(36 days)
The Linearity LQ Special Diabetes 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 the following analytes: fructosamine, insulin, and C-peptide.
Linearity LQ Special Diabetes is for In Vitro Diagnostic use only.
The Audit® MicroControls™ Linearity LQ Special Diabetes product is an in-vitro diagnostic device consisting of five levels of liquid, linearity/QC material, containing Fructosamine, Insulin, C-peptide and additives in human serum. There are five levels labeled A, B, C, D and E which contain 2ml for each level.
Materials of human origin used in the manufacture of this linearity set have been tested using FDA approved methods and are found to be non-reactive for HbsAg and antibodies to HCV and HIV-1/2.
This document describes the 510(k) summary for the Audit® MicroControls™ Linearity LQ Special Diabetes device. This device is an assayed quality control material intended to simulate human patient samples for use in determining linearity, calibration verification, and the verification of the reportable range for fructosamine, insulin, and C-peptide.
Here's an analysis of the acceptance criteria and the study that proves the device meets those criteria, based on the provided text:
1. Table of Acceptance Criteria and Reported Device Performance:
The document primarily focuses on the stability (shelf life and open vial stability) and value assignment (expected range) as performance criteria.
| Acceptance Criteria Category | Specific Criteria | Reported Device Performance |
|---|---|---|
| Shelf Life Stability | Product claims supported by accelerated stability studies. | 18 months, when stored unopened at 2-8°C. |
| Open Vial Stability | Product claims supported by accelerated + real-time stability studies. | 14 days, when stored tightly capped at 2-8°C, once opened. |
| Value Assignment (Analytes) | Target ranges calculated as +/-15% of the target mean values. | |
| Fructosamine (µmol/L): |
- Level A: Target 24.10 (Range 20.49-27.72)
- Level B: Target 258.25 (Range 219.52-296.99)
- Level C: Target 496.44 (Range 421.97-570.91)
- Level D: Target 748.14 (Range 635.92-860.36)
- Level E: Target 975.70 (Range 829.35-1122.06)
Insulin (µU/mL):
- Level A: Target 1.37 (Range 1.17-1.58)
- Level B: Target 233.78 (Range 198.71-268.85)
- Level C: Target 456.20 (Range 387.77-524.63)
- Level D: Target 628.08 (Range 533.87-722.29)
- Level E: Target 814.79 (Range 692.57-937.00)
C-peptide (ng/mL):
- Level A: Target 0.32 (Range 0.27-0.37)
- Level B: Target 9.27 (Range 7.88-10.66)
- Level C: Target 18.22 (Range 15.49-20.96)
- Level D: Target 26.96 (Range 22.91-31.00)
- Level E: Target 35.37 (Range 30.07-40.68) |
2. Sample Size Used for the Test Set and Data Provenance:
- Sample Size:
- Shelf Life - Real Time Stability: Vials from two lots of finished product. Samples taken at 9 months, 18 months, and 19 months.
- Value Assignment/Linearity: Implicitly, the "five levels labeled A, B, C, D and E" of the device itself are the samples for which values are assigned. Each analyte was "measured multiple times" at each level.
- Data Provenance: Not explicitly stated regarding country of origin, but the company is Aalto Scientific, Ltd. in Carlsbad, CA. The context is a 510(k) submission to the US FDA. The studies appear to be prospective as they involve accelerated and real-time stability studies with samples taken over time.
3. Number of Experts Used to Establish the Ground Truth for the Test Set and Qualifications of those Experts:
This information is not provided in the document. The "ground truth" for value assignment seems to be established internally by Aalto Scientific, Ltd. through multiple measurements on specific analytical instruments (Roche Modular P and Roche Cobas e411). There is no mention of external experts or their qualifications for establishing these values.
4. Adjudication Method for the Test Set:
This information is not provided. The value assignment appears to be based on "mean value of the analyte," indicating an averaging approach rather than an adjudication among multiple independent assessments.
5. If a Multi-Reader Multi-Case (MRMC) Comparative Effectiveness Study was done:
No, an MRMC comparative effectiveness study was not done. This device is an in-vitro diagnostic quality control material, not a diagnostic imaging or AI-driven interpretative device that would typically involve human readers. Therefore, the concept of human readers improving with or without AI assistance is not applicable here.
6. If a Standalone (i.e. algorithm only without human-in-the-loop performance) was done:
Yes, in essence. The performance data presented (stability and value assignment) describes the intrinsic characteristics of the linearity material itself when measured on laboratory instruments. This is analogous to a "standalone" assessment of the material's properties without human interpretative intervention beyond operating the instruments and recording results. The device's "performance" is its ability to maintain its target values and linearity, which is assessed directly by analytical measurements.
7. The Type of Ground Truth Used:
The ground truth used for value assignment and stability assessment appears to be analytical measurements obtained from established, FDA-approved methods on specific laboratory instruments (Roche Modular P for Fructosamine, Roche Cobas e411 for Insulin and C-peptide). For stability, the "Day0 vials" serve as the baseline ground truth reference for comparison with real-time samples.
8. The Sample Size for the Training Set:
This information is not applicable as this device is a quality control material and not an AI/ML algorithm that requires a "training set." The materials used for "value assignment" and "stability studies" are the product itself across different levels and time points.
9. How the Ground Truth for the Training Set Was Established:
This information is not applicable for the same reason as above. There is no training set for this type of device. The ground truth for the device's characteristics (analyte concentrations at each level) is established by multiple analytical measurements on a specified instrument, and the mean value is used.
§ 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.