(42 days)
The Iron method for the Dimension Vista ™ system is an in vitro diagnostic test intended to quantitatively measure iron in human serum and plasma. Iron measurements are used in the diagnosis and treatment of diseases such as iron deficiency anemia and other disorders of iron metabolism.
The IRON Calibrator is an in vitro diagnostic product intended to be used to calibrate the IRON method for the Dimension Vista TM system.
The Dimension Vista™ IRON Flex® reagent cartridge is an in vitro diagnostic device that consists of prepackaged reagents in a plastic eight well cartridge for use on the Dade Behring Dimension Vista ™ system for the quantitative determination of iron in serum and plasma.
The Dimension Vista™ Iron Calibrator is an aqueous solution of iron wire dissolved in a dilute solution of HCl. The kit contains three glass screw top vials, 1.0 mL each, of the Calibrator A (1075 ug/dL).
Here's an analysis of the acceptance criteria and study information for the Dimension Vista™ IRON Flex® reagent cartridge and Calibrator, based on the provided document:
This document is a 510(k) summary for an in vitro diagnostic device and its calibrator. For such devices, acceptance criteria typically relate to performance characteristics like precision, accuracy (comparison to a predicate device or reference method), linearity, and interference. The study described is primarily a comparative study to demonstrate substantial equivalence to a predicate device.
1. Table of Acceptance Criteria and Reported Device Performance
The provided 510(k) summary does not explicitly list quantitative acceptance criteria for performance metrics. Instead, it states that "The performance testing according to the verification and validation test protocols demonstrate that the Dimension Vista™ IRON Flex® reagent cartridge is substantially equivalent to the designated predicate device."
However, the comparison table between the device and predicate for the reagent cartridge (Section I.3) highlights similarities in performance-related parameters which imply the new device is expected to meet similar performance standards to the predicate. The stated "Assay Range: 0 to 1,000 µg/dL" is a key performance metric.
For the calibrator, similar qualitative substantial equivalence is claimed without specific quantitative acceptance criteria or performance metrics beyond its intended use for calibrating the IRON method.
Therefore, a table cannot be fully generated with explicit acceptance criteria as they are not quantitatively stated in the document. However, we can infer performance characteristics from the comparison to the predicate.
Inferred Performance Characteristics (from comparison to predicate):
| Performance Metric | Acceptance Criteria (Implicit/Inferred) | Reported Device Performance |
|---|---|---|
| For Reagent Cartridge: | ||
| Measurement Method | Bi-chromatic endpoint measurement (600 and 700 nm) | Bi-chromatic endpoint measurement (600 and 700 nm) |
| Calibration Type | Linear calibration | Linear calibration |
| Assay Range | 0 to 1,000 µg/dL (same as predicate) | 0 to 1,000 µg/dL |
| Sample Types | Serum and Heparin plasma (same as predicate) | Serum and Heparin plasma |
| Standardization | NIST SRM 937 (same as predicate) | NIST SRM 937 |
| For Calibrator: | ||
| Intended Use | To calibrate the iron method (same as predicate) | To calibrate the iron method |
| Traceability | NIST SRM 937 (same as predicate) | NIST SRM 937 |
| Matrix | Aqueous solution of iron wire dissolved in dilute HCl (same as predicate) | Aqueous solution of iron wire dissolved in dilute HCl |
2. Sample Size Used for the Test Set and Data Provenance
The document does not explicitly state the sample size used for the test set or the data provenance (e.g., country of origin, retrospective/prospective). It generally refers to "performance testing according to the verification and validation test protocols." The guidance documents referenced (e.g., NCCLS EP7-A for interference, EP5-A2 for precision, EP09-A2 for method comparison) suggest standardized sample sizes and methodologies for specific tests, but the actual numbers used in this specific submission are not provided.
3. Number of Experts Used to Establish the Ground Truth for the Test Set and Qualifications of Those Experts
Not applicable for this type of in vitro diagnostic device (IVD). Ground truth for IVDs like this is established through comparison to a well-characterized predicate device or reference methods, not human expert interpretation of images or clinical cases.
4. Adjudication Method for the Test Set
Not applicable. Adjudication methods (like 2+1, 3+1) are relevant for studies where human interpretation or diagnostic decisions are being evaluated, such as in imaging studies. For an IVD measuring a chemical analyte, the "ground truth" is determined by the reference method or predicate device's measurement, not by expert consensus or adjudication.
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. MRMC studies are used to evaluate human reader performance, often with or without AI assistance, in diagnostic imaging or similar fields. This document concerns an in vitro diagnostic reagent cartridge for measuring an analyte, 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 device is a standalone instrument-based measurement system. Its performance is evaluated intrinsically through analytical studies (precision, accuracy, linearity, interference) against established analytical methods and a predicate device. The performance is the "algorithm only" in the sense that it is the device's ability to accurately measure iron without human interpretation beyond operating the instrument and reading the numerical result.
7. The Type of Ground Truth Used
For the Dimension Vista™ IRON Flex® reagent cartridge, the primary type of "ground truth" or reference for establishing performance and substantial equivalence is:
- Comparison to a legally marketed predicate device: Dimension® Iron Flex® reagent cartridge (K060264).
- Reference materials/methods: The device's standardization is traceable to NIST SRM 937 (National Institute of Standards and Technology - Standard Reference Material), which serves as a highly accurate reference for iron concentration.
- Established analytical principles: The method adapts direct iron assays using Ferene® chromophore, a recognized chemical principle for iron measurement.
For the Dimension Vista™ IRON Calibrator, the ground truth for its value and performance is primarily NIST SRM 937 traceability and its ability to properly calibrate the iron method on the Dimension Vista™ system, aligning with the predicate calibrator.
8. The Sample Size for the Training Set
Not applicable. This device is an in vitro diagnostic reagent and calibrator kit. It does not use machine learning or AI that requires a "training set" in the conventional sense. Its performance is based on chemical reactions and optical measurements, with an analytical curve (likely established through instrument calibration and validation runs, not machine learning) guiding its quantitative output.
9. How the Ground Truth for the Training Set was Established
Not applicable, as there is no "training set" in the context of machine learning for this device. The accuracy of measurements is established via traceability to NIST SRM 937 and comparison to the predicate device, following established laboratory quality control and validation procedures.
§ 862.1410 Iron (non-heme) test system.
(a)
Identification. An iron (non-heme) test system is a device intended to measure iron (non-heme) in serum and plasma. Iron (non-heme) measurements are used in the diagnosis and treatment of diseases such as iron deficiency anemia, hemochromatosis (a disease associated with widespread deposit in the tissues of two iron-containing pigments, hemosiderin and hemofuscin, and characterized by pigmentation of the skin), and chronic renal disease.(b)
Classification. Class I (general controls). The device is exempt from the premarket notification procedures in subpart E of part 807 of this chapter subject to the limitations in § 862.9.