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510(k) Data Aggregation
(308 days)
(1) Elecsys Folate III: Binding assay for the in vitro quantitative determination of folate in human serum and plasma. The binding assay is intended for use on Elecsys and cobas e immunoassay analyzers. Measurements obtained by these devices are used in the diagnosis and treatment of anemias. For in vitro diagnostic use.
(2) Elecsys RBC Folate Hemolyzing Reagent: Elecsys RBC Folate Hemolyzing Reagent is used together with the Elecsys Folate III assay for the quantitative determination of folate in erthrocytes (RBC (red blood cell) folate). Binding assay for the in vitro quantitative determination of folate in human serum and plasma. The binding assay is intended for use on Elecsys and cobas e immunoassay analyzers. Measurements obtained by these devices are used in the diagnosis and treatment of anemias.
(3) Elecsys Folate III CalSet: Elecsys Folate III CalSet is used for calibrating the quantitative Elecsys Folate III assay on the Elecsys and cobas e immunoassay analyzers.
(4) Elecsys Folate III CalCheck: Elecsys Folate III CalCheck is used for the verification of the calibration established by the Elecsys Folate III reagent on the indicated Elecsys and cobas e immunoassay analyzers.
(5) Elecsys PreciControl Anemia: Elecsys PreciControl Anemia is used for the quality control of specified Elecsys immunoassays on Elecsys and cobas e immunoassay analyzers.
(1) The Elecsys Folate III 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 FBP (labeled with ruthenium complex). Results are determined via a calibration curve which is instrument-specifically generated by 2-point calibration and a master curve provided via the reagent barcode.
(2) The Elecsys RBC Folate Hemolyzing Reagent is a 0.2% ascorbic acid solution with which whole blood treated with anticoagulants (heparin or EDTA) is diluted. After incubation the erythrocytes are lysed and intracellular folate is liberated and stabilized. The hemolysate is then used as a prediluted sample for subsequent measurement in the Elecsys Folate III assay.
(3) The Elecsys Folate III CalSet is a lyophilized product consisting of human serum with folic acid in two concentration ranges. During manufacture, the analyte is spiked into the matrix. This calibrator is used to calibrate the Elecsys Folate III assay.
(4) Elecsys Folate III CalCheck is a lyophilized product consisting of human serum with folic acid. During manufacture, the analyte is spiked into the matrix. This solution is used to verify the calibration established with the Elecsys Folate III CalSet.
(5) The Elecsys PreciControl Anemia is a lyophilized control serum based on human serum matrix in three concentration ranges. The controls are used for monitoring the accuracy and precision of the Elecsys Ferritin, Folate III, and Vitamin B12 immunoassays.
The Elecsys Folate III Test System, including Elecsys Folate III, Elecsys RBC Folate Hemolyzing Reagent, Elecsys Folate III CalSet, Elecsys Folate III CalCheck, and Elecsys PreciControl Anemia, is designed for the in vitro quantitative determination of folate in human serum, plasma, and erythrocytes. This system is intended for use in the diagnosis and treatment of anemias on Elecsys and cobas e immunoassay analyzers.
The acceptance criteria for the Elecsys Folate III and Elecsys RBC Folate Hemolyzing Reagent assays were established through comparison studies against their respective predicate devices (Elecsys Folate II Assay and Elecsys RBC Folate Hemolyzing Reagent (K051292)). The primary method for proving the device meets these criteria is through Method Comparison studies using Passing-Bablok and Linear Regression analysis.
Here's the breakdown of the acceptance criteria and performance:
| Acceptance Criteria Category | Acceptance Criteria (Predicate Device) | Reported Device Performance (Elecsys Folate III) |
|---|---|---|
| Elecsys Folate III Assay | ||
| Measuring Range | 0.600 - 20.00 ng/mL | 1.5 - 20.0 ng/mL |
| Precision (Total CV for Human Samples 10 ng/mL) | 7.0% | 5.0% |
| Analytical Sensitivity (Lower Detection Limit) | 0.6 ng/mL | Limit of Detection = ≤1.5 ng/mL |
| Interferences (Icterus) | recovery within ± 10% of initial value for bilirubin |
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(84 days)
The Elecsys® Red Blood Cell Folate Lysing Reagent is to be used in combination with the Elecsys® Folate Assay for the quantitation of folate in human red blood cells. The electrochemiluminescence assay "ECLIA" is intended for use on the Boehringer Mannheim Elecsys 2010 immunoassay analyzer.
The Elecsys® test principle is based on the competitive principle. Total duration of assay: 90 +- 15 minutes. Reconstitution Step: Add contents of the ascorbic acid packet to 100 mL distilled or deionized water. Pretreatment Step: By incubating the sample (15 μl) with the folate pretreatment 1 (15 μl) and pretreatment 2 (10 μl), bound folate is liberated into the serum. Proceed to conduct the Elecsys® Folate Assay (K973674) as per insert instructions.
The provided text does not contain detailed acceptance criteria or a study that explicitly proves the device meets specific performance criteria beyond general statements about evaluation of assay precision, demonstration of linearity, and correlation with a predicate device. The document primarily focuses on regulatory approval and equivalence to a predicate device.
However, based on the information provided, we can infer some details related to the study conducted.
Here's an attempt to structure the information based on your request, with significant caveats that much of the detailed information you asked for is not present in the provided text.
1. A table of acceptance criteria and the reported device performance
| Acceptance Criteria (Implied) | Reported Device Performance (Implied from studies performed) |
|---|---|
| Assay Precision acceptable per NCCLS recommendations | Evaluation of assay precision according to NCCLS recommendations (result not detailed) |
| Demonstration of linearity | Demonstration of linearity (result not detailed) |
| Correlation with predicate device | Correlation with the predicate device (result not detailed) |
| Suitability for various sample types | Sample type studies (result not detailed) |
| Performance of the Elecsys® Red Blood Cell Folate Lysing Reagent in combination with the Elecsys® Folate Assay for quantitation of folate in human red blood cells. | The device is intended for this use on the Boehringer Mannheim Elecsys 2010 immunoassay analyzer. Studies were performed to support this. |
2. Sample sized used for the test set and the data provenance
- Sample Size for Test Set: Not specified.
- Data Provenance: Not specified (e.g., country of origin, retrospective or prospective).
3. Number of experts used to establish the ground truth for the test set and the qualifications of those experts
Not specified. The context suggests a laboratory assay, so "experts" in the clinical interpretation sense might not be directly applicable for establishing ground truth for the raw assay results themselves, but rather for clinical validation or interpretation of results.
4. Adjudication method for the test set
Not specified.
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
Not applicable. This is an in-vitro diagnostic (IVD) assay, not an AI-assisted diagnostic imaging device requiring human reader comparison.
6. If a standalone (i.e. algorithm only without human-in-the-loop performance) was done
Yes, in a sense. This is an IVD assay. Its performance is evaluated as a standalone system (reagent + analyzer) that produces a quantitative result without a "human-in-the-loop" step in generating the primary measurement. The "study" here refers to the analytical performance of the assay itself.
7. The type of ground truth used
For an IVD assay like this, the "ground truth" for assay performance evaluation is typically established through:
- Reference Methods: Using established, highly accurate analytical methods to determine true folate concentrations in samples.
- Known Concentration Samples: Using samples with accurately known concentrations of the analyte (e.g., spiked samples, certified reference materials).
- Clinical Samples with Clinical Diagnosis: For correlation studies, comparing assay results to a clinical diagnosis (though the document only mentions correlation with the predicate device, not directly with patient outcomes).
- Predicate Device Comparison: The document explicitly mentions "correlation with the predicate device," implying the predicate device's results serve as a comparative "ground truth" or standard.
8. The sample size for the training set
Not applicable in the context of traditional machine learning "training sets" as this is a chemical assay, not an AI algorithm. The assay itself doesn't have a "training set" in that sense. However, the development and optimization of the assay would involve various experiments and sample analyses, but these are not referred to as a "training set."
9. How the ground truth for the training set was established
Not applicable.
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