(21 days)
Binding assay for the in vitro quantitative determination of folate in human serum. Measurements obtained by this devices are used in the diagnosis and treatment of anemias. The binding assay is intended for use on the Roche Elecsys 2010 and MODULAR ANALYTICS E170 (Elecsys module) immunoassay analyzers.
The Elecsys Folate II Assay employs a competitive test principle. In the first step, bound folate in the sample is released from endogenous folate binding proteins through incubation with pretreatment reagents. In the second step, ruthenium labeled folate binding protein complexes with the sample. In the third step, after the addition of streptavidin-coated microparticles and folate labeled with biotin, the unbound sites of the ruthenium labeled folate binding protein become occupied, with formation of a ruthenium labeled folate binding protein-folate biotin complex. The complex becomes bound to the solid phase. The reaction mixture is aspirated into the measuring cell where the microparticles are magnetically captured onto the surface of the electrode, unbound substances are removed. Voltage is applied to the electrode inducing chemiluminescent emission which is measured by a photomultiplier. Results are determined using a calibration curve that is generated specifically on each instrument by a 2 point calibration and a master curve provided with the reagent bar code.
The provided text does not contain detailed information about the acceptance criteria or a specific study proving the device meets these criteria in the way typically expected for complex medical devices like AI algorithms or imaging analysis tools. This document is a 510(k) summary for an immunoassay, which is a laboratory test.
The document focuses on demonstrating substantial equivalence to a predicate device, rather than outlining stringent acceptance criteria and performance against them. Information provided mainly compares the new device to a previous version and confirms its intended use and technical specifications.
Therefore, many of the requested points cannot be directly answered from the provided text. However, I will extract relevant information where available and note when information is not present.
Acceptance Criteria and Device Performance for Elecsys® Folate II Immunoassay
The provided document is a 510(k) summary for an in vitro diagnostic immunoassay. Its primary purpose is to demonstrate substantial equivalence to a legally marketed predicate device, not to detail the specific performance metrics and acceptance criteria in the same way one would for a novel AI device or imaging system. Therefore, an explicit table of acceptance criteria with reported device performance is not present in this format.
The "performance" in this context is demonstrated through similarities to the predicate device and the continuation of the intended use. The key aspects highlighted are the measuring range and expected values, which are consistent with the predicate device.
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Table of Acceptance Criteria and Reported Device Performance:
Note: The document does not provide a formal table of acceptance criteria with corresponding performance data for the specific changes in the modified device. Instead, it details that the modified device has the "Same" performance characteristics as the predicate device (K031756) for several key attributes. The main change noted in performance is the stability of the opened reagent on the analyzer.
Characteristic Predicate Device (K031756) Performance Modified Device Performance (Elecsys® Folate II) Implicit "Acceptance Criteria" (by equivalence) Intended Use Quantitative determination of folate in human serum, for Elecsys 2010 and MODULAR ANALYTICS E170. Same Must meet the same intended use. Indications for Use Diagnosis and treatment of anemias of gastrointestinal malabsorption. Diagnosis and treatment of anemias. Must indicate use in diagnosis/treatment of anemias. (Slight broadening in modified device) Test Principle Competitive chemiluminescence Same Must be competitive chemiluminescence. Sample Type Serum Same Must use serum. Expected Values 3.1-17.5 ng/ml Same Must fall within 3.1-17.5 ng/ml. Measuring Range 0.600-20.00 ng/ml Same Must be 0.600-20.00 ng/ml. Traceability Standardized against Elecsys Folate (itself against a commercial radiobinding assay). Standardized against Elecsys Folate. Must maintain traceability to Elecsys Folate. Stability (Opened) At 2-8°C for 12 weeks; On E170/2010 for 6 weeks. At 2-8°C for 12 weeks; On E170/2010 for 1 week. Must demonstrate specified stability (note change). (The "Acceptance Criteria" column is inferred from the declaration of "Same" or the stated values for the predicate device, as the submission relies on substantial equivalence.)
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Sample size used for the test set and the data provenance:
The document does not specify a separate "test set" or its sample size. The substantial equivalence is largely based on the device's formulation, method, and a slight modification in stability on one analyzer, implying that comprehensive re-testing on a new clinical sample set was not the primary focus of this specific 510(k) submission. Data provenance is not mentioned. -
Number of experts used to establish the ground truth for the test set and the qualifications of those experts:
Not applicable. This is an immunoassay, and "ground truth" for clinical performance is typically established by comparison to reference methods or clinical outcomes, not expert consensus on individual "cases." The performance is inherent to the chemical reactions and detection system. -
Adjudication method for the test set:
Not applicable. No "test set" requiring adjudication by experts is described. -
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 an immunoassay, not an imaging or AI-assisted diagnostic device that involves human readers. -
If a standalone (i.e. algorithm only without human-in-the-loop performance) was done:
Not applicable. This is an immunoassay, which is a standalone measurement device without a human-in-the-loop component in its analytical operation. -
The type of ground truth used:
For an immunoassay, ground truth is established through analytical validation comparing results to known standards, reference methods, and correlation with clinical conditions. The document mentions traceability to "Elecsys Folate which was itself standardized against a commercially available radiobinding folate assay" for both the predicate and modified device. This implies the "ground truth" for standardization is established by comparison to a recognized, validated method for folate measurement. -
The sample size for the training set:
Not applicable. This is an immunoassay, not a machine learning or AI device that uses "training sets" in the conventional sense. -
How the ground truth for the training set was established:
Not applicable. As above, this is an immunoassay. The device's performance is based on its chemical and physical principles, not on learning from a training set. Standardization against a reference method serves a similar function to establishing accuracy, but it's not a "training set" in the AI context.
§ 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.