(23 days)
The IMMULITE 2500 Vitamin B12 assay is for in vitro diagnostic use with the IMMULITE 2500 Analyzer — for the quantitative measurement of vitamin B12 in serum or heparinized plasma, as an aid in clinical diagnosis and treatment of anemia.
The IMMULITE 2500 Folic Acid is for in vitro diagnostic use with the IMMULITE 2500 Analyzer - for the quantitative measurement of folic acid in serum, heparinized plasma or ascorbic acid-treated whole blood, as an aid in clinical diagnosis and treatment of anemia.
IMMULITE 2500 Vitamin B12 is a solid-phase, two-site chemiluminescent enzyme immunoassay for use with the IMMULITE 2500 Automated Analyzer.
IMMULITE 2500 Folic Acid is a solid-phase, two-site chemiluminescent enzyme immunoassay for use with the IMMULITE 2500 Automated Analyzer.
The provided text is a 510(k) summary for the IMMULITE 2500 Vitamin B12 and IMMULITE 2500 Folic Acid assay. This type of submission focuses on demonstrating substantial equivalence to a legally marketed predicate device rather than providing extensive de novo clinical study data with specific acceptance criteria and detailed performance statistics as might be found in a PMA submission or a full clinical study report.
Therefore, the document does not contain the detailed information required to fill out all sections of your request. Specifically, it lacks:
- Explicit acceptance criteria: While the claim of "substantial equivalence" implies that performance is comparable to the predicate, specific quantitative acceptance criteria for each analytical performance parameter are not listed.
- Detailed study results (test set sample size, provenance, ground truth establishment, expert details, adjudication methods, MRMC studies, standalone performance): The summary states the conclusion of substantial equivalence based on information presented in the Special 510(k), but it doesn't provide the raw data, study design, or methodology for how that equivalence was demonstrated in terms of clinical performance or specific analytical studies for new aspects of the device. Special 510(k)s often refer to changes that do not affect the intended use or fundamental scientific technology, relying on previous data and analytical verification.
- Training set details: Information on a separate training set is not present as this is typically required for AI/ML device submissions, which this is not.
Based on the information available:
1. A table of acceptance criteria and the reported device performance:
This information is not explicitly provided in the given 510(k) summary. The document focuses on demonstrating substantial equivalence to a predicate device (IMMULITE 2000 Vitamin B12 and IMMULITE 2000 Folic Acid), implying that its performance is critically comparable to that predicate. Specific numerical acceptance criteria and detailed performance results of verification and validation studies are not included in this summary document. Performance data would typically be found in the manufacturer's internal validation reports, which are not publicly available in this summary.
2. Sample sized used for the test set and the data provenance (e.g. country of origin of the data, retrospective or prospective):
This information is not provided in the given 510(k) summary.
3. Number of experts used to establish the ground truth for the test set and the qualifications of those experts (e.g. radiologist with 10 years of experience):
This information is not applicable as this device is an in-vitro diagnostic test for quantitative measurement of biomarkers, not an imaging device requiring expert interpretation for ground truth establishment.
4. Adjudication method (e.g. 2+1, 3+1, none) for the test set:
This information is not applicable as this device is an in-vitro diagnostic test.
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 information is not applicable. This device is an in-vitro diagnostic test, not an AI-assisted diagnostic tool for human readers.
6. If a standalone (i.e. algorithm only without human-in-the-loop performance) was done:
This information is not applicable in the context of an "algorithm only" performance for an IVD test in the same way it would be for an AI/ML device. The device's performance is intrinsically standalone as it quantitatively measures a biomarker. The summary implies the device's analytical performance (accuracy, precision, linearity, etc.) was assessed, but details are not provided here.
7. The type of ground truth used (expert consensus, pathology, outcomes data, etc):
For an in-vitro diagnostic device like IMMULITE 2500 Vitamin B12, the "ground truth" would typically refer to the true concentration of Vitamin B12 in a sample. This "ground truth" is usually established through:
- Reference Methods: Comparison against established, highly accurate reference methods, often involving mass spectrometry or validated laboratory methods.
- Certified Reference Materials: Using materials with known, accurately assigned concentrations of the analyte.
- Spiked Samples: Samples artificially augmented with known amounts of the analyte.
The specific methods used to establish this "ground truth" for the performance studies are not detailed in this 510(k) summary.
8. The sample size for the training set:
This information is not provided/not applicable for this type of IVD device in the context of AI/ML training data.
9. How the ground truth for the training set was established:
This information is not provided/not applicable for this type of IVD device in the context of AI/ML training data.
§ 862.1810 Vitamin B
12 test system.(a)
Identification. A vitamin B12 test system is a device intended to measure vitamin B12 in serum, plasma, and urine. Measurements obtained by this device are used in the diagnosis and treatment of anemias of gastrointestinal malabsorption.(b)
Classification. Class II.