(275 days)
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No
The description details a standard immunoturbidimetric assay and does not mention any AI or ML components.
No
The device is described as an immunoturbidimetric assay for the quantitative in vitro determination of ceruloplasmin, aiding in diagnosis, which is a diagnostic function, not a therapeutic one.
Yes
This device is an immunoturbidimetric assay that quantitatively determines ceruloplasmin levels, and the results aid in the diagnosis of copper metabolism disorders, fulfilling the definition of a diagnostic device.
No
The device is an in vitro diagnostic assay, which is a chemical reagent-based test, not a software-only medical device.
Yes, this device is an IVD (In Vitro Diagnostic).
Here's why:
- Intended Use: The "Intended Use / Indications for Use" section explicitly states it is an "in vitro determination of ceruloplasmin in human serum and plasma". This clearly indicates the test is performed outside of the body using biological samples.
- Device Description: The description details an "immunoturbidimetric assay" which is a common method used in laboratory testing of biological samples.
- Performance Studies: The inclusion of method comparison and analytical sensitivity data are typical for IVD devices to demonstrate their performance characteristics.
- Predicate Device: The mention of a "Predicate Device" with a K number (K062114) is a strong indicator that this device is being submitted for regulatory clearance as an IVD, often through the 510(k) pathway in the US.
All of these elements align with the definition and characteristics of an In Vitro Diagnostic device.
N/A
Intended Use / Indications for Use
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.
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.
In vitro test for the quantitative determination of ceruloplasmin in human serum and plasma on Roche automated clinical chemistry analyzers.
Product codes (comma separated list FDA assigned to the subject device)
CHN
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.
Mentions image processing
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Mentions AI, DNN, or ML
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Input Imaging Modality
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Anatomical Site
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Indicated Patient Age Range
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Intended User / Care Setting
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Description of the training set, sample size, data source, and annotation protocol
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Description of the test set, sample size, data source, and annotation protocol
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Summary of Performance Studies (study type, sample size, AUC, MRMC, standalone performance, key results)
Precision:
Repeatability (Within-run):
Control Low: SD 0.4 mg/dL; CV 1.5%
Control High: SD 0.9 mg/dL; CV 0.9%
Serum Low: SD 1.2 mg/dL, CV 1.2%
Serum Medium: SD 0.5 mg/dL, CV 0.8%
Serum High: SD 0.9 mg/dL, CV 0.8%
Intermediate Precision (Total):
Control Low: SD 0.4 mg/dL; CV 1.6%
Control High: SD 0.7 mg/dL; CV 1.1%
Serum Low: SD 0.4 mg/dL, CV 1.6%
Serum Medium: SD 0.7 mg/dL, CV 1.0%
Serum High: SD 1.1 mg/dL, CV 0.9%
Method Comparison:
A comparison of the Roche Tina-quant Ceruloplasmin assay (x) with the Roche Ceruloplasmin assay on cobas c510 (y) gave the following correlation (mg/dL):
Passing Bablock
y = 1.02x + .302
tau = 0.934
Linear Regression
y = 0.980x - 0.411
r = 0.997
n = 82
Samples concentrations were between 13.2 and 132.1 mg/dL
Key Metrics (Sensitivity, Specificity, PPV, NPV, etc.)
Analytical Sensitivity:
Limit of Blank (LoB)
§ 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.
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Tina-quant Ceruloplasmin Assay
510(k) Summary MAR } 8 2010 According to the requirements of 21 CFR 807.92, the following information Introduction provides sufficient detail to understand the basis for a determination of substantial equivalence. Submitter . Roche Diagnostics name, address, 9115 Hague Road contact Indianapolis, IN 46250 (317) 521 - 3723 Contact Person: Kathie J. Goodwin Date Prepared: June 10, 2009 Device Name Proprietary names: Tina-Quant Ceruloplasmin Common names: Ceruloplasmin assay Classification names: Ceruloplasmin Immunological Test System Product codes: CHN The Tina-quant Ceruloplasmin assay employs an immunoturbidimetric test in Device Description which anti-ceruloplasmin antibodies react with antigen in the sample to form antigen/antibody complexes which, following agglutination can be determined turbidimetrically. and the manager of the comments of the comments of the comments of Intended use 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 Indications for Use metabolism disorders. The Tina-quant Ceruloplasmin assay is substantially equivalent to the Roche Substantial equivalence Ceruloplasmin assay on the cobas c501 analyzer. The cobas c501 Ceruloplasmin assay was cleared under K062114.
1
Tina-quant Ceruloplasmin Assay
510(k) Summary, Continued
Substantial
equivalence –
comparison
| Feature | Tina-quant Ceruloplasmin Assay | Predicate Device: cobas c501
Ceruloplasmin Assay (K062114) |
|-----------------------------|-------------------------------------------------------------------------------------------------------------------------------------------------------------------------------|----------------------------------------------------------------------------------------------------------------------------------------------------------------|
| Intended Use | Immunoturbidimetric assay for the
quantitative in vitro determination of
ceruloplasmin in human serum and
plasma on Roche automated clinical
chemistry analyzers. | Immunoturbidimetric assay for the
quantitative in vitro determination of
ceruloplasmin in human serum and
plasma on Roche/Hitachi cobas c
systems. |
| Indication for Use | Measurements obtained by this device
aid in the diagnosis of copper
metabolism disorders. | Same |
| Assay Protocol | Immunoturbidimetric | Same |
| Sample Type | Serum and Li-heparin Plasma | Same |
| Labeled Instrument Platform | Roche/Hitachi analyzers | Roche Hitachi cobas c systems |
| Calibrator | C.f.a.s. PAC | Same |
| Calibration frequency | Full calibration is recommended after
reagent lot change and as required
following quality control procedures. | Same |
| Controls | Commercially available control | Same |
| Traceability | Standardized against the reference
preparation CRM 470 (RPPHS -
Reference Preparation for Proteins in
Human Serum) | Same |
| Reagent Stability | 3 days at 2-8 Deg. C
4 weeks at (-15)-(-25) Deg. C | Same |
| Measuring Range | 3-140 mg/dL | Same |
2
| Precision | Repeatability (Within-run) | Within-run |
|---|---|---|
| Control Low: SD 0.4 mg/dL; CV 1.5% Control High: SD 0.9 mg/dL; CV 0.9% Serum Low: SD 1.2 mg/dL, CV 1.2% Serum Medium: SD 0.5 mg/dL, CV 0.8% Serum High: SD 0.9 mg/dL, CV 0.8% | Precinorm Protein: SD 0.2 mg/dL; CV 0.6% Precipath Protein: SD 0.2 mg/dL; CV 0.6% Human Serum 1: 0.3 mg/dL, CV 1.5% Human serum 2: 0.3 mg/dL, CV 0.8% | |
| Intermediate Precision (Total) Control Low: SD 0.4 mg/dL; CV 1.6% Control High: SD 0.7 mg/dL; CV 1.1% Serum Low: SD 0.4 mg/dL, CV 1.6% Serum Medium: SD 0.7 mg/dL, CV 1.0% Serum High: SD 1.1 mg/dL, CV 0.9% | Total Precinorm Protein: SD 0.4, CV 1.4% Precipath Protein: SD 0.4, CV 1.0% Human Serum 3: SD 0.5, CV 2.6% Human Serum 4: SD 0.7, CV 1.5% | |
| Analytical | ||
| Sensitivity | Limit of Blank (LoB) $≤$ 2 mg/dL | |
| Limit of Detection (LoD) $≤$ 3 mg/dL | Lower Detection Limit = 3 mg/dL | |
| Analytical | ||
| Specificity | No interference was found at common | |
| therapeutic concentrations using | ||
| common drug panels. | Same |
.
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3
| Interferences | Criterion: Recovery within ± 10% of initial value. | Criterion: Same |
|---|---|---|
| Icterus: no significant interference up to an I index of 60 (approximate conjugated and unconjugated bilirubin concentration: 60 mg/dL) | Icterus: Same | |
| Hemolysis: No significant interference up to an H index of 350 (approximate hemoglobin concentration: 350 mg/dL) | Hemolysis: Same | |
| Lipemia No significant interference up to an L Index of 400 mg/dL. | Lipemia (Intralipid): No significant interference up to an L index of 200. There is poor correlation between the L index (corresponds to turbidity) and triglyceride concentration. | |
| Rheumatoid Factor: Rheumatoid factors |