The Alere Cholestech LDX® System is a small, portable analyzer and test cassette system. The System is for in vitro diagnostic use only. The Lipid Profile GLU Cassette is for the quantitative determination of total cholesterol, HDL (high-density lipoprotein) cholesterol, triglycerides and glucose in whole blood. A TC/HDL (total cholesterol/HDL cholesterol ratio and estimated values for LDL (low-density lipoprotein) and non-HDL cholesterol are calculated by the Alere Cholestech LDX® Analyzer.
- Cholesterol measurements are used in the diagnosis and treatment of disorders involving excess cholesterol in the blood and lipid and lipoprotein metabolism disorders.
- HDL (lipoprotein) measurements are used in the diagnosis and treatment of lipid disorders (such as diabetes mellitus), atherosclerosis, and various liver and renal diseases.
- Triglyceride measurements are used in the diagnosis and treatment of patients with diabetes mellitus, nephrosis, liver obstruction, other diseases involving lipid metabolism, or various endocrine disorders.
- Glucose measurements are used in the diagnosis and treatment of carbohydrate metabolism disorders including diabetes mellitus, neonatal hypoglycemia, and idiopathic hypoglycemia, and of pancreatic islet cell carcinoma.
The Alere Cholestech LDX® System is a small, portable analyzer and test cassette system is for in vitro diagnostic use only. The Lipid Profile GLU Cassette is for the quantitative determination of total cholesterol, HDL (high-density lipoprotein) cholesterol, triglycerides and glucose in whole blood. A TC/HDL (total cholesterol/HDL cholesterol ratio and estimated values for LDL (low-density lipoprotein) and non-HDL cholesterol are calculated by the Alere Cholestech LDX® Analyzer.
Here's an analysis of the acceptance criteria and study information based on the provided text:
1. Table of Acceptance Criteria and Reported Device Performance:
The document describes acceptability based on substantial equivalence to an earlier version of the device, primarily focusing on the impact of a software upgrade that incorporates a humidity sensor. The acceptance criteria aren't explicitly stated as numerical targets in a table, but rather as demonstrating that the updated device performs equivalently to the predicate device, especially considering the correction factor applied for humidity.
The key performance aspect mentioned is that analytical results are unchanged when operated between 40% and 60% relative humidity, and that a small correction factor is applied for humidity levels between 20-40% RH and 60-80% RH. This implies that the device, after applying the correction, should produce results comparable to the predicate device across the specified humidity ranges.
| Acceptance Criteria (Implied) | Reported Device Performance |
|---|---|
| Substantial equivalence to predicate device (v3.30 software). | Performance testing demonstrates that the software upgrade from revision v3.30 to v3.41 is substantially equivalent. |
| Analytical results unchanged at 40-60% Relative Humidity (RH). | Analytical results when the analyzer is operated between 40% and 60% relative humidity are unchanged and no correction factor is required. |
| Small correction factor applied for 20-40% RH and 60-80% RH. | In more extreme cases, when the ambient humidity is between 20% RH and 40% RH, or between 60% RH and 80%RH, a small correction factor is applied (from a lookup table to the result from the assay algorithm). The analytical performance has been returned to its original intent (implying the correction maintains accuracy). |
| Intended Use and Indications for Use remain unchanged. | The Intended use is unchanged. The Indications for use is unchanged. |
| Manufacturing process remains unchanged. | The manufacturing process is unchanged. |
| Performance maintained despite humidity changes/corrections. | (Implied by "substantial equivalence" and "analytical performance has been returned to its original intent" after applying the correction factor.) |
2. Sample Size Used for the Test Set and Data Provenance:
The document mentions "Performance testing demonstrates that the software upgrade..." but does not specify the sample size used for the test set.
Data Provenance: The document does not explicitly state the country of origin or whether the data was retrospective or prospective. It is a submission to the FDA, suggesting a US-centric regulatory context, but detailed provenance is absent.
3. Number of Experts Used to Establish Ground Truth and Qualifications:
This information is not provided in the document. The device is an in-vitro diagnostic system for quantitative determination of analytes (cholesterol, HDL, triglycerides, glucose), typically validated against reference methods rather than expert consensus on images or clinical assessments.
4. Adjudication Method for the Test Set:
This information is not provided. Given that this is an IVD device for quantitative measurements, adjudication in the sense of multiple experts reviewing results is unlikely to be the primary method for ground truth establishment. Instead, comparison against a reference method would be expected.
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 imaging devices or AI tools where human readers interpret results, and the document describes an automated in-vitro diagnostic system.
6. If a Standalone Study (Algorithm Only Without Human-in-the-Loop Performance) Was Done:
Yes, a standalone study was done. The "Performance testing" mentioned is specifically to demonstrate the performance of the device itself (analyzer + software + cassette), operating without human interpretation of the results to establish the primary measurements. The update specifically addresses the algorithm's behavior with the new humidity sensor and correction factor.
7. Type of Ground Truth Used:
The document does not explicitly state the type of ground truth used. However, for quantitative in-vitro diagnostic devices, the typical ground truth established in performance testing would involve:
- Reference Methods: Comparison of the device's quantitative results against established, highly accurate laboratory reference methods (e.g., CDC-certified reference methods for lipids and glucose).
- Traceability to Certified Standards: Ensuring the device's measurements are traceable to international or national certified reference materials and methods.
The phrase "analytical performance has been returned to its original intent" implies that the new software's results, especially after humidity correction, align with the performance previously validated against such reference methods.
8. Sample Size for the Training Set:
The document does not mention a training set in the context of machine learning or AI algorithm development. The change is described as a software revision that incorporates a humidity sensor and applies a correction factor from a "lookup table." This suggests a rule-based or empirically derived correction rather than a machine learning model that would require a distinct training set.
9. How the Ground Truth for the Training Set Was Established:
Since there is no mention of a training set in the context of machine learning, this information is not applicable and not provided. The "lookup table" for humidity correction would likely have been developed through internal testing and calibration processes, comparing device readings at various humidity levels against known, accurate values, but this is not explicitly detailed as a "training set" in the AI sense.
§ 862.1345 Glucose test system.
(a)
Identification. A glucose test system is a device intended to measure glucose quantitatively in blood and other body fluids. Glucose measurements are used in the diagnosis and treatment of carbohydrate metabolism disorders including diabetes mellitus, neonatal hypoglycemia, and idiopathic hypoglycemia, and of pancreatic islet cell carcinoma.(b)
Classification. Class II (special controls). The device, when it is solely intended for use as a drink to test glucose tolerance, is exempt from the premarket notification procedures in subpart E of part 807 of this chapter subject to the limitations in § 862.9.