(50 days)
The ATAC PAK Direct HDL Reagent Kit, the ATAC Direct HDL Calibrator and the ATAC 8000 Random Access Chemistry System are intended for use as a system for the quantitative determination of HDL-cholesterol in serum and plasma. HDL-cholesterol results are used in the diagnosis and treatment of lipid disorders (such as diabetes mellitus), atherosclerosis, and various liver and renal diseases, and for the risk of developing cardiovascular disease. This reagent is intended to be used by trained personnel in a professional setting and is not intended for home use.
The ATAC PAK Direct HDL Reagent determines HDL-cholesterol through the enzymatic action of cholesterol esterase and cholesterol oxidase on HDL-cholesterol while rendering other sources of cholesterol inactive. The resulting increase in absorbance at approximately 600 nm is proportional to the HDL-cholesterol concentration in the sample.
Here's a breakdown of the acceptance criteria and the study details for the ATAC PAK Direct HDL Reagent Kit, ATAC Direct HDL Calibrator, and ATAC 8000 Random Access Chemistry System, based on the provided document:
1. Table of Acceptance Criteria and Reported Device Performance
| Acceptance Criteria | Reported Device Performance (ATAC PAK Direct HDL Reagent) |
|---|---|
| Linearity Range | 10 to 140 mg/dL |
| Linearity Regression | (ATAC Recoveries) = 0 mg/dL + 0.9570 x (Standard Factors), sv.x = 4.5 mg/dL, r = 0.995 (for n = 40) |
| Precision (Within Run) - Serum 1 (~26 mg/dL) | 1SD = 1.0 mg/dL, %CV = 3.8% |
| Precision (Within Run) - Serum 2 (~55 mg/dL) | 1SD = 1.5 mg/dL, %CV = 2.8% |
| Precision (Within Run) - Serum 3 (~68 mg/dL) | 1SD = 2.0 mg/dL, %CV = 2.9% |
| Precision (Total) - Serum 1 (~26 mg/dL) | 1SD = 1.9 mg/dL, %CV = 7.4% |
| Precision (Total) - Serum 2 (~55 mg/dL) | 1SD = 2.8 mg/dL, %CV = 5.1% |
| Precision (Total) - Serum 3 (~68 mg/dL) | 1SD = 2.7 mg/dL, %CV = 3.9% |
| Comparison to Competitive Reagent (Regression) | ATAC 8000 = 2.8 mg/dL + 0.912 x Competitive Reagent |
| Comparison to Competitive Reagent (Correlation) | r = 0.978 |
| Comparison to Competitive Reagent (Range) | 4.7 - 123 mg/dL |
| Detection Limit Claim | 10 mg/dL |
| Observed Detection Limit | 1.5 mg/dL (calculated as two standard deviations of a 30 replicate within-run precision study of a diluted serum pool) |
| On-board Reagent Stability | 30 days |
| Calibration Stability | 14 days |
| Stability Performance (Total Imprecision during stated stability periods) | Less than 3 mg/dL or 6% |
2. Sample Sizes Used for the Test Set and Data Provenance
- Linearity Study: n = 40 (for regression comparison of standard recoveries to standard factors, indicating the number of data points used to establish linearity). The provenance of these "standard factors" is not explicitly stated, but it implies a controlled laboratory setting.
- Precision (Replicate Assay): n = 66 (replicates for each of Serum 1, Serum 2, and Serum 3). The samples are described as "commercially available control serum and a serum pool," suggesting a controlled lab setting, likely in the US, but the country of origin is not explicitly stated. This was a retrospective analysis of method performance.
- Serum/Plasma Comparison: n = 156 ("mixed serum and plasma specimens, collected from adult patients"). The specific country of origin is not mentioned, but the overall context of the submission to the FDA in the US suggests a US-based study or data relevant to the US market. The phrasing "collected from adult patients" suggests a prospective or retrospectively collected clinical sample set.
- Detection Limit: 30 replicates of a diluted serum pool. Provenance is not specified, but likely a controlled lab setting.
3. Number of Experts Used to Establish the Ground Truth for the Test Set and Qualifications of Those Experts
This document describes a clinical chemistry device for quantitative determination, not an imaging or diagnostic interpretation device that typically relies on expert consensus for ground truth. Therefore, the concept of "experts" to establish ground truth in the traditional sense (e.g., radiologists interpreting images) does not apply here.
The "ground truth" for comparison is often established by a reference method or a competitive reagent. In this case, the Roche HDL-Cholesterol plus Reagent Kit is identified as the substantially equivalent predicate device, and the "Competitive Reagent" is used for comparison in the serum/plasma study. The qualifications of those who developed or validated the competitive reagent are not stated in this document.
4. Adjudication Method for the Test Set
Not applicable. This is a quantitative measurement device, not one requiring diagnostic interpretation and adjudication of results by multiple experts. The "ground truth" for comparison is either a known value (for linearity standards), a reference method, or a competitive reagent.
5. If a Multi-Reader Multi-Case (MRMC) Comparative Effectiveness Study Was Done
No. An MRMC study is relevant for diagnostic devices where human readers interpret cases (e.g., radiology images). This documentation describes the performance of a quantitative laboratory diagnostic system, not one involving human interpretation of cases.
6. If a Standalone (i.e., algorithm only without human-in-the-loop performance) Was Done
Yes, this entire study describes the standalone performance of the ATAC PAK Direct HDL Reagent Kit and the ATAC Direct HDL Calibrator used on the ATAC 8000 Random Access Chemistry System. It reports the analytical performance characteristics of the device itself (linearity, precision, detection limit, correlation with a competitive method, and stability). There is no "human-in-the-loop" component in the direct measurement of HDL-cholesterol by this automated chemistry system.
7. The Type of Ground Truth Used
- Known Values/Standards: For the linearity study, "standard recoveries to standard factors" were compared, implying a ground truth established by known concentrations of HDL-cholesterol.
- Reference Method/Competitive Reagent: For the serum/plasma comparison, the "Competitive Reagent" (implicitly the Roche HDL-Cholesterol plus Reagent Kit or a similar validated method) served as the comparative standard.
- Analytical Determination: For precision and detection limit, the ground truth is based on statistical analysis of repeated measurements, effectively using the device's own measurements against each other to assess consistency.
8. The Sample Size for the Training Set
The document does not explicitly mention a "training set" in the context of machine learning. This is a traditional chemical assay, not an AI/ML-based device that typically requires distinct training and test sets. The studies described here are analytical validation studies for the device's performance.
9. How the Ground Truth for the Training Set Was Established
Not applicable, as there is no mention of a "training set" in the context of an AI/ML model. The ground truth for the analytical validation studies was established as described in section 7.
§ 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.