(135 days)
In vitro diagnostic reagents for the quantitative determination of ceruloplasmin and hemopexin in human serum and heparinization of only and one of immunonephelometry on the BN™ Systems.
In vitro diagnostic reagents for the quantitative determination of ceruloplasmin and hemopexin in serum and heparinized plasma by means of immunonephelometery on the BN™ Systems. Measurement of ceruloplasmin aids in the diagnosis of cooply of metabolism disorders.
Proteins contained in human body fluids form immune complexes in an immunochemical reaction with specific antibodies. These complexes scatter a beam of light passed through the sample. The intensity of the scattered light is proportional to the concentration of the relevant protein in the sample. The result is evaluated by comparison with a standard of known concentration.
This document describes the 510(k) summary for the "N Antisera to Human Ceruloplasmin" device, which is an in vitro diagnostic reagent used for the quantitative determination of ceruloplasmin and hemopexin in human serum and heparinized plasma. The submission claims substantial equivalence to a legally marketed predicate device (K860894).
Here's a breakdown of the requested information based on the provided text:
1. Table of Acceptance Criteria and Reported Device Performance:
The document doesn't explicitly state "acceptance criteria" in a quantitative format for specific performance metrics like accuracy, precision, or detection limits. Instead, it focuses on demonstrating equivalence to a predicate device.
| Performance Characteristic | Acceptance Criteria (Implied) | Reported Device Performance |
|---|---|---|
| Method Equivalence | Substantially equivalent to predicate device (K860894) | Demonstrated equivalent performance to the predicate device. |
| Serum vs. Heparinized Plasma Measurement | Method comparison should show high correlation | 0.99 correlation coefficient between serum and heparinized plasma measurements. |
2. Sample Size Used for the Test Set and Data Provenance:
- Sample Size: Not explicitly stated. The document mentions "a method comparison was performed" but does not give the number of samples or subjects used in this comparison.
- Data Provenance: Not explicitly stated. The document doesn't specify the country of origin of the data or whether it was retrospective or prospective.
3. Number of Experts Used to Establish Ground Truth for the Test Set and Qualifications:
- Not applicable as this is an in vitro diagnostic reagent claiming equivalence, not a medical imaging or clinical diagnostic device requiring expert interpretation for ground truth.
4. Adjudication Method for the Test Set:
- Not applicable for a chemistry assay where the "ground truth" is typically established by reference methods or comparison to a predicate device.
5. If a Multi-Reader Multi-Case (MRMC) Comparative Effectiveness Study Was Done:
- No, an MRMC study was not performed. This type of study is relevant for devices involving human interpretation of medical images or data. This device is an automated in vitro diagnostic reagent.
6. If a Standalone (Algorithm Only Without Human-in-the-Loop Performance) Was Done:
- Yes, this device operates as a standalone diagnostic reagent on the BN™ Systems. Its performance is evaluated based on its ability to quantitatively determine ceruloplasmin and hemopexin levels, without requiring human interpretation of results beyond reading the quantitative output. The "method comparison" study conducted is essentially a standalone performance evaluation against a comparable method.
7. The Type of Ground Truth Used:
- The ground truth for this device's performance evaluation is established through comparison to a legally marketed predicate device (K860894), and by demonstrating correlation between different sample types (serum and heparinized plasma). The predicate device itself would have been validated against established reference methods or clinical outcomes.
8. The Sample Size for the Training Set:
- Not applicable. This device is an in vitro diagnostic reagent, not an AI/ML algorithm that undergoes a "training" phase with a dataset. Its development likely involved R&D, formulation, and analytical validation.
9. How the Ground Truth for the Training Set Was Established:
- Not applicable, as there is no "training set" in the context of this traditional in vitro diagnostic reagent.
§ 866.5210 Ceruloplasmin immunological test system.
(a)
Identification. A ceruloplasmin immunological test system is a device that consists of the reagents used to measure by immunochemical techniques the ceruloplasmin (copper-transporting serum protein) in serum, other body fluids, or tissues. Measurements of ceruloplasmin aid in the diagnosis of copper metabolism disorders.(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 § 866.9.