(54 days)
N Latex Ferritin is an in vitro diagnostic reagent for the quantitative determination of ferritin in human serum or heparinized plasma by particle enhanced immunonephelometry using the Behring Nephelometer Systems, and aids in the diagnosis of diseases affecting iron metabolism, such as hemochromatosis (iron overload) and iron deficiency anemia.
Polystyrene latex particles coated with specific antibodies to human ferritin are agglutinated when mixed with samples containing ferritin. The intensity of scattered light in the nephelometer is proportional to the ferritin content of the sample; therefore, the ferritin concentration can be quantitated by comparison to dilutions of a standard of known concentration.
Here's an analysis of the provided text regarding the N Latex Ferritin device, focusing on the acceptance criteria and study details.
The provided document describes a 510(k) submission for N Latex Ferritin, an in vitro diagnostic reagent. The goal of this submission is to demonstrate substantial equivalence to a legally marketed predicate device (also N Latex Ferritin, K950707). As such, the "acceptance criteria" are predominantly about demonstrating comparable performance to the predicate and meeting standard analytical validation requirements for precision and correlation. The study described is a performance comparison study against the predicate device.
1. Table of Acceptance Criteria and Reported Device Performance
| Acceptance Criteria / Performance Metric | Reported Device Performance (N Latex Ferritin) |
|---|---|
| Correlation to Predicate Device | Correlation coefficient of 1.0 |
| Y-intercept value of -0.87 | |
| Slope of 1.05 | |
| Inter-Assay Precision | Ranged from 1.2% to 3.1% |
| Intra-Assay Precision | Ranged from 1.0% to 4.6% |
Note: The document does not explicitly state pre-defined acceptance criteria values for these metrics (e.g., "correlation coefficient must be ≥ 0.95"). However, the presented results (especially a correlation of 1.0) are clearly intended to demonstrate acceptable performance for substantial equivalence.
2. Sample Size Used for the Test Set and Data Provenance
- Sample Size for Correlation Study: 79 samples
- Sample Size for Precision Study: Three levels of human serum pools. (The exact number of individual samples within these pools is not specified, but this refers to the number of distinct concentrations tested).
- Data Provenance: The document does not explicitly state the country of origin of the data. It is a retrospective study, as it evaluates samples against an existing, legally marketed device.
3. Number of Experts Used to Establish Ground Truth for the Test Set and Qualifications
- Not Applicable. This is an in vitro diagnostic device measuring a biomarker (ferritin concentration). The "ground truth" for the test set is established by the predicate device's measurement. There are no human experts "establishing ground truth" in the way one might for image interpretation or diagnosis. The predicate device itself acts as the reference.
4. Adjudication Method for the Test Set
- Not Applicable. As noted above, this is an in vitro diagnostic device comparison study. There is no human adjudication process involved in determining the "truth" for the test samples in this context. The predicate device provides the reference measurement.
5. If a Multi-Reader Multi-Case (MRMC) Comparative Effectiveness Study Was Done
- No. This is an in vitro diagnostic device that provides a quantitative measurement of ferritin. It does not involve human readers interpreting cases, and therefore, an MRMC study is not applicable.
6. If a Standalone (Algorithm Only Without Human-in-the-Loop Performance) Was Done
- Yes, this is a standalone study. The N Latex Ferritin device (reagent and Behring Nephelometer System) operates independently to provide a ferritin concentration measurement. Its performance is evaluated directly through correlation and precision studies, without human intervention in the measurement process itself.
7. The Type of Ground Truth Used
- The "ground truth" in this context is established by the measurement obtained from the legally marketed predicate device (N Latex Ferritin, K950707). The study aims to show that the new device produces results that correlate strongly with, and are as precise as, the predicate device.
8. The Sample Size for the Training Set
- Not explicitly stated or applicable in the traditional sense. In vitro diagnostic reagents like N Latex Ferritin are typically developed and optimized through extensive R&D, rather than "trained" on a dataset in the way a machine learning algorithm is. The document describes a comparison study of the final product with a predicate device. The information related to defining the standard curve, optimizing reagents, etc., would be part of the manufacturing and R&D process, not necessarily a "training set" in the context of this 510(k) summary.
9. How the Ground Truth for the Training Set Was Established
- Not explicitly stated or applicable. Similar to point 8, the "training set" concept doesn't directly apply. The method relies on known concentrations of ferritin for calibration standards, which are established through analytical chemistry principles and reference materials, but this isn't a "ground truth for training" in the common understanding of the term for AI/ML devices.
§ 866.5340 Ferritin immunological test system.
(a)
Identification. A ferritin immunological test system is a device that consists of the reagents used to measure by immunochemical techniques the ferritin (an iron-storing protein) in serum and other body fluids. Measurements of ferritin aid in the diagnosis of diseases affecting iron metabolism, such as hemochromatosis (iron overload) and iron deficiency amemia.(b)
Classification. Class II (performance standards).