(115 days)
Lyphochek Allergen sIgE Control is intended for use as an assayed quality control serum to monitor the precision of laboratory testing procedures for the analytes listed in this package insert.
Lyphochek Allergen sIgE Control is prepared from human serum source material with added chemicals, stabilizers, and preservatives. Each human donor unit used to manufacture this control was tested by FDA accepted methods and found non-reactive for Hepatitis B Surface Antigen (HBsAg), antibody to Hepatitis C (HCV) and antibody to HIV-1/HIV-2.
This document pertains to the 510(k) submission for the Lyphochek Allergen sIgE Control. This device is a quality control material intended to monitor the precision of laboratory testing procedures for specific analytes (allergens).
The provided text focuses on establishing substantial equivalence to an existing predicate device rather than presenting a study for meeting novel acceptance criteria in the typical sense of a diagnostic or treatment device. For a quality control (QC) product, the primary "acceptance criterion" is typically its ability to function consistently and predictably to monitor the performance of other assays, and its stability over time. The "study" here involves demonstrating that the new device performs similarly and is stable, much like the predicate.
Here's an analysis of the "acceptance criteria" and "study" as implied by the document:
1. Table of Acceptance Criteria and Reported Device Performance
Since this is a control material, the performance is centered on its stability and its intended use to monitor precision. The document doesn't explicitly state numerical acceptance criteria for a "study outcome" but rather presents factual data about the device's stability.
| Acceptance Criterion (Implied) | Reported Device Performance |
|---|---|
| Intended Use | Monitors precision of laboratory testing procedures for listed analytes |
| Matrix Type | Human Serum |
| Preservation | Contains preservatives |
| Storage (unopened) | 2-8°C until expiration date |
| Levels | Negative and Panel A controls |
| Form | Lyophilized |
| Open Vial Stability | 28 days at 2 to 8°C |
| Shelf Life Stability | 37 Months at 2°C to 8°C |
| Fill Volume | 2 mL |
| Content (Allergens) | Contains specific allergens (D1, D2, E1, E3, E5, F13, G2, G3, G6, M3, M6, F1, F2) |
2. Sample Size Used for the Test Set and Data Provenance
- Sample Size for Test Set: The document states that "replicate analyses" were performed to derive mean values and ±3SD ranges. "Manufacturer and/or independent laboratories using manufacturer supported reagents and a representative sampling of this lot of product" conducted these tests. It also mentions "real time stability studies" and "accelerated stability studies." However, no specific sample sizes (number of vials, number of tests, or number of lots) are provided for these studies.
- Data Provenance: Not explicitly stated regarding country of origin. The studies appear to be prospective in nature, as they involve testing the manufactured product over time to assess stability and assign values.
3. Number of Experts Used to Establish the Ground Truth for the Test Set and Their Qualifications
This question is not directly applicable in the context of this device. The "ground truth" for a quality control material is its assigned value and established stability. This is determined through rigorous laboratory testing and statistical analysis by the manufacturer (Bio-Rad Laboratories) and/or independent laboratories, not by expert consensus interpreting images or clinical data. The "experts" are likely skilled laboratory personnel and method development scientists involved in assaying the control material, but their specific number and qualifications are not detailed.
4. Adjudication Method for the Test Set
Not applicable. Adjudication methods like "2+1" are typically used in clinical studies where human readers are assessing findings (e.g., radiology images) and disagreements need to be resolved. For a quality control material where values are assigned through analytical measurement, statistical methods are used to determine means and ranges, not expert adjudication.
5. If a Multi-Reader Multi-Case (MRMC) Comparative Effectiveness Study Was Done, and Effect Size
Not applicable. An MRMC study assesses the performance of human readers, often with and without AI assistance, on a set of cases. This device is a diagnostic control material, not an AI or imaging device, and does not involve human reader interpretation in its intended use.
6. If a Standalone (i.e., algorithm only without human-in-the-loop performance) Was Done
Not applicable. This device is a physical quality control material for laboratory tests, not a software algorithm.
7. The Type of Ground Truth Used
The "ground truth" for this device is the analytically determined concentration/value of the allergens within the control material, established by the manufacturer through repeated testing with supported reagents and instrumentation. It is confirmed by stability studies demonstrating that these values remain within acceptable ranges over time and under specified storage conditions.
8. The Sample Size for the Training Set
Not applicable. This device does not use an "algorithm" or "AI" that requires a training set. Its "performance" is based on its chemical and biological stability and the accuracy of its assigned values.
9. How the Ground Truth for the Training Set Was Established
Not applicable, as there is no training set for this type of device. The values and stability characteristics are established through the manufacturer's internal validation and quality control processes.
§ 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.