(19 days)
Binding assay for the in vitro quantitative determination of folate in human serum. Measurements obtained by this device are used in the diagnosis and treatment of anemias of gastrointestinal malabsorption. The binding assay is intended for use on the Roche Elecsys 2010 and Modular Analytics E170 immunoassay analyzers.
The Elecsys® Folate II Assay employs a competitive test principle using natural folate binding protein (FBP) specific for folate. Folate in the sample competes with the added folate labeled with biotin for the binding sites on the ruthenium labeled FBP-complex.
Here's an analysis of the provided text regarding the Elecsys® Folate II Assay, focusing on acceptance criteria and supporting studies.
Important Note: The provided text is a 510(k) Summary for a laboratory assay (in vitro diagnostic device). This type of device does not typically involve the same type of "acceptance criteria" and "studies" as an AI-powered diagnostic device, especially regarding aspects like "sample size used for the test set," "number of experts," "adjudication method," "MRMC studies," or "standalone performance" in the context of image analysis or algorithm-based diagnostics.
For a laboratory assay, "acceptance criteria" generally refer to performance characteristics like precision, accuracy, linearity, measuring range, interference, and agreement with a predicate device. The "studies" are typically analytical and clinical validation studies demonstrating these characteristics.
Given this context, I will address your questions from the perspective of an in vitro diagnostic device.
Description of Acceptance Criteria and Supporting Study for Elecsys® Folate II Assay
The Elecsys® Folate II Assay is a binding assay for the in vitro quantitative determination of folate in human serum, intended for use on Roche Elecsys 2010 and Modular Analytics E170 immunoassay analyzers. It is used in the diagnosis and treatment of anemias of gastrointestinal malabsorption. The device claims substantial equivalence to the previously marketed Elecsys® Folate Assay (K973674).
1. Table of Acceptance Criteria and Reported Device Performance
For an in vitro diagnostic device like this, "acceptance criteria" and "reported device performance" are often demonstrated through comparison with a predicate device and validation of key analytical specifications. The summary explicitly states a comparison to a predicate device and highlights areas of similarity and difference.
| Performance Characteristic | Acceptance Criteria (Implied by Predicate & Assay Type) | Elecsys® Folate II Reported Performance (where available) |
|---|---|---|
| Intended Use | Same as predicate Elecsys® Folate (K973674) | Same |
| Method | Competitive chemiluminescent immunoassay | Same |
| Sample Type | Human Serum | Same |
| Measuring Range | 0.600 - 20.00 ng/ml (or 1.36 - 45.4 nmol/L) | Same |
| Expected Values | Similar to predicate, but with potentially refined range | 3.1 - 17.5 ng/ml (Predicate: 4.2 - 19.9 ng/ml) |
| (Implied) Precision | Meet established internal and regulatory standards for IVD assays | Not explicitly detailed in this summary |
| (Implied) Accuracy | Demonstrate agreement with predicate and/or reference methods | Not explicitly detailed in this summary |
| (Implied) Linearity | Demonstrate linear response across measuring range | Not explicitly detailed in this summary |
| (Implied) Interference | Demonstrate lack of significant interference from common substances | Not explicitly detailed in this summary |
Note: The provided 510(k) summary is highly abbreviated. Detailed acceptance criteria for precision, accuracy, linearity, etc., would typically be found in the full 510(k) submission, not necessarily in the public summary. The change in "Expected Values" is a notable difference that would have required specific clinical validation.
2. Sample Size Used for the Test Set and Data Provenance
The provided 510(k) summary does not specify sample sizes used for performance testing (e.g., precision, accuracy, comparison studies). It also does not specify the country of origin of the data or whether the studies were retrospective or prospective.
For an In Vitro Diagnostic (IVD) device, studies typically involve:
- Analytical Studies: Using controlled panels, spiked samples, and patient samples to assess precision, accuracy, linearity, limits of detection/quantitation, interference, etc. The "test set" here would refer to the number of samples and replicates used in these analytical studies.
- Clinical Studies (if applicable): Patient samples analyzed and compared to a reference method or clinical outcome, often guided by the change in expected values.
Without the full submission, these details are not available from the given text.
3. Number of Experts Used to Establish the Ground Truth for the Test Set and Their Qualifications
This concept is not applicable to an in vitro diagnostic assay like the Elecsys® Folate II. Ground truth for an assay is established by:
- Reference Methods: Highly accurate and precise methods (e.g., LC-MS/MS for folate)
- Expert Diagnosis/Clinical Outcome: For clinical utility, the assay's results would be correlated with the clinical diagnosis of anemia, but "experts to establish ground truth for the test set" (as in image interpretation) doesn't fit here.
- Predicate Device Results: For substantial equivalence, results are often compared to the legally marketed predicate device.
4. Adjudication Method for the Test Set
This concept is not applicable to an in vitro diagnostic assay. Adjudication, like 2+1 or 3+1, is typically used for subjective assessments (e.g., radiology image interpretation) where human readers disagree. For an assay, results are quantitative or qualitative measurements, and disagreement implies a technical issue with the assay or instrumentation, not an interpretation difference requiring adjudication.
5. If a Multi-Reader Multi-Case (MRMC) Comparative Effectiveness Study was done
This concept is not applicable to an in vitro diagnostic assay. MRMC studies are designed to compare the performance of human readers, sometimes with and without AI assistance, especially in radiology or pathology. An IVD assay is a standalone measurement device; there are no "human readers" interpreting its output in a comparative effectiveness study in this manner.
6. If a Standalone (i.e. algorithm only without human-in-the-loop performance) was done
The Elecsys® Folate II Assay is a standalone device. It is an immunoassay system where the instrument (Elecsys 2010 or Modular Analytics E170) performs the measurement and provides a quantitative result. The human "in the loop" aspects are sample preparation, loading, and interpretation of the numerical result; the assay itself does not involve an "algorithm" in the sense of AI image analysis. Its performance is always its "standalone" performance.
7. The Type of Ground Truth Used
For an in vitro diagnostic assay, the ground truth is typically established through:
- Reference Measurement Procedures: Highly accurate and precise methods for measuring folate, often involving mass spectrometry or validated chromatographic techniques.
- Comparison to Predicate Device: Demonstration of agreement (correlation, bias) with the legally marketed predicate device.
- Clinical Diagnosis/Outcomes Data: For understanding diagnostic utility, folate levels would be correlated with the clinical diagnosis of folate deficiency anemia and associated clinical outcomes.
The provided summary does not explicitly state which "ground truth" method was predominantly used for the performance studies, but given its role as an IVD, comparison to a reference method and/or the predicate device would be standard.
8. The Sample Size for the Training Set
This concept is not applicable to the Elecsys® Folate II Assay. This device is a chemical immunoassay, not an AI/machine learning algorithm that requires a "training set." Its calibration and validation methods are based on analytical chemistry principles and statistical methods, not machine learning training.
9. How the Ground Truth for the Training Set was Established
This question is not applicable as there is no "training set" for this type of device (see point 8).
§ 862.1295 Folic acid test system.
(a)
Identification. A folic acid test system is a device intended to measure the vitamin folic acid in plasma and serum. Folic acid measurements are used in the diagnosis and treatment of megaloblastic anemia, which is characterized by the presence of megaloblasts (an abnormal red blood cell series) in the bone marrow.(b)
Classification. Class II.