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510(k) Data Aggregation
(265 days)
Atellica IM Folate Assay
The Atellica™ Folate assay is for in vitro diagnostic use in the quantitative determination of folate in serum or red blood cells using the Atellica IM Analyzer. Folic acid measurements are used in the diagnosis and treatment of anemias.
The Atellica™ IM Folate Assay is an immunoassay with the following components: Atellica™ IM Folate Primary Reagent ReadyPack (including Lite Reagent, Solid Phase Reagent, and Folate Binding Protein), Atellica™ IM Folate Calibrator (including Low and High Calibrators), Atellica IM Folate DTT/Releasing Agent (sold separately, including Dithiothreitol and Sodium hydroxide), and Atellica IM RBC Folate (sold separately, including Lyophilized ascorbic acid and RBC Folate Ascorbic Acid Diluent).
The provided text is a 510(k) summary for an in vitro diagnostic device (Atellica™ IM Folate Assay), not an AI/ML medical device. Therefore, much of the requested information regarding AI/ML device acceptance criteria and study design (such as multi-reader multi-case studies, expert adjudication, training set ground truth, etc.) is not applicable to this document.
However, I can extract information related to the acceptance criteria for this diagnostic assay and how its performance was proven.
Here's a summary based on the provided document, addressing the applicable points:
Device Name: Atellica™ IM Folate Assay
Indications for Use: For in vitro diagnostic use in the quantitative determination of folate in serum or red blood cells using the Atellica IM Analyzer. Folic acid measurements are used in the diagnosis and treatment of anemias.
1. Table of Acceptance Criteria and Reported Device Performance
The document doesn't explicitly state "acceptance criteria" in a singular table, but rather presents performance characteristics of the device, implying that the observed performance met internal or regulatory (CLSI) standards. The predicate device (ADVIA Centaur Folate Assay, K010050) serves as the benchmark for substantial equivalence.
Here's a compilation of key performance characteristics, acting as de-facto acceptance criteria for a new in vitro diagnostic assay, and the reported performance. The "Acceptance Criteria" here are implicitly derived from CLSI guidelines and comparison to the predicate.
| Performance Characteristic | Implicit/Stated Acceptance Criteria (often based on CLSI guidelines or predicate performance) | Reported Device Performance (Atellica™ IM Folate Assay) |
|---|---|---|
| Precision (Repeatability CV) | Acceptable Coefficient of Variation (CV) for different analyte levels (e.g., typically 0.95) with predicate device. | Serum: r = 0.99 |
| RBC hemolysate: r = 0.93 | ||
| Method Comparison (Regression Equation) | Slope and intercept close to 1 and 0, respectively, when compared to predicate. | Serum: y = 0.94x - 0.01 ng/mL |
| RBC hemolysate: y = 1.06x – 2.52 ng/mL | ||
| Detection Limits (LoB, LoD, LoQ) | Values demonstrated to be fit for clinical purpose. | Serum: LoB 0.19 ng/mL, LoD 0.38 ng/mL, LoQ 0.56 ng/mL |
| RBC: LoB 0.00 ng/mL, LoD 0.21 ng/mL, LoQ 0.56 ng/mL | ||
| Interference | No significant interference ( |
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