Search Results

Good Biotech Corp. CRPex-HS CRP Calibrator Set is intended to be used with CRPex-HS C-Reactive Protein LIT Assay for the quantitative determination of C-reactive protein (CRP) in serum samples. For In Vitro Diagnostic Use.

The calibrators contain certain quantities of human C-reactive protein (CRP). CRPex-HS CRP Calibrator Set is intended to be used with CRPex-HS C-Reactive Protein LIT Assay for the quantitative determination of CRP in serum samples.

Here's an analysis of the provided text regarding the CRPex-HS CRP Calibrator Set, focusing on acceptance criteria and study details:

1. Table of Acceptance Criteria and Reported Device Performance

The submission for the CRPex-HS CRP Calibrator Set is a 510(k) premarket notification for a device that is substantially equivalent to a predicate. As such, explicit "acceptance criteria" for performance are not typically presented in the same way they would be for a de novo device. Instead, the primary "acceptance criterion" is generally "substantial equivalence" to the predicate device.

For calibration devices, this usually involves demonstrating comparable performance characteristics, particularly in terms of correlation with the predicate device across a range of expected concentrations.

2. Sample Size Used for the Test Set and Data Provenance

• Sample Size for Test Set: N = 67 (This refers to the number of data points used in the correlation study between the CRPex-BR CRP LIT Kit and the Wako CRP-UL predicate.)
• Data Provenance: Not specified in the provided document. It does not mention the country of origin of the data or whether it was retrospective or prospective.

3. Number of Experts Used to Establish Ground Truth for the Test Set and Qualifications

• This is a calibration device used with an immunoassay for measuring C-reactive protein. The "ground truth" for such a device is typically established through reference materials and methodologies, rather than expert consensus on diagnostic images or clinical outcomes.
• The document states that both the CRPex-HS CRP Calibrator Set and the predicate device are traceable to CAP/BCR/IFCC RPPHS, lot 91/0619. This implies that the 'ground truth' or accuracy of the calibrators is linked to this internationally recognized reference material, which would have been characterized by expert committees in the field of clinical chemistry/immunology. The number and specific qualifications of the experts involved in establishing this reference material are not provided within this 510(k) summary, as it's an external, established reference.

4. Adjudication Method for the Test Set

• Not applicable in the conventional sense. The test set involves quantitative comparison of CRP concentrations, not subjective interpretations requiring adjudication. The correlation study directly compares measurements from the test device's associated assay (CRPex-BR CRP LIT Kit) when calibrated by the test calibrator, against measurements given by the predicate calibrator.

5. If a Multi-Reader Multi-Case (MRMC) Comparative Effectiveness Study Was Done

• No, a Multi-Reader Multi-Case (MRMC) comparative effectiveness study was not done. MRMC studies are typically used for diagnostic imaging devices where human readers interpret results, and the study assesses the impact of AI assistance on their performance. This device is a calibrator for an in vitro diagnostic assay, where direct human interpretation of the calibrator itself is not the primary function.

6. If a Standalone (i.e., algorithm only without human-in-the-loop performance) Was Done

• This question is not directly applicable in the typical sense for a calibrator. A calibrator is a physical substance used to set the measurement scale for an assay that then quantifies an analyte (CRP). It's not an "algorithm" in the way an AI diagnostic tool would be. However, the performance data provided (correlation, R²) effectively represents the "standalone" performance of the new calibrator in conjunction with its intended assay, compared to the predicate. The "human-in-the-loop" for this type of device would be the lab technician performing the assay, which is external to the calibrator's function itself.

7. The Type of Ground Truth Used

• The ground truth used for the CRP concentrations in the calibrators themselves is based on traceability to a recognized international reference material: CAP/BCR/IFCC RPPHS, lot 91/0619. This ensures the measured values of CRP in the calibrator are accurate and standardized.

8. The Sample Size for the Training Set

• The document does not explicitly mention a "training set" in the context of an AI/machine learning algorithm. This device is a calibrator, not an AI system that learns from data.
• The reported "N = 67" likely refers to the number of samples or measurements in the correlation study (test set), not a training set.

9. How the Ground Truth for the Training Set Was Established

• As a "training set" for an AI algorithm is not applicable here, this question is not relevant. The CRP concentrations in the calibrators are established through the manufacturing process and verified against the aforementioned international reference standard.

Ask a specific question about this device