(55 days)
IMMUNOASSAY PLUS CONTROL, Levels 1, 2 and 3, is a lyophilized human serum based assayed quality control material intended to monitor the performance of clinical immunoassay test procedures that analyze immunochemistries and theraputic drugs as listed in this package insert.
IMMUNOASSAY PLUS CONTROL is designed to monitor the performance of test procedures that analyze immunochemistries and therapeutic drugs as listed in the package insert. Human origin components are added to a human serum based matrix. The product contains 0.1% sodium azide. IMMUNOASSAY PLUS CONTROL will be offered in three levels of 5.0 mL filled vials.
The provided text describes a 510(k) submission for a medical device called "IMMUNOASSAY PLUS CONTROL, Levels 1, 2 and 3". This is a quality control material used to monitor the performance of immunoassay and therapeutic drug test procedures.
This document describes a substantial equivalence determination for a quality control material, not an AI/ML powered device. Therefore, many of the requested categories (such as human-in-the-loop performance, expert ground truth, adjudication methods, multi-reader multi-case studies, and training/test set details typically associated with AI/ML device studies) are not applicable or described in this type of submission.
The study described here is focused on demonstrating that the new control material (IMMUNOASSAY PLUS CONTROL) is substantially equivalent to a previously cleared predicate device (QUALITROL IMMUNOASSAY PLUS CONTROL) based on its intended use and physical properties.
Here's an attempt to fill in the table and answer the questions based on the provided text, noting where information is not applicable or not provided for this type of device:
1. Table of Acceptance Criteria and Reported Device Performance
For this quality control material, the "acceptance criteria" are implicitly tied to demonstrating substantial equivalence to the predicate device. The performance is assessed by comparing key characteristics.
| Device Characteristic | Predicate Device (QUALITROL IMMUNOASSAY PLUS CONTROL) | Subject Device (IMMUNOASSAY PLUS CONTROL) | Acceptance Criteria (Implicit for Substantial Equivalence) |
|---|---|---|---|
| Intended Use | Assayed quality control serum for monitoring performance of serum immunoassay and therapeutic drug test procedures. | Assayed quality control serum for monitoring performance of serum immunoassay and therapeutic drug test procedures. | Match the intended use of the predicate device. |
| Matrix | Human Serum | Human Serum | Match the matrix of the predicate device. |
| Form | Lyophilized | Lyophilized | Match the form of the predicate device. |
| Vial | 5 mL glass | 5 mL glass | Match the vial type of the predicate device. |
| Analytes | 68 analytes of clinical significance | 59 analytes of clinical significance | The number of analytes is different but considered acceptable for substantial equivalence, likely because the type of analytes and overall purpose remain the same. The focus is on the device's ability to act as a control for listed analytes, not the sheer number. |
| Storage | 2-8°C | 2-8°C | Match the storage conditions of the predicate device. |
| Stability | Until expiration date noted on vial label. | Until expiration date noted on vial label. | Match the stability claim/method of the predicate device. |
Detailed Study Information (Based on availability in the text):
2. Sample size used for the test set and the data provenance (e.g. country of origin of the data, retrospective or prospective)
- Sample Size: Not explicitly stated as a "test set" in the context of an algorithm's performance. For a quality control material, performance is demonstrated by characterizing the material itself against predicate characteristics and potentially through internal validation testing (stability, homogeneity, assigned values), but specific "sample sizes" for a clinical test set are not typically relevant or provided in this type of submission for a control.
- Data Provenance: Not specified. As a control material, the performance data would typically be generated by the manufacturer during product development and validation.
3. Number of experts used to establish the ground truth for the test set and the qualifications of those experts (e.g. radiologist with 10 years of experience)
- Not Applicable. For a quality control material, "ground truth" relates to the assigned values for the analytes within the control. These are established through rigorous testing and assay calibration, not expert consensus in the way an AI diagnostic device would. No experts are mentioned as establishing "ground truth" in the provided text.
4. Adjudication method (e.g. 2+1, 3+1, none) for the test set
- Not Applicable. Adjudication methods are relevant for ambiguous cases in diagnostic image interpretation or similar tasks; they do not apply to the characterization of a quality control material.
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
- No. This type of study (MRMC for human readers with/without AI assistance) is not applicable to a quality control material.
6. If a standalone (i.e. algorithm only without human-in-the-loop performance) was done
- Not Applicable. This is not an algorithmic device. Performance is inherent to the control material's composition and manufacturing.
7. The type of ground truth used (expert concensus, pathology, outcomes data, etc)
- For quality control materials, the "ground truth" for the analytes within the control is established by assaying the material against highly calibrated reference methods or against established methods using qualified instruments and reagents. This generally involves internal lab testing and statistical methods to assign target values and ranges, rather than clinical outcomes, pathology, or expert consensus on a diagnostic finding.
8. The sample size for the training set
- Not Applicable. This is not an AI/ML device that requires a training set.
9. How the ground truth for the training set was established
- Not Applicable. This is not an AI/ML 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.