(50 days)
The Piccolo HDL - Capillary Test System used with the Piccolo xpress Chemistry Analyzer is intended for the in vitro quantitative determination of HDL in capillary (fingerstick) heparinized whole blood in a clinical laboratory setting or point-of-care location.
Lipoprotein measurements are used in the diagnosis and treatment of lipid disorders (such as diabetes mellitus), atherosclerosis, and various liver and renal diseases.
The Piccolo® Lipid Panel – Capillary Reagent Disc (which contains the Piccolo® HDL - Capillary Test System) is designed to separate a heparinized whole blood sample into plasma and blood cells. The disc meters the required quantity of plasma and diluent, mixes the plasma with diluent, and delivers the mixture to the reaction cuvettes along the disc perimeter. The diluted plasma mixes with the reagent beads, initiating the chemical reactions that are then monitored by the analyzer.
Here's a breakdown of the acceptance criteria and study information for the Abaxis Piccolo HDL - Capillary Test System, based on the provided text:
Acceptance Criteria and Device Performance
The provided document doesn't explicitly state numerical "acceptance criteria" in a table format alongside the performance. Instead, it presents the results of various validation tests, implying that the device's performance within these studies was deemed acceptable for substantial equivalence. The predicate devices' specifications provide the implicit benchmarks for comparison.
Here's a table summarizing the reported device performance, with implicit acceptance criteria derived from the comparisons and intended use:
| Test / Characteristic | Acceptance Criteria (Implicit, based on predicates & intended use) | Reported Device Performance (Piccolo® HDL - Capillary Test System) |
|---|---|---|
| Intended Use | Quantitative HDL determination in clinical/POC setting. | Quantitative HDL in capillary (fingerstick) heparinized whole blood in a clinical laboratory setting or point-of-care location. |
| Methodology | Enzymatic colorimetric end-point test. Similar to predicate. | Hybrid enzymatic colorimetric end-point test, making use of dextran/sulfate precipitation, centrifugation, and PEG-modified enzymes. |
| Sample Type | Appropriate for intended use (e.g., whole blood, plasma, serum). | Lithium heparinized capillary whole blood. |
| Dynamic Range | ≥ 15 mg/dL lower limit. | 15 mg/dL. |
| Assay Range | Similar to predicate, covering relevant clinical range. | 15 - 100 mg/dL. |
| Linearity (Slope) | Close to 1. | 0.983 |
| Linearity (Intercept) | Close to 0. | 0.5 |
| Linearity (Correlation Coefficient, r) | Close to 1. | 0.997 |
| Precision (Within-Run %CV) | Acceptable for clinical use, comparable to predicate. | Serum 1 (Mean 55.3 mg/dL): 2.6% |
| Serum 2 (Mean 38.0 mg/dL): 3.5% | ||
| Precision (Total %CV) | Acceptable for clinical use, comparable to predicate. | Serum 1 (Mean 55.3 mg/dL): 3.5% |
| Serum 2 (Mean 38.0 mg/dL): 4.3% | ||
| Method Comparison (Slope vs. Roche HDL Test) | Close to 1 (indicating agreement). | 0.99 (95% CI: 0.97 to 1.01) (Linear Regression) |
| 1.01 (95% CI: 0.99 to 1.03) (Deming Regression) | ||
| Method Comparison (Intercept vs. Roche HDL Test) | Close to 0 (indicating agreement). | -1.6 (95% CI: -2.4 to -0.8) (Linear Regression) |
| -2.6 (95% CI: -3.4 to -1.7) (Deming Regression) | ||
| Method Comparison (Correlation Coefficient, R²) | Close to 1 (indicating strong correlation). | 0.962 |
| Method Comparison (Std. Error of the Estimate, SEE) | Low (indicating good agreement). | 2.7 |
Study Details
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 unique patient samples, but the statistical results (Slope, Intercept, Correlation Coefficient) indicate multiple data points were analyzed across the dynamic range.
- Precision Study:
- Sample Size: n = 160 (for both within-run and total precision for each serum level). This likely refers to 160 individual measurements for each of the two serum levels or 160 replicates of each serum level.
- Data Provenance: Not explicitly stated, but the samples are referred to as "Serum 1" and "Serum 2," suggesting laboratory-prepared or pooled serum samples. No mention of country of origin or retrospective/prospective collection is provided for these particular samples.
- Method Comparison Study:
- Sample Size: N = 559.
- Data Provenance: Not explicitly stated regarding country of origin or retrospective/prospective. The samples are "analyzed by the Abaxis Piccolo HDL - Capillary Test System and the Roche HDL Test," suggesting human samples. The range of samples is 21 - 93 mg/dL for Piccolo and 23 - 92.5 mg/dL for Roche, indicating real-world patient samples covering a clinical range.
3. Number of Experts Used to Establish Ground Truth for the Test Set and Qualifications
This device is an in-vitro diagnostic (IVD) chemistry analyzer for quantitative determination of HDL. For such devices, "ground truth" is typically established by:
- Reference laboratory methods,
- Predicate devices (clinically accepted and legally marketed), or
- NIST (National Institute of Standards and Technology) traceable standards.
In this case, the ground truth for the performance studies was established through comparison with a legally marketed predicate device (Roche HDL Test), which serves as the reference for method comparison. The precision and linearity studies use internal quality controls or characterized samples.
Therefore, the concept of "experts" establish ground truth in the same way as for imaging or clinical diagnosis is not directly applicable here. The "experts" would be the manufacturers and developers of the reference/predicate methods, and the laboratory professionals performing the analyses.
4. Adjudication Method for the Test Set
Adjudication methods (like 2+1, 3+1) are typically used in studies where human readers interpret data, and there's a need to resolve discrepancies. Since this study concerns the performance of an automated IVD device comparing its results to a reference method (or itself for precision/linearity), no human adjudication method was employed or necessary. The quantitative results are compared statistically.
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 diagnostic devices that involve human interpretation of results (e.g., radiology AI). The Piccolo® HDL - Capillary Test System is an automated quantitative chemical analyzer, not a device requiring human interpretation in its output.
6. Standalone (Algorithm Only Without Human-in-the-Loop Performance)
Yes, this was a standalone performance study in the context of an IVD device. The "algorithm" here is the device's integrated system of reagents, fluidic handling, and photometric detection, which automatically produces a quantitative HDL value. The performance metrics (linearity, precision, method comparison) evaluate the device's output without human intervention influencing the final analytical result. Human involvement is limited to sample collection, loading, and initiating the test.
7. Type of Ground Truth Used
- Linearity and Precision Studies: The ground truth for these studies relies on characterized samples or quality controls with known analyte concentrations. For linearity, serial dilutions of a high-concentration sample are used, with the expected values serving as the truth. For precision, control materials with specified concentrations are repeatedly measured.
- Method Comparison Study: The ground truth was established by comparison to a legally marketed predicate device: the Roche HDL Test (specifically, the "Roche HDL Test: Average of Duplicates"). The predicate device's results are considered the reference against which the new device's performance is measured.
8. Sample Size for the Training Set
No training set is explicitly mentioned or relevant in the context of this 510(k) submission. This device is a chemical analyzer based on established enzymatic calorimetric principles. It does not utilize machine learning or AI models that require a "training set" in the conventional sense. The "training" of the device involves its internal calibration (factory calibrated lot-specific data via bar code) and manufacturing processes to ensure it accurately measures the analyte.
9. How the Ground Truth for the Training Set Was Established
As noted above, there is no "training set" in the AI/ML sense. The device's calibration and manufacturing are based on established chemical principles and metrology standards, ensuring the accuracy of its measurements across its assay range.
§ 862.1475 Lipoprotein test system.
(a)
Identification. A lipoprotein test system is a device intended to measure lipoprotein in serum and plasma. Lipoprotein measurements are used in the diagnosis and treatment of lipid disorders (such as diabetes mellitus), atherosclerosis, and various liver and renal diseases.(b)
Classification. Class I (general controls). The device is exempt from the premarket notification procedures in subpart E of part 807 of this chapter subject to § 862.9.