(30 days)
The Linearity FD Tumor Markers II 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: Alpha fetoprotein (AFP), Carcinoembryonic antigen (CEA), Prostate-specific antigen-total (PSA), Carbonic Anhydrase-125 (CA-125), Carbonic Anhydrase 19-9 (CA19-9), Carbonic Anhydrase 27-29 (CA27-29)(BR), free-PSA (fPSA), and Carbonic Anhydrase 15-3 (CA15-3).
The Linearity FD Tumor Markers II is for In Vitro Diagnostic use only.
The Audit® MicroControls™ Linearity FD Tumor Markers II product is an in-vitro diagnostic device consisting of two sets of five levels of liquid, linearity/QC material. Set 1 contains the analytes: Alpha fetoprotein (AFP), Carcinoembryonic antigen (CEA), Prostate-specific antigentotal (PSA), Carbonic Anhydrase-125 (CA-125), Carbonic Anhydrase 19-9 (CA19-9), and Carbonic Anhydrase 27-29 (CA27-29) (BR) and additives in human serum. Set 2 contains the analytes: free-PSA (fPSA), and Carbonic Anhydrase 15-3 (CA15-3) and additives in human serum and bovine serum. For each set there are five levels labeled A, B, C, D and E. Both sets contain 1ml 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 is a 510(k) summary for the Audit® MicroControls™ Linearity FD Tumor Markers II, a quality control material. It describes the device's intended use and compares it to a predicate device (K082717 Audit® MicroCV™ Tumor Markers Linearity Set). The primary focus of the performance data section is on stability studies and value assignment, not diagnostic accuracy or comparative effectiveness with human readers.
Here's an analysis of the provided information concerning acceptance criteria and study details:
1. A table of acceptance criteria and the reported device performance
The document outlines acceptance criteria for stability (shelf life and reconstituted vial stability) and expected value ranges for various analytes.
Acceptance Criteria and Reported Device Performance
| Feature/Analyte | Acceptance Criteria | Reported Device Performance |
|---|---|---|
| Shelf Life | Not explicitly stated as a numerical criterion, but implies meeting product claims. | 2 years, when stored unopened at 2-8°C. (Supported by accelerated stability studies). |
| Reconstituted Stability | Not explicitly stated as a numerical criterion, but implies meeting product claims. | 14 days when stored tightly capped at 2-8°C. (Supported by accelerated stability + real-time stability studies). |
| Expected Values (General) | Target ranges calculated as +/-20% of the target mean values. | All analytes (AFP, CEA, PSA, CA125, CA27-29 (BR), CA15-3, CA19-9, fPSA) were assigned target values and corresponding target ranges (e.g., AFP: 8.2 ng/ml target, 6.5-9.8 ng/ml range). Specific values are provided in the tables within the document. |
| Real-time Stability (% Difference) | % difference of real-time mean values compared to Day0 mean value is within "the acceptance criteria" (specific numerical criterion not provided). | Studies are ongoing. Suggests initial results met internal acceptance criteria for the time points tested. |
2. Sample size used for the test set and the data provenance (e.g. country of origin of the data, retrospective or prospective)
- Test Set Sample Size: The document does not specify a "test set" in the context of diagnostic accuracy. The performance data focuses on stability and value assignment of the quality control material itself.
- For accelerated stability, it mentions "All supporting data is retained on file at Aalto Scientific, Ltd." but doesn't quantify the number of samples or lots.
- For real-time stability, it states "Vials from two lots of finished product are stored at 2-8℃ (real time vials) and -80℃ (Dayl vials). Samples are taken at two different time points."
- For value assignment, it mentions each analyte was "measured multiple times" on specific instruments (Siemens Advia Centaur and Abbott Architect i1000SR).
- Data Provenance: The studies were conducted by Aalto Scientific, Ltd., located in Carlsbad, CA, USA. The data would therefore be considered prospective as it relates to the manufacturing and testing of their product. The matrix for the product uses "Human Based Serum and bovine based serum," but this refers to the components of the QC material itself, not patient samples.
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)
This section is not applicable to this document. The device is a quality control material, not a diagnostic device that requires expert interpretation of results for ground truth. The "ground truth" for the QC material is its assigned target values based on measurements by calibrated instruments and established reference methods (implied through the use of specific analyzers and reagents).
4. Adjudication method (e.g. 2+1, 3+1, none) for the test set
This section is not applicable. There is no "test set" in the context of diagnostic performance requiring adjudication.
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
This section is not applicable. The device is a quality control material, not an AI-assisted diagnostic tool.
6. If a standalone (i.e. algorithm only without human-in-the loop performance) was done
This section is not applicable. The device is a quality control material, not an algorithm. What might be considered "standalone performance" for this device is its ability to maintain its assigned values over time (stability) and the accuracy of its initial value assignments, which are demonstrated through the described studies.
7. The type of ground truth used (expert consensus, pathology, outcomes data, etc)
For this quality control material, the "ground truth" is established through:
- Reference Instrument Measurement: Analytes were measured multiple times on specific, high-precision clinical chemistry analyzers (Siemens Advia Centaur and Abbott Architect i1000SR) using corresponding reagents. These instruments themselves are calibrated against established reference standards.
- Mean Value Calculation: The mean value of multiple measurements for each analyte at each level was used to establish the "target concentration value."
8. The sample size for the training set
This section is not applicable. This device is not an AI algorithm and therefore does not have a "training set" in the conventional sense. The development of the QC material involves formulation and initial testing, but not machine learning training.
9. How the ground truth for the training set was established
This section is not applicable for the same reasons 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.