(57 days)
The "Wiener lab. Fer-Color Transferrina" iron-binding capacity test system is a quantitative in vitro diagnostics device intended to measure iron-binding capacity in serum or plasma. Iron-binding capacity measurements are used in the diagnosis and treatment of anemia.
End point method.
Transferrin or specific iron carrier protein is assayed through its physiologic activity of binding Fe (III) (TIBC) at a pH higher than 7.2 in which transferrin is saturated in the presence of excess Fe (III). The remaining unbound Fe (III) is totally removed by coprecipitation with magnesium carbonate. After centrifugation, iron in the supernatant is determined as follows: iron bound to transferrin is released and colorimetrically measured according to Fer-Color procedure.
Such measurement proceeds as follows: iron is released from its specific carrier protein (transferrin) in a pH 4.5 acetate buffer, and in presence of a reducing agent (ascorbic acid). Then it reacts with color reagent, pyridyl bis-phenyl triazine sulfonate (ferrozine) producing a colored complex measured at 570 nm.
The provided document is a 510(k) premarket notification for a medical device called "WIENER LAB FER-COLOR TRANSFERRINA", which is a photometric method for Total-Iron Binding Capacity determination. The document indicates that this device is substantially equivalent to a predicate device, the RANDOX TOTAL-IRON BINDING CAPACITY / IRON test system. However, the document does not contain information about specific acceptance criteria or a study proving the device meets those criteria, as typically found in clinical validation reports or performance studies.
Therefore, I cannot provide the requested information. The document focuses on demonstrating substantial equivalence to a predicate device, which is a regulatory pathway, rather than detailing a study against predefined acceptance criteria for novel claims.
Here's a breakdown of why the information isn't available in the provided text:
- Acceptance Criteria and Reported Device Performance: This information is not present. A 510(k) summary primarily focuses on comparing the new device to a predicate device to demonstrate substantial equivalence, not on establishing performance against specific acceptance criteria through a dedicated study with quantified results.
- Sample Size and Data Provenance: Not mentioned for any test set. The document does not describe a performance study with a distinct test set.
- Number of Experts and Qualifications: Not applicable as no expert-based ground truth establishment is described.
- Adjudication Method: Not applicable.
- MRMC Comparative Effectiveness Study: Not mentioned. This type of study is more common for imaging or diagnostic devices where human interpretation plays a significant role. The device is a laboratory assay.
- Standalone Performance Study: A standalone performance study against explicit acceptance criteria with quantitative results is not detailed in this 510(k) summary. The comparison is between the new device and a predicate device.
- Type of Ground Truth Used: Not described. For laboratory assays, ground truth often involves reference methods or established clinical diagnoses, which are not outlined here as part of a formal study.
- Sample Size for Training Set: Not mentioned. The device appears to be a reagent-based assay, not a machine learning algorithm that would typically require a training set.
- How Ground Truth for Training Set was Established: Not applicable.
The document primarily states:
- Device Name: WIENER LAB FER-COLOR TRANSFERRINA
- Intended Use: Quantitative determination of Total Iron binding capacity in human serum and plasma. Used in the diagnosis and treatment of anemia.
- Predicate Device: RANDOX TOTAL-IRON BINDING CAPACITY / IRON test system.
- Equivalencies and Differences: A table comparing the intended use, test principle, reagents, and expected values between the new device and the predicate. The expected values for the Wiener Lab device are stated as 250 - 400 µg/dl. The RANDOX device states 46.0 - 69.5 µmol/l (259 - 388 µg/dl). This comparison serves as the basis for claiming substantial equivalence, implying that similar performance is expected.
To answer your request, a detailed performance study report with specific acceptance criteria and detailed statistical analysis would be required, which is beyond the scope of this 510(k) summary.
§ 862.1415 Iron-binding capacity test system.
(a)
Identification. An iron-binding capacity test system is a device intended to measure iron-binding capacity in serum. Iron-binding capacity measurements are used in the diagnosis and treatment of anemia.(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.