(50 days)
Liquichek ToRCH Plus IgM Control is intended for use as an unassayed quality control serum to monitor precision of IgM laboratory testing procedures for the analytes listed in this package insert. This product is not intended for use in blood donor screening assays.
Liquichek ToRCH Plus IgM Control, Positive is prepared from negative human serum based material with mouse IgM monoclonal antibodies conjugated to non-specific human IgM molecules for each analyte tested. The positive control reagent also contains constituents of animal origin and preservatives.
Here's an analysis of the provided text regarding the Liquichek ToRCH Plus IgM Control device, focusing on acceptance criteria and supporting studies:
This document ([K040827](https://510k.innolitics.com/search/K040827)) is a 510(k) premarket notification for a Class I medical device, the Liquichek ToRCH Plus IgM Control. As such, the focus of the submission is on demonstrating "substantial equivalence" to a predicate device, rather than proving novel clinical effectiveness through extensive clinical trials with detailed acceptance criteria for diagnostic performance metrics (e.g., sensitivity, specificity).
The "acceptance criteria" for this type of device are primarily related to its performance as a quality control material (stability, matrix, form, usability) compared to the predicate device, and demonstrating that it meets its intended use of "monitoring precision of IgM laboratory testing procedures." The study provided is a stability study.
Here's the breakdown based on your requested information:
1. Table of Acceptance Criteria and Reported Device Performance
Note: The acceptance criteria for this Class I quality control device are not typically defined by diagnostic performance metrics like accuracy, sensitivity, or specificity in the same way a diagnostic test would be. Instead, they relate to its function as a stable and reliable control material. The "reported device performance" is essentially the results of the stability studies, which demonstrate it meets its intended function over time.
| Acceptance Criteria Category | Specific Criterion (Implied/Stated) | Reported Device Performance |
|---|---|---|
| Intended Use | Monitor precision of IgM laboratory testing procedures (unassayed). | Confirmed by substantial equivalence to predicate with similar intended use. |
| Form | Liquid | Is Liquid |
| Matrix | Human serum based | Is Human serum based |
| Preservatives | Contains preservatives | Contains preservatives |
| Open Vial Stability (Storage: 2-8°C) | All analytes stable for 60 days. | All analytes are stable for 60 daysat 2-8°C. |
| Shelf Life (Storage: -20°C or colder) | All analytes stable for 3 years. | All analytes are stable for 3 years at -20°C or colder. |
| Number of Levels | Reactive (positive) and Non-reactive (negative) | Provides Reactive and Non-reactive levels. |
| Analyte Coverage | IgM antibodies to CMV, EBV (VCA), HSV-1/2, Lyme, Rubella, Toxoplasma. | Covers these specified IgM analytes. |
2. Sample Size Used for the Test Set and Data Provenance
- Sample Size for Test Set: The document does not explicitly state a "sample size" in terms of cases or patient samples for testing diagnostic performance. For a quality control device, the "test set" would refer to the samples (replicates) used in the stability studies. The document states "All supporting data is retained on file at Bio-Rad Laboratories," but does not provide details on the number of control vials tested, the number of replicates per analyte, or the frequency of testing during the stability studies.
- Data Provenance: Not explicitly stated beyond "retained on file at Bio-Rad Laboratories." This implies the studies were conducted by Bio-Rad Laboratories themselves, likely in their own facilities. The nature of the device (a control material) suggests the stability testing would be internal R&D/QC, not involving external patient data. It is prospective in the sense that the stability studies were performed to establish the claims.
3. Number of Experts Used to Establish the Ground Truth for the Test Set and Qualifications of Those Experts
Not applicable for this type of device. The "ground truth" for a quality control material is its known concentration/reactivity, which is internally prepared and characterized by the manufacturer (Bio-Rad Laboratories). Expert consensus regarding diagnostic interpretation of patient cases is not relevant here.
4. Adjudication Method for the Test Set
Not applicable. Adjudication methods (like 2+1, 3+1) are used to resolve disagreements among human readers or determine ground truth in situations where variability in interpretation exists (e.g., reading medical images). For a quality control material undergoing stability testing, the "ground truth" is established by the assay methods used during manufacturing and stability monitoring, not by human interpretation requiring adjudication.
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 a quality control material, not a diagnostic AI or imaging device, so MRMC studies, AI effectiveness, or human reader improvement are not relevant.
6. If a Standalone (i.e., algorithm only without human-in-the-loop performance) was Done
Not applicable. This device is a biochemical quality control material, not an algorithm or AI.
7. The Type of Ground Truth Used
For the purpose of stability testing, the "ground truth" is the initial characterization and measured values of the control material using standardized laboratory assays for each analyte (CMV IgM, EBV IgM, etc.) at the time of manufacturing. The stability studies then monitor how these measured values change over time under specified storage conditions relative to these initial known values or established reference ranges.
8. The Sample Size for the Training Set
Not applicable. This device is a quality control material, not an algorithm or machine learning model that requires a "training set."
9. How the Ground Truth for the Training Set Was Established
Not applicable, as there is no "training set" for this 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.