(51 days)
The AHDL method for the Dimension® clinical chemistry system is an in vitro diagnostic test intended to quantitatively measure high density lipoprotein cholesterol (HDL-C) in human serum and plasma. HDL-C measurements are used as an aid in the diagnosis of lipid disorders.
The Dimension® Automated HDL Cholesterol (AHDL) Flex® reagent cartridge (DF48A) is an in vitro diagnostic device that consists of prepackaged reagents in a plastic cartridge (Flex®) for use on the Dade Behring Dimension® clinical chemistry system.
This document describes a 510(k) premarket notification for a revised in vitro diagnostic device, the Dimension® Automated HDL Cholesterol (AHDL) Flex® reagent cartridge (DF48A). The purpose of the submission is to demonstrate substantial equivalence to a predicate device, the Dimension® Automated HDL Cholesterol (AHDL) Flex® reagent cartridge (DF48).
Here's an analysis of the provided information, framed by your requested criteria:
1. Table of Acceptance Criteria and Reported Device Performance
For this type of device (in vitro diagnostic for quantitative measurement), acceptance criteria are typically related to the correlation and agreement with a predicate device. The performance is demonstrated through a split-sample comparison study.
| Acceptance Criteria (Implied) | Reported Device Performance |
|---|---|
| Strong linear correlation (e.g., correlation coefficient close to 1) between the revised device and the predicate device. | Correlation Coefficient: 0.995 |
| Acceptable agreement in slope (close to 1) and intercept (close to 0) between the revised device and the predicate device. | Slope: 1.04 |
| Intercept: -3.38 mg/dL [-0.09 mmol/L] |
Note: The document explicitly states "Comments on Substantial Equivalence" and presents these statistical parameters. While explicit 'acceptance criteria' values (e.g., "correlation coefficient > 0.98") are not formally listed, these statistical measures infer the criteria for demonstrating substantial equivalence.
2. Sample Size for the Test Set and Data Provenance
| Sample Size (Test Set) | Data Provenance |
|---|---|
| 101 samples | Clinical patient samples (retrospective/prospective not specified, but typically retrospective for method comparison studies) |
Note: The country of origin for the data is not specified in the provided text.
3. Number of Experts Used to Establish Ground Truth for the Test Set and Qualifications
This information is not applicable and not provided in the document.
- For in vitro diagnostic devices measuring a quantitative analyte like HDL Cholesterol, the "ground truth" for method comparison is typically the result obtained from a legally marketed and accepted predicate device or a reference method, not an expert panel.
- The study compares the new device (DF48A) to an existing, legally marketed predicate device (DF48). The predicate device's results are considered the benchmark for comparison, not a consensus of human experts.
4. Adjudication Method for the Test Set
This information is not applicable and not provided in the document. As explained above, this study is a quantitative method comparison, not one that requires adjudication by experts.
5. Multi-Reader Multi-Case (MRMC) Comparative Effectiveness Study
This information is not applicable and not provided in the document.
- MRMC studies are typically performed for diagnostic imaging devices where human readers interpret images, sometimes with AI assistance.
- This device is an automated in vitro diagnostic test for a chemical analyte (HDL-C) and does not involve human interpretation of cases or a "human-in-the-loop" application in the way an imaging device would.
6. Standalone (Algorithm Only Without Human-in-the-Loop Performance) Study
Yes, this study represents a standalone performance evaluation of the device.
- The device is an "Automated HDL Cholesterol (AHDL) Flex® reagent cartridge." It is designed to quantitatively measure HDL-C in human serum and plasma directly.
- The comparison study evaluates the performance of this automated system directly against the predicate automated system, without any human interpretation or intervention in the measurement process itself.
7. Type of Ground Truth Used
The "ground truth" (or reference standard) for this study is the results obtained from the predicate device, the "Current" Dimension® Automated HDL Cholesterol Flex® reagent cartridge (DF48). This is a common approach for demonstrating substantial equivalence of a new in vitro diagnostic device to an already cleared one.
8. Sample Size for the Training Set
This information is not provided and likely not applicable in the context of this device.
- The Dimension® Automated HDL Cholesterol (AHDL) Flex® reagent cartridge is an in vitro diagnostic device composed of prepackaged reagents that use an "Enzymatic Colormetric Bichromatic Endpoint" detection method. These methods are based on established chemical reactions and principles.
- There's no indication that this device uses machine learning or AI models that would require a "training set" in the conventional sense (e.g., for pattern recognition or classification). The development would involve chemical optimization and calibration, not machine learning model training.
9. How the Ground Truth for the Training Set Was Established
This information is not applicable as there is no indication of a "training set" in the context of machine learning for this device.
§ 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.