(62 days)
The FERR method is an in vitro diagnostic device for the quantitative measurement of ferritin in human serum and plasma (lithium or sodium heparin, and EDTA) on the Dimension Vista® System. Measurements of ferritin aid in the diagnosis of diseases affecting iron metabolism, such as hemochromatosis (iron overload) and iron deficiency anemia.
The Dimension Vista™ LOCI 4 Calibrator is an in vitro diagnostic device intended to be used to calibrate the ferritin (FERR) assay on the Dimension Vista™ system.
The Dimension Vista™ FERR Flex® reagent cartridge assay is a homogenous, sandwich chemiluminescent immunoassay based on LOCI™ technology. The LOCT™ reagents include two synthetic bead reagents and a biotinylated anti-ferritin monoclonal antibody fragment. The first bead reagent (Sensibeads) is coated with streptavidin and contains a photosensitizer dye. The second bead reagent (Chemibeads) is coated with a second anti-ferritin monoclonal antibody and contains chemiluminescent dye. Sample is incubated with biotinylated antibody and Chemibeads to form a particle/ferritin/biotinylated antibody sandwich. Sensibeads are added and bind to the biotin to form bead-pair immunocomplexes. Illumination of the complex at 680 nm generates singlet oxygen from Sensibeads which diffuses into the Chemibeads, triggering a chemiluminescent reaction. The resulting signal is measured at 612 mm and is a direct function of the ferritin concentration in the sample.
The Dimension Vista™ LOCI 4 Calibrator is a five level, liquid calibrator. It is packaged as a kit of 10 vials, two vials each of five levels. The product matrix is 6% bovine serum albumin with buffer, stabilizer and preservatives. Level A is zero. Levels B through E contain Ferritin at the following target concentrations: Level A 0 ng/mL, Level B 26 ng/mL, Level C 210 ng/mL, Level D 1050 ng/mL, Level E 2000 ng/mL. Values are assigned to new lots from a masterpool that is referenced to the WHO standard for FERR, 3 rd IS 94/572.
The provided document, K070552, is a 510(k) Pre-Market Notification for the Dimension Vista™ Ferritin Flex® reagent cartridge and the Dimension Vista™ LOCI 4 Calibrator. It establishes substantial equivalence to existing predicate devices.
Here's the breakdown of the acceptance criteria and study information:
1. Table of Acceptance Criteria and Reported Device Performance
For the Dimension Vista™ Ferritin Flex® reagent cartridge (FERR):
| Acceptance Criteria (Implied) | Reported Device Performance |
|---|---|
| Clinical equivalence to the predicate device (Dimension® Ferritin Flex® reagent cartridge) for quantitative ferritin measurement. | Method Comparison Data (Dimension Vista™ FERR vs. Predicate Method): |
- Slope: 1.01
- Intercept: 1.48 ng/mL
- Correlation Coefficient (r): 0.996
- n (sample size): 158 |
2. Sample Size Used for the Test Set and Data Provenance
- Sample Size: 158 clinical patient samples.
- Data Provenance: Retrospective, as indicated by the use of "clinical patient samples" for a method comparison to an existing predicate device. The country of origin of the data is not specified in the provided summary.
3. Number of Experts Used to Establish the Ground Truth for the Test Set and Qualifications of Those Experts
Not applicable. For this device (an immunological test system), ground truth usually refers to a reference method or a "gold standard" assay, not expert consensus on image interpretation or diagnosis. The predicate device itself serves as the reference for comparison in this 510(k) submission.
4. Adjudication Method for the Test Set
Not applicable. Adjudication methods are typically relevant for studies involving human interpretation (e.g., radiologists reviewing images), where disagreement among experts needs resolution. This submission focuses on the analytical performance of an in-vitro diagnostic assay.
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 device for quantitative measurement of a biomarker, not an AI-assisted diagnostic imaging device that involves human readers.
6. If a Standalone (i.e. algorithm only without human-in-the-loop performance) was done
Yes, the study is a standalone performance assessment of the new Dimension Vista™ FERR Flex® reagent cartridge against its predicate device. The performance metrics (slope, intercept, correlation coefficient) are derived directly from the analytical results without human interpretation in the diagnostic process.
7. The Type of Ground Truth Used
The ground truth for the comparison was the results obtained from the predicate device, the Dimension® Ferritin Flex® reagent cartridge. This is a common approach for demonstrating substantial equivalence for in-vitro diagnostic devices, where the legally marketed predicate device acts as the "gold standard" for comparison.
8. The Sample Size for the Training Set
Not applicable. This device is an in-vitro diagnostic assay, not a machine learning or AI algorithm that requires a "training set" in the conventional sense. The "training" for such devices typically involves optimizing reagent formulations, instrument parameters, and calibration procedures, which are internal development activities not usually presented as a "training set" size in a 510(k) summary.
9. How the Ground Truth for the Training Set Was Established
Not applicable, as there isn't a "training set" in the AI/ML context. The calibration for the device itself (Dimension Vista™ LOCI 4 Calibrator) is traced to the WHO Standard for Ferritin, 3rd IS 94/572. This international standard serves as the primary reference for ensuring accuracy and consistency in ferritin measurements.
§ 862.1150 Calibrator.
(a)
Identification. A calibrator is a device intended for medical purposes for use in a test system to establish points of reference that are used in the determination of values in the measurement of substances in human specimens. (See also § 862.2 in this part.)(b)
Classification. Class II (special 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.