(37 days)
The Linearity LQ Cystatin-C 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 Cystatin-C analyte.
The Linearity LQ Cystatin-C is for In Vitro Diagnostic use only.
The Audit® MicroControls™ Linearity LQ Cystatin-C product is an in-vitro diagnostic device consisting of one set of five levels of liquid, linearity/QC material. For the set there are five levels labeled A, B, C, D and E. The set contains 1ml for each level. The set contains the Cystatin-C analyte and additives in human and bovine based serum. 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.
Here's a breakdown of the acceptance criteria and study information based on the provided document:
This document is a 510(k) Premarket Notification for a Linearity LQ Cystatin-C quality control material (device). The goal of the submission is to demonstrate substantial equivalence to a predicate device.
1. Table of Acceptance Criteria and Reported Device Performance
| Feature/Study | Acceptance Criteria | Reported Device Performance |
|---|---|---|
| Shelf Life (Unopened) | Product claims: 3 years, when stored unopened at 2-8°C. | Accelerated stability studies were conducted to establish the shelf life stability claims. Acceptance criteria were met to support the product claims of 3 years, when stored unopened at 2-8°C. (Real-time studies are ongoing). |
| Open Vial Stability | Product claims: Once a vial has been opened, the product will be stable for 30 days when stored tightly capped at 2-8°C. | Real-time stability studies conducted at the end of accelerated stability studies. Acceptance criteria were met to support the product claims of 30 days when stored tightly capped at 2-8°C. |
| Target Ranges for Cystatin-C | Target ranges for each of the 5 levels were calculated as ± 10% of the target value. (Implied: Measured values should fall within these ranges). | The mean value of the Cystatin-C analyte was used to establish target concentration value at each level. The target ranges for Cystatin-C (in mg/L) for each level are: |
- Level A: 0.584-0.714 (Target 0.649)
- Level B: 2.09-2.56 (Target 2.33)
- Level C: 3.69-4.51 (Target 4.10)
- Level D: 5.08-6.21 (Target 5.65)
- Level E: 6.44-7.87 (Target 7.15) |
| Non-reactivity for Infectious Disease Markers | Human-origin materials used must be tested using FDA approved methods and found to be non-reactive for HbsAg and antibodies to HCV and HIV-1/2. | 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. |
2. Sample Size Used for the Test Set and Data Provenance
This document describes a quality control material used for linearity, calibration verification, and reportable range for a specific analyte (Cystatin-C). It's not a diagnostic device with a "test set" in the traditional sense of patient data.
- Test Set Description: The "test set" here refers to the actual device (Linearity LQ Cystatin-C) which comes in five levels (A, B, C, D, E) of a liquid material. Each level contains 1ml.
- Sample Size:
- For stability studies: Vials from two lots of finished product were used for real-time stability (stored at 2-8℃ and -80℃). Measurements were taken at two different time points. The analyte values from these vials were tested in duplicate.
- For value assignment: The Cystatin-C analyte was measured multiple times.
- Data Provenance: The document does not specify the country of origin of the data. The studies were conducted by Aalto Scientific, Ltd., located in Carlsbad, CA. These are prospective studies performed to characterize the device's stability and assigned values.
3. Number of Experts Used to Establish the Ground Truth for the Test Set and Qualifications of Those Experts
This type of device (quality control material) does not typically involve human "experts" establishing a ground truth for a test set in the way a diagnostic algorithm for medical images would. Instead, the ground truth (target concentration values) is established through technical laboratory measurements.
- Number of Experts: Not applicable.
- Qualifications: Not applicable. The "ground truth" (target values) is established through analytical testing methods on a specific instrument.
4. Adjudication Method for the Test Set
Not applicable. As described above, this is not a diagnostic device where patient cases are reviewed and adjudicated. The "ground truth" (target analyte concentrations) for the quality control material is inherent to its formulation and confirmed through laboratory measurements.
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 a quality control material, not an AI-powered diagnostic device, and therefore no MRMC study was conducted or relevant.
6. If a Standalone (i.e., algorithm only without human-in-the-loop performance) Was Done
Not applicable. This is a laboratory quality control material, not an algorithm or AI.
7. The Type of Ground Truth Used (Expert Consensus, Pathology, Outcomes Data, etc.)
The ground truth used for this device, the Audit® MicroControls™ Linearity LQ Cystatin-C, is analytical reference measurement. Specifically:
- Analyte Value Assignment: "The mean value of the Cystatin-C analyte was used to establish target concentration value at each level." This refers to the measured concentration on a reference instrument (Beckman Immage) using a specific reagent.
- Stability: Measured values at different time points and storage conditions are compared against initial or expected values established through analytical testing.
8. The Sample Size for the Training Set
Not applicable. This is a quality control material, not a machine learning algorithm, and therefore does not have a "training set."
9. How the Ground Truth for the Training Set Was Established
Not applicable. As there is no training set for this type of device, the concept of establishing ground truth for it does not apply.
§ 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.