(50 days)
1 & 2. The VITROS Immunodiagnostic Products Vitamin B12 Reagent Pack 1/2 and the VITROS Immunodiagnostic Products Vitamin B12/Folate Reagent Pack 3 - for the in vitro quantitative measurement of vitamin B12 in human serum and plasma (EDTA or heparin) to aid in the differential diagnosis of anemia.
- The VITROS Immunodiagnostic Products Vitamin B12 Calibrators - for in vitro use in the calibration of the VITROS Immunodiagnostic System for the quantitative measurement of vitamin B12 in human serum and plasma (EDTA or heparin).
The VITROS Immunodiagnostic System uses luminescence as the signal in the quantitative and semi-quantitative determination of selected analytes in human body fluids, commonly serum, plasma and urine. Coated microwells are used as the solid phase separation system.
The system is comprised of three main elements:
- The VITROS Immunodiagnostic Products range of products, in this case VITROS Immunodiagnostic Products Vitamin B12 Reagent Pack 1/2, VITROS Immunodiagnostic Products Vitamin B12/Folate Reagent Pack 3, VITROS Immunodiagnostic Products Vitamin B12 Calibrators and the VITROS Immunodiagnostic System.
- The VITROS Immunodiagnostic System instrumentation, which provides automated use of the immunoassay kits.
- Common reagents used by the VITROS System in each assay. The VITROS Immunodiagnostic Products Signal Reagent and VITROS Immunodiagnostic Products Universal Wash Reagent.
The VITROS System and common reagents are dedicated specifically only for use with the VITROS Immunodiagnostic Products range of immunoassay products.
The provided text describes the VITROS Immunodiagnostic Products Vitamin B12 assay, an in vitro diagnostic device for the quantitative measurement of vitamin B12. The data outlines a substantial equivalence study rather than a traditional clinical study with acceptance criteria often seen for imaging or AI devices.
Here's an analysis based on the provided text:
Acceptance Criteria and Device Performance:
The primary acceptance criterion is substantial equivalence to a predicate device. This is demonstrated by comparing key characteristics and performing a regression analysis.
| Acceptance Criterion | Reported Device Performance (VITROS Vitamin B12 assay) |
|---|---|
| Substantial Equivalence to Predicate Device | Demonstrated through comparison of device characteristics and Deming's Regression analysis. |
| Calibration Range | 0 - 2000 pg/mL (Matches predicate) |
| Basic Principle | Solid phase immunoassay (Different from predicate's radioassay, but equivalent for purpose) |
| Tracer | Enzyme labeled (Different from predicate's 57Co, but equivalent for purpose) |
| Instrumentation | VITROS Immunodiagnostic System (Different from predicate's Gamma Counter, but equivalent for purpose) |
| Sample Type | Serum, plasma (EDTA or heparin) (Broader than predicate's serum, plasma (EDTA)) |
| Sample Volume | 30 μL (Matches predicate) |
| Incubation Time & Temperature | 58 minutes at 37° C (Different from predicate's 1 hour at room temperature, but equivalent for purpose) |
| Correlation with Predicate Device (Deming's Regression) | VITROS Vitamin B12 assay = 0.984 x Bio-Rad Quantaphase II B12 Radioassay + 9.59 (pg/mL) |
| Analytical Sensitivity | Performed (Specific value not provided in this summary) |
| Specificity | Performed (Specific value not provided in this summary) |
| Precision | Performed (Specific value not provided in this summary) |
| Dilution | Performed (Specific value not provided in this summary) |
| Expected Values | Performed (Specific value not provided in this summary) |
Study Details:
The study conducted is a substantial equivalence study for an in vitro diagnostic (IVD) device, not a multi-reader multi-case (MRMC) comparative effectiveness study or a standalone algorithm performance study typical for AI/imaging devices.
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Sample size used for the test set and the data provenance:
- The text states: "Comparisons of the VITROS Vitamin B12 assay and the predicate device were performed with samples from a variety of clinical categories."
- It also mentions: "Equivalence was demonstrated using currently commercially available reagents along with patient specimens covering a variety of clinical categories."
- Specific sample size is not provided in this summary.
- Data provenance: Not explicitly stated, but the reference to "patient specimens" suggests human biological samples. The geographical origin (country) and whether the data was retrospective or prospective are not mentioned.
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Number of experts used to establish the ground truth for the test set and the qualifications of those experts:
- This is not applicable in the context of this type of IVD device study. The "ground truth" for an IVD assay like this is typically established by the predicate device's measurement, against which the new device is compared. There are no human "experts" establishing annotated ground truth for diagnosing B12 deficiency from images or clinical data in this document.
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Adjudication method (e.g., 2+1, 3+1, none) for the test set:
- Not applicable. This is not a study involving human readers' interpretations that require adjudication.
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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:
- No, an MRMC comparative effectiveness study was not done. This device is an in vitro diagnostic assay, not an AI or imaging device that assists human readers.
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If a standalone (i.e. algorithm only without human-in-the-loop performance) was done:
- The VITROS Immunodiagnostic System itself, which performs the assay, operates in a standalone manner for generating the quantitative B12 result. The performance data presented (calibration range, correlation with predicate, analytical sensitivity, etc.) are inherent to the assay and instrumentation, without human interpretation in the measurement process. However, this is not "standalone AI algorithm performance." It's standalone device performance.
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The type of ground truth used (expert consensus, pathology, outcomes data, etc):
- The "ground truth" for comparison in this substantial equivalence study is the measurement obtained from the legally marketed predicate device (Bio-Rad Quantaphase II B12 Radioassay) for the same patient samples. The intent is to show the new device provides comparable quantitative results.
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The sample size for the training set:
- This concept of a "training set" is not directly applicable to an IVD analytical performance study like this. The device itself (reagents, calibrators, and instrumentation) is developed and manufactured, and then its performance is validated. There isn't an "algorithm" being trained on a dataset in the way an AI model is.
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How the ground truth for the training set was established:
- Not applicable as there is no "training set" in the context of AI model development for this type of IVD device. The reagents and assay method are developed based on scientific principles and validated through internal studies and often external clinical sample comparisons.
§ 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.