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510(k) Data Aggregation
(78 days)
The IMMULITE® IMMULITE® 1000 High Sensitivity CRP assay is intended for use as follows: For in vitro diagnostic use with the IMMULITE/IMMULITE 1000 Analyzer for the quantitative measurement of C-Reactive protein (CRP) in serum or plasma as an aid in the detection and evaluation of infection, tissue injury and inflammatory disorders, and associated diseases. Measurements may also be used as an aid in the identification of individuals at risk for future cardiovascular disease. High sensitivity CRP (hsCRP) measurements when used in conjunction with traditional clinical laboratory evaluation of acute coronary syndrome may be useful as an independent marker for recurrent events in patients with stable coronary disease or acute coronary syndrome.
IMMULITE® 2000 High Sensitivity CRP assay is intended for use as follows: For in vitro diagnostic use with the IMMULITE 2000 Analyzer - for the quantitative measurement of C-Reactive protein (CRP) in serum or plasma as an aid in the detection and evaluation of infection, tissue injury and inflammatory disorders, and associated diseases. Measurements may also be used as an aid in the identification of individuals at risk for future cardiovascular disease. High sensitivity CRP (hsCRP) measurements when used in conjunction with traditional clinical laboratory evaluation of acute coronary syndrome may be useful as an independent marker for recurrent events in patients with stable coronary disease or acute coronary syndrome.
The IMMULITE/IMMULITE 1000 and IMMULITE 2000 High Sensitivity CRP is a solid-phase, chemiluminescent immunometric assay. The assay utilizes a 14-inch polystyrene bead coated with anti-ligand. The bead is co-incubated with sample, murine monoclonal anti-CRP, and alkaline phosphatase (bovine calf intestine)-conjugated to rabbit polyclonal anti-CRP in buffer for 30 minutes on each IMMULITE/IMMULITE 1000 and IMMULITE 2000 platform. Unbound enzyme conjugate is removed by a centrifugal wash procedure. Substrate is added and the resulting chemiluminescence is read in the luminometer.
The IMMULITE®/IMMULITE® 1000 and IMMULITE® 2000 High Sensitivity CRP assays are immunological test systems designed for the quantitative measurement of C-Reactive protein (CRP) in serum or plasma. These devices are intended to aid in the detection and evaluation of infection, tissue injury, inflammatory disorders, associated diseases, and in the identification of individuals at risk for future cardiovascular disease. High sensitivity CRP measurements, when used with traditional clinical evaluations of acute coronary syndrome, may also serve as an independent marker for recurrent events in patients with stable coronary disease or acute coronary syndrome.
1. Table of Acceptance Criteria and Reported Device Performance:
| Performance Characteristic | Acceptance Criteria (from predicate/literature) | IMMULITE/IMMULITE 1000 Performance (Reported) | IMMULITE 2000 Performance (Reported) |
|---|---|---|---|
| Working Range | Predicate: 0.175 to 1100 mg/L | 0.3 to 100 mg/L | 0.2 to 100 mg/L |
| Analytical Sensitivity | Predicate: 0.175 mg/L | 0.1 mg/L | 0.1 mg/L |
| Functional Sensitivity | Not reported in predicate | 0.3 mg/L (at 10% CV) | 0.2 mg/L (at 10% CV) |
| Precision (Intra-assay CV%) | Predicate not explicitly stated for specific levels. Literature-based expectations for CRP assays. | Did not exceed 6.0% (0.3-78 mg/L) | Did not exceed 8.7% (0.23-93.7 mg/L) |
| Precision (Inter-assay CV%) | Predicate not explicitly stated for specific levels. Literature-based expectations for CRP assays. | Not greater than 7.5% (0.8 mg/L), 6% (1.5 mg/L), 4.8% (3.1 mg/L), 4.9% (15.0 mg/L). Did not exceed 10% (0.3-78 mg/L). | Not greater than 7.1% (0.85 mg/L), 3.1% (3.2 mg/L), 3.3% (12.3 mg/L). Did not exceed 8.7% (0.23-93.7 mg/L). |
| Linearity | Demonstrated | Demonstrated within precision of the assay | Demonstrated within precision of the assay |
| Spiked Recovery | Demonstrated | Demonstrated within precision of the assay | Demonstrated within precision of the assay |
| Interference (Bilirubin) | Predicate: No significant interference up to 230 mg/L | No effect up to 200 mg/L | No effect up to 200 mg/L |
| Interference (Hemoglobin) | Predicate: No significant interference up to 36 g/L (36000 mg/L) | No effect up to 570 mg/L | No effect up to 512 mg/L |
| Interference (Triglycerides) | Predicate: No significant interference up to 7.4 g/L (7400 mg/L) | No effect up to 3000 mg/L | No effect up to 3000 mg/L |
| Cross-Reactivity | Not specified for predicate | No cross-reactivity (HSA, IgG, Transferrin) | No cross-reactivity (HSA, IgG, Transferrin) |
| High Dose Hook Effect | Not reported in predicate | No hook effect up to 3780 mg/L | No hook effect up to 3780 mg/L |
| Method Comparison (Regression) | Substantial equivalence to predicate (slope ~1, intercept ~0, r > 0.95 generally for IVDs) | IMMULITE/IMMULITE 1000 vs. Dade Behring HSCRP: Full range (N=175): slope = 0.952, intercept = 0.022, r = 0.996 <10 mg/L range (N=165): slope = 0.943, intercept = 0.030, r = 0.987 | IMMULITE 2000 vs. Dade Behring HSCRP: Full range (N=185): slope = 1.010, intercept = -0.0888, r = 0.995 <10 mg/L range (N=175): slope = 1.0006, intercept = -0.0818, r = 0.993 |
2. Sample Sizes Used for the Test Set and Data Provenance:
The available document describes performance studies, clinical comparisons, and assay characteristics for both the IMMULITE/IMMULITE 1000 and the IMMULITE 2000 assays.
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Method Comparison (Test Set):
- IMMULITE/IMMULITE 1000 vs. Dade Behring N HSCRP:
- Full range (0.3 to 22.9 mg/L): N=175 samples
- Range < 10 mg/L (0.3 to 9.4 mg/L): N=165 samples (a subset of the full range)
- IMMULITE 2000 vs. Dade Behring N HSCRP:
- Full range (0.2 to 22.9 mg/L): N=185 samples
- Range < 10 mg/L (0.2 to 9.4 mg/L): N=175 samples (a subset of the full range)
- IMMULITE/IMMULITE 1000 vs. Dade Behring N HSCRP:
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Data Provenance: The document does not explicitly state the country of origin for the samples used in the method comparison or whether the data was retrospective or prospective. Given the nature of a 510(k) submission and the context of comparing a new device to an existing predicate, it's highly probable that these were prospective studies conducted using patient samples in a clinical laboratory setting. However, this is not definitively stated.
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 the provided document. The "ground truth" for the method comparison studies was established by the measurement results from the legally marketed predicate device, the Dade Behring N High Sensitivity CRP assay. There were no human experts or diagnosticians establishing ground truth for these quantitative measurements.
4. Adjudication Method for the Test Set:
This information is not applicable to the provided document. Adjudication methods are typically used in clinical studies where subjective interpretations (e.g., image readings, clinical assessments) are made by multiple experts, and disagreements need to be resolved. In this context of quantitative laboratory assays, the comparison is directly between the numerical results of two different analytical methods, not subjective expert interpretations.
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 information is not applicable to the provided document. The device is an in vitro diagnostic assay (a laboratory test) that provides a quantitative measurement. It is not an AI-assisted diagnostic tool that human readers would interpret or use to improve their performance. Therefore, an MRMC comparative effectiveness study involving human readers and AI assistance is not relevant to this device.
6. If a Standalone (i.e. algorithm only without human-in-the-loop performance) was done:
This information is partially applicable to the provided document. The performance characteristics described (Working Range, Analytical Sensitivity, Functional Sensitivity, Precision, Linearity, Spiked Recovery, Interfering Substances, Cross-Reactivity, High Dose Hook Effect) represent the "standalone" performance of the IMMULITE/IMMULITE 1000 and IMMULITE 2000 assays. These are objective measurements of the device's analytical capabilities without human interpretation influencing the numerical result. The method comparison study also assesses the standalone numerical output against a predicate. While a human initiates the test and reviews the result, the core performance reported is the algorithm/assay's ability to accurately quantify CRP.
7. The Type of Ground Truth Used (expert consensus, pathology, outcomes data, etc.):
The ground truth for the performance studies and method comparison was primarily:
- Reference Standards: The assays are standardized to WHO IS 85/506 and CRM 470 reference standards.
- Predicate Device Measurements: For the method comparison, the measurements obtained from the legally marketed Dade Behring N High Sensitivity CRP assay served as the comparator or "ground truth" to demonstrate substantial equivalence.
- Established Analytical Methods: For other performance characteristics (e.g., precision, linearity), standard analytical methodologies and established quality control practices define the expected performance against internal standards or known concentrations.
8. The Sample Size for the Training Set:
The document describes a 510(k) submission for an in vitro diagnostic assay, which typically does not involve machine learning algorithms that require "training sets" in the conventional sense. The performance characteristics and comparison studies are analogous to "test sets" for verifying the analytical performance of the assay.
However, the "Expected Values" section mentions: "A study performed on 100 apparently healthy volunteers yielded a median of 1.4 mg/L and an upper 97.5th percentile of 11 mg/L." This could be considered a reference range study, but it's not a "training set" for an algorithm.
The document states that assay reagents, components, and performance characteristics "remain as previously established in 510(k) K003372." This implies that the current submission builds upon previous extensive validation data, which would have involved numerous samples (calibrators, controls, patient samples) used in the development and initial validation of the original IMMULITE hsCRP assays. The sample sizes for those earlier studies are not detailed in this specific document.
9. How the Ground Truth for the Training Set Was Established:
As there is no "training set" for a machine learning algorithm described, this question is not directly applicable. If considering the development and validation of the original assays (from K003372), the "ground truth" for calibrators and controls would be established through highly characterized reference materials (like WHO IS 85/506 and CRM 470) and rigorous analytical chemistry methods. For patient samples used in method development, the "ground truth" would be the measurements obtained from an established, clinically accepted reference method or comparison to other well-validated commercial assays.
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