Search Results

Immunoturbidimetric assay for the quantitative in vitro determination of ceruloplasmin in human serum and plasma on Roche automated clinical chemistry analyzers. Measurements obtained by this device aid in the diagnosis of copper metabolism disorders.

Device Description

The Tina-quant Ceruloplasmin assay employs an immunoturbidimetric test in which anti-ceruloplasmin antibodies react with antigen in the sample to form antigen/antibody complexes which, following agglutination can be determined turbidimetrically.

AI/ML Overview

Here's a breakdown of the acceptance criteria and study information for the Tina-quant Ceruloplasmin Assay, based on the provided text:

Acceptance Criteria and Device Performance

Acceptance Criteria Category	Specific Criterion	Criteria Value / Threshold	Reported Device Performance	Study Type to Demonstrate Performance (Implicit)
Precision (Repeatability)	Control Low	SD ≤ 0.4 mg/dL; CV ≤ 1.5%	SD 0.4 mg/dL; CV 1.5%	Internal Verification
	Control High	SD ≤ 0.9 mg/dL; CV ≤ 0.9%	SD 0.9 mg/dL; CV 0.9%	Internal Verification
	Serum Low	SD ≤ 1.2 mg/dL, CV ≤ 1.2%	SD 1.2 mg/dL, CV 1.2%	Internal Verification
	Serum Medium	SD ≤ 0.5 mg/dL, CV ≤ 0.8%	SD 0.5 mg/dL, CV 0.8%	Internal Verification
	Serum High	SD ≤ 0.9 mg/dL, CV ≤ 0.8%	SD 0.9 mg/dL, CV 0.8%	Internal Verification
Precision (Intermediate/Total)	Control Low	SD ≤ 0.4 mg/dL; CV ≤ 1.6%	SD 0.4 mg/dL; CV 1.6%	Internal Verification
	Control High	SD ≤ 0.7 mg/dL; CV ≤ 1.1%	SD 0.7 mg/dL; CV 1.1%	Internal Verification
	Serum Low	SD ≤ 0.4 mg/dL, CV ≤ 1.6%	SD 0.4 mg/dL, CV 1.6%	Internal Verification
	Serum Medium	SD ≤ 0.7 mg/dL, CV ≤ 1.0%	SD 0.7 mg/dL, CV 1.0%	Internal Verification
	Serum High	SD ≤ 1.1 mg/dL, CV ≤ 0.9%	SD 1.1 mg/dL, CV 0.9%	Internal Verification
Analytical Sensitivity	Limit of Blank (LoB)	≤ 2 mg/dL	≤ 2 mg/dL	Internal Verification
	Limit of Detection (LoD)	≤ 3 mg/dL	≤ 3 mg/dL	Internal Verification
Analytical Specificity	Interference (Common Drugs)	No interference at common therapeutic concentrations	No interference was found at common therapeutic concentrations using common drug panels.	Interference Study
Interferences (Recovery)	Icterus	Recovery within ±10% up to I-index 60	No significant interference up to an I index of 60 (approx. 60 mg/dL conjugated/unconjugated bilirubin)	Interference Study
	Hemolysis	Recovery within ±10% up to H-index 350	No significant interference up to an H index of 350 (approx. 350 mg/dL hemoglobin)	Interference Study
	Lipemia	Recovery within ±10% up to L-index 400	No significant interference up to an L Index of 400 mg/dL.	Interference Study
	Rheumatoid Factor (RF)	No interference up to RF < 76 IU/mL (highest tested)	Rheumatoid factors <76 IU/mL do not interfere.	Interference Study
High-Dose Hook Effect	No Hook Effect	Up to 500 mg/dL ceruloplasmin	No high-dose hook effect was found up to ceruloplasmin concentrations of 500 mg/dL.	Internal Verification
Method Comparison	Correlation with predicate device	y = 1.02x + 0.302 (Passing Bablock); $\tau$ = 0.934 y = 0.980x - 0.411 (Linear Regression); r = 0.997	Passing Bablock: y = 1.02x + .302; $\tau$ = 0.934 Linear Regression: y = 0.980x - 0.411; r = 0.997	Method Comparison Study

Study Information

Here's the detailed study information based on the provided text, recognizing that this is a 510(k) summary for an in vitro diagnostic (IVD) assay, which typically focuses on analytical performance rather than clinical endpoints or interpretation by human readers.

Sample size used for the test set and the data provenance:
- Precision Studies (Repeatability and Intermediate Precision):
  - Test set size: Not explicitly stated as a single "test set" size. The data for precision studies are typically derived from replicate measurements of control materials and human serum samples. The text lists values for "Control Low," "Control High," "Serum Low," "Serum Medium," and "Serum High." The number of replicates or days over which these were run is not detailed in the provided summary.
  - Data provenance: Not specified, but generally, analytical validation studies for IVDs use samples from various sources to ensure broad applicability. Likely internal lab data.
- Analytical Sensitivity (LoB, LoD):
  - Test set size: Not specified. These are determined through statistical methods based on multiple measurements of blank samples and low-level analyte samples.
  - Data provenance: Not specified. Likely internal lab data.
- Analytical Specificity/Interferences:
  - Test set size: Not specified for each interference substance, but implies various concentrations of bilirubin, hemoglobin, intralipid, and rheumatoid factor were tested.
  - Data provenance: Not specified. Likely internal lab data and commercially available panels.
- Method Comparison Study:
  - Test set size: n = 82 samples.
  - Data provenance: Not specified (e.g., country of origin). The study involved "samples concentrations were between 13.2 and 132.1 mg/dL," suggesting human serum/plasma samples. It's a retrospective comparison against the predicate device.
Number of experts used to establish the ground truth for the test set and the qualifications of those experts:
- This question is not applicable to this type of device and study. The "ground truth" for an IVD diagnostic assay's analytical performance is the true concentration of the analyte (ceruloplasmin) in a sample, determined by a reference method or known concentration in control materials. It does not involve expert interpretation or consensus.
Adjudication method (e.g. 2+1, 3+1, none) for the test set:
- This question is not applicable to this type of device and study. Adjudication methods are relevant for studies involving human interpretation (e.g., imaging studies) where disagreements among readers need resolution. For an analytical assay, the "result" is a quantitative value.
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:
- This question is not applicable. This is an in vitro diagnostic assay, not an AI-assisted diagnostic tool that aids human readers. The study compares the new assay's performance to a predicate device, not human performance with/without AI.
If a standalone (i.e. algorithm only without human-in-the-loop performance) was done:
- Yes, implicitly. The Tina-quant Ceruloplasmin Assay is a fully automated immunoturbidimetric assay on Roche automated clinical chemistry analyzers. Its performance is measured independently of human interpretation of the assay result. Humans operate the analyzer and interpret the quantitative output in a clinical context, but the assay itself is standalone in generating the ceruloplasmin concentration.
The type of ground truth used (expert consensus, pathology, outcomes data, etc):
- For precision and analytical sensitivity/specificity, the "ground truth" generally refers to:
  - Known concentrations in control materials: For controls with assigned ceruloplasmin values.
  - Reference measurement procedures: For spiked samples or characterized serum pools where the true ceruloplasmin concentration is established by a highly accurate method.
- For interferences, the ground truth is the expected recovery of ceruloplasmin in the presence of interferents, with the baseline ceruloplasmin value serving as the reference.
- For the method comparison study, the "ground truth" for evaluating the new device's accuracy is the results obtained from the predicate device (Roche Ceruloplasmin assay on cobas c510). This is a common approach for demonstrating substantial equivalence for IVDs.
The sample size for the training set:
- This information is not provided in the 510(k) summary. For an immunoturbidimetric assay like this, there isn't a "training set" in the sense of machine learning. The assay's parameters (e.g., reagent concentrations, reaction times) are developed and optimized internally by the manufacturer through R&D, not through an explicit "training set" of patient data.
How the ground truth for the training set was established:
- Since there isn't a "training set" in the machine learning sense, this question is not applicable. The underlying method for establishing the analytical accuracy of instruments or assays relies on reference materials and reference methods. The device is standardized against the reference preparation CRM 470 (RPPHS - Reference Preparation for Proteins in Human Serum), which serves as a fundamental aspect of establishing accuracy and traceability.

Ask a Question

Ask a specific question about this device

Page 1 of 1