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510(k) Data Aggregation
(107 days)
The cassette COBAS INTEGRA HDL - Cholesterol Direct (HDL-D) contains an in vitro diagnostic reagent system intended for use on COBAS INTEGRA for the quantitative determination of HDL - cholesterol direct concentration in serum and plasma.
The COBAS INTEGRA HDL-D reagent cassette is intended for use with the COBAS INTEGRA Analyzer. The COBAS INTEGRA Analyzer and COBAS INTEGRA Reagent cassettes together provide an integrated system for in vitro diagnostic testing. The COBAS INTEGRA Analyzer utilizes three measuring principles, i.e., absorbance, fluorescence polarization and ion-selective electrodes. The analyzer has a throughput of up to 600 tests per hour with STAT samples prioritized and tested immediately. Random sample access, robotics and a user interface optimize time management and streamline workflow. The COBAS INTEGRA can store up to 68 COBAS INTEGRA Reagent Cassettes on board, 24 hours a day at 2-8°C. The COBAS INTEGRA Reagent Cassettes are compact and preparation-free with the added convenience of long term on-board stability. Barcode readers are used to identify newly loaded reagent cassettes, samples for patient identification, and rack inserts and to read calibration and control data from the cassette label. COBAS INTEGRA tests include chemistry, drugs of abuse, immunology, ion selective electrodes, therapeutic drug monitoring, and hematology reagents.
The COBAS INTEGRA HDL-D reagent cassette is an in vitro diagnostic reagent system intended for use on COBAS INTEGRA for the quantitative determination of High Density Lipoprotein cholesterol direct (HDL-D) in serum and plasma.
The principle of the COBAS INTEGRA HDL-D reagent cassette is based on the absorption of synthetic polyanions to the surface of lipoproteins. LDL, VLDL, and chylomicrons are transformed into a detergent-resistant form. whereas HDL is not. Combined action of polyanions and detergent solubilizes cholesterol from HDL, but not from LDL, VLDL, and chylomicrons. Solubilized cholesterol is oxidized by the sequential enzymatic action of cholesterol esterase and cholesterol oxidase. The hydrogen peroxide produced in this reaction is reacted with chromogens to form a colored dye. The increase in absorbance at 552 nm is directly proportional to the HDL cholesterol concentration of the sample.
Here's an analysis of the acceptance criteria and study as presented in the provided text for the Roche COBAS INTEGRA® HDL-D Reagent Cassette:
1. Table of Acceptance Criteria and Reported Device Performance
The document compares the new device (COBAS INTEGRA HDL-D reagent cassette) to a predicate device (COBAS INTEGRA HDL reagent system) rather than explicitly stating acceptance criteria a priori. However, the performance characteristics of the new device serve as its reported performance, and by demonstrating substantial equivalence to the predicate, it implicitly meets the established performance expectations for such devices.
| Performance Characteristic | Acceptance Criteria (Predicate Device Performance) | Reported Device Performance (COBAS INTEGRA HDL-D) |
|---|---|---|
| Assay Range | 0 - 5.0 mmol/L (0 - 193 mg/dL) | 0.01 - 4.0 mmol/L (0.386 - 155 mg/dL) |
| Precision (Level 1) | ||
| Mean (mmol/L) | 0.82 mmol/L (31.7 mg/dL) | 0.60 mmol/L (23.2 mg/dL) |
| % CV (within run) | 1.2% | 1.4% |
| % CV (total) | 2.7% | 2.2% |
| Precision (Level 2) | ||
| Mean (mmol/L) | 1.42 mmol/L (54.9 mg/dL) | 1.41 mmol/L (54.6 mg/dL) |
| % CV (within run) | 0.85% | 1.1% |
| % CV (total) | 5.5% | 2.3% |
| Sensitivity | 6.4 X 10⁻² ΔA per mmol/L (1.7 X 10⁻³ ΔA per mg/dL) | 8.2 X 10⁻² ΔA per mmol/L (2.1 X 10⁻³ ΔA per mg/dL) |
| Accuracy (Sample Size n) | 232 | 258 |
| Corr. Coefficient | 0.998 | 0.901 |
| Linear Regression | 0.99x - 0.05 mmol/L (0.99x - 1.93 mg/dL) | 0.77x + 0.33 mmol/L (0.77x + 12.8 mg/dL) |
| On-board Stability | 8 weeks | 12 weeks |
Note: The document presents the performance of both the "new device" (COBAS INTEGRA HDL-D reagent cassette) and the "predicate device" (COBAS INTEGRA HDL reagent system) side-by-side. The acceptance criteria for the new device are implied to be achieving comparable performance to the predicate, demonstrating substantial equivalence. The table above uses the predicate's performance as the benchmark for "acceptance criteria."
2. Sample Size Used for the Test Set and Data Provenance
- Sample Size for Accuracy: 258 clinical samples were used for the accuracy study of the COBAS INTEGRA HDL-D reagent cassette.
- Data Provenance: The document does not explicitly state the country of origin or whether the data was retrospective or prospective. Given the nature of medical device submissions, it would typically be prospective clinical data collected under controlled conditions.
3. Number of Experts Used to Establish Ground Truth for the Test Set and Qualifications
The document describes an assay for quantitative determination of HDL-Cholesterol Direct. The "ground truth" in this context refers to the true concentration of HDL cholesterol in the samples.
- Experts: Not applicable in the traditional sense for establishing ground truth for a quantitative assay. The ground truth for such assays is established through a reference method or a predicate device that has already been validated and accepted. The predicate device (COBAS INTEGRA HDL reagent system) served as the comparator for accuracy.
- Qualifications of Experts: Not relevant here as ground truth is determined by chemical analysis or comparative measurement, not expert opinion.
4. Adjudication Method for the Test Set
Not applicable. Adjudication is typically used when human interpretation or subjective assessment is part of the ground truth determination (e.g., in imaging studies). For a quantitative chemical assay, the comparison is directly between the result of the new device and the result of the reference/predicate method.
5. Multi-Reader Multi-Case (MRMC) Comparative Effectiveness Study
No, a Multi-Reader Multi-Case (MRMC) comparative effectiveness study was not conducted. MRMC studies are typically used for imaging or diagnostic tools where human readers interpret results, and the study aims to assess the impact of AI assistance on human performance. This submission is for a quantitative in vitro diagnostic reagent, which does not involve human interpretation in the same manner.
6. Standalone (Algorithm Only) Performance Study
Yes, a standalone performance study was conducted. The accuracy, precision, and sensitivity results presented in Table 2 for the COBAS INTEGRA HDL-D reagent cassette represent its standalone performance without human-in-the-loop assistance. The device directly measures HDL-D concentration.
7. Type of Ground Truth Used
The ground truth used for performance evaluation, particularly for accuracy, was based on comparison to a legally marketed predicate device (COBAS INTEGRA HDL reagent system). This predicate device itself quantifies HDL cholesterol using an enzymatic, colorimetric method. In essence, the new device's measurements were compared against the established measurements from the predicate device to show agreement.
8. Sample Size for the Training Set
The document does not provide information regarding a separate training set. For in vitro diagnostic reagents like this, the development process typically involves internal method development and optimization, but the specific term "training set" (common in AI/ML contexts) is not used, nor is a sample size provided for such a set. The presented data appears to be for verification and validation of the final product.
9. How the Ground Truth for the Training Set Was Established
As no training set information is provided, there is no information on how ground truth for a training set (if one existed during development) was established. For chemical assays, the development process would involve optimizing reagents and reaction conditions against known standards or reference methods to ensure accurate measurement across a range of concentrations.
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