(29 days)
In-vitro diagnostic reagents for the quantitative determination of free light chains (FLC), type kappa or type lambda in human serum and EDTA-plasma. FLC measurements are used as an aid in the diagnosis and monitoring of multiple myeloma (MM) and as an aid in the diagnosis of amyloidosis (AL) in conjunction with other laboratory and clinical findings.
The response category assignment of 'Complete Response' for the monitoring of MM, is reliant upon the combination of clinical history and other tests including protein electrophoresis, immunofixation and bone marrow, imaging and urine assessments.
The N Latex FLC (free light chain) assays are in vitro diagnostic reagents for the quantitative determination of free light chains, type kappa or type lambda, in human serum and EDTA plasma by means of particle-enhanced immunoassay determination. Used in conjunction with other clinical and laboratory findings, FLC measurements are used as an aid in the diagnosis and monitoring of multiple myeloma (MM) and as an aid in the diagnosis of amyloidosis (AL).
Polystyrene particles coated with antibodies to human free light chains, type kappa or lambda, respectively, are agglutinated with samples containing FLC. A concentration curve is obtained by monitoring agglutination and measuring the increase in turbidity. The actual change in absorbance is proportional to the concentration of the respective protein in the sample. The result is evaluated by comparison with a standard of known concentration.
The provided text describes the submission for a 510(k) premarket notification for the N Latex FLC kappa and N Latex FLC lambda assays, adapted for use on the Atellica® CH Analyzer. The submission aims to demonstrate substantial equivalence to previously cleared devices.
Here's a breakdown of the requested information based on the provided text:
1. A table of acceptance criteria and the reported device performance
The document states that "The test methods and acceptance criteria used for N Latex FLC kappa and lambda on the Atellica® CH Analyzer are equivalent to those used for the predicate device." However, specific numerical acceptance criteria and reported device performance (e.g., accuracy, precision, sensitivity, specificity values) are not detailed in the provided text. The text mentions "comparative testing was performed, and the results obtained demonstrate substantial equivalent performance," but does not present the direct results of these tests against specific acceptance criteria.
The only comparative performance aspect mentioned specifically is the "Analytical Measuring Range":
| Feature | Predicate (BN Systems) | Modified Device (Atellica® CH Analyzer) |
|---|---|---|
| Analytical Measuring Range | ||
| Kappa | Typical range: 3.4 to 110 mg/L | 3.91 to 60 mg/L |
| Lambda | Typical range: 1.9 to 60 mg/L | 5.47 to 70 mg/L |
Note: Without the specific performance study results (e.g., accuracy, precision, limit of detection, linearity) and their corresponding acceptance criteria, a complete table cannot be generated from the given text.
2. Sample size used for the test set and the data provenance (e.g. country of origin of the data, retrospective or prospective)
The text mentions "comparative testing" and "verification activities" but does not specify the sample size used for these test sets.
Data provenance (country of origin, retrospective/prospective) is also not specified.
3. Number of experts used to establish the ground truth for the test set and the qualifications of those experts (e.g. radiologist with 10 years of experience)
This product is an in-vitro diagnostic reagent for quantitative determination, not an imaging device requiring expert interpretation for ground truth. The "ground truth" for such devices typically relies on reference methods or spiked samples with known concentrations. The text does not mention the involvement of experts or their qualifications for establishing ground truth, as it's not applicable in the same way it would be for an image-based diagnostic.
4. Adjudication method (e.g. 2+1, 3+1, none) for the test set
Adjudication methods like 2+1 or 3+1 are typically used in studies involving human interpretation (e.g., radiologists reading images). For an in-vitro diagnostic device that provides quantitative results, an adjudication method in this sense is not applicable and therefore not mentioned.
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
There is no mention of a multi-reader multi-case (MRMC) comparative effectiveness study. This type of study is specifically relevant for imaging devices or AI-assisted diagnostic tools that involve human readers. The N Latex FLC assays are IVD reagents that provide quantitative measurements, meaning human "readers" don't interact with the device in the same way they would with an imaging AI. The submission focuses on the performance of the assay on a new instrument platform.
6. If a standalone (i.e. algorithm only without human-in-the-loop performance) was done
The N Latex FLC assays are standalone in the sense that they provide a quantitative result without human "interpretation" of the analytical output in the way an imaging AI would be interpreted. It's a fully automated analytical process on the Atellica® CH Analyzer. The entire study implicitly focuses on the standalone analytical performance of the combined reagent/analyzer system. The results generated by the device are numerical values, which are then used by clinicians in conjunction with other findings.
7. The type of ground truth used (expert consensus, pathology, outcomes data, etc)
The text does not explicitly state the type of ground truth used. For quantitative laboratory assays, ground truth is typically established through:
- Reference methods: Comparing results to a well-established, often more complex or gold-standard analytical method.
- Certified reference materials: Using samples with accurately known concentrations of the analyte.
- Commutability studies: Ensuring that control materials behave similarly to patient samples.
The document mentions "Traceability: Internal Reference Plasma Pool," which suggests that internal standards are used to calibrate and ensure consistency, contributing to the establishment of reliable measurements which act as the 'ground truth' for the assay's performance claims.
8. The sample size for the training set
The provided text describes a 510(k) submission for an in-vitro diagnostic reagent system, not an AI/ML algorithm. Therefore, the concept of a "training set" in the context of machine learning does not apply. The assays are based on established immunoassay principles, not on learned patterns from a training dataset.
9. How the ground truth for the training set was established
As explained in point 8, the concept of a "training set" for an AI/ML algorithm is not applicable here.
§ 866.5550 Immunoglobulin (light chain specific) immunological test system.
(a)
Identification. An immunoglobulin (light chain specific) immunological test system is a device that consists of the reagents used to measure by immunochemical techniques both kappa and lambda types of light chain portions of immunoglobulin molecules in serum, other body fluids, and tissues. In some disease states, an excess of light chains are produced by the antibody-forming cells. These free light chains, unassociated with gamma globulin molecules, can be found in a patient's body fluids and tissues. Measurement of the various amounts of the different types of light chains aids in the diagnosis of multiple myeloma (cancer of antibody-forming cells), lymphocytic neoplasms (cancer of lymphoid tissue), Waldenstrom's macroglobulinemia (increased production of large immunoglobulins), and connective tissue diseases such as rheumatoid arthritis or systemic lupus erythematosus.(b)
Classification. Class II (performance standards).