(30 days)
The Access Folate assay is a paramagnetic particle, chemiluminescent immunoassay for the quantitative determination of folic acid levels in human serum, plasma (heparin) and red blood cells using the Access Immunoassay Systems.
Folate levels in both serum and red blood cells are used to assess folate status. The serum folate level is an indicator of recent folate intake. Red blood cell (RBC) folate is the best indicator of long term folate stores. A low RBC folate value can indicate a prolonged folate deficiency.
The Access Folate reagents, Access Folate Calibrators, Access Folate Lysing Agent, Folate Calibrator S0 and the Access Immunoassay Analyzers (Access, Access 2, Synchron LX® 725, UniCel Dxl™ 800, and UniCel DxC 600i) comprise the Access Immunoassay Systems for the quantitative determination of folic acid levels in human serum, plasma (heparin) and red blood cells.
The provided text describes a 510(k) summary for the "Access Folate on the Access Immunoassay Systems" device. However, it does not include a detailed study proving the device meets specific acceptance criteria with performance metrics, sample sizes for test sets, expert information, or multi-reader studies.
The document states that the modification to the device (a change in buffers and re-establishment of the reference interval) "does not affect the intended use or indications of the device or alter the fundamental scientific technology of the device. The modification does not affect the safety and efficacy of the device." This implies that the device is considered substantially equivalent to its predicate device, and thus, its performance is assumed to meet the same standards as the predicate.
Given the information, I can only extract the intended use and technological characteristics for comparison, but not performance data from a specific study with acceptance criteria.
1. Table of Acceptance Criteria and Reported Device Performance
The provided text does not contain explicit acceptance criteria or quantitative performance data from a study demonstrating specific metrics like sensitivity, specificity, or accuracy. It focuses on demonstrating substantial equivalence to a predicate device based on technological characteristics and intended use.
The "Acceptance Criteria" here are implicitly centered around demonstrating that the modified device's characteristics are "Same" or do not significantly alter the established performance of the predicate device.
| Attribute | Acceptance Criteria (Implicit) | Reported Device Performance (Modified Device) |
|---|---|---|
| Intended Use | Should remain the same as the predicate device. | Same |
| Methodology | Should remain the same as the predicate device. | Same |
| Product Type | Should remain the same as the predicate device. | Same |
| Sample Type | Should remain the same as the predicate device. | Same |
| Assay Components | Should remain the same as the predicate device (apart from the specified buffer change which is deemed not to affect safety/efficacy). | Same |
| Solid Phase | Should remain the same as the predicate device. | Same |
| Conjugate | Should remain the same as the predicate device. | Same |
| Calibrators | Should remain the same as the predicate device regarding composition and levels. | Same |
| Reportable Range | Should remain the same as the predicate device. | Serum folate: 0.5 – 20 ng/mL |
| Sample Size | Should remain the same as the predicate device. | 55 μl |
| Impact of | The modification (change in buffers for pH adjustment and re-establishment of reference interval) should not affect the intended use, indications, fundamental scientific technology, safety, or efficacy of the device. | "Does not affect the intended use or indications of the device or alter the fundamental scientific technology of the device. The modification does not affect the safety and efficacy of the device." |
2. Sample Size Used for the Test Set and the Data Provenance
The document does not specify a sample size for a test set as part of a performance study. It mentions the re-establishment of the "reference interval to reflect the prevalence of folic acid fortification of foods," which would imply a study was done for this purpose, but no details on sample size, data provenance (country of origin, retrospective/prospective), or methodology are provided.
3. Number of Experts Used to Establish the Ground Truth for the Test Set and the Qualifications of Those Experts
This information is not provided in the document.
4. Adjudication Method for the Test Set
This information is not provided in the document.
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 is an immunoassay device, not an AI-assisted diagnostic imaging or interpretation system. Therefore, an MRMC comparative effectiveness study involving human readers and AI assistance is not applicable and was not performed.
6. If a Standalone (i.e., algorithm only without human-in-the-loop performance) Was Done
This is an immunoassay device, which measures folic acid levels quantitatively. Its performance is inherent to the assay itself, not an algorithm in the typical sense of AI or image analysis. The "standalone" performance would be the assay's precision, accuracy, linearity, etc., none of which are detailed here as acceptance criteria in the context of this 510(k) summary. The document states the modification "does not affect the safety and efficacy of the device," implying prior standalone performance was established for the predicate.
7. The Type of Ground Truth Used (Expert Consensus, Pathology, Outcomes Data, etc.)
For an immunoassay, "ground truth" typically refers to:
- Reference Standards: For accuracy/calibration.
- Clinical Samples with Confirmed Folate Status: For establishing reference intervals or clinical correlation.
- Spiked Samples: For analytical recovery.
The document mentions "re-establishment of the reference interval," which would rely on clinical samples from a population to define normal/expected folate levels. However, specific details about confirmed folate status or how this "ground truth" was established are not provided.
8. The Sample Size for the Training Set
The document does not mention a training set in the context of machine learning or AI. For an immunoassay, method validation studies would involve various samples for calibration, linearity, precision, and accuracy, but these are not referred to as "training sets."
9. How the Ground Truth for the Training Set Was Established
As no training set (in the AI/ML sense) is mentioned, this information is not applicable. For typical immunoassay validation, ground truth for analytical performance (e.g., accuracy) is established using reference materials or split samples tested by a highly accurate reference method. For clinical performance, it's typically established using carefully characterized patient samples. Specific details are not provided in this summary.
§ 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.