TINA-QUANT CERULOPLASMIN

K091741 · Roche Diagnostics · CHN · Mar 18, 2010 · Immunology

Device Facts

• Record ID: K091741
• Device Name: TINA-QUANT CERULOPLASMIN
• Applicant: Roche Diagnostics
• Product Code: CHN · Immunology
• Decision Date: Mar 18, 2010
• Decision: SESE
• Submission Type: Traditional
• Regulation: 21 CFR 866.5210
• Device Class: Class 2

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 metabolism disorders.

Device Story

Tina-quant Ceruloplasmin assay is an in vitro diagnostic test for human serum and plasma; used on Roche automated clinical chemistry analyzers. Principle: immunoturbidimetric; anti-ceruloplasmin antibodies react with sample antigen to form complexes; agglutination measured via turbidimetry. Output: quantitative ceruloplasmin concentration (mg/dL). Used in clinical laboratory settings by trained technicians. Results aid physicians in diagnosing copper metabolism disorders. Benefits: provides standardized, automated measurement of ceruloplasmin levels to support clinical assessment.

Clinical Evidence

No clinical studies were performed. Evidence consists of bench testing, including precision (CLSI EP5-A2), linearity, limit of detection (CLSI EP17-A), analytical specificity (interference testing), and a method comparison study (n=97) against the predicate device, yielding a correlation of y=1.012x-1.04 (τ=0.945).

Technological Characteristics

Immunoturbidimetric assay; utilizes anti-ceruloplasmin antibodies. Measuring range: 3-140 mg/dL. Standardized against CRM 470 (RPPHS). Reagent stability: 3 days at 2-8°C or 4 weeks at -15 to -25°C. Designed for use on Roche automated clinical chemistry analyzers. Software performs automated turbidimetric calculations based on agglutination intensity.

Indications for Use

Indicated for the quantitative measurement of ceruloplasmin in human serum and plasma to aid in the diagnosis of copper metabolism disorders. For prescription use only.

Regulatory Classification

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.

Special Controls

*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.

Predicate Devices

• cobas c501 Ceruloplasmin Assay (K062114)

Submission Summary (Full Text)

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K091741

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.

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Tina-quant Ceruloplasmin Assay

## 510(k) Summary, Continued

Substantial
equivalence –
comparison

| Feature | Tina-quant Ceruloplasmin Assay | Predicate Device: cobas c501<br>Ceruloplasmin Assay (K062114) |
|-----------------------------|-------------------------------------------------------------------------------------------------------------------------------------------------------------------------------|----------------------------------------------------------------------------------------------------------------------------------------------------------------|
| Intended Use | Immunoturbidimetric assay for the<br>quantitative in vitro determination of<br>ceruloplasmin in human serum and<br>plasma on Roche automated clinical<br>chemistry analyzers. | Immunoturbidimetric assay for the<br>quantitative in vitro determination of<br>ceruloplasmin in human serum and<br>plasma on Roche/Hitachi cobas c<br>systems. |
| Indication for Use | Measurements obtained by this device<br>aid in the diagnosis of copper<br>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<br>reagent lot change and as required<br>following quality control procedures. | Same |
| Controls | Commercially available control | Same |
| Traceability | Standardized against the reference<br>preparation CRM 470 (RPPHS -<br>Reference Preparation for Proteins in<br>Human Serum) | Same |
| Reagent Stability | 3 days at 2-8 Deg. C<br>4 weeks at (-15)-(-25) Deg. C | Same |
| Measuring Range | 3-140 mg/dL | Same |

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| 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<br>Sensitivity | Limit of Blank (LoB) $≤$ 2 mg/dL<br>Limit of Detection (LoD) $≤$ 3 mg/dL | Lower Detection Limit = 3 mg/dL |
| Analytical<br>Specificity | No interference was found at common<br>therapeutic concentrations using<br>common drug panels. | Same |

.

・

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| 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 <76 IU/mL do not interfere. (Highest concentration tested) | RF: Rheumatoid factors up to 100 IU/mL do not interfere. |
| | No high-dose hook effect was found up to ceruloplasmin concentrations of 500 mg/dL. | High-dose hook effect: Same |
| | In very rare cases, gammopathy, in particular type IgM (Waldenstrom's macroglobulinemia), may cause unreliable results. | Same |
| Expected Values | Male: 15-30 mg/dL<br>Female: 16-45 mg/dL | 20.0 - 60.0 mg/dL |
| Method<br>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) :<br><br>Passing Bablock<br>y = 1.02x + .302<br>$\tau$ = 0.934<br><br>Linear Regression<br>y = 0.980x - 0.411<br>r = 0.997<br><br>n = 82<br>Samples concentrations were between 13.2 and 132.1 mg/dL | |
| | | |

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Food and Drug Administration 10903 New Hampshire Avenue Document Mail Center - WO66-0609 Silver Spring, MD 20993-0002

Roche Diagnostics c/o Ms. Kathie Goodwin, MBA, MT (ASCP)BB, RAC Regulatory Affairs Consultant 9115 Hague Road, PO Box 50416 Indianapolis, IN 46250-0416

MAR 1 8 2010

Re: k091741

Trade/Device Name: Tina-Quant Ceruloplasmin Regulation Number: 21 CFR & 866.5210 Regulation Name: Ceruloplasmin Immunological Test System Regulatory Class: Class II Product Code: CHN Dated: March 2, 2010 Received: March 10, 2010

Dear Ms. Goodwin:

We have reviewed your Section 510(k) premarket notification of intent to market the device referenced above and have determined the device is substantially equivalent (for the indications for use stated in the enclosure) to legally marketed predicate devices marketed in interstate commerce prior to May 28, 1976, the enactment date of the Medical Device Amendments, or to devices that have been reclassified in accordance with the provisions of the Federal Food, Drug, and Cosmetic Act (Act) that do not require approval of a premarket approval application (PMA). You may, therefore, market the device, subject to the general controls provisions of the Act. The general controls provisions of the Act include requirements for annual registration, listing of devices, good manufacturing practice, labeling, and prohibitions against misbranding and adulteration.

If your device is classified (see above) into class II (Special Controls), it may be subject to such additional controls. Existing major regulations affecting your device can be found in Title 21, Code of Federal Regulations (CFR), Parts 800 to 895. In addition, FDA may publish further announcements concerning your device in the Federal Register.

Please be advised that FDA's issuance of a substantial equivalence determination does not mean that FDA has made a determination that your device complies with other requirements of the Act or any Federal statutes and regulations administered by other Federal agencies. You must comply with all the Act's requirements, including, but not limited to: registration and listing (21 CFR Part 807); labeling (21 CFR Parts 801 and 809); medical device reporting (reporting of

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Page 2 – Ms. Kathie Goodwin

medical device-related adverse events) (21 CFR 803); and good manufacturing practice requirements as set forth in the quality systems (QS) regulation (21 CFR Part 820). This letter will allow you to begin marketing your device as described in your Section 510(k) premarket notification. The FDA finding of substantial equivalence of your device to a legally marketed predicate device results in a classification for your device and thus, permits your device to proceed to the market.

If you desire specific advice for your device on our labeling regulation (21 CFR Parts 801 and 809), please contact the Office of In Vitro Diagnostic Device Evaluation and Safety at [phone]. Also, please note the regulation entitled, "Misbranding by reference to premarket notification" (21 CFR Part 807.97). For questions regarding the reporting of adverse events under the MDR regulation (21 CFR Part 803), please go to http://www.fda.gov/MedicalDevices/Safety/ReportalProblem/default.htm for the CDRH's Office of Surveillance and Biometrics/Division of Postmarket Surveillance.

You may obtain other general information on your responsibilities under the Act from the Division of Small Manufacturers, International and Consumer Assistance at its toll-free number [phone] or [phone] or at its Internet address http://www.fda.gov/cdrh/industry/support/index.html.

Sincerely yours,

in char

Maria M. Chan, Ph.D. Director Division of Immunology and Hematology Devices Office of In Vitro Diagnostic Device Evaluation and Safety Center for Devices and Radiological Health

Enclosure

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## Indication for Use

510(k) Number (if known):

k091741

## Device Name: Roche/Hitachi Tina-Quant Ceruloplasmin

Indication For Use:

In vitro test for the quantitative determination of ceruloplasmin in human serum and plasma on Roche automated clinical chemistry analyzers.

Prescription Use XXXX (21 CFR Part 801 Subpart D) And/Or

Over the Counter Use (21 CFR Part 801 Subpart C)

(PLEASE DO NOT WRITE BELOW THIS LINE; CONTINUE ON ANOTHER PAGE IF NEEDED)

Concurrence of CDRH, Office of In Vitro Diagnostic Device Evaluation and Safety (OIVD)

Beena Philip

Division Sign-Off Office of In Vitro Diagnostic Device Evaluation and Safety

510(k) k091741