(87 days)
Qualitrol Immunology Control, Level 1, 2 and 3, is a lyophilized human serum based assayed quality control material intended to monitor the performance of clinical immunological test procedures that analyze immunoglobulins and other serum proteins.
Qualitrol Immunology Control, is designed to monitor the performance of test procedures that analyze immunoqlobulin and other proteins in serum. Human origin components are added to a human serum based matrix. The product contains 0.1% sodium azide. Qualitrol Immunology Control will be offered in three levels of 5.0 mL fill vials.
This submission describes a quality control material rather than a diagnostic device, therefore, the typical acceptance criteria and study designs are not directly applicable in the same way they would be for an AI-powered diagnostic tool. The "performance" being evaluated is its suitability as a control material, primarily by comparing its characteristics to a legally marketed predicate device.
Here's how the provided information relates to your request, with explanations for where certain criteria are not applicable:
1. Table of Acceptance Criteria and the Reported Device Performance
For this type of device, the "acceptance criteria" are implied by the characteristics of the predicate device and the manufacturer's claim of "substantial equivalence." The reported "device performance" is a comparison of these characteristics.
| Device Characteristic | Qualitrol Immunology Control (Reported Performance) | Acceptance Criteria (Implied by Predicate Device: Liquichek™ Immunology Plus Control) |
|---|---|---|
| Intended Use | Assayed quality control serum for monitoring performance of serum immunological test procedures. | Assayed quality control serum for monitoring precision of laboratory testing procedures. |
| Matrix | Human Serum | Human Serum |
| Form | Lyophilized | Liquid |
| Analytes | 26 analytes of clinical significance that may be found in serum. | 24 analytes |
| Storage | 2-8°C | 2-8°C |
| Stability | Until expiration date noted on vial label. | Until expiration date noted on vial label. |
Explanation of "Acceptance": The FDA's letter (K992770) explicitly states: "We have determined the device is substantially equivalent... to legally marketed predicate devices." This substantial equivalence determination serves as the "acceptance" for marketing the product. The minor differences (e.g., number of analytes, lyophilized vs. liquid form) were deemed not to raise new questions of safety or effectiveness.
2. Sample size used for the test set and the data provenance
- Sample Size: Not applicable in the traditional sense of a diagnostic test set. This is a quality control material, and the "test" involved comparing its formulation and intended use characteristics against a predicate device. Performance would typically be assessed during internal validation of its stability, analyte levels, and consistency, but those details are not provided in this 510(k) summary.
- Data Provenance: Not explicitly stated. The comparison is against a commercially available predicate device (LIQUICHEK IMMUNOLOGY CONTROL, BIO-RAD Laboratories K-945651). The information provided is a comparative analysis of product characteristics.
3. Number of experts used to establish the ground truth for the test set and the qualifications of those experts
- Not applicable. "Ground truth" in the context of a quality control material refers to the established target values for the analytes within the control. This is typically determined through rigorous analytical methods and inter-laboratory studies conducted by the manufacturer, rather than by human experts establishing diagnostic "ground truth" as in an imaging study. The provided document focuses on the equivalence of the control's characteristics to another control, not its accuracy in mimicking a clinical condition.
4. Adjudication method for the test set
- Not applicable. There was no "test set" requiring adjudication in the diagnostic sense. The comparison was a direct assessment of physical and functional characteristics against a predicate device.
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 an immunology control, not an AI-assisted diagnostic tool. Therefore, no MRMC study, human reader improvement, or AI component is relevant.
6. If a standalone (i.e. algorithm only without human-in-the-loop performance) was done
- Not applicable. This device is an immunology control, not an algorithm.
7. The type of ground truth used (expert consensus, pathology, outcomes data, etc.)
- For this device, "ground truth" (if we stretch the definition) would refer to the assigned values of the analytes within the control material, and the physical/chemical properties that define it as a suitable control. These are established through manufacturing processes, analytical testing, and stability studies, not expert consensus, pathology, or outcomes data related to patient diagnosis. The document primarily uses the characteristics of the predicate device as a benchmark.
8. The sample size for the training set
- Not applicable. This is a quality control material, not a machine learning model. There is no concept of a "training set" for its development or validation as described in this document.
9. How the ground truth for the training set was established
- Not applicable. As above, there is no training set for this product.
§ 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.