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510(k) Data Aggregation
(95 days)
BIO-RAD HOMOCYSTEINE BY HPLC
The Bio-Rad Homocysteine by HPLC test is intended for the quantitative determination of total Homocysteine in human plasma or serum. The device can assist in the diagnosis and treatment of patients suspected of having hyperhomocysteinemia or homocysteinuria. For in vitro diagnostic use only.
The Bio-Rad Homocysteine by HPLC test is based on precolumn derivatization and a 5 minute chromatography. The precolumn derivatization includes a release of the plasma/serum bound fraction of Homocysteine by a chemical reduction and subsequent fluorescent labeling with a thiolspecific dye. Reduction and derivatization require only 5 minute incubation. Separation of Homocysteine, Internal Standard and other biological thiols (Glutathione, Cysteine, Cysteinglycine) takes place on a selected Reversed Phase cartridge followed by fluorescence detection (lex = 385 nm, lem = 515 nm). Quantitative analysis is performed using the Bio Rad Clinical Data Management System (K960392).
The Bio-Rad Homocysteine by HPLC assay establishes substantial equivalence to an existing device, the AXIS® Homocysteine Enzyme Immunoassay, to demonstrate its safety and effectiveness.
1. Table of Acceptance Criteria and Reported Device Performance:
The document doesn't explicitly state "acceptance criteria" for the Bio-Rad Homocysteine by HPLC assay. However, it presents a comparison of its performance characteristics against the predicate device, AXIS® Homocysteine Enzyme Immunoassay, to establish substantial equivalence. The key performance indicator for proving substantial equivalence appears to be the correlation study.
| Parameter | Bio-Rad Homocysteine by HPLC (Reported Performance) | AXIS® Homocysteine Enzyme Immunoassay (Predicate Performance) |
|---|---|---|
| Coefficient of Correlation | 0.9472 (against AXIS® Homocysteine) | N/A (this is the reference for correlation) |
| Slope | 1.023 (against AXIS® Homocysteine) | N/A |
| Y-Intercept | -0.542 (against AXIS® Homocysteine) | N/A |
| Analytes Measured/Reported | Homocysteine | Homocysteine |
| Basic Principle | Chromatography | Immunoassay |
| Derivatization | Pre-column | Enzymatic conversion to SAH |
| Separation Mechanism | Reverse Phase | Monoclonal Antibody |
| Detection Mechanism | Fluorescence | Spectrophotometric |
| Measurement Type | Quantitative | Quantitative |
| Sample Type | Serum or Plasma | Serum or Plasma |
| Calibrators | Single (15 - 20 µMol/L) | 2, 4, 8, 15, 30, & 50 µMol/L |
| Reportable Range | 0.5 - 100 µMol/L | 2 - 50 µMol/L |
| Precision (Within Run Total) | Low: 8.25 µMol/L, 3.77% CV (intra), 4.40% CV (total) | |
| Mid: 19.53 µMol/L, 1.87% CV (intra), 2.60% CV (total) | ||
| High: 39.96 µMol/L, 1.16% CV (intra), 2.74% CV (total) | Low: 6.1 µMol/L, 7.3% CV (intra), 9.3% CV (total) | |
| Mid: 10.3 µMol/L, 6.8% CV (intra), 8.1% CV (total) | ||
| High: 21.4 µMol/L, 5.2% CV (intra), 7.1% CV (total) | ||
| Sensitivity | 0.5 µMol/L | 0.5 µMol/L |
| Expected Values (95% Conf. L.) | 5.7 - 15.1 µMol/L | 5 - 15 µMol/L |
Acceptance Criteria (Implied): The primary acceptance criterion for substantial equivalence is an excellent correlation between the Bio-Rad Homocysteine by HPLC method and the predicate AXIS® Homocysteine Enzyme Immunoassay. The reported correlation coefficient of 0.9472 is presented as fulfilling this criterion, along with a slope close to 1.0 (1.023) and a Y-intercept close to 0 (-0.542). The other performance parameters are presented for comparative purposes to demonstrate similar performance characteristics.
2. Sample Size Used for the Test Set and Data Provenance:
The document mentions a "correlation study" to determine accuracy but does not specify the sample size used for this test set. The data provenance is also not explicitly stated (e.g., country of origin, retrospective or prospective).
3. Number of Experts Used to Establish the Ground Truth for the Test Set and Qualifications of Those Experts:
This information is not applicable as the "ground truth" for the test set in this context is the measurement obtained from the predicate device, the AXIS® Homocysteine Enzyme Immunoassay, not expert consensus. Therefore, no experts were used to establish ground truth in the traditional sense.
4. Adjudication Method for the Test Set:
This is not applicable. The comparison is a quantitative measurement against a predicate device, not a subjective interpretation requiring adjudication.
5. If a Multi-Reader Multi-Case (MRMC) Comparative Effectiveness Study Was Done, and If So, What Was the Effect Size of How Much Human Readers Improve With AI vs Without AI Assistance:
This is not applicable. This device is an in-vitro diagnostic assay, not an imaging device or an AI-assisted diagnostic tool that involves human readers.
6. If a Standalone (i.e., algorithm only without human-in-the-loop performance) Was Done:
The study performed is effectively a standalone performance evaluation of the Bio-Rad Homocysteine by HPLC assay, comparing its results directly to the predicate device. It assesses the algorithm's (or, in this case, the assay's) performance without human interpretation or intervention in the measurement process for the purpose of the correlation study.
7. The Type of Ground Truth Used:
The ground truth used for establishing substantial equivalence is the results obtained from the legally marketed predicate device, the AXIS® Homocysteine Enzyme Immunoassay method.
8. The Sample Size for the Training Set:
This information is not applicable. The Bio-Rad Homocysteine by HPLC device is an analytical assay, not a machine learning algorithm that requires a "training set" in the conventional sense. Its method is based on established chemical and chromatographic principles.
9. How the Ground Truth for the Training Set Was Established:
This information is not applicable for the reasons stated in point 8.
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