(6 days)
Liquichek Anti-Sm Control, EIA is intended for use as an unassayed quality control to monitor enzyme immunoassay procedures for the detection of Smith (Sm) autoantibodies.
Liquichek Anti-Sm Control, EIA is prepared from human serum with added preservatives and stabilizers. This product is provided in liquid form for convenience. This product contains 0.1% sodium azide as a preservative.
The provided text is a 510(k) Summary for the Bio-Rad Liquichek Anti-Sm Control, EIA. This document is a premarket notification for an in vitro diagnostic device and focuses on establishing substantial equivalence to a predicate device, rather than presenting a study proving the device meets specific acceptance criteria in terms of analytical performance.
Therefore, much of the requested information regarding acceptance criteria, study design, sample sizes, ground truth establishment, expert involvement, and comparative effectiveness studies is not available in this type of regulatory submission. The document explicitly states its purpose is to claim substantial equivalence, which is a different regulatory pathway than demonstrating performance against established acceptance criteria through a comprehensive clinical or analytical study.
Here's a breakdown of what can be extracted and what is not available based on the provided text:
1. Table of Acceptance Criteria and Reported Device Performance:
This information is not available in the provided 510(k) Summary. The document focuses on comparing the technological characteristics of the new device to a predicate device, not on presenting performance data against defined acceptance criteria for the new device itself.
2. Sample Size Used for the Test Set and Data Provenance:
This information is not available. The document describes the device and claims substantial equivalence, but it does not detail any performance studies that would involve a "test set" in the context of analytical or clinical performance evaluation.
3. Number of Experts Used to Establish the Ground Truth for the Test Set and Qualifications of Those Experts:
This information is not available. As no performance study with a test set is described, there's no mention of experts or ground truth establishment.
4. Adjudication Method for the Test Set:
This information is not available.
5. If a Multi-Reader Multi-Case (MRMC) Comparative Effectiveness Study Was Done, and the Effect Size of How Much Human Readers Improve with AI vs. Without AI Assistance:
This information is not available. The device described is an "unassayed quality control" for an enzyme immunoassay. It is a control material, not an AI-assisted diagnostic tool that would involve human readers or MRMC studies.
6. If a Standalone (i.e., algorithm only without human-in-the-loop performance) Was Done:
This information is not available. The device is a quality control material, not an algorithm.
7. The Type of Ground Truth Used:
This information is not available.
8. The Sample Size for the Training Set:
This information is not available. The document does not describe the development of an algorithm or model that would require a training set.
9. How the Ground Truth for the Training Set Was Established:
This information is not available.
Summary of Available Information from the Provided Text:
- Device Name: Liquichek Anti-Sm Control, EIA
- Intended Use: "An unassayed quality control serum for monitoring enzyme immunoassay procedures for the detection of Smith (Sm) autoantibodies."
- Device Description: Prepared from human serum with added preservatives and stabilizers, in liquid form. Contains 0.1% sodium azide as a preservative.
- Predicate Device: Helix Enzyme Immunoassay Antinuclear Antibody Screening Test Kit (K954723)
- Comparison to Predicate: A table is provided contrasting the intended use, form, matrix, levels, storage, and analytes of the new device and the predicate device. Key differences highlighted:
- Intended Use: Predicate is a diagnostic screening test for various ANAs; New device is an unassayed QC for Anti-Sm autoantibodies.
- Levels: Predicate has Negative, Positive, Cutoff; New device has Negative, Positive, High Positive.
- Analytes: Predicate detects many ANAs; New device specifically targets Anti-Sm.
- Open Vial Claim: Predicate states "Shelf life"; New device claims "30 Days at 2-8°C".
- Regulatory Outcome: Substantial Equivalence (K984479) was granted by the FDA on December 22, 1998, under Class II, Product Code LKP.
In conclusion, this document serves its purpose as a 510(k) summary for substantial equivalence but does not contain the detailed study information typically associated with proving a device meets specific performance acceptance criteria through a dedicated study.
§ 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).