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Good Biotech Corp. Transferrin test system is intended to be used for the quantitative determination of transferrin in human serum by turbidimetric immunoassay (TIA). Measurement of transferrin levels aids in the diagnosis of malnutrition, acute inflammation, infection, and red blood cell disorders, such as iron deficiency anemia.

Good Biotech Corp. Transferrin Calibrator Set is intended to be used with Transferrin TIA for the quantitative determination of transferrin in serum samples.

Good Biotech Corp. Transferrin Controls are intended to be used as the assayed quality control material for transferrin analysis.

For In Vitro Diagnostic Use.

Good Biotech Corp. Transferrin TIA is a ready to use reagent for the quantitative determination of transferrin in human serum by turbidimetric immunoassay (TIA). When transferrin of the serum sample encounters with duck anti-transferrin antibody, the aqqlutination based on the antigen-antibody reaction increases the turbidity of the sample. The value of the absorbance change at 505 nm is proportional to the transferrin concentration of the sample and is recorded by a general chemistry autoanalyzer. Then, the actual transferrin concentration of the serum sample is determined by interpolation of the calibration curve obtained by standard samples with known transferrin concentrations.

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

1. Table of Acceptance Criteria and Reported Device Performance

The submission does not explicitly state pre-defined acceptance criteria in terms of specific numeric thresholds for slope, intercept, and correlation coefficient. Instead, it relies on a "high correlation coefficient" as an indicator of substantial equivalence. The predicate device's performance characteristics (slope, intercept, correlation coefficient) likely serve as an implicit benchmark for "high correlation."

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

• Sample Size: 82 serum samples
• Data Provenance: The document does not explicitly state the country of origin or whether the data was retrospective or prospective. It only mentions "serum samples."

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

This type of information is generally not applicable to this kind of diagnostic device (immunoassay). The "truth" for the test set is established by the measurements obtained from the predicate device, which is an already legally marketed and validated assay. No human experts are used to interpret the results or establish "ground truth" in the way they would for imaging or clinical diagnosis.

4. Adjudication Method for the Test Set

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

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

No, an MRMC comparative effectiveness study was not done. This type of study is relevant for devices that involve human interpretation, such as imaging AI, where the impact of AI assistance on human reader performance is evaluated. This submission is for a quantitative immunoassay.

6. Standalone (i.e., algorithm only without human-in-the-loop performance) Study

Yes, a standalone study was performed. The device's performance was compared directly against the predicate device without human intervention or interpretation as part of the primary measurement. The "algorithm" here refers to the immunoassay's ability to quantitatively determine transferrin levels.

7. Type of Ground Truth Used

The "ground truth" in this context is the quantitative determination of transferrin levels by the predicate device (Roche Tina-quant Transferrin ver.2). This is a common approach for establishing substantial equivalence for new diagnostic assays, where a well-established and legally marketed device serves as the reference standard.

8. Sample Size for the Training Set

The document does not specify a training set. This is a pre-market submission for an immunoassay, not a machine learning algorithm that typically requires a distinct training and test set in the same way. The development and optimization of the immunoassay reagents and methodology would have been an iterative process by the manufacturer, but the term "training set" as commonly applied to AI/ML is not relevant here. The studies described are for validation/testing.

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

As no training set (in the AI/ML sense) is explicitly mentioned, this question is not directly applicable. The "ground truth" for the comparative performance study was established by the predicate device's measurements.

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Good Biotech Corp. (GBC) Ferritin LIT Assay is intended to be used for the quantitative determination of ferritin in human serum by latex particle enhanced immunoturbidimetry (LIT). Measurement of ferritin aids in the diagnosis of diseases affecting iron metabolism.

GBC Ferritin Calibrator Set is intended to be used with GBC Ferritin LIT Assay for the quantitative determination of ferritin in serum samples.

GBC ferritin Controls are intended to be used as the assayed quality control material for ferritin analysis.

For In Vitro Diagnostic Use.

For Prescription Use Only

Good Biotech Corp. Ferritin LIT Assay is a ready to use reagent for the quantitative determination of ferritin by latex particle enhanced immunoturbidimetry (LIT). Duck anti-ferritin IgY(ΔFc) is coupled to polystyrene microparticles, which greatly increase the analytical sensitivity. When ferritin of the sample encounters with the latex microparticles sensitized with duck anti-ferritin IgY(AFc), agglutination among the latex microparticles occurs based on the antigen-antibody reaction. The agglutination increases the turbidity of the sample and the degree of agglutination is detected by the absorbance change at 570 nm. The value of the absorbance change is proportional to the ferritin concentration of the sample and is recorded by a general chemistry autoanalyzer. Then, the actual ferritin concentration of the sample is determined by interpolation of the calibration curve obtained by standard samples with known ferritin concentrations.

This 510(k) submission describes the Ferritin LIT Assay, Ferritin Calibrator Set, and Ferritin Controls (Level-L & Level-H) developed by Good Biotech Corp. The purpose of the study was to demonstrate substantial equivalence to a predicate device, the Biokit quantex Ferritin system.

Here's a breakdown of the requested information based on the provided text:

1. Table of Acceptance Criteria and Reported Device Performance

Note: The document does not explicitly state numerical acceptance criteria for slope, intercept, or correlation coefficient. However, a "high correlation coefficient" is an implicit acceptance criterion for demonstrating substantial equivalence based on comparative performance studies.

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

• Sample Size: 50 serum samples
• Data Provenance: Retrospective (clinical samples for comparative study). The country of origin is not specified but given the submitter is in Taiwan, it is likely the samples were sourced there.

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 (IVD) device for quantifying ferritin in human serum. The "ground truth" for comparative studies in IVD typically refers to the results obtained from a reference method (the predicate device in this case) rather than expert interpretation of images or other subjective data. No human experts were involved in establishing the "ground truth" in the way described for medical imaging devices.

4. Adjudication Method for the Test Set

Not applicable. Adjudication methods (e.g., 2+1, 3+1) are typically used when subjective interpretations are involved, such as in clinical trials or medical imaging studies to resolve discrepancies among experts. This study involves quantitative measurements, where the "ground truth" is established by the predicate device's numerical output.

5. If a Multi-Reader Multi-Case (MRMC) Comparative Effectiveness Study Was Done, and the Effect Size

No, a Multi-Reader Multi-Case (MRMC) comparative effectiveness study was not done. This type of study is relevant for diagnostic devices where human readers interpret results, often with and without AI assistance, to assess improvements in reader performance. This device is an automated IVD assay, not a device requiring human interpretation of complex data.

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

Yes, the performance study conducted was a standalone performance of the device. The Ferritin LIT Assay directly measures ferritin concentration in serum samples without human intervention in the measurement process (beyond sample handling and initiation of the automated analyzer). The comparison was between the new assay and the predicate device's measurements.

7. The Type of Ground Truth Used

The "ground truth" used for the comparative study was the results obtained from the predicate device (Biokit quantex Ferritin). This is a common practice in IVD substantial equivalence demonstrations, where the new device's performance is compared against an already legally marketed and accepted device.

8. The Sample Size for the Training Set

The document does not report a separate training set size. For IVD assays, development often involves internal optimization and calibration using various samples, but a formally defined "training set" in the context of machine learning or AI is not typically described in these types of 510(k) summaries unless the device incorporates such algorithms. The 50 serum samples mentioned were for the comparative performance study (test set).

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

Since a distinct "training set" (as typically defined in AI/ML contexts) is not described, the method for establishing its "ground truth" is not provided. For IVD assay development, calibration is typically performed using calibrators with known concentrations, and controls are used to verify performance within established ranges. The "GBC Ferritin Calibrator Set" and "GBC ferritin Controls" are mentioned as being used with the assay to establish the calibration curve and for quality control, respectively. These materials would have their "ground truth" concentrations established through rigorous analytical methods by the manufacturer.

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Good Biotech Corp. Duet hs-CRP LIT Assay is intended to be used as a high sensitive assay for the quantitative determination of C-reactive protein in serum by latex particle enhanced immunoturbidimetry (LIT). Highly sensitive measurement of C-reactive protein is useful for the detection and evaluation of infection, tissue injury, inflammatory disorders and associated diseases.

Good Biotech Corp. Duet hs-CRP Calibrator Set is intended to be used with Duet hs-CRP LIT Assay for the quantitative determination of C-reactive protein in serum samples.

For In Vitro Diagnostic Use.

Duet hs-CRP LIT kit is the ready-to-use reagent suitable for quantification of C-reactive protein by latex particle enhanced immunoturbidimetry (LIT). Duck anti-CRP IgY (ΔFc) is coupled to polystyrene microparticles, which greatly increased the analytical sensitivity. When CRP of the sample encounters with the latex microparticles sensitized with duck anti-CRP IgY (ΔFc), agglutination among the latex microparticles occurs based on the antigen-antibody reaction. The agglutination increases the turbidity of the sample and the degree of agglutination is detected by the absorbance change at 570 nm. The value of the absorbance change is proportional to the CRP concentration of the sample and is recorded by a general chemistry autoanalyzer. Then, the actual CRP concentration of the sample is determined by interpolation of the calibration curve obtained by standard samples with known CRP concentrations.

Here's a breakdown of the acceptance criteria and the study details for the Duet hs-CRP LIT Assay:

1. Table of Acceptance Criteria and Reported Device Performance

The submission frames its acceptance criteria through demonstrating "substantial equivalence" to a predicate device, the K-ASSAY CRP (3). The primary performance metric presented to establish this equivalence is correlation. While explicit numerical acceptance criteria (e.g., R² > 0.95) are not stated, the high R² values achieved are presented as evidence of equivalence.

Regression Equation (0-10 mg/L): y = 1.075x + 0.226 mg/L
Correlation Coefficient (R²): 0.996 |
| Intended Use Equivalence: The device should have comparable intended use to the predicate device. | Duet hs-CRP LIT Assay: Intended for quantitative determination of C-reactive protein in serum by latex particle enhanced immunoturbidimetry (LIT) as a high-sensitive assay, useful for detection and evaluation of infection, tissue injury, inflammatory disorders, and associated diseases.
K-ASSAY CRP (3) (Predicate): Intended for quantitative determination of CRP in serum and plasma by immunoturbidimetric assay as a high-sensitive assay, aiding in detection and evaluation of tissue injury, inflammatory disorders, and related diseases. (Both uses are highly similar.) |
| Methodology Equivalence: The test principles and components should be similar to the predicate. | Methodology: Both use Latex particle enhanced immunoturbidimetry.
Reagent Composition: Both have Reagent 1 (Reactive buffer solution) and Reagent 2 (Latex suspension). |
| Analytical Performance Characteristics: Similar analytical range, interference profiles, and calibrator properties. | Assay Range:
Duet hs-CRP LIT Assay: 0.3-200 mg/L
K-ASSAY CRP (3): 0.1-320 mg/L (Predicate has a slightly wider range)

Interference (Bilirubin C/F, Hemoglobin, Lipemia/Lipid):
Duet hs-CRP LIT Assay generally shows tolerance equal to or greater than the predicate in mg/dl thresholds for Bilirubin and Hemoglobin (e.g., Bilirubin C: 45 mg/dl vs 30 mg/dl for predicate; Hemoglobin: 805 mg/dl vs 500 mg/dl for predicate). Lipemia tolerance is different units but comparable.

Calibrator Traceability: Both traceable to IFCC CRM470.
Calibrator Matrix: Both use Human serum. |

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

• Sample Sizes:
  • N = 93 for CRP concentrations ranging from 0 to 200 mg/L.
  • N = 64 for CRP concentrations ranging from 0 to 10 mg/L (likely a subset focusing on the high-sensitivity range).
• Data Provenance: Not explicitly stated in the provided text. It is common for such clinical correlation studies to use patient samples, but details like country of origin or whether they were retrospectively collected or prospectively gathered are not available here. The submission is from a Taiwanese company, so it's plausible the samples originated there. The study appears to be a retrospective comparative study as it involves comparing the new device's measurements against a predicate device's measurements on the same samples.

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

This type of in-vitro diagnostic (IVD) device does not typically involve expert review for "ground truth" in the same way an imaging or pathology device would. For CRP assays, the "ground truth" is established by the predicate device's measurement itself, which is considered the reference method for establishing substantial equivalence. No human experts are involved in creating a "ground truth" label for each sample; rather, the predicate device provides the comparative value.

4. Adjudication Method for the Test Set

Not applicable for this type of IVD device. The comparison is objective, based on direct numerical outputs from the new device versus the predicate device, not subjective interpretation requiring adjudication.

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 assay, not an imaging or interpretive device that would involve human "readers" or AI assistance in interpretation. The output is a quantitative CRP concentration.

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

Yes, this is essentially what was performed. The Duet hs-CRP LIT Assay is a standalone automated assay. Its performance was evaluated by directly comparing its quantitative results against those obtained from the predicate device on the same samples, without human intervention in the result generation or comparison process (beyond operating the instruments).

7. The Type of Ground Truth Used

The "ground truth" for the test set was the measurements obtained from the predicate device (K-ASSAY CRP (3)). For IVD devices seeking substantial equivalence, the performance of the legally marketed predicate device often serves as the de facto "ground truth" or reference for comparison.

8. The Sample Size for the Training Set

The provided documentation does not mention a "training set" in the context of machine learning or algorithm development. For IVD assays like this, the development process involves reagent formulation and optimization, calibration curve fitting, and then analytical validation (as presented here). There isn't typically a separate "training set" of patient data for an algorithm as there would be for AI-based diagnostic tools.

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

Not applicable, as a "training set" as commonly understood in AI/ML contexts is not mentioned or relevant for this type of IVD device submission. The device's calibration curve is established using known CRP standards, as mentioned in the description, and this is part of the manufacturing process, not a "training set" of unknown patient samples.

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Good Biotech Corp. (GBC) Microalbumin TIA system is intended to be used for the quantitative determination of low level albumin in human urine by turbidimetric immunoassay (TIA). Measurement of albumin aids in the diagnosis of kidney disease.

GBC mAlb Calibrator Set 200 is intended to be used with GBC Microalbumin TIA for the quantitative determination of microalbumin in urine samples.

GBC Microalbumin Controls are intended to be used as the assayed quality control material for the urinary albumin analysis.

For In Vitro Diagnostic Use.

Good Biotech Corp. Microalbumin TIA is a ready to use reagent for the quantitative determination of low level albumin in human urine by turbidimetric immunoassay (TIA). When microalbumin of the urine sample encounters with duck anti-albumin antibody, the agglutination based on the antigen-antibody reaction increases the turbidity of the sample. The value of the absorbance change at 340 nm is proportional to the albumin concentration of the sample and is recorded by a general chemistry autoanalyzer. Then, the actual microalbumin concentration of the urine sample is determined by interpolation of the calibration curve obtained by standard samples with known albumin concentrations.

Here's an analysis of the provided text regarding the acceptance criteria and study for the Microalbumin TIA device:

Acceptance Criteria and Device Performance Study

The provided document describes a 510(k) submission for the Good Biotech Corp. Microalbumin TIA system, which includes the TIA reagent, mAlb Calibrator Set 200, and mAlb Control-L, Control-H. The study presented is a comparative performance study to demonstrate substantial equivalence to predicate devices.

1. Table of Acceptance Criteria and Reported Device Performance

The acceptance criteria for substantial equivalence are inferred from the comparison to predicate devices, focusing on correlation coefficients. The document does not explicitly state pre-defined numerical thresholds as "acceptance criteria" but rather presents the results of the comparison and concludes equivalence.

Note: The document states "high correlation coefficients" as the basis for substantial equivalence, implying that correlation values close to 1.0 (e.g., above 0.95 or 0.98) would be considered acceptable. The reported values of 0.997 and 0.998 clearly meet this implied criterion. Slopes close to 1.0 and intercepts close to 0 would also indicate good agreement, which are reasonably met here for the purpose of demonstrating equivalence in a 510(k) submission in vitro diagnostic.

2. Sample Size and Data Provenance for the Test Set

• Sample Size for Test Set: 50 urine samples.
• Data Provenance: Not explicitly stated regarding country of origin or whether it was retrospective or prospective. However, given that it's a comparative performance study for a diagnostic device, the samples would typically be collected prospectively or from a well-characterized biobank for analytical validation. The company is based in Taiwan, so the samples were likely collected there, but this is not confirmed.

3. Number of Experts and Qualifications for Ground Truth

• Number of Experts: Not applicable. The study is a comparative analytical performance study against existing, legally marketed diagnostic devices (Randox Microalbumin Test kit and Wako Micro-Albumin B). The "ground truth" for each sample is the measurement obtained from these predicate devices. There is no mention of expert consensus or interpretation being used to establish a "ground truth" independent of the and predicate device measurements.
• Qualifications of Experts: N/A

4. Adjudication Method for the Test Set

• Adjudication Method: Not applicable. The study compares the quantitative results of the GBC Microalbumin TIA system directly against the results from the predicate devices. There is no need for human adjudication of results in this type of analytical validation.

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

• MRMC Study: No, a multi-reader multi-case (MRMC) comparative effectiveness study was not conducted. This type of study is typically performed for AI-driven image analysis or diagnostic support systems where human readers interpret medical images or data. The GBC Microalbumin TIA system is an in vitro diagnostic (IVD) Turbidimetric Immunoassay (TIA) that provides a quantitative measurement, not an AI system assisting human readers.

6. Standalone (Algorithm Only) Performance

• Standalone Performance: Yes, the described study essentially represents the "standalone" performance of the GBC Microalbumin TIA system. As an IVD, the device itself performs the measurement (generating a quantitative result) without human input in the interpretation loop, other than standard laboratory practices for sample handling and running the assay. The performance demonstrated (correlation with predicate devices) is of the device on its own.

7. Type of Ground Truth Used

• Type of Ground Truth: The "ground truth" in this analytical validation is established by the measurements obtained from the predicate devices (Randox Microalbumin Test kit and Wako Micro-Albumin B). This is a common approach for demonstrating substantial equivalence for in vitro diagnostics where a new device's analytical performance is compared against established, legally marketed methods.

8. Sample Size for the Training Set

• Sample Size for Training Set: This information is not provided in the document. For an IVD like this, there isn't typically a "training set" in the machine learning sense. However, the manufacturer would have performed internal R&D and optimization studies (which might involve various sample sets) to develop and refine the reagent and assay method before the pivotal validation study. The 50 urine samples refer to the validation or test set used for the 510(k) submission.

9. How Ground Truth for the Training Set Was Established

• How Ground Truth for Training Set Was Established: Not applicable, as there's no explicitly defined "training set" with ground truth in the context of this analytical performance study. The development process would have involved establishing the accuracy and precision of the assay, likely using internal reference materials, calibrated standards, and known-concentration samples, but these are part of R&D and not typically detailed as a "training set" in a 510(k) summary for an IVD.

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Good Biotech Corp. CRPex CRP Controls are intended to be used as the assayed quality control material for serum C-reactive protein (CRP) analysis. For in vitro diagnostic use.

Good Biotech Corp. CRPex CRP Controls are intended to be used as the assayed quality control material for serum C-reactive protein (CRP) analysis. Each CRP Control contains certain level of human serum CRP to assist in monitoring the precision and accuracy of assay systems within the clinical range.

The provided text describes the 510(k) summary for Good Biotech Corp.'s CRPex CRP Controls, intended for use as an assayed quality control material for serum C-reactive protein (CRP) analysis. It focuses on demonstrating substantial equivalence to a predicate device, Roche CRP T Control N.

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

1. Table of Acceptance Criteria and Reported Device Performance

The acceptance criteria in this context are primarily demonstrating substantial equivalence to a predicate device by showing comparable characteristics. The "performance" is implicitly the C-reactive protein concentration range.

Note: While the exact "acceptance criteria" for the concentration ranges aren't explicitly stated as numerical targets that were met, the submission implies that these ranges are deemed acceptable for the intended use and demonstrate equivalence to the predicate control.

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

This document does not provide information on sample sizes used for a test set or data provenance for performance studies. As a quality control material, the "study" typically involves determining the assigned values and stability of the control, rather than a diagnostic performance study on patient samples.

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

This information is not provided in the document. For a quality control material, "ground truth" would typically refer to the accurately assigned values of CRP within the control, established through rigorous analytical methods and reference materials, rather than expert consensus on diagnostic images or clinical data.

4. Adjudication Method for the Test Set

This information is not provided in the document. Adjudication methods are relevant for studies involving human interpretation or multi-reader scenarios, which are not applicable to the evaluation of a quality control material.

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

This document does not mention an MRMC comparative effectiveness study. MRMC studies are typically conducted for diagnostic devices (e.g., imaging AI) where human readers interpret cases with and without AI assistance. This is not applicable to a CRP control material.

6. Standalone Performance Study (Algorithm Only Without Human-in-the-Loop Performance)

This is not applicable to the given device. The CRPex CRP Controls are a material used to assess the performance of other assay systems, not a standalone diagnostic algorithm. The "performance" of the controls themselves relates to their stability, homogeneity, and accurately assigned values, which are evaluated through analytical methods.

7. The Type of Ground Truth Used

For a quality control material, the "ground truth" refers to the assigned C-reactive protein concentrations within the various control levels (L, M, H). This would be established through:

• Quantitative analytical methods: Using a reference method or a highly accurate clinical analyzer calibrated against certified reference materials.
• Traceability to international standards: Ensuring the assigned values are traceable to recognized CRP standards.

The document states that the controls have "assigned C-reactive protein concentration," indicating this type of ground truth was established.

8. Sample Size for the Training Set

This information is not provided. As a quality control material, there isn't a "training set" in the context of machine learning or AI. The development of the control involves formulation, testing for stability, homogeneity, and value assignment, not training an algorithm.

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

This is not applicable as there is no "training set" in the context of this device. The ground truth (assigned CRP concentrations) for the control material itself would be established through analytical testing and value assignment protocols, as described in point 7.

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Good Biotech Corp. CRPex-BR C-reactive protein LIT assay is intended to be used for quantitative determination of C-reactive protein in serum. The measurement of C-reactive protein aids in evaluation of the amount of injury to body tissues. For in vitro diagnostic use.

Good Biotech Corp. CRPex-BR CRP calibrator set is intended to be used with CRPex-BR C-reactive protein LIT assay for the quantitative determination of C-reactive protein in serum samples.

For In Vitro Diagnostic Use.

CRPex-BR C-reactive protein LIT Kit is the ready-to-use reagent suitable for quantification of C-reactive protein by latex particle enhanced immunoturbidimetry (LIT). Duck anti-CRP IgY (△Fc) is coupled to polystyrene microparticles, which greatly increased the analytical sensitivity.

This document describes the CRPex-BR C-reactive protein LIT assay, a device for the quantitative determination of C-reactive protein in serum. The submission aims to demonstrate its substantial equivalence to the predicate device, K-ASSAY CRP (1).

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

The document does not explicitly state "acceptance criteria" in a numerical or pass/fail format. However, substantial equivalence is claimed based on a correlation study comparing the CRPex-BR C-reactive protein LIT kit with the predicate device, K-ASSAY CRP (1). The performance is reported as a regression analysis and correlation coefficient:

Additional characteristics for substantial equivalence were presented, indicating the CRPex-BR device aims to match the predicate device in aspects such as intended use, methodology, test objective, test principle, type of test, specimen type, operating requirement, calibrator, sample volume, reagent volume, wavelength selection, and assay range. The interference results are also presented for comparison.

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

• Sample size for the test set: N = 94
• Data provenance: The document does not specify the country of origin of the data. It's also not explicitly stated whether the study was retrospective or prospective, but given it's a correlation study with patient samples, it's likely retrospective or a cross-sectional prospective study comparing results from the two devices on collected samples.

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

This information is not provided in the document. For an in vitro diagnostic device like this, "ground truth" is typically established by comparative measurement to a gold standard or a well-established predicate device, rather than expert review of images or clinical cases. The predicate device (K-ASSAY CRP (1)) served as the reference for comparison, and its measurements were presumably used as the 'truth' for evaluating the new device.

4. Adjudication method for the test set

This information is not applicable/not provided for this type of in vitro diagnostic device study. Adjudication methods (like 2+1, 3+1) are typically used in clinical studies involving interpretation of medical images or clinical outcomes, where human experts might disagree. For an assay comparing quantitative measurements, the comparison is directly between the numerical results of the two devices.

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

This is not applicable to this submission. MRMC studies are relevant for medical imaging AI devices where human readers interpret cases with and without AI assistance. This device is an in vitro diagnostic assay for C-reactive protein measurement, not an imaging interpretation tool. There is no human-in-the-loop interpretation intended for this device.

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

This concept is fundamentally applicable to this device, though the wording "algorithm only" is more typical for AI software. This device is an automated in vitro diagnostic assay. Its performance, as reported by the y = 0.976 x + 1.179 mg/L and R² = 0.998 correlation with the predicate device, represents its "standalone" performance. There is no human interpretation or intervention in the measurement process of the CRPex-BR assay itself, beyond operating the instrument and preparing samples.

7. The type of ground truth used

The ground truth for evaluating the CRPex-BR device was established by comparison to the results obtained from the predicate device, K-ASSAY CRP (1). This is a common method for demonstrating substantial equivalence for in vitro diagnostic devices, where the predicate is considered the established method.

8. The sample size for the training set

This information is not provided and is generally not applicable in the context of traditional in vitro diagnostic assays like this. "Training set" is a concept primarily used in machine learning or AI where an algorithm learns from data. This device relies on chemical and immunoturbidimetric principles, not machine learning, so there is no "training set" in the AI sense.

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

As there is no "training set" in the AI sense for this device, this question is not applicable.

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Good Biotech Corp. CRPex-HS CRP Calibrator Set is intended to be used with CRPex-HS C-Reactive Protein LIT Assay for the quantitative determination of C-reactive protein (CRP) in serum samples. For In Vitro Diagnostic Use.

The calibrators contain certain quantities of human C-reactive protein (CRP). CRPex-HS CRP Calibrator Set is intended to be used with CRPex-HS C-Reactive Protein LIT Assay for the quantitative determination of CRP in serum samples.

Here's an analysis of the provided text regarding the CRPex-HS CRP Calibrator Set, focusing on acceptance criteria and study details:

1. Table of Acceptance Criteria and Reported Device Performance

The submission for the CRPex-HS CRP Calibrator Set is a 510(k) premarket notification for a device that is substantially equivalent to a predicate. As such, explicit "acceptance criteria" for performance are not typically presented in the same way they would be for a de novo device. Instead, the primary "acceptance criterion" is generally "substantial equivalence" to the predicate device.

For calibration devices, this usually involves demonstrating comparable performance characteristics, particularly in terms of correlation with the predicate device across a range of expected concentrations.

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

• Sample Size for Test Set: N = 67 (This refers to the number of data points used in the correlation study between the CRPex-BR CRP LIT Kit and the Wako CRP-UL predicate.)
• Data Provenance: Not specified in the provided document. It does not mention the country of origin of the data or whether it was retrospective or prospective.

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

• This is a calibration device used with an immunoassay for measuring C-reactive protein. The "ground truth" for such a device is typically established through reference materials and methodologies, rather than expert consensus on diagnostic images or clinical outcomes.
• The document states that both the CRPex-HS CRP Calibrator Set and the predicate device are traceable to CAP/BCR/IFCC RPPHS, lot 91/0619. This implies that the 'ground truth' or accuracy of the calibrators is linked to this internationally recognized reference material, which would have been characterized by expert committees in the field of clinical chemistry/immunology. The number and specific qualifications of the experts involved in establishing this reference material are not provided within this 510(k) summary, as it's an external, established reference.

4. Adjudication Method for the Test Set

• Not applicable in the conventional sense. The test set involves quantitative comparison of CRP concentrations, not subjective interpretations requiring adjudication. The correlation study directly compares measurements from the test device's associated assay (CRPex-BR CRP LIT Kit) when calibrated by the test calibrator, against measurements given by the predicate calibrator.

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

• No, a Multi-Reader Multi-Case (MRMC) comparative effectiveness study was not done. MRMC studies are typically used for diagnostic imaging devices where human readers interpret results, and the study assesses the impact of AI assistance on their performance. This device is a calibrator for an in vitro diagnostic assay, where direct human interpretation of the calibrator itself is not the primary function.

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

• This question is not directly applicable in the typical sense for a calibrator. A calibrator is a physical substance used to set the measurement scale for an assay that then quantifies an analyte (CRP). It's not an "algorithm" in the way an AI diagnostic tool would be. However, the performance data provided (correlation, R²) effectively represents the "standalone" performance of the new calibrator in conjunction with its intended assay, compared to the predicate. The "human-in-the-loop" for this type of device would be the lab technician performing the assay, which is external to the calibrator's function itself.

7. The Type of Ground Truth Used

• The ground truth used for the CRP concentrations in the calibrators themselves is based on traceability to a recognized international reference material: CAP/BCR/IFCC RPPHS, lot 91/0619. This ensures the measured values of CRP in the calibrator are accurate and standardized.

8. The Sample Size for the Training Set

• The document does not explicitly mention a "training set" in the context of an AI/machine learning algorithm. This device is a calibrator, not an AI system that learns from data.
• The reported "N = 67" likely refers to the number of samples or measurements in the correlation study (test set), not a training set.

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

• As a "training set" for an AI algorithm is not applicable here, this question is not relevant. The CRP concentrations in the calibrators are established through the manufacturing process and verified against the aforementioned international reference standard.

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Good Biotech Corp. CRPex-HS C-reactive protein LIT assay is intended to be used for quantitative determination of C-reactive protein in serum. The measurement of C-reactive protein is useful for the detection and evaluation of infection, tissue injury, inflammatory disorders and associated diseases. For in vitro diagnostic use.

CRPex-HS C-reactive protein LIT assay is the ready-to-use reagent suitable for quantification of C-reactive protein by latex particle enhanced immunoturbidimetry (LIT). Duck anti-CRP IgY (△Fc) is coupled to polystyrene microparticles, which greatly increased the analytical sensitivity. CRPex-HS C-reactive protein LIT assay is a hs-CRP assay for CRP quantification in the lower range.

Here's a breakdown of the acceptance criteria and study findings for the CRPex-HS C-reactive protein LIT Assay, based on the provided 510(k) summary:

1. Table of Acceptance Criteria and Reported Device Performance

The acceptance criteria are implied by the comparison to the predicate device, Wako CRP-UL. The primary performance metric presented is correlation.

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

• Sample Size: N = 141 (for the correlation study).
• Data Provenance: Not explicitly stated (e.g., country of origin). Likely retrospective, as it involves comparing results to an existing predicate device using collected samples.

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

Not applicable. This is an in vitro diagnostic (IVD) assay for quantitative measurement. The "ground truth" for the test set is established by the measured values from the predicate device (Wako CRP-UL) and the CRPex-HS assay itself, as well as the known concentrations of calibrators. There are no human experts "establishing ground truth" in the diagnostic interpretation sense for this type of device.

4. Adjudication Method for the Test Set

Not applicable. As described above, the study involves quantitative measurement and comparison to a predicate device, not subjective interpretation requiring adjudication.

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

No, an MRMC comparative effectiveness study was not done. This type of study is typically performed for diagnostic imaging devices or other tests that rely on human interpretation to assess reader performance with and without AI assistance. This device is an automated in vitro diagnostic assay.

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

Yes, the study primarily demonstrates standalone performance of the CRPex-HS C-reactive protein LIT assay. It measures the assay's output directly and compares it to a predicate device. "Human-in-the-loop" is relevant for clinical interpretation, but the assay itself, as an IVD, functions as a standalone measurement tool.

7. The Type of Ground Truth Used

The ground truth for the correlation study is the quantitative result obtained from the predicate device, Wako CRP-UL. For the assay range and interference studies, the "ground truth" refers to known concentrations of CRP in control samples and known concentrations of interfering substances added to samples. Essentially, it's a reference measurement or established reference material.

8. The Sample Size for the Training Set

Not applicable. This device is a reagent-based assay system, not an AI/machine learning algorithm requiring a "training set" in the conventional sense. The "training" of the device involves the development and optimization of the chemical reagents and protocols, which is an iterative laboratory process, not a data-driven model training.

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

Not applicable, as there is no specific "training set" for an AI algorithm. The development of the assay's performance characteristics (like sensitivity, specificity of the antibodies, reagent concentrations, etc.) is based on standard laboratory practices and experimentation to achieve optimal performance, utilizing calibrated reference materials and internal standards.

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