(47 days)
The ADVIA Chemistry Microalbumin Control is intended for in vitro diagnostic use in the control of the ADVIA® Chemistry systems for the Microalbumin method.
The ADVIA® Chemistry Microalbumin Controls is a human urine based solution containing various constituents.
Here's the analysis of the provided text regarding the ADVIA® Chemistry Microalbumin Controls:
Acceptance Criteria and Study for ADVIA® Chemistry Microalbumin Controls
This device is a Quality Control Material, and the "acceptance criteria" and "study" are focused on its stability and performance as a control, establishing substantial equivalence to a predicate device rather than a clinical efficacy study typically seen for diagnostic devices.
1. Table of Acceptance Criteria and Reported Device Performance
For this type of device (quality control material), the "acceptance criteria" revolve around its stability and intended function, demonstrating it performs as expected for quality control. The provided information focuses on aspects related to its stability and composition compared to a predicate.
| Feature | Acceptance Criteria (Implied / Predicate) | Reported Device Performance (ADVIA® Chemistry Microalbumin Controls) |
|---|---|---|
| Stability (Shelf-life) | Reconstituted urine controls stable for 8 hours at 25°C, 5 days at 4°C, or 14 days at -20°C (Predicate) | Reconstituted, capped, and stored at 2-8°C stable for 28 days |
| Shelf Life (Unreconstituted) | Not explicitly stated for predicate in this context | 24 month shelf life |
| Constituent Analytes | Multiple analytes (Predicate) | Microalbumin values only (This is a differentiating feature, not a failure to meet criteria) |
| Format | Lyophilized mixture of human urine base with added constituents (Predicate) | Same (Lyophilized mixture of human urine base with added constituents) |
| Levels | Two levels (Predicate) | Same (Two levels) |
| Overall Performance | Similar to other products in commercial distribution intended for similar use (Predicate implication) | The performance of the control is similar to other products in commercial distribution intended for similar use. Values validated according to established procedures. |
2. Sample Size Used for the Test Set and Data Provenance
- Test Set Sample Size: The document does not specify a "test set" in the traditional sense of a patient cohort. For this quality control material, the "test" primarily refers to stability studies. The actual number of control vials or batches tested for stability is not provided.
- Data Provenance: The stability validation was performed at the manufacturing site: Randox Laboratories, Inc. 55 Diamond Road Crumlin, Antrim Country, UK. The data is retrospective in the sense that the studies were completed before the 510(k) submission.
3. Number of Experts Used to Establish Ground Truth for the Test Set and Qualifications of Experts
This information is not applicable and not provided. For a quality control material, "ground truth" is established by laboratory analytical methods to determine its stated values and stability characteristics, not by expert consensus on clinical images or diagnoses.
4. Adjudication Method for the Test Set
This information is not applicable and not provided. Adjudication methods (like 2+1, 3+1) are used in studies where human readers interpret data (e.g., images) and their interpretations need to be reconciled for ground truth. This is not relevant for a quality control material.
5. If a Multi-Reader Multi-Case (MRMC) Comparative Effectiveness Study was done
No, a Multi-Reader Multi-Case (MRMC) comparative effectiveness study was not done. This type of study is used for diagnostic algorithms or imaging devices to assess how AI impacts human reader performance, which is not relevant for a quality control material.
6. If a Standalone (i.e., algorithm only without human-in-the-loop performance) Study was done
No, a standalone (algorithm-only) study was not performed. The device itself is a physical quality control material, not a software algorithm. Its "performance" is its inherent stability and stated values, validated through laboratory procedures.
7. The Type of Ground Truth Used
The "ground truth" for the ADVIA® Chemistry Microalbumin Controls is established through laboratory analytical testing (e.g., using a reference method or validated assays) to determine the concentration of microalbumin and to confirm the stability of these concentrations over time and under various storage conditions. This is considered a form of analytical truth.
8. The Sample Size for the Training Set
This information is not applicable and not provided. The device is a physical control material, not an AI/ML algorithm that requires a "training set."
9. How the Ground Truth for the Training Set was Established
This information is not applicable and not provided for the same reason as point 8.
§ 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.