(118 days)
Thermo Scientific MAS® Omni•IMMUNE is intended for use as an assayed control for monitoring assay conditions in many clinical laboratory determinations. Include OmnirIMMUNE with patient serum specimens when assaying for any of the listed constituents. Assay values are provided for the specific systems listed. The user can compare observations with expected ranges as a means of assuring consistent performance of reagent and instrument
Thermo Scientific MAS® Omni•IMMUNE PRO is intended for use as an assayed control for monitoring assay conditions in many clinical laboratory determinations. Include Omni•IMMUNE PRO with patient serum specimens when assaying for any of the listed constituents. Assay values are provided for the specific systems listed. The user can compare observations with expected ranges as a means of assuring consistent performance of reagent and instrument.
Omni•IMMUNE is a liquid stable control material prepared from human serum. Analyte levels are adjusted with various pure chemicals and preparations from human tissue or body fluids. Preservatives and stabilizers are added to maintain product integrity.
The control is offered in three levels with the following configuration:
MAS® Omni•IMMUNE
Catalog Number Description Size
OIM-101 Level 1 6 vials of Level 1, 5 mLs per vial
OIM-202 Level 2 6 vials of Level 2, 5 mLs per vial
OIM-303 Level 3 6 vials of Level 3, 5 mLs per vial
OIM-SP Sample-pack 1 vial of Level 1, 5 mLs per vial
1 vial of Level 2, 5 mLs per vial
1 vial of Level 3, 5 mLs per vial
MAS® Omni•IMMUNE PRO
Catalog Number Description Size
OPRO-1 Level 1 6 vials of Level 1, 5 mLs per vial
OPRO-2 Level 2 6 vials of Level 2, 5 mLs per vial
OPRO-3 Level 3 6 vials of Level 3, 5 mLs per vial
OPRO-SP Sample-pack 1 vial of Level 1, 5 mLs per vial
1 vial of Level 2, 5 mLs per vial
1 vial of Level 3, 5 mLs per vial
This document is a 510(k) summary for a Quality Control Material (assayed and unassayed), not an AI medical device. Therefore, many of the requested elements for describing an AI device's acceptance criteria and study are not applicable.
However, I can extract the relevant information from the provided text regarding the device's performance and the study demonstrating its equivalence.
1. Table of Acceptance Criteria and Reported Device Performance
For this type of device (quality control material), the "acceptance criteria" relate to demonstrating substantial equivalence to a predicate device, primarily through comparable design, intended use, and performance characteristics in the context of quality control. The "reported device performance" focuses on the stability and matrix properties of the control material, and its ability to function as intended across various analytes.
| Criterion Type | Acceptance Criteria (Implied) | Reported Device Performance |
|---|---|---|
| Intended Use | Comparable to predicate device: "assayed control for monitoring assay conditions... compare observations with expected ranges" | Identical: "intended for use as an assayed control for monitoring assay conditions in many clinical laboratory determinations. ... The user can compare observations with expected ranges as a means of assuring consistent performance of reagent and instrument." |
| Matrix | Human Serum | Human Serum |
| Form | Effectively serves as a control material, regardless of physical form. (Predicate: Lyophilized) | Frozen Liquid (Note: This is a difference but the submission argues it does not raise new questions of safety or efficacy and is therefore still substantially equivalent.) |
| Control Levels | Three levels (1, 2, 3) | Three levels (1, 2, 3) |
| Shelf Life | Comparable shelf life for stability. (Predicate: 36 months) | 36 months |
| Open Vial Stability | Comparable open vial stability for practical use. (Predicate: 7 days, with some analytes shorter) | 30 days (2-8 °C). (Note: This is an improvement over the predicate, further supporting equivalence and potentially enhanced utility.) |
| Analytes | Capable of monitoring performance for a broad range of relevant analytes. | Extensive list of analytes provided, largely overlapping with the predicate, and including additional analytes, demonstrating broad applicability. Implicitly, laboratory performance data (not detailed in this summary but part of the full 510(k) submission) would have shown the control material provides accurate target values and ranges for each analyte. |
| Overall Performance | Functions as intended, demonstrating substantial equivalence to the predicate device in safety and effectiveness for its intended use. | "Substantial equivalence has been demonstrated through performance testing to verify that the device functions as intended and that design specifications have been satisfied." |
The following points are largely not applicable as the device is a quality control material, not an AI device. I will address them with "N/A" and briefly explain why if appropriate.
2. Sample size used for the test set and the data provenance (e.g., country of origin of the data, retrospective or prospective)
- N/A. This is a quality control material, not an AI algorithm processing diagnostic images or patient data. The "test set" would primarily involve internal laboratory validation of the control material's stability, homogeneity, and assigned values across various assay systems, rather than a dataset of patient samples in the traditional sense of an AI study. The data provenance would be internal laboratory testing data.
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)
- N/A. Ground truth for a quality control material involves establishing precise target values and acceptable ranges for analytes. This is done through extensive analytical testing, calibration, and statistical analysis by qualified laboratory scientists and chemists, not "experts" in the clinical diagnostic sense of interpreting patient results.
4. Adjudication method (e.g., 2+1, 3+1, none) for the test set
- N/A. Adjudication methods like 2+1 or 3+1 are used in clinical studies where expert consensus is needed to establish a "true" diagnosis or finding for a given patient case, often in the context of medical imaging interpretation. This is not relevant for the technical validation of a laboratory 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
- N/A. This device is a quality control material for laboratory assays, not an AI-powered diagnostic tool, and therefore, no MRMC study or assessment of human reader improvement with AI assistance was performed.
6. If a standalone (i.e., algorithm only without human-in-the-loop performance) was done
- N/A. This device is a consumable laboratory reagent, not an algorithm. Its "performance" is inherent in its chemical composition and stability characteristics, which allow it to provide known concentrations of analytes for quality control purposes.
7. The type of ground truth used (expert consensus, pathology, outcomes data, etc.)
- For a quality control material, the "ground truth" (i.e., the assigned values and acceptable ranges for each analyte) are established through:
- Reference Methods: Using highly accurate and precise reference methods to determine the true concentration of each analyte in the control material.
- Inter-laboratory Consensus: Often involving assays on multiple high-performing instruments across different laboratories to ensure robustness and generalizability of the assigned values.
- Traceability: Ensuring traceability to recognized international standards (where available) for the analytes.
8. The sample size for the training set
- N/A. This device is not an AI algorithm and does not have a "training set."
9. How the ground truth for the training set was established
- N/A. As there is no training set for an AI algorithm, this question is not applicable.
§ 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.