TINA-QUANT FERRITIN GEN. 4

K100538 · Roche Diagnostics · DBF · Jun 22, 2010 · Immunology

Device Facts

• Record ID: K100538
• Device Name: TINA-QUANT FERRITIN GEN. 4
• Applicant: Roche Diagnostics
• Product Code: DBF · Immunology
• Decision Date: Jun 22, 2010
• Decision: SESE
• Submission Type: Traditional
• Regulation: 21 CFR 866.5340
• Device Class: Class 2

Intended Use

Tina-Quant Ferritin assay is an in vitro immunoturbidimetric test for the quantitative determination of ferritin in human serum and plasma using Roche/Hitachi clinical chemistry analyzers.

Device Story

Tina-Quant Ferritin Gen. 4 is an in vitro diagnostic assay for quantitative ferritin measurement in human serum and plasma. It utilizes immunoturbidimetric technology; anti-ferritin antibodies coupled with latex microparticles react with ferritin in the sample to form antigen-antibody complexes. Agglutination creates turbidity proportional to ferritin concentration. The assay is performed on Roche/Hitachi clinical chemistry analyzers (902/912/917/Modular P). Healthcare providers use the resulting ferritin levels to assist in diagnosing iron metabolism disorders. The device provides improved analytical sensitivity and expanded measuring ranges compared to the predicate.

Clinical Evidence

Bench testing only. Precision was evaluated per CLSI EP5, showing repeatability (within-run) CVs of 0.9-7.2% and intermediate precision CVs of 1.5-9.9%. Analytical sensitivity: LoB 3 ng/mL, LoD 5 ng/mL, LoQ 7 ng/mL. Method comparison against the predicate (n=94) yielded a Passing Bablok slope of 0.987 and r=0.999. Interference testing confirmed no significant interference from icterus (up to 60 mg/dL bilirubin), hemolysis (up to 500 mg/dL hemoglobin), or lipemia (up to 1000 mg/dL Intralipid). No high-dose hook effect observed up to 80,000 ng/mL.

Technological Characteristics

Immunoturbidimetric assay; utilizes latex particles coated with polyclonal anti-human ferritin antibodies (rabbit). Reagents include TRIS buffer, pH 7.5, and NaCl. Operates on Roche/Hitachi automated clinical chemistry analyzers. Measuring range: 5-1000 ng/mL (platform dependent). Connectivity: Integrated with Roche/Hitachi analyzer software. Calibration: C.f.a.s. Proteins. Reagent stability: 84 days refrigerated on-analyzer.

Indications for Use

Indicated for the quantitative determination of ferritin in human serum and plasma to aid in the diagnosis of diseases affecting iron metabolism. For use by clinicians in conjunction with other clinical and laboratory findings.

Regulatory Classification

Identification

A ferritin immunological test system is a device that consists of the reagents used to measure by immunochemical techniques the ferritin (an iron-storing protein) in serum and other body fluids. Measurements of ferritin aid in the diagnosis of diseases affecting iron metabolism, such as hemochromatosis (iron overload) and iron deficiency amemia.

Predicate Devices

• Tina-Quant Ferritin (k964282)

Submission Summary (Full Text)

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K100538

.

Tina-quant Ferritin Gen. 4 Assay

:

# JUN 2 2 2010

# 510(k) Summary

| Introduction | According to the requirements of 21 CFR 807.92, the following information provides sufficient detail to understand the basis for a determination of substantial equivalence. |
|----------------------------------|-----------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------|
| Submitter name, address, contact | Roche Diagnostics<br>9115 Hague Road<br>Indianapolis, IN 46250<br>Phone: (317) 521 - 3831<br>Fax: (317) 521 - 2324 |
| | Contact Person: Kathie Goodwin, Regulatory Principal |
| | Roche Diagnostics, Indianapolis |
| | Phone: [phone] |
| | Fax: [phone] |
| | Date Prepared: February 22nd, 2010 |
| Device Name | Proprietary names: Tina-Quant Ferritin Gen. 4 Assay |
| | Common names: Ferritin Gen. 4 assay |
| | Regulation: 21 CFR 866.5340 |
| | Classification names: Ferritin Immunological Test System |
| | Product codes: DBF |
| Device Description | The Tina-quant Ferritin Gen. 4 assay employs an immunoturbidimetric test in which human ferritin agglutinates with latex particles coated with anti-ferritin antibodies. The precipitate is determined turbidimetrically at 570/800 nm. |
| Intended use | In vitro test for the quantitative determination of ferritin in human serum and plasma on Roche automated clinical chemistry analyzers. |
| | Continued on next page |

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Immunological in vitro immunoturbidometric test for the quantitative Indications for Use determination of ferritin in human serum and plasma using Roche/Hitachi clinical chemistry analyzers. Measurements obtained by this device are used in the aid of diagnosis of diseases affecting iron metabolism in conjunction with other clinical and laboratory findings.

The Tina-quant Ferritin Gen. 4 assay is substantially equivalent to the Tina-Substantial equivalence Quant Ferritin assay cleared in K964282.

Substantial equivalence comparison

| Feature | Tina-quant Ferritin Gen. 4 Assay | Predicate Device: Tina-Quant Ferritin (K964283) |
|----------------|-----------------------------------------------------------------------------------------------------------------------------------------------------|-------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------|
| Intended Use | In vitro test for the quantitative<br>determination of ferritin in human<br>serum and plasma on Roche<br>automated clinical chemistry<br>analyzers. | Immunoturbidimetric assay for the in<br>vitro quantitative determination of<br>ferritin in human serum and plasma<br>using automated clinical chemistry<br>analyzers. |
| Assay Protocol | Same | Immunoturbidimetric<br>Anti-ferritin antibodies bound to latex<br>react with the antigen in the sample to<br>form an antigen-antibody complex.<br>Following agglutination, this is<br>measured turbidimetrically. |
| Sample Type | Serum and Li-heparin, K2-EDTA or<br>K3-EDTA plasma | Serum and heparinized, citrated or K2<br>or K3-EDTA plasma |

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| Feature | Tina-quant Ferritin Gen. 4 Assay | Predicate Device: Tina-Quant<br>Ferritin (K964283) |
|-----------------------------------|----------------------------------------------------------------------------------------------------------------------------------------|---------------------------------------------------------------------------------------------------------------------------------------|
| Reagent<br>Composition | R1: TRIS Buffer, pH 7.5,<br>stabilizing polyclonal antibodies,<br>NaCl preservative | R1: TRIS Buffer, pH 8.2, stabilizing<br>polyclonal antibodies, NaCl<br>Preservative |
| | R3: Aqueous matrix containing<br>latex particles coated with anti-<br>human ferritin antibodies (rabbit);<br>preservative, stabilizers | R2: Aqueous matrix containing latex<br>particles coated with anti-human<br>ferritin antibodies (rabbit);<br>preservative, stabilizers |
| Labeled<br>Instrument<br>Platform | Roche/Hitachi | Roche/Hitachi |
| Calibrator | Same | C.f.a.s. Proteins |
| Calibration<br>Frequency | Same | After lot change and as required<br>following quality control procedures |
| Controls | Same | Precinorm and Precipath Protein |
| Reagent<br>Stability | Unopened: Up to stated expiration<br>date of 24 months | Unopened: Up to stated expiration<br>date of 15 months |
| | Opened:<br>84 days, refrigerated on the analyzer | Opened:<br>28 days, refrigerated on the analyzer |
| Measuring<br>Range | Roche/Hitachi 902:<br>5 - 800 ng/mL | Roche/Hitachi 902:<br>5 - 400 ng/mL |
| | Roche/Hitachi 912/917/Modular P:<br>5 - 1000 ng/mL | Roche/Hitachi 912/917/Modular P:<br>15 - 800 ng/mL |

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| Feature | Tina-quant Ferritin Gen. 4 Assay | | Predicate Device: Tina-Quant Ferritin (K964283) | | | | | | | |
|---------------------------|---------------------------------------------------------------------------------------------------------|-----------------------------|--------------------------------------------------------------------------------------------------------------------------------------------------|---------------|------|----------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------|---------------|------|---------------|------|
| Precision | Precision was determined using human samples and controls in accordance with the CLSI EP5 requirements. | | Imprecision: Reproducibility was determined using human samples and controls in an internal protocol: n=21. The following results were obtained. | | | | | | | |
| | | Repeatability<br>Within run | Intermediate Precision -<br>Between Day | | | | | | | |
| | Sample | Mean<br>ng/mL | % CV | Mean<br>ng/mL | % CV | Sample | Mean<br>ng/mL | % CV | Mean<br>ng/mL | % CV |
| | PNP | 128 | 0.9 | 128 | 1.5 | HS | 32 | 6.0 | 32 | 5.6 |
| | PPP | 332 | 1.2 | 332 | 2.0 | PNP | 77 | 2.5 | 76 | 2.7 |
| | HS1 | 8.48 | 7.2 | 8.48 | 9.9 | PPP | 333 | 1.2 | 329 | 1.3 |
| | HS2 | 25.5 | 4.7 | 25.5 | 5.2 | | | | | |
| | HS3 | 235 | 0.9 | 235 | 1.8 | | | | | |
| | HS4 | 619 | 1.2 | 619 | 2.1 | | | | | |
| | HS5 | 820 | 1.1 | 820 | 2.1 | | | | | |
| Analytical<br>Sensitivity | Limit of Blank = 3 ng/mL<br>Limit of Detection = 5 ng/mL | | | | | | | | | |
| Functional<br>Sensitivity | Limit of Quantitation = 7 ng/mL | | | | | NA | | | | |
| Analytical<br>Specificity | Same | | | | | The polyclonal antibodies used in the assay are specific for ferritin from human liver and also recognize ferritin from human spleen. The antibodies show no cross reactivity to the human ferritin H subunit; which is the major component of human heart ferritin. | | | | |

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| Feature | Tina-quant Ferritin Gen. 4 Assay | Predicate Device: Tina-Quant<br>Ferritin (K964283) |
|----------------------|--------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------|----------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------|
| Interferences | Icterus:<br>No Significant interference up to an I<br>index of 60 (approximate conjugated<br>and unconjugated bilirubin<br>concentration: 60 mg/dL) | Icterus:<br>No Significant interference up to an I<br>index of 60 (approximate conjugated and<br>unconjugated bilirubin concentration: 60<br>mg/dL) |
| | Hemolysis:<br>No significant interference up to an H<br>index of 500 (approximate hemoglobin<br>concentration: 500 mg/dL) | Hemolysis:<br>No significant interference up to an H<br>index of 500 (approximate hemoglobin<br>concentration: 500 mg/dL) |
| | Lipemia (Intralipid):<br>No significant interference up to an<br>Intralipid concentration of 1000 mg/dL<br>on Roche/Hitachi 912, 917 and<br>MODULAR P analyzers and up to an<br>Intralipid concentration of 800 mg/dL<br>on Roche/Hitachi 902 analyzers. There<br>is poor correlation between the<br>Intralipid concentration (corresponds to<br>turbidity) and triglycerides<br>concentration. | Lipemia (Intralipid):<br>No significant interference up to an L<br>index of 750 (approximate triglyceride<br>concentration: 1500 mg/dL). There is<br>poor correlation between turbidity and<br>triglyceride concentration. |
| | Rheumatoid factors <1200 IU/ml do<br>not interfere. | Rheumatoid factors <100 IU/ml do not<br>interfere. |
| | No high-dose hook effect is seen up to<br>a ferritin concentration of 80000 ng/mL<br>on Roche/Hitachi<br>902/912/917/MODULAR P analyzers. | A high-dose hook effect may occur at<br>ferritin concentrations above 20,000<br>ng/mL (Roche/Hitachi<br>911/912/917/MODULAR P). |
| | Drugs: No interference was found at<br>therapeutic concentrations using<br>common drug panels. | |
| Feature | Tina-quant Ferritin Gen. 4 Assay | Predicate Device: Tina-Quant Ferritin (K964283) |
| Expected<br>Values | Men (20-60 yrs):<br>30-400 ng/mL<br><br>Women (17-60 yrs):<br>15-150 ng/mL | Men:<br>30-400 ng/mL<br><br>Women:<br>15-150 ng/mL<br><br>Children (3 months - 16 years):<br>20-200 ng/mL<br>2nd-3rd month:<br>80-500 ng/mL<br>1st month:<br>150-450 ng/mL<br>Umbilical cord blood:<br>50-250 ng/mL |
| Method<br>Comparison | A comparison of the Roche Tina-quant Ferritin Gen. 4 assay on the<br>Roche/Hitachi 917 analyzer (y) with the Roche Tina-quant Ferritin assay on<br>the same analyzer (x) using human serum and plasma samples gave the<br>following correlation (ng/mL):<br><br>Passing Bablok:<br>y = 0.987x + 0.040<br>tau = 0.983<br><br>Number of samples measured: 94<br>The sample concentrations were between 15.0 and 775 ng/mL (according the<br>measuring range of the predicate device).<br><br>Linear regression:<br>y = 0.987x + 0.591<br>r = 0.999 | |

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#### DEPARTMENT OF HEALTH & HUMAN SERVICES

Image /page/6/Picture/1 description: The image shows the logo for the U.S. Department of Health & Human Services. The logo consists of a stylized eagle with its wings spread, and the text "DEPARTMENT OF HEALTH & HUMAN SERVICES - USA" arranged in a circular fashion around the eagle. The text is in all capital letters and is relatively small compared to the eagle symbol.

Food & Drug Administration 10903 New Hampshire Avenue Building 66 Silver Spring, MD 20993

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

JUN 2 2 2010

Re: k100538

Trade/Device Name: Tina-Quant Ferritin Gen. 4 Regulation Number: 21 CFR § 866.5340 Regulation Name: Ferritin Immunological Test System Regulatory Class: Class II Product Code: DBF Dated: May 7, 2010 Received: May10, 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/ReportaProblem/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,

Marie M Chan

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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## Indications for Use Form

K100538 510(k) Number (if known):

Device Name: Tina-Quant Ferritin Gen. 4

Indications for Use:

Immunological in vitro immunoturbidometric test for the quantitative determination of ferritin in human serum and plasma using Roche/Hitachi clinical chemistry analyzers. Measurements obtained by this device are used in the aid of diagnosis of diseases affecting iron metabolism in conjunction with other clinical and laboratory findings.

Prescription Use X (Part 21 CFR 801 Subpart D)

AND/OR

Over-The-Counter Use (21 CFR 801 Subpart C)

(PLEASE DO NOT WRITE BELOW THIS LINE-CONTINUE ON ANOTHER PAGE OF NEEDED)

Concurrence of CDRH, Office of In Vitro Diagnostic Devices (OIVD)

Reena Philip

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

510(k) k100538

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