(277 days)
The Piccolo® C-Reactive Protein Test System used with the Piccolo xpress™ Chemistry Analyzer is intended to be used for the in vitro quantitative determination of CRP concentration in lithium heparinized whole blood, lithium heparinized plasma, or serum in a clinical laboratory setting or point of care location. This test is not intended for high sensitivity CRP measurement.
C-Reactive Protein test results aid in the evaluation of infection, tissue injury, and inflammatory disorders in conjunction with other laboratory and clinical findings.
The Piccolo MetLyte Plus CRP Reagent Disc (which contains the Piccolo C-Reactive Protein Test System) is designed for lithium heparinized whole blood, lithium heparinized plasma, and serum, only. The disc meters the required quantity of sample and diluent, mixes the sample with diluent, and delivers the mixture to the reaction cuvettes along the disc perimeter. The diluted sample mixes with the reagent beads, initiating the chemical reactions that are then monitored by the analyzer.
This document describes the Abaxis Piccolo C-Reactive Protein (CRP) Test System and demonstrates its substantial equivalence to a legally marketed predicate device (Beckman Synchron LX20 Chemistry System K070626). The information provided focuses on the performance characteristics of the Abaxis device.
Here's a breakdown of the requested information based on the provided text:
1. Table of Acceptance Criteria and Reported Device Performance:
The document does not explicitly state "acceptance criteria" for linearity or precision in a numerical format that would represent target values. Instead, it presents the results of linearity and precision studies. The implicit acceptance is that these results demonstrate performance comparable to clinical expectations for such a device and are sufficient to prove substantial equivalence to the predicate device.
| Performance Characteristic | Acceptance Criteria (Implicit) | Reported Device Performance (Abaxis Piccolo CRP Test System) |
|---|---|---|
| Linearity | Demonstrate a strong linear relationship across the assay range. | Slope: 1.037 |
| Intercept: -0.764 | ||
| Correlation Coefficient: 0.997 | ||
| Precision (Within-Run & Total) | Demonstrate acceptable repeatability and reproducibility for different CRP levels in serum and plasma. | C-Reactive Protein (mg/L) |
| Serum Level 1 (n=80) | ||
| Mean: 8.3, SD: 0.70 (Within-Run), 0.81 (Total), %CV: 8.4 (Within-Run), 9.8 (Total) | ||
| Serum Level 2 (n=40) | ||
| Mean: 8.1, SD: 0.49 (Within-Run), 0.51 (Total), %CV: 6.1 (Within-Run), 6.3 (Total) | ||
| Serum Level 3 (n=40) | ||
| Mean: 8.8, SD: 0.54 (Within-Run), 0.54 (Total), %CV: 6.2 (Within-Run), 6.2 (Total) | ||
| Plasma 1 (n=40) | ||
| Mean: 34.5, SD: 1.04 (Within-Run), 1.09 (Total), %CV: 3.0 (Within-Run), 3.2 (Total) | ||
| Plasma 2 (n=40) | ||
| Mean: 105.5, SD: 2.06 (Within-Run), 2.30 (Total), %CV: 1.9 (Within-Run), 2.2 (Total) | ||
| Control Level 1 (n=80) | ||
| Mean: 33.0, SD: 1.21 (Within-Run), 2.12 (Total), %CV: 3.7 (Within-Run), 6.4 (Total) | ||
| Control Level 2 (n=80) | ||
| Mean: 108.0, SD: 1.88 (Within-Run), 3.14 (Total), %CV: 1.7 (Within-Run), 2.9 (Total) | ||
| Sample Type Comparability | Demonstrate comparable results across lithium heparinized whole blood, lithium heparinized plasma, and serum. | Comparability was established for CRP. |
Study Proving Device Meets Criteria:
The study conducted to prove the device meets these criteria is a series of clinical and non-clinical tests summarized in Tables 2 and 3 and described under Section 7: "Brief discussion of the clinical and nonclinical tests relied on for a determination of substantial equivalence."
2. Sample Size Used for the Test Set and Data Provenance:
- Linearity Study: The sample size for the linearity study is not explicitly stated in terms of number of patient samples. It reports a slope, intercept, and correlation coefficient, which are derived from a series of measurements across a range of concentrations.
- Precision Studies:
- Serum Level 1: n = 80
- Serum Level 2: n = 40
- Serum Level 3: n = 40
- Plasma 1: n = 40
- Plasma 2: n = 40
- Control Level 1: n = 80
- Control Level 2: n = 80
- Sample Type Comparison Study: The document states "A study was conducted to examine and compare results for lithium heparinized whole blood, lithium heparinized plasma, and serum," but does not explicitly provide the number of samples used in this comparison.
- Data Provenance: The document does not specify the country of origin of the data or whether the studies were retrospective or prospective. Given the nature of a 510(k) submission for a clinical laboratory test system, such studies are typically prospective analytical validation studies using prepared samples or patient samples collected for the purpose of the study.
3. Number of Experts Used to Establish the Ground Truth for the Test Set and Qualifications of Those Experts:
This information is not provided in the document. For an invitro diagnostic (IVD) device like a CRP test, "ground truth" is typically established by reference methods or validated comparative methods ("predicate device" in this case) rather than by expert consensus on qualitative interpretation. The "ground truth" for the test set is considered to be the quantitative values obtained from a reference method or the predicate device.
4. Adjudication Method for the Test Set:
This information is not applicable/provided for this type of IVD device. Adjudication methods (like 2+1, 3+1) are common in studies involving expert interpretation of images or other subjective data. For a quantitative test like CRP, the "adjudication" is essentially the comparison of results against a reference method or the predicate device with predefined statistical measures.
5. If a Multi-Reader Multi-Case (MRMC) Comparative Effectiveness Study was Done:
No, a MRMC comparative effectiveness study was not done. MRMC studies are typically performed for devices that involve human interpretation (e.g., radiologists reading images) to assess the impact of a device on reader performance. This document concerns a fully automated quantitative test system.
6. If a Standalone (i.e., algorithm only without human-in-the-loop performance) was Done:
Yes, a standalone performance evaluation was done. The document focuses exclusively on the analytical performance of the "Piccolo C-Reactive Protein Test System" run on the "Piccolo xpress Chemistry Analyzer" (an automated system). The precision and linearity data presented directly reflect the performance of the device without human interpretation affecting the result. The comparison is between the new device and a predicate device, both being automated quantitative systems.
7. The Type of Ground Truth Used:
The ground truth used for this type of quantitative IVD device is generally based on:
- Comparison to a legally marketed predicate device: The document explicitly states the "Piccolo C-Reactive Protein Test System" is compared to the "Beckman Synchron LX20 Chemistry System K070626". The performance characteristics (e.g., linearity, precision) are evaluated using samples for which the CRP concentration is known or reliably determined by established methods or the predicate device.
- Reference materials/methods: Implicitly, the linearity and precision studies would rely on samples with known or traceable CRP concentrations, potentially established using reference materials or highly accurate reference methods, to assess the accuracy of the device across its measuring range.
8. The Sample Size for the Training Set:
The document does not provide information regarding a "training set" or its sample size. This is typical for analytical validation reports of IVD devices for 510(k) submissions, which focus on analytical performance testing rather than machine learning model development. The device itself is an immunoassay system, not an AI/ML algorithm that requires a separate training set.
9. How the Ground Truth for the Training Set Was Established:
As there is no mention of a "training set" in the context of an AI/ML model, this question is not applicable to the provided document. The "ground truth" for the analytical performance studies (linearity, precision) would be established by reference methods or the performance of the predicate device, as mentioned in point 7.
§ 866.5270 C-reactive protein immunological test system.
(a)
Identification. A C-reactive protein immunological test system is a device that consists of the reagents used to measure by immunochemical techniques the C-reactive protein in serum and other body fluids. Measurement of C-reactive protein aids in evaluation of the amount of injury to body tissues.(b)
Classification. Class II (performance standards).