(23 days)
The new Liquichek™ Anti-Smooth Muscle Control, Positive, is intended for use as an unassayed quality control to monitor indirect immunofluorescent testing for the detection of smooth muscle autoantibodies.
This product is prepared from human serum with added preservatives. The control is provided in liquid form for convenience.
This is a 510(k) premarket notification for a quality control device, not a diagnostic or AI-powered device. Therefore, the typical acceptance criteria and study design elements you've requested for such devices (e.g., sample size for test/training set, expert ground truth, MRMC study, standalone performance) are not applicable or provided in this document.
The document describes the submission of a "Liquichek™ Anti-Smooth Muscle Control, Positive" to the FDA, claiming substantial equivalence to a predicate device, the "Kallestad™ Autoantibody Positive Control." The purpose of this device is to serve as an unassayed quality control for indirect immunofluorescent testing to detect smooth muscle autoantibodies.
Here's an attempt to address your points based on the provided document, noting the limitations due to the nature of the device:
1. Table of Acceptance Criteria and Reported Device Performance
For this type of quality control device, "acceptance criteria" and "device performance" are typically related to its ability to consistently produce expected results when used in the intended assay, demonstrating its suitability as a control. However, this document does not explicitly state specific acceptance criteria or quantitative performance data beyond the claim of substantial equivalence. The "performance" is primarily implied by its similarity to the predicate device and its intended use as a quality control.
| Characteristic | Acceptance Criteria (Implied/General for QC) | Reported Device Performance (Implied by Substantial Equivalence and Intended Use) |
|---|---|---|
| Intended Use | To effectively monitor indirect immunofluorescent testing for smooth muscle autoantibodies. | The new device is intended for the same purpose as the predicate, to monitor indirect immunofluorescent testing for smooth muscle autoantibodies. |
| Matrix | Formulated in a human serum matrix. | Prepared from human serum. |
| Storage | Stable at specified storage conditions (2°C to 8°C) until expiration. | Stable at 2°C to 8°C until expiration date. |
| Form | Provided in a liquid, ready-to-use format. | Provided in liquid form. |
| Equivalence | Demonstrated substantial equivalence to a legally marketed predicate device (Kallestad™ Autoantibody Positive Control). | Through comparison (Table 1), the new device shares key characteristics (intended use, matrix, storage, form) with the predicate device, leading to an FDA finding of substantial equivalence (K024224). |
2. Sample Size for the Test Set and Data Provenance
This document describes a 510(k) submission for a quality control material. It does not involve a "test set" in the sense of patient data for diagnostic classification. The "comparison" is between the new control fluid and an existing predicate control fluid. The document does not specify a "sample size" in relation to a patient test set, nor does it refer to data provenance (country of origin, retrospective/prospective) because it's not evaluating the performance of a diagnostic algorithm or predictive model on patient samples.
3. Number of Experts Used to Establish Ground Truth and Their Qualifications
Not applicable for this type of submission. There is no "ground truth" to be established by experts in the context of diagnostic accuracy for this quality control device. The FDA's review process relies on regulatory experts assessing the substantial equivalence claim based on the provided data comparing the new device to the predicate.
4. Adjudication Method
Not applicable. No adjudication method is described as there is no diagnostic outcome being evaluated for human readers or algorithms.
5. Multi-Reader Multi-Case (MRMC) Comparative Effectiveness Study
Not applicable. This is not a diagnostic device involving human readers or AI assistance in interpretation. Therefore, an MRMC study and effect size for human improvement are not relevant.
6. Standalone Performance (Algorithm Only without Human-in-the-Loop)
Not applicable. This device is a quality control material, not an algorithm. Its "performance" is about its stability and consistency as a control for an assay, not a standalone diagnostic interpretation by an algorithm.
7. Type of Ground Truth Used
Not applicable. The concept of "ground truth" (expert consensus, pathology, outcomes data) is typically used for evaluating diagnostic devices or algorithms against a definitive reference standard. This document concerns a quality control product, not a diagnostic test seeking to establish a specific medical condition.
8. Sample Size for the Training Set
Not applicable. This is a quality control material, not an AI/algorithm-driven device requiring a training set.
9. How the Ground Truth for the Training Set Was Established
Not applicable, as there is no training set for this type of device.
§ 866.5100 Antinuclear antibody immunological test system.
(a)
Identification. An antinuclear antibody immunological test system is a device that consists of the reagents used to measure by immunochemical techniques the autoimmune antibodies in serum, other body fluids, and tissues that react with cellular nuclear constituents (molecules present in the nucleus of a cell, such as ribonucleic acid, deoxyribonucleic acid, or nuclear proteins). The measurements aid in the diagnosis of systemic lupus erythematosus (a multisystem autoimmune disease in which antibodies attack the victim's own tissues), hepatitis (a liver disease), rheumatoid arthritis, Sjögren's syndrome (arthritis with inflammation of the eye, eyelid, and salivary glands), and systemic sclerosis (chronic hardening and shrinking of many body tissues).(b)
Classification. Class II (performance standards).