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510(k) Data Aggregation
(35 days)
IMMAGE IMMUNOCHEMISTRY SYSTEM C-REACTIVE PROTEIN (CRP) REAGENT
The IMMAGE Immunochemistry System C-reactive protein (CRP) reagent, in conjunction with Beckman Coulter IMMAGE® Immunochemistry Systems and Calibrator 5 Plus, is intended for use in the quantitative determination of human C-reactive protein concentrations in human serum and plasma samples by rate nephelometry.
The IMMAGE Immunochemistry System C-Reactive Protein (CRP) reagent, in conjunction with Calibrator 5 Plus, is intended for use in the quantitative determination of human C-reactive protein concentrations in human serum and plasma samples by rate nephelometry. This assay is designed for use with Beckman's IMMAGE® Immunochemistry System.
Here's an analysis of the provided text regarding the acceptance criteria and study for the IMMAGE® Immunochemistry System C-Reactive Protein (CRP) Reagent:
1. Table of Acceptance Criteria and Reported Device Performance
The document does not explicitly state pre-defined acceptance criteria with specific numerical thresholds for method comparison, stability, linearity, or imprecision. Instead, it indicates that the provided data "supports a finding of substantial equivalence to chemistry test systems already in commercial distribution." The reported performance data for imprecision is presented below:
| Performance Metric | Acceptance Criteria (Not explicitly stated with thresholds, but implied to be comparable to predicate) | Reported Device Performance (IMMAGE System CRP Reagent) |
|---|---|---|
| Within-Run Imprecision | (Implied to be acceptable for substantial equivalence) | |
| Level 1 | Mean: 0.35 mg/dL, SD: 0.039 mg/dL, %CV: 11.1 | |
| Level 2 | Mean: 4.95 mg/dL, SD: 0.129 mg/dL, %CV: 2.6 | |
| Level 3 | Mean: 6.69 mg/dL, SD: 0.236 mg/dL, %CV: 3.5 | |
| Total Imprecision | (Implied to be acceptable for substantial equivalence) | |
| Level 1 | Mean: 0.35 mg/dL, SD: 0.043 mg/dL, %CV: 12.1 | |
| Level 2 | Mean: 4.95 mg/dL, SD: 0.149 mg/dL, %CV: 3.0 | |
| Level 3 | Mean: 6.69 mg/dL, SD: 0.266 mg/dL, %CV: 4.0 | |
| Method Comparison | (Implied to show substantial equivalence to predicate) | (Results are mentioned as part of the study but not detailed in this section.) |
| Stability | (Implied to be acceptable for substantial equivalence, with 30 days once opened) | (Results are mentioned as part of the study but not detailed in this section.) |
| Linearity | (Implied to be acceptable for substantial equivalence) | (Results are mentioned as part of the study but not detailed in this section.) |
2. Sample Size and Data Provenance for the Test Set
- Sample Size for Test Set:
- For the imprecision study, N=80 samples were used at each of the three levels (Level 1, Level 2, Level 3) for both within-run and total imprecision calculations.
- The sample size for the method comparison, stability, and linearity studies is not explicitly stated in the provided text.
- Data Provenance: The document does not specify the country of origin of the data or whether the study was retrospective or prospective. It is a submission to the FDA in the US by Beckman Coulter, Inc., based in California, so it's likely the studies were conducted in the US, but this is not explicitly stated.
3. Number of Experts and Qualifications for Ground Truth
- This device is an in-vitro diagnostic (IVD) reagent for quantitative determination of a biomarker (C-reactive protein). The "ground truth" for such devices typically refers to the true concentration of the analyte in a sample. Expert consensus or human interpretation (like radiologists) is not relevant in this context.
- The ground truth would have been established through a reference method or validated assays/calibrators, often with traceable standards. The document does not specify how the ground truth was established for the samples used in the imprecision, linearity, or method comparison studies. It mentions the use of "Calibrator 5 Plus" in the intended use, implying a calibrated system.
4. Adjudication Method for the Test Set
- Adjudication methods (e.g., 2+1) are usually relevant for studies involving human interpretation or subjective assessments, often in areas like imaging.
- For an IVD device like the CRP reagent, the "adjudication method" as typically understood in human-read studies is not applicable. The measurement is quantitative and objective, based on the instrument's reading.
5. Multi-Reader Multi-Case (MRMC) Comparative Effectiveness Study
- No, a Multi-Reader Multi-Case (MRMC) comparative effectiveness study was not performed or is not applicable here. This type of study involves multiple human readers assessing cases (e.g., medical images) to evaluate the impact of an AI algorithm on their performance.
- The IMMAGE® Immunochemistry System CRP Reagent is an automated laboratory assay that quantifies a biomarker. It does not involve human readers interpreting cases in the same way an imaging AI might. Therefore, the concept of "human readers improve with AI vs without AI assistance" does not apply to this device.
6. Standalone (Algorithm-Only) Performance Study
- Yes, the performance data presented (imprecision, method comparison, stability, linearity) represents the standalone performance of the IMMAGE® Immunochemistry System CRP Reagent in conjunction with the IMMAGE® Immunochemistry System.
- This refers to the performance of the device itself (reagent + instrument) without human intervention in the result generation beyond operating the instrument according to instructions.
7. Type of Ground Truth Used
- The document does not explicitly state the specific type of ground truth used for the performance studies.
- For quantitative IVD assays, ground truth is typically established through:
- Reference materials/calibrators: Samples with known, validated concentrations of the analyte.
- Validated reference methods: Using a method considered the gold standard for measuring CRP.
- Comparative methods: Often, a well-established predicate device's results are used as the comparative "truth" or reference for evaluating substantial equivalence, as indicated in the "Method Comparison Study Results" section.
8. Sample Size for the Training Set
- The IMMAGE® Immunochemistry System CRP Reagent is a diagnostic reagent, likely based on well-established nephelometric principles and antibody-antigen reactions. It does not employ machine learning or artificial intelligence that would require a "training set" in the computational sense.
- Therefore, there is no training set sample size mentioned or applicable in the context of this device.
9. How Ground Truth for the Training Set Was Established
- As concluded in point 8, there is no "training set" for this type of chemical reagent and its associated measurement system.
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(89 days)
IMMAGE IMMUNOCHEMISTRY SYSTEM C-REACTIVE PROTEIN (CRP) REAGENT
The IMMAGE Immunochemistry Systems C-reactive protein (CRP) reagent, in conjunction with Beckman CAL 5 Plus, is intended for use in the quantitative determination of human C-reactive protein concentrations in human serum and plasma samples by rate nephelometry. This assay is designed for use with Beckman's IMMAGE Immunochemistry System.
The IMMAGE Immunochemistry Systems C-reactive protein (CRP) reagent, in conjunction with Beckman CAL 5 Plus, is intended for use in the quantitative determination of human C-reactive protein concentrations in human serum and plasma samples.
The provided text describes the Beckman IMMAGE™ Immunochemistry System C-Reactive Protein (CRP) Reagent. Here's a breakdown of the requested information based on the document:
1. Table of Acceptance Criteria and Reported Device Performance
The document doesn't explicitly state "acceptance criteria" for the method comparison in a clear quantitative manner (e.g., a specific R-value threshold). However, it implies that the device is substantially equivalent to the predicate through the presented performance data.
| Performance Metric | Acceptance Criteria (Implied/Direct) | Reported Device Performance (IMMAGE CRP Reagent) |
|---|---|---|
| Method Comparison | Substantial equivalence to Behring N Latex CRP Reagent. | Demonstrated through method comparison study (details not fully provided in text). |
| Stability (Shelf-life) | Not explicitly stated (typically defined internally by manufacturer). | 24 month shelf-life |
| Stability (Open Container) | Not explicitly stated. | 14 days |
| Stability (Calibration) | Not explicitly stated. | 14 days |
| Within-run Imprecision | Not explicitly stated (typically defined by industry standards or manufacturer's target). | Level 1 (Mean 1.65 mg/dL): %CV = 8.1% |
| Level 2 (Mean 5.41 mg/dL): %CV = 3.1% | ||
| Level 3 (Mean 12.6 mg/dL): %CV = 1.8% |
2. Sample Size Used for the Test Set and Data Provenance
- Test Set Sample Size: The document does not specify the sample size for the method comparison study (comparison between IMMAGE CRP Reagent and Behring N Latex CRP Reagent).
- Data Provenance: Not specified (e.g., country of origin, retrospective or prospective).
3. Number of Experts Used to Establish the Ground Truth for the Test Set and Qualifications of those Experts
- This information is not applicable to an immunochemistry reagent like the one described. "Ground truth" for such a device is established by comparing its quantitative results against a recognized reference method or a legally marketed predicate device, not by expert interpretation of images or clinical cases.
4. Adjudication Method for the Test Set
- Not applicable as this is a quantitative chemical assay, not a diagnostic imaging or interpretive device 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 device is an in-vitro diagnostic (IVD) reagent for automated quantitative measurement, not an AI-assisted diagnostic tool that would involve human readers or MRMC studies.
6. If a Standalone (i.e. algorithm only without human-in-the-loop performance) was done
- Yes, the performance data presented (method comparison, stability, imprecision) represents the standalone performance of the IMMAGE CRP Reagent system. The device itself performs the quantitative measurement without human interpretation of the results for its basic function.
7. The Type of Ground Truth Used
- For the method comparison study, the "ground truth" was established by the results obtained from the predicate device (Behring N Latex CRP Reagent). The study aimed to demonstrate substantial equivalence to this legally marketed device.
- For the stability and imprecision studies, the "ground truth" is typically derived from known control materials or calibrated reference solutions with assigned values.
8. The Sample Size for the Training Set
- This information is not applicable as this is not a machine learning or AI device that requires a distinct "training set" in the context of the reported performance studies. The "training" of such a system involves internal development and optimization based on chemical and analytical principles.
9. How the Ground Truth for the Training Set was Established
- Not applicable for the reasons stated in point 8.
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