis and treatment of diseases associated with iron metabolism such as iron deficiency anemia, hemochromatosis (a disease associated with widespread deposit in the tissues of two iron-containing pigments, hemosiderin and hemofuscin, and characterized by pigmentation of the skin), and chronic renal disease.

The Vitalab Iron Reagent Kit and the Vitalab Selectra Analyzer are used as a system for the quantitative determination of total iron in serum and plasma. Iron in the sample is specifically released from transferrin using an acidic buffer. The released iron is then reduced and reacts with a chromogenic indicator. The increase in absorbance at 578 nm is measured photometrically. The increase in absorbance at 578 nm is proportional to the iron concentration of the sample.

The provided text describes the acceptance criteria and study for the Vitalab Iron Reagent Kit and Vitalab Selectra Analyzer, which are used as a system for the quantitative determination of total iron in serum and plasma.

Here's a breakdown of the requested information:

1. Table of Acceptance Criteria and Reported Device Performance

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The Vitalab Direct Bilirubin Reagent is intended for use with the Vitalab Selectra Analyzer for the quantitative determination of conjugated (direct) bilirubin in serum and plasma. Direct bilirubin results may be used for the diagnosis and treatment of liver, hematological, and metabolic disorders, including hepatitis and gall bladder block.

The Vitalab Total Bilirubin Reagent is intended for use with the Vitalab Selectra Analyzer for the quantitative determination of total bilirubin in serum and plasma. Total bilirubin results may be used for the diagnosis and treatment af liver, hemolytic hematological, and metabolic disorders, including hepatitis and gall bladder block.

The Vitalab Bilirubin Calibrator is intended to calibrate the Vitalab Selectra Analyzer for the quantitative determination of total and direct bilirubin in serum and plasma.

The Vitalab Direct Bilirubin Reagent is a two-part reagent for use with the Vitalab Selectra Analyzer. This reagent determines conjugated bilirubin through a reaction with diazotized 2,4-dichloroanaline to produce a colored chromogen in acidic solution.

The Vitalab Total Bilirubin Reagent is a two-part reagent for use with the Vitalab Selectra Analyzer. This reagent determines total bilirubin through a reaction with diazotized 2,4-dichloroanaline in the presence of detergents to produce a colored chromogen in acidic solution.

The Vitalab Bilirubin Calibrator is a liquid stable bilirubin calibrator prepared from purified components in a human serum albumin matrix. Bilirubin set points are traceable to NIST reference materials.

Below is a summary of the acceptance criteria and performance study details for the Vitalab Direct Bilirubin Reagent, Vitalab Total Bilirubin Reagent, and Vitalab Bilirubin Calibrator, based on the provided text.

1. Table of Acceptance Criteria and Reported Device Performance:

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The Vitalab c .- Amylase Reagent Kit is intended for use with the Vitalab Selectra Analyzer as a system for the quantitative determination of a-amylase in serum and plasma. Amylase results may be used for the diagnosis and treatment of pancreatitis (inflammation of the pancreas).

The Vitalab a-Amylase Reagent is a single-part reagent for use with the Vitalab Selectra Analyzer. This reagent determines amylase through the cleavage of 2-chloro-4-nitrophenyl-a-D-maltotrioside (CNP-a-G3) to produce 2-chloro-4-nitrophenol.

This document describes the acceptance criteria and the study that demonstrates the Vitalab α-Amylase Reagent meets those criteria.

1. Table of Acceptance Criteria and Reported Device Performance

No explicit acceptance criteria values are provided in the document for each performance parameter. However, the study's reported performance serves as the basis for demonstrating its suitability and equivalence to the predicate device.

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

• Linearity (Usable Range):
  • Default sample volume: n = 28 (number of recovery solutions/dilution factors)
  • Rerun sample volume: n = 60 (number of recovery solutions/dilution factors)
• Detection Limit: 30 replicates of normal saline.
• Precision: 60 replicates for each of the 6 serum samples tested (3 in default mode, 3 in rerun mode).
• Correlation: n = 120 mixed serum and plasma specimens. The document states these were "collected from adult patients", but the country of origin is not specified. The study appears to be retrospective, as specimens were "assayed" and then compared.
• Stability: Not explicitly stated, but involved the assay of "serum controls" over the 14-day period.

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

Not applicable. This is an in vitro diagnostic device for measuring α-amylase levels, not an imaging or diagnostic algorithm requiring expert interpretation for ground truth. The "ground truth" for the performance studies is based on established analytical methods and reference ranges for the analyte.

4. Adjudication Method for the Test Set

Not applicable, as this is a quantitative chemical assay, not an interpretive diagnostic device.

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

Not applicable. This is an in vitro diagnostic reagent, not an AI-assisted diagnostic tool requiring human interpretation.

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

Yes, the studies described are standalone performance evaluations of the Vitalab α-Amylase Reagent operating on the Vitalab Selectra Analyzer. The device directly produces quantitative results for α-amylase.

7. The Type of Ground Truth Used

• Linearity: Based on theoretical dilution factors and measured recovery values, with the assumption that serial dilutions accurately represent the true concentration.
• Detection Limit: Statistical calculation from repeated measurements of a blank (normal saline).
• Precision: Defined by the variability of repeated measurements of control sera with known concentrations.
• Correlation: The "ground truth" for correlation was the measurement obtained from a "commercially available method" (predicate device: Roche α-Amylase EPS ver.2 Reagent). This is a comparative study against an established predicate, rather than an absolute ground truth from pathology or outcomes.
• Stability: Measured against the initial performance of the reagent and accepted analytical variation limits.

8. The Sample Size for the Training Set

Not applicable. This is not a machine learning or AI-based device, so there is no "training set" in the conventional sense. The development of the reagent and its optimization would have involved internal R&D, but not a formally defined "training set" for an algorithm.

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

Not applicable, as explained in point 8.

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The Vitalab Triglycerides Reagent, the Vitalab Calibrator and the Vitalab Selectra Analyzer are intended for use as a system for the quantitative determination of triglycerides in serum and plasma. Triglycerides results may be used for the diagnosis and treatment of patients with diabetes mellitus, nephrosis, liver diseases involving lipid metabolism, various endocrine disorders, or for assessing of the risk of developing cardiovascular diseases.

The Vitalab Triglycerides Reagent, the Vitalab Calibrator and the Vitalab Selectra Analyzer are used as a system for the quantitative analysis of triglycerides in serum and plasma. The Vitalab Triglycerides Reagent determines triglycerides using the lipase/GPO enzymatic assay procedure coupled to a Trinder indicator reaction. The resulting increase in absorbance at 505 nm is proportional to the triglycerides concentration of the sample.

This response is based on the provided text.

1. Table of Acceptance Criteria and Reported Device Performance:

(Note: The "Acceptance Criteria (Implied)" column contains interpretations of what would generally be considered acceptable performance for such a device in comparison to a predicate, as explicit criteria are not always stated but inferred from the study design and conclusion of substantial equivalence.)

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

• Linearity/Recovery: n = 44 (This sample size likely refers to dilution factors or individual measurements across the range). Provenance: Not explicitly stated, but likely laboratory-prepared standards or spiked samples.
• Precision:
  • Serum 1: 60 replicates
  • Serum 2: 60 replicates
  • Serum 3: 60 replicates
    Provenance: Commercially available control serum.
• Method Comparison:
  • Serum samples: 59 specimens
  • Heparinized plasma samples: 60 specimens
    Provenance: Collected from adult patients. Country of origin not specified, but the submission is to the FDA, implying studies likely conducted in the US or internationally to US standards. Retrospective or prospective design is not explicitly stated, but the description "were collected from adult patients and were assayed for triglycerides" often implies a prospective or at least recently collected set of samples for the purpose of the study.
• Minimum Detection Limit: 30 replicate measurements of normal saline. Provenance: Laboratory materials.
• Onboard Reagent Stability & Calibration Stability: Not explicitly stated beyond "serum controls."
• Reconstituted Calibrator Stability: Not explicitly stated beyond "calibrators of increasing ages."

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

• This device is a quantitative clinical chemistry assay. The "ground truth" for such assays is typically established by reference methods or comparison to a legally marketed predicate device, rather than expert consensus on individual cases.
• In this case, the "ground truth" for the method comparison study was the results from "another commercially available method," which served as the reference standard for comparison. The predicate device, the Beckman Trighycerides Reagent Kit and Synchron Multi-Calibrator, also serves as a benchmark for substantial equivalence.
• Therefore, traditional "experts" like radiologists establishing ground truth for images are not applicable here. The "expertise" lies in the validated performance of the reference method and the established accuracy of commercially available control sera.

4. Adjudication Method for the Test Set:

• Not applicable. This is a quantitative chemical assay, not a subjective interpretation task that would typically involve adjudication by multiple experts. The comparison is statistical (Deming regression) between the new device and a reference method.

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 a standalone in-vitro diagnostic (IVD) device for quantitative measurement of triglycerides, not an AI-assisted diagnostic tool that involves human readers interpreting results. Therefore, no MRMC study with human readers was conducted, and the concept of "improvement with AI vs without AI" does not apply.

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

• Yes, this entire submission describes standalone performance studies for the Vitalab Triglycerides Reagent and Calibrator on the Vitalab Selectra Analyzer. The performance metrics (linearity, precision, method comparison, detection limit, stability) are all intrinsic to the device system itself, operating without direct human interpretive input influencing the quantitative result. The device outputs a numerical value for triglyceride concentration.

7. The Type of Ground Truth Used:

• Reference Method Comparison: For the method comparison studies, the "ground truth" was established by analyzing patient samples with "another commercially available method" (presumably a validated and accepted diagnostic method for triglycerides).
• Known Concentrations/Standards: For linearity and detection limit, the ground truth was based on known concentrations of standards or normal saline (effectively 0 mg/dL).
• Certified Control Sera: For precision and stability studies, commercially available control serum with established target values was used.

8. The Sample Size for the Training Set:

• This submission describes performance validation studies for an IVD reagent and calibrator. It does not mention any "training set" in the context of machine learning or AI algorithms. The assay procedure is based on a well-established lipase/GPO enzymatic reaction coupled to a Trinder indicator, not a statistical model that requires a training set.

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

• Not applicable, as there is no mention of a training set for an AI/machine learning algorithm.

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The Vitalab Uric Acid Reagent Kit is intended for use with the Vitalab Selectra Analyzer as a system for the quantitative determination of uric acid in serum and plasma. Uric acid results may be used for the diagnosis and treatment of numerous renal and metabolic disorders, including renal failure, gout, leukemia, psoriasis, starvation or other wasting conditions, and of patients receiving cytotoxic drugs.

The Vitalab Uric Acid Reagent is a two-part for use with the Vitalab Selectra Analyzer. This reagent determines uric acid through enzymatic oxidation by uricase linked to a Trinder indicator reaction utilizing N-ethyl-N-(bydroxy-3sulfopropyl)-toluidine (TOOS) and 4-aminoantipyrine.

Here's a breakdown of the acceptance criteria and study information for the Vitalab Uric Acid Reagent, based on the provided text:

Acceptance Criteria and Device Performance

1. Table of Acceptance Criteria and Reported Device Performance

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

• Linear Range: n = 40 (number of recovery samples for linearity standards)
• Detection Limit: n = 30 (normal saline assays)
• Precision: n = 60 for each of the 3 serum samples (total 180 individual measurements).
• Correlation: n = 60 serum specimens and n = 60 heparinized plasma specimens (total n = 120 patient specimens).
• Data Provenance: The text states, "Sixty serum specimens ranging from 3.6 to 10.2 mg/dL uric acid and 60 heparinized plasma specimens ranging from 2.1 to 10.6 mg/dL uric acid were collected from adult patients..." This indicates the data is prospective (collected for the study) from adult patients, but the country of origin is not specified.

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

• This device is a reagent for diagnostic testing, not an imaging or AI system that requires expert interpretation to establish ground truth for performance evaluation.
• The "ground truth" (or reference method) for the correlation study was "another commercially available method" (the predicate device). No human experts were explicitly involved in establishing "ground truth" in the manner of medical imaging interpretation.

4. Adjudication Method for the Test Set

• Not applicable. This is a chemical reagent and an analytical performance study, not an imaging or diagnostics study requiring adjudication of interpretations. The performance is assessed by comparing results to a reference method (the predicate device) or by intrinsic analytical measures (precision, linearity).

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 a study of a chemical reagent, not an AI-based diagnostic tool requiring human-in-the-loop evaluation or MRMC studies.

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

• Not applicable. This is a study of a chemical reagent, not an algorithm. The performance described is the standalone analytical performance of the reagent on the Vitalab Selectra Analyzer.

7. The Type of Ground Truth Used

• Linear Range: The ground truth was based on the known concentrations of "linearity standards."
• Detection Limit: The ground truth was normal saline (assumed to have 0 mg/dL uric acid).
• Precision: The ground truth was the known mean concentration of "commercially available control serum."
• Correlation: The ground truth was established by the results from a "another commercially available method" (the predicate device). This serves as the reference method against which the new device's performance is compared.

8. The Sample Size for the Training Set

• Not applicable. This is a chemical reagent, not a machine learning algorithm that requires a "training set." The performance characteristics are determined through analytical testing.

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

• Not applicable, as there is no "training set" for a chemical reagent.

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The Vitalab Magnesium Reagent Kit is intended for use with the Vitalab Selectra Analyzer as a system for the quantitative determination of magnesium in serum and plasma. Magnesium results may be used for the diagnosis and treatment of hypomagnesemia (abnomally low plasma levels of magnesium) and hypermagnesemia (abnomally high plasma levels of magnesium).

The Vitalab Magnesium Reagent is a single-part reagent for use with the Vitalab Selectra Analyzer. This reagent determines magnesium through chelation by xylidyl blue producing a colored complex.

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

Acceptance Criteria and Device Performance

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The ATAC Hemoglobin A1C Reagent Kit is intended for use with the ATAC 8000 Random Access Chemistry System as a system for the quantitative determination of Hemoglobin A1C results are used to assess the level of control of a patient's diabetes.

This reagent is intended to be used by trained personnel in a professional setting and is not intended for home use.

The ATAC HemoglobinAlC Reagent Kit is intended for the quantitative determination of HemoglobinA1C in whole blood. HemoglobinA1Cresults are used in monitoring glycemic control in diabetic patients. The assay determines total hemoglobin and umole A1C. These values are then used in the calculation of %Hemoglobin A1C reagent is substantially equivalent to the Bayer HemoglobinA1C reagent, Bayer product no. T01-3639-01, cuttently marketed by Bayer Corporation, Tarrytown, New York.

The provided text describes the ATAC HemoglobinA1C Reagent Kit and studies performed to demonstrate its effectiveness. Here's an analysis based on your requested information:

1. Table of Acceptance Criteria and Reported Device Performance

The text doesn't explicitly state "acceptance criteria" for precision or method comparison in a pass/fail format. Instead, it presents the results of these studies. The "acceptance criteria" are implied by the performance statistics themselves, specifically that the results fall within generally accepted ranges for such assays or are comparable to the predicate device.

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The ATAC PAK Uric Acid Reagent Kit, the ATAC Calibrator and the ATAC 8000 Random Access Chemistry System are intended for use as a system for the quantitative determination of uric acid in serum and plasma. Unc acid results are for the diagnosis and treatment of numerous renal and metabolic disorders, including renal failure, gour, leukemia, psoriasis, starvation or other wasting conditions, and of patients receiving cytotoxic drugs.

This reagent is intended to be used by trained personnel in a professional setting and is not intended for home use.

The ATAC PAK Uric Acid Reagent determines uric acid through the exzymatic oxidation coupled with a Trinder indicator reaction. The resulting increase in absorbance at 510 mm is proportional to the uric acid concentration of the sample.

The provided text describes the ATAC PAK Uric Acid Reagent Kit and its performance studies as part of a 510(k) submission. It's important to note that this is a diagnostic reagent, not an AI-based device, so some of the requested categories (like "effect size of how much human readers improve with AI vs without AI assistance" or "adjudication method") are not applicable in the context of this product. I will address the relevant information as presented in the document.

Acceptance Criteria and Reported Device Performance for ATAC PAK Uric Acid Reagent Kit

The studies were conducted to demonstrate the substantial equivalence of the ATAC PAK Uric Acid Reagent Kit to a legally marketed predicate device (Roche Uric Acid Reagent Kit) on the ATAC 8000 Random Access Chemistry System.

1. Table of Acceptance Criteria and Reported Device Performance

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

• Linearity/Recovery: n = 30 (for regression statistics, representing standard values/recoveries). No information on provenance (e.g., country of origin, retrospective/prospective) is provided, but it pertains to the behavior of the reagent with known standard concentrations.
• Precision: n = 60 for each of the three serum control samples. This implies 60 replicate measurements for each control. No information on provenance for these commercially available control sera.
• Method Comparison: n = 120 (mixed serum and plasma specimens). No information on country of origin. The data provenance is described as "collected from adult patients," suggesting prospective or freshly collected samples for the purpose of the study.
• Detection Limit: n = 30 (for within-run precision study of a diluted serum pool).
• Reagent Stability: "serum controls" assayed over the claimed periods. Specific 'n' not given, but likely multiple measurements of controls.
• Calibration Stability: "serum controls" assayed over the claimed periods. Specific 'n' not given, but likely multiple measurements of controls.

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

Not applicable. This is a chemical assay, not an imaging device requiring expert interpretation. The "ground truth" for linearity and precision is based on known concentrations of standards and control materials. For method comparison, the "ground truth" is established by a "commercially available method" (the competitive reagent), and the goal is to show agreement between the two methods, rather than an expert ground truth.

4. Adjudication method for the test set

Not applicable. As noted above, this is a chemical assay.

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 a diagnostic reagent, not an AI-based system or an imaging device requiring human reader interpretation. No AI component is described.

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

The performance data presented are for the "ATAC PAK Uric Acid Reagent Kit on the ATAC 8000 Random Access Chemistry System." This represents the standalone performance of the reagent kit and analyzer system in determining uric acid levels in samples. Human involvement is limited to operating the instrument, performing calibration/quality control, and interpreting quantitative numerical results provided by the system.

7. The type of ground truth used

• Linearity/Recovery: Known concentrations of "linearity standards."
• Precision: Assays of "commercially available control serum" with expected target ranges/values.
• Method Comparison: Results from a "commercially available method" (predicate device or similar). This serves as the reference for comparison, rather than an absolute "ground truth" in the sense of pathology or outcome data.
• Detection Limit: A "diluted serum pool" and its statistical properties.
• Stability Studies: "Serum controls" with known target values.

8. The sample size for the training set

Not applicable. This is a chemical reagent and analyzer system, not an algorithm that requires a "training set." The system's operation is based on established chemical principles and pre-programmed instrument parameters, not machine learning.

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

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

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