(27 days)
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The Wako L-Type Triglyceride test is an in vitro assay for the quantitative determination of triglyceride in serum. The Wako L-Type Triglyceride is an enzymatic method utilizing N-ethyl-N-(2-hydroxy-3sulfopropyl)-3,5-dimethoxyaniline sodium salt (DAOS) that produces blue pigment. Triglycerides in a sample are hydrolyzed to glycerol and free fatty acids in a reaction catalyzed by lipoprotein lipase (LPL). Glycerol is converted to glycerol-3-phosphate by glycerokinase (GK) in the presence of adenosine-5'-triphosphate(ATP). Glycerol-3-phosphate formed is oxidized by GPO in a reaction that produces hydrogen peroxide. The hydrogen peroxide produced causes DAOS and 4-aminoantipyrine to undergo a quantitative condensation catalyzed by peroxidase (POD), producing a blue pigment. The amount of triglycerides contained in the sample is determined by measuring the absorbance of the blue color.
This Preamarket Notification (510(k)) for the Wako L-Type Triglyceride Test focuses on demonstrating substantial equivalence to a predicate device rather than presenting a standalone study with detailed acceptance criteria and performance metrics typically seen for novel diagnostic algorithms or devices.
Here's an analysis based on the provided text:
1. Table of Acceptance Criteria and Reported Device Performance
| Acceptance Criteria | Reported Device Performance |
|---|---|
| Correlation to Predicate Device (Wako Triglyceride 30R) | Correlation coefficient of 0.9995 |
| Regression Equation (vs. Predicate) | y = 0.970x + 2.2 |
| Precision | "Precision studies indicate acceptable values can be obtained on a day to day basis." (No specific numerical criteria or performance provided beyond this qualitative statement) |
| Minimum Detectable Level | 1.2 mg/dL |
| Clinical Use/Indications | "Measurements obtained by this test are used in the diagnosis and treatment of hyperlipidemia, hyperlipoproteinemia, and atherosclerosis, and in connection with diabetes mellitus, nephrosis, some metabolic diseases and other diseases of the liver and thyroid." |
2. Sample Size Used for the Test Set and Data Provenance
- The document does not specify the sample size used for the comparison studies against the predicate assay.
- The document does not specify the country of origin of the data.
- The document does not explicitly state if the data was retrospective or prospective. However, typically, such comparison studies for 510(k) submissions would likely use retrospective samples or samples collected specifically for the comparison.
3. Number of Experts Used to Establish the Ground Truth for the Test Set and Qualifications of Those Experts
- This information is not applicable in the context of this 510(k) submission. For this type of in vitro diagnostic device (IVD), the "ground truth" for the comparison study is the performance of the legally marketed predicate device (Wako Triglyceride 30R). There are no human experts "establishing ground truth" in the way one would for image-based diagnostics requiring expert consensus. The predicate device itself serves as the reference standard.
4. Adjudication Method for the Test Set
- This is not applicable as there is no "adjudication" in the sense of reconciling disagreements between multiple human readers or interpretations. The comparison is between the new device's measurements and 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 type of study is relevant for devices that assist human readers in interpreting complex data (e.g., medical images). The Wako L-Type Triglyceride Test is an in vitro assay that provides a quantitative measurement, not an interpretative aid for human readers.
6. If a Standalone (i.e., algorithm only without human-in-the-loop performance) Was Done
- Yes, the study presented is inherently a standalone performance study for an in vitro diagnostic device. The Wako L-Type Triglyceride test is an automated enzymatic assay. Its performance (correlation, regression, precision, minimum detectable level) is assessed directly without human input in the measurement process itself, only in the handling of samples and running the assay.
7. The Type of Ground Truth Used
- The "ground truth" for the comparison study was the measurements obtained from the legally marketed predicate device, Wako Triglyceride 30R. This functions as a reference standard for establishing substantial equivalence.
8. The Sample Size for the Training Set
- This document does not provide information on a "training set" sample size. For an IVD like this, there isn't a traditional "training set" in the machine learning sense. The device's formulation and assay parameters would have been developed/optimized by the manufacturer prior to these validation studies.
9. How the Ground Truth for the Training Set Was Established
- This is not applicable as there's no explicit "training set" or "ground truth for training" described in the context of this 510(k) summary for an enzymatic assay. The development process for such an assay involves chemical and enzymatic optimization, calibration, and early-stage validation, but not a "ground truth" establishment in the data-driven sense of algorithm training.
§ 862.1705 Triglyceride test system.
(a)
Identification. A triglyceride test system is a device intended to measure triglyceride (neutral fat) in serum and plasma. Measurements obtained by this device are used in the diagnosis and treatment of patients with diabetes mellitus, nephrosis, liver obstruction, other diseases involving lipid metabolism, or various endocrine disorders.(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.