(70 days)
This in vitro method is intended to quantitatively measure Quiniciding drug, in human serum or plasma (heparin) using Syva EMIT® 2000 Assay on a Technicon Immuno-10 system. Measurements of quinidine are used in the diagnosis and treatment of quinidine overdose and in monitoring serum levels of quinidine to ensure appropriate therapy.
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Acceptance Criteria and Device Performance Study
The provided document describes a comparison study rather than an explicit set of acceptance criteria for a new device. However, by comparing the performance of the Immuno 1 Quinidine method to a previously cleared predicate device (Syva EMIT® 2000 Quinidine Assay), the "acceptance criteria" can be inferred as demonstrating comparable performance to the predicate device.
1. Table of Acceptance Criteria and Reported Device Performance
| Performance Metric | Inferred Acceptance Criteria (Based on Predicate Device) | Reported Immuno 1 Quinidine Performance |
|---|---|---|
| Minimum Detectable Conc. | ≤ 0.25 µg/mL | 0.06 µg/mL |
| Precision (Between-Run) | 1.5 µg/mL: ≤ 6.5% CV | 1.2 µg/mL: 5.5% CV |
| (Between-Run) | 3.4 µg/mL: ≤ 5.2% CV | 3.5 µg/mL: 4.8% CV |
| (Between-Run) | 5.7 µg/mL: ≤ 5.6% CV | 6.0 µg/mL: 5.3% CV |
| Correlation (vs. Predicate) | High correlation (e.g., r > 0.95 and slope ≈ 1, intercept ≈ 0) | y = 1.02x - 0.16, r = 0.991, Syx = 0.148 µg/mL |
2. Sample Size Used for the Test Set and Data Provenance
- Sample Size: Initial sample size for the correlation study was
n = 25. An additional number of patients were requested, and data was provided in a 11/26/96 memo, which reportedly caused "no significant change in correlation." The exact total sample size after the addition is not specified, but it's more than 25. - Data Provenance: Not explicitly stated (e.g., country of origin). The study is retrospective in the sense that the data was collected and then analyzed for submission, typical for a comparison study to a predicate. The samples were human serum or plasma.
3. Number of Experts Used to Establish the Ground Truth for the Test Set and Qualifications of those Experts
Not applicable. This study does not involve expert-established ground truth in the traditional sense of diagnostic imaging or clinical consensus. The "ground truth" for the comparison is the measurement obtained from the predicate device (Syva EMIT® 2000 Quinidine Assay).
4. Adjudication Method for the Test Set
Not applicable. No expert adjudication method (like 2+1, 3+1) was used as the ground truth was established by the predicate device's measurements.
5. If a Multi-Reader Multi-Case (MRMC) Comparative Effectiveness Study was Done
No, an MRMC comparative effectiveness study was not done. This is a comparison of analytical performance between two laboratory assays, not a study evaluating human reader performance with or without AI assistance.
6. If a Standalone (i.e., algorithm only without human-in-the-loop performance) was Done
Yes, this study inherently describes the standalone performance of the Immuno 1 Quinidine method (the "algorithm" in this context refers to the assay's methodology). Its measurements are compared directly to the predicate device's measurements.
7. The Type of Ground Truth Used
The ground truth used for the comparison study was the measurements obtained from the predicate device, the Syva EMIT® 2000 Quinidine Assay. This is a form of "reference method" comparison, where the predicate serves as the established and accepted measurement technique.
8. The Sample Size for the Training Set
Not applicable. This document describes a validation study for an in vitro diagnostic (IVD) assay, not a machine learning model that requires a distinct training set. The assay itself is a chemical-biological system, not an algorithm that learns from training data.
9. How the Ground Truth for the Training Set Was Established
Not applicable, as there is no training set in the context of this IVD assay's development and validation.
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DEC 24 1998
SUMMARY OF SAFETY AND EFFECTIVENESS
Quinidine Method for Bayer Technicon Immuno 1 System
Listed below is a comparison of the performance between the Immuno 1 Quinidine method and a similar device that was granted clearance of substantial equivalence (Syva EMTT® 2000 Quindine Assay, Behring Diagnostics Inc.). The information used in the Summary of Safety and Effectiveness was extracted from the Immuno 1 Quinidine method sheet and the Syva EMIT® 2000 Quinidine Assay insert.
INTENDED USED
This in vitro method is intended to quantitatively measure Quiniciding drug, in human serum or plasma (heparin) using Syva EMIT® 2000 Assay on a Technicon Immuno-10 system. Measurements of quinidine are used in the diagnosis and treatment of quinidine overdose and in monitoring serum levels of quinidine to ensure appropriate therapy.
| METHOD | Immuno 1 Quinidine | Syva EMIT® 2000(predicate Device) | ||
|---|---|---|---|---|
| Part No. | Reagents T01-3678-51Calibrators T03-3680-01 | ReagentsCalibrators | 4Q019UL4Q109UL | |
| Minimum Detectable Conc. | 0.06 µg/mL | 0.25 µg/mL | ||
| Precision (Between-Run) | 1.2 µg/mL 5.5%3.5 µg/mL `4.8%6.0 µg/mL 5.3% | 1.5 µg/mL 6.5%3.4 µg/mL 5.2%5.7 µg/mL 5.6% | ||
| Correlation | * | y = 1.02x - 0.16wherey = Immuno 1 Quinidine methodx = Syva EMIT® 2000 Quinidine Assay*n = 25r=0.991Syx =0.148 µg/mL |
*This assay was performed on Roche COBAS FARA II® Instrument.
Gabriel J. Menaca, Jr.
Gabriel J. Muraca, Jr. Manager Regulatory Affairs Bayer Corporation 511 Benedict Avenue Tarrytown, New York 10591-5097
10/11/96
Date
- Please Note: Additional # patients requested, DATA provided in 11/26/96 memo. No significant Change in Correlatioい。 R013.
§ 862.3320 Digoxin test system.
(a)
Identification. A digoxin test system is a device intended to measure digoxin, a cardiovascular drug, in serum and plasma. Measurements obtained by this device are used in the diagnosis and treatment of digoxin overdose and in monitoring levels of digoxin to ensure appropriate therapy.(b)
Classification. Class II.