(92 days)
Lipid Controls: Assayed quality control materials for use with the Alere Cholestech LDX® system. Alere Cholestech LDX® Level 1 and Level 2 Controls are designed to be used only for monitoring the performance of test procedures on the Alere Cholestech LDX® System.
Multianalyte Control: Assayed quality control materials for use with the Alere Cholestech LDX® system. Alere Cholestech LDX® Level 1 and Level 2 Controls are designed to be used only for monitoring the performance of test procedures on the Alere Cholestech LDX® System.
Calibration Verification: Assayed calibration verification material is designed to be used for verifying the reportable range of tests on the Alere Cholestech LDX® System. This material is designed for use with any Alere Cholestech LDX® cassette type that includes total cholesterol, HDL cholesterol, triglycerides and glucose.
Assayed Quality Control materials and Assayed Calibration Verification materials for use with the Alere Cholestech LDX® system.
The provided text describes the Alere Cholestech LDX® Lipid Controls, Multianalyte Controls, and Calibration Verification materials, but does not contain information about acceptance criteria or a study that proves the device meets specific performance criteria through a clinical trial or algorithm performance evaluation typically associated with medical imaging or AI devices.
This document is a 510(k) summary for a set of quality control materials for an existing diagnostic system (Alere Cholestech LDX® System). The purpose of this submission is to demonstrate substantial equivalence to a legally marketed predicate device, not to evaluate the performance of a new diagnostic algorithm or device against a disease outcome.
Here's a breakdown of why many of your requested items cannot be answered from the provided text:
- Type of Device: The device in question is "Assayed Quality Control materials" and "Assayed Calibration Verification materials." These are reagents/consumables used to ensure an existing diagnostic system (Alere Cholestech LDX® System) is performing correctly. They are not a diagnostic device that interprets patient data or images.
- Nature of the Submission: This is a 510(k) submission focused on a change in manufacturing location and demonstrating that the newly manufactured controls are substantially equivalent to the previously manufactured controls. It explicitly states: "Streck has transferred the responsibility for manufacturing the controls from the Streck manufacturing site (Omaha, Nebraska) to the Alere manufacturing site (San Diego, California). All raw materials, vendors, raw material specifications, generic manufacturing processes, in-process test methods, final release test methods, release specifications and methods of value assignment are unchanged."
Therefore, the information regarding acceptance criteria for diagnostic accuracy, sample sizes for test/training sets, expert consensus, adjudication methods, multi-reader multi-case studies, or standalone algorithm performance against disease outcomes is not relevant to this submission and thus not present in the document.
However, I can extract information related to the substantial equivalence claim, which is the core of this document:
1. A table of acceptance criteria and the reported device performance
The document does not specify quantitative acceptance criteria in terms of sensitivity, specificity, accuracy, or similar metrics typically applied to diagnostic devices for patient outcomes. Instead, the acceptance is based on "substantial equivalence" to a predicate device for quality control materials.
| Acceptance Criteria (Implied by Substantial Equivalence Claim) | Reported Device Performance (Summary of Findings) |
|---|---|
| Intended use is unchanged | Performed as well as the predicate device |
| Indications for use is unchanged | Performed as well as the predicate device |
| The operating principle is unchanged | Performed as well as the predicate device |
| The technology is unchanged | Performed as well as the predicate device |
| The analytical performance is unchanged or improved | Performed as well as the predicate device |
| The manufacturing process is unchanged | Performed as well as the predicate device |
| The formulation is unchanged | Performed as well as the predicate device |
| Safe and effective as the predicate device | Performance testing demonstrates the new controls are as safe, as effective and performs as well as the predicate device. |
Note: The "reported device performance" is a summary statement asserting substantial equivalence, not specific numerical results.
2. Sample sized used for the test set and the data provenance (e.g. country of origin of the data, retrospective or prospective)
The document does not detail specific sample sizes for a "test set" in the context of evaluating a diagnostic algorithm. It mentions "Bench performance testing was performed comparing the new device and the predicate device," but provides no specifics on the number of samples, analytes, or origin of these samples. Given it's quality control material, the "samples" would be aliquots of the control material itself, run on the Cholestech LDX® system.
3. Number of experts used to establish the ground truth for the test set and the qualifications of those experts (e.g. radiologist with 10 years of experience)
This concept is not applicable to the submitted device. There is no "ground truth" established by experts in the context of diagnostic interpretation, as this device consists of quality control materials. The "ground truth" for quality control materials would be their assigned target values, which are established through certified reference methods or robust internal validation processes (not described in detail here beyond "methods of value assignment are unchanged").
4. Adjudication method (e.g. 2+1, 3+1, none) for the test set
Not applicable. Adjudication methods are used in diagnostic studies to resolve discrepancies among multiple expert readers. This is not relevant for quality control materials.
5. If a multi reader multi case (MRMC) comparative effectiveness study was done, If so, what was the effect size of how much human readers improve with AI vs without AI assistance
Not applicable. This device is not an AI diagnostic algorithm; it is quality control material for an existing diagnostic system. An MRMC study is therefore not relevant.
6. If a standalone (i.e. algorithm only without human-in-the-loop performance) was done
Not applicable. This device is not an algorithm.
7. The type of ground truth used (expert consensus, pathology, outcomes data, etc)
Not applicable. As noted in point 3, the concept of a diagnostic "ground truth" (like pathology or outcomes data) is not relevant for quality control materials. The "ground truth" for controls relates to their assayed values.
8. The sample size for the training set
Not applicable. Quality control materials do not involve a "training set" in the AI or machine learning sense.
9. How the ground truth for the training set was established
Not applicable. See point 8. The document states that "methods of value assignment are unchanged," indicating that the established procedures for determining the values of the control materials remain the same as for the predicate device.
§ 862.1660 Quality control material (assayed and unassayed).
(a)
Identification. A quality control material (assayed and unassayed) for clinical chemistry is a device intended for medical purposes for use in a test system to estimate test precision and to detect systematic analytical deviations that may arise from reagent or analytical instrument variation. A quality control material (assayed and unassayed) may be used for proficiency testing in interlaboratory surveys. This generic type of device includes controls (assayed and unassayed) for blood gases, electrolytes, enzymes, multianalytes (all kinds), single (specified) analytes, or urinalysis controls.(b)
Classification. Class I (general controls). Except when intended for use in donor screening tests, quality control materials (assayed and unassayed) are exempt from the premarket notification procedures in subpart E of part 807 of this chapter subject to the limitations in § 862.9.