(31 days)
The Linearity FD Unsaturated Iron Binding Capacity is an assayed quality control material intended to simulate human patient samples for use in determining linearity, calibration, and the verification of reportable range for unsaturated iron binding capacity.
Linearity FD Unsaturated Iron Binding Capacity is for In Vitro Diagnostic use only.
Audit® MicroControls™ Linearity FD Unsaturated Iron Binding Capacity product is an in-vitro diagnostic device consisting of five levels of freeze dried, linearity/QC material, containing additives in human serum. There are five levels labeled A,B,C,D and E which contain 1ml for each level.
The provided document is a 510(k) premarket notification decision letter from the FDA for the Audit® MicroControls™ Linearity FD Unsaturated Iron Binding Capacity device. It describes the device, its intended use, and its substantial equivalence to a predicate device. However, it does not contain a detailed study proving the device meets acceptance criteria in the way typically expected for a diagnostic or AI-driven medical device.
The document primarily focuses on demonstrating substantial equivalence to a legally marketed predicate device (K130157 Audit® MicroCV™ Beta-Hydroxybutyric Acid Linearity Set) based on similar intended use and technical characteristics. It mentions performance data related to stability and value assignment, but not clinical performance with respect to patient outcomes or comparison against a diagnostic gold standard in a traditional clinical study.
Here's an attempt to extract and organize the information based on your request, with significant caveats that much of the requested information (especially for AI/ML device performance) is not present in this type of regulatory submission for a quality control material:
Device Name: Audit® MicroControls™ Linearity FD Unsaturated Iron Binding Capacity
Device Type: Assayed Quality Control Material for Unsaturated Iron Binding Capacity (UIBC)
Intended Use: To simulate human patient samples for use in determining linearity, calibration verification, and the verification of reportable range for unsaturated iron binding capacity. For In Vitro Diagnostic use only.
1. Table of Acceptance Criteria and Reported Device Performance
Given the nature of this device (a quality control material), the "acceptance criteria" and "device performance" are primarily related to its stability and its ability to provide target values within a specified range, demonstrating linearity. This is not a diagnostic device with performance metrics like sensitivity, specificity, or AUC.
| Acceptance Criteria Category | Specific Criteria/Metric | Reported Device Performance/Status |
|---|---|---|
| Shelf Life Stability | Not explicitly stated as a numerical criterion in % difference, but implied "within acceptance criteria" for comparison of real-time vials to Day0 values. | - Accelerated Stability: Met acceptance criteria to support 24 months shelf life. |
- Real-Time Stability: Ongoing studies, but "product is determined to meet its predicted shelf life if the % difference of the real-time mean values compared to the Day0 mean value is within the acceptance criteria." (indicating current data supports predicted shelf life)
Claimed Shelf Life: 24 months, when stored unopened at 2-8°C. |
| Reconstituted Vial Stability | Not explicitly stated as a numerical criterion, but implied "within acceptance criteria." | - Accelerated + Real-Time Stability: Met acceptance criteria.
Claimed Reconstituted Vial Stability: 30 days when stored tightly capped at 2-8°C. |
| Value Assignment / Linearity | Target ranges for each of the five levels (calculated as +/-15% of the target mean values). | Individual analyte values for Level A through Level E were measured multiple times on a Hitachi P-Modular analyzer. The mean value of UIBC was used to establish target values.
Reported Target Values and Ranges (µg/dL): - Level A: Target 75.7 (Range 64.4-87.1)
- Level B: Target 185.5 (Range 157.7-213.4)
- Level C: Target 297.3 (Range 252.7-341.9)
- Level D: Target 403.7 (Range 343.2-464.3)
- Level E: Target 525.1 (Range 446.3-603.8) |
| AMR (Analytical Measuring Range) | Not explicitly stated as an "acceptance criterion" but reported as a characteristic. | Unsaturated Iron Binding Capacity: 10-500 µg/dL. This range encompasses the target values of the linearity levels. |
Information Not Applicable or Not Provided in this Document:
The following points are typically relevant for AI/ML-driven diagnostic devices or clinical studies, which are not the subject of this 510(k) for a quality control material. Therefore, the requested information is either not applicable or not provided in this submission.
2. Sample size used for the test set and the data provenance (e.g. country of origin of the data, retrospective or prospective)
- Not applicable for a QC material in this context. The "test sets" would refer to analytical samples used for stability and value assignment, not patient data for diagnostic evaluation. The document mentions "samples are taken at four different time points" for real-time stability and "each analyte was measured multiple times" for value assignment.
- Data Provenance: The studies were conducted internally by Aalto Scientific, Ltd. (Carlsbad, CA, USA).
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. "Ground truth" in the clinical diagnostic sense is not established for a quality control material. The "truth" here relates to the analytical value determined by the reference method (Hitachi P-Modular) and the stability performance compared to a baseline.
4. Adjudication method (e.g. 2+1, 3+1, none) for the test set
- Not applicable. No expert adjudication process is described for this type of analytical validation.
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 is not an AI/ML device or a diagnostic device requiring human interpretation.
6. If a standalone (i.e. algorithm only without human-in-the-loop performance) was done
- Not applicable. This is a quality control material, not an algorithm.
7. The type of ground truth used (expert consensus, pathology, outcomes data, etc)
- The "ground truth" for the performance of this quality control material is its analytical value as determined by a reference laboratory instrument (Hitachi P-Modular) and its demonstrated stability over time according to pre-defined internal acceptance criteria. It is an analytical "truth," not a clinical "ground truth."
8. The sample size for the training set
- Not applicable. This device is not an AI/ML algorithm that requires a "training set." The measurements for stability and value assignment are based on multiple replicates as described in the methodology.
9. How the ground truth for the training set was established
- Not applicable. (See 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.