ADVIA CHEMISTRY FERRITIN (FRT) METHOD

K110736 · Siemens Healthcare Diagnostics, Inc. · DBF · Aug 17, 2011 · Immunology

Device Facts

• Record ID: K110736
• Device Name: ADVIA CHEMISTRY FERRITIN (FRT) METHOD
• Applicant: Siemens Healthcare Diagnostics, Inc.
• Product Code: DBF · Immunology
• Decision Date: Aug 17, 2011
• Decision: SESE
• Submission Type: Traditional
• Regulation: 21 CFR 866.5340
• Device Class: Class 2

Intended Use

The ADVIA® 1650 Chemistry Ferritin (FRT) Reagent: For in vitro diagnostic use in the quantitative determination of ferritin in human serum and plasma on the ADVIA® 1650 Chemistry system. Measurements of ferritin aid in the diagnosis of diseases affecting iron metabolism, such as hemochromatosis (iron overload) and iron deficiency anemia. The ADVIA® Chemistry Liquid Specific Protein Calibrators: For in vitro diagnostic use in the calibration of ADVIA® Chemistry systems for the Alpha-Acid-Glycoprotein (AAG), Alpha-1-Antitrypsin (AAT), Anti-streptolysin-O_2 (ASO_2), Complement C3 (C3), Complement C4 (C4), Ferritin (FRT), Haptoglobin (HAPT), Immunoglobulin A_2 (IGA_2), Immunoglobulin G_2 (IGG_2), Immunoglobulin M_2 (IGM_2), Prealbumin (PREALB), Rheumatoid Factor (RF), and Transferrin (TRF) methods.

Device Story

ADVIA Chemistry Ferritin is a ready-to-use liquid reagent for automated clinical chemistry analyzers. Sample is diluted and reacted with antibody-coated latex particles; antibody-antigen complex formation increases turbidity, measured via light absorbance at 658 nm. Ferritin concentration is determined by comparing sample absorbance against a standard curve generated by the ADVIA Chemistry Liquid Specific Protein Calibrator. Used in clinical laboratories by technicians to assist physicians in diagnosing iron metabolism diseases. Output is a quantitative ferritin concentration value used for clinical decision-making regarding iron status.

Clinical Evidence

Method comparison study performed on 47 patient samples comparing ADVIA 1650 Chemistry Ferritin assay to N Latex Ferritin predicate. Results showed a slope of 1.00 (95% CI: 0.97–1.03) and an intercept of 0.00 (95% CI: -3.4–3.4), indicating substantial equivalence.

Technological Characteristics

Liquid, ready-to-use reagents; turbidometric measurement principle; 658 nm wavelength; multi-analyte liquid calibrator derived from human sources; traceable to WHO 3rd International Standard IBSC 94/572; automated chemistry system integration.

Indications for Use

Indicated for quantitative determination of ferritin in human serum and plasma to aid in diagnosis of iron metabolism disorders, including hemochromatosis and iron deficiency anemia. Used on ADVIA Chemistry systems by clinical laboratory professionals.

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

• N Latex Ferritin reagent (k993273)
• Randox Liquid Protein Calibrator (k061056)

Submission Summary (Full Text)

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K110736

#### 510(k) Summary

AUG 1 7 2011

This summary of 510(k) safety and effectiveness information is being submitted in accordance with the requirements of SMDA 1990 and 21 CFR 807.92.

| Submitter's Name: | Kira Gordon<br>Siemens Healthcare Diagnostics Inc.<br>511 Benedict Ave,<br>Tarrytown, NY 10591 |
|--------------------------|------------------------------------------------------------------------------------------------|
| Date of Preparation: | March 07, 2011 |
| Name of Product: | ADVIA® Chemistry Ferritin (FRT) Reagent<br>ADVIA® Chemistry Liquid Specific Protein Calibrator |
| FDA Classification Name: | Ferritin immunological test system (Class II)<br>Calibrator (Class II) |

### Predicate Device:

The following table describes the predicate devices, device classification, regulation and product code associated with this pre-market notification:

| New Product | Predicate Device | 510(k)<br>number | Device<br>Class | Regulation | Product<br>Code |
|-----------------------------------------------------------|-------------------------------------|------------------|-----------------|------------|-----------------|
| ADVIA® Chemistry<br>Ferritin (FRT)<br>Reagent | N Latex Ferritin<br>reagent | k993273 | Class II | 866.5340 | DBF |
| ADVIA® Chemistry<br>Liquid Specific<br>Protein Calibrator | Randox Liquid<br>Protein Calibrator | k061056 | Class II | 862.1150 | JIX |

### Device Description:

The Ferritin reagents are ready-to-use liquid reagents. They are supplied in two different package sizes: 200 tests/wedge, 4 wedges/kit and 800 tests/wedge, 4 wedges/kit. In the ADVIA Chemistry Ferritin assay, sample is diluted and reacted with a buffer containing latex particles coated with antibody specific for ferritin. The formation of the antibodyantigen complex during the reaction results in an increase in turbidity, the extent of which is measured as the amount of light absorbed at 658 nm. By constructing a standard curve from the absorbance of standards, ferritin concentration of a sample can be determined.

ADVIA Chemistry Liquid Specific Protein Calibrator is a multi-analyte, liquid, buffer based product containing multiple analytes derived from human sources. The kit consists of 6 vials each of 6 calibrator levels which are ready for use (no preparation is required).

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The constituent concentrations of these Calibrators are present at levels 2, 3, 4, 5 and 6. Level 1 is a zero level. The volume per vial is 1.0 mL.

Values for the new lots are assigned from a master lot that is referenced to the WHO 3rd International Standard IBSC 94/572

## Intended Use:

The ADVIA Chemistry Ferritin reagent is for in vitro diagnostic use in the quantitative measurements of ferritin in human serum and plasma on the ADVIA Chemistry systems. Measurements of ferritin aid in the diagnosis of diseases affecting iron metabolism, such as hemochromatosis (iron overload) and iron deficiency anemia.

The ADVIA Chemistry Liquid Protein Calibrator is for in vitro diagnostic use in the calibration of ADVIA® Chemistry system for the Alpha-Acid-Glycoprotein (AAG), Alpha-1-Antitrypsin (AAT), Anti-streptolysin-O_2 (ASO_2), Complement C3 (C3), Complement C4 (C4), Haptoglobin (HAPT), Ferritin (FRT), Immunoglobulin A_2 (IGA 2), Immunoglobulin G 2 (IGG 2), Immunoglobulin M_2 (IGM_2), Prealbumin (PREALB), Rheumatoid Factor (RF), and Transferrin (TRF) methods

## Comparison to Predicate Device:

Both the ADVIA Chemistry Ferritin reagent and the predicate N Latex Ferritin reagent employ prepackaged reagents for use on automated clinical chemistry test systems. A comparison of the important similarities and differences of these methods is provided in the following table:

| Item | New Device:<br>ADVIA Chemistry Ferritin | Predicate Device:<br>N Latex Ferritin |
|----------------------------------|----------------------------------------------------------------------------|---------------------------------------------------------------------------------------------------------------------------------------|
| Analyte | Ferritin | Ferritin |
| Intended Use | For in vitro diagnostic use in the<br>quantitative measurement of ferritin | For in vitro diagnostic use in the<br>quantitative determination of<br>ferritin |
| Measurement | quantitative | quantitative |
| Sample type | Serum , Heparinized Plasma, EDTA<br>plasma | Serum , Heparinized Plasma |
| Reference interval | Men: 20-250 ng/mL (20-250 µg/L)<br>Women: 10–120 ng/mL (10–120<br>µg/L) | Men (n = 216): 20 - 290 µg/L<br>Women, premenopausal (n = 193):<br>4.5 - 170 µg/L<br>Women, postmenopausal (n = 47):<br>24 - 260 µg/L |
| Format | Liquid | Liquid |
| Use of Calibrators | Yes | Yes |
| Analytical<br>measuring interval | 6 - (450-500) ng/mL | Up to 640 ng/mL |

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| Method Principle | turbidometric | nephelometry |
|--------------------------|----------------------|--------------------------------------------------------|
| Reagents | Two: R1 and R2 | Three: Reagent, Supplementary A<br>and Supplementary B |
| Instrument to be<br>used | ADVIA 1650 Chemistry | BN System |
| Hook | Up to 40,000 ng/mL | Up to 10,000 ng/mL |

Both the ADVIA Chemistry Liquid Specific Protein Calibrator and the predicate Randox Liquid Protein Calibrator are used in calibrations of ferritin on Chemistry systems. A comparison of the important similarities and differences is provided in the following table:

| Item | New Device:<br>ADVIA Chemistry Liquid<br>Specific Protein Calibrator | Predicate Device:<br>Randox Liquid Protein<br>Calibrator |
|---------------------------------------|----------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------|-----------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------|
| Intended Use | for <i>in vitro</i> diagnostic use in the<br>calibration of ADVIA®<br>Chemistry system for the Alpha-<br>Acid-Glycoprotein (AAG), Alpha-<br>1-Antitrypsin (AAT), Anti-<br>streptolysin-O_2 (ASO_2),<br>Complement C3 (C3),<br>Complement C4 (C4), Ferritin<br>(FRT)*, Haptoglobin (HAPT),<br>Immunoglobulin A_2 (IGA_2),<br>Immunoglobulin G_2 (IGG_2),<br>Immunoglobulin M_2 (IGM_2),<br>Prealbumin (PREALB),<br>Rheumatoid Factor (RF),<br>Transferrin (TRF) methods<br>* - subject of this submission | Liquid Protein Calibrators are an<br><i>in vitro</i> diagnostic product used for<br>the calibration of ASO,<br>Complement C3, Complement C4,<br>CRP, Ferritin, Haptoglobin, IgA,<br>IgG, IgM, Prealbumin and<br>Transferrin assays on Clinical<br>Chemistry and Immunoassay<br>systems |
| Instrument | ADVIA® Chemistry Systems | Abbott Spectrum, Abbott Aeroset,<br>Abbott<br>Architect i2000, Architect i2000sr,<br>Ace analyser, Bayer Advia 1650,<br>Advia 2400,<br>Advia 1200, Dade Dimension<br>RXL, Dimension AR, Hitachi 704,<br>Hitachi 717,<br>Hitachi 911, Hitachi 917, Hitachi<br>912, Hitachi 747, Kone progress,<br>AU800,<br>AU600, AU400, AU2700,<br>AU5400, Selectra Vitalab,<br>Synchron CX4, Synchron |
| | | CX5, Synchron CX7, Synchron<br>LX20, ILAB300, ILAB900,<br>ILAB1800,<br>ILAB600, RX Daytona, RX Imola,<br>Cobas Mira, Cobas Mira S, Cobas<br>Mira Plus<br>systems. |
| Formulation /<br>analytes present | Alpha-acid-glycoprotein<br>Anti-streptolysin<br>Alpha-1-Antitrypsin<br>Ferritin<br>Immunoglobulin A<br>Immunoglobulin G<br>Immunoglobulin M<br>Immunoglobulin E<br>Complement C3<br>Complement C4<br>Haptoglobin<br>Microalbumin<br>Myoglobin<br>Prealbumin<br>Rheumatoid Factor<br>Transferrin<br>CRP | Same |
| Measured Analytes<br>(value assigned) | Alpha-acid-glycoprotein (AAG)<br>Anti-streptolysin-O (ASO)<br>Alpha-1-Antitrypsin (AAT)<br>Ferritin (FRT)<br>Immunoglobulin A_2 (IGA_2)<br>Immunoglobulin G_2 (IGG_2)<br>Immunoglobulin M_2 (IGM_2)<br>Complement C3 (C3)<br>Complement C4 (C4)<br>Haptoglobin (HAPT)<br>Prealbumin (PREALB)<br>Rheumatoid Factor (RF)<br>Transferrin (TRF) | ASO<br>Complement C3<br>Complement C4<br>CRP<br>Ferritin<br>Haptoglobin<br>IgA<br>IgG<br>IgM<br>Prealbumin<br>Transferrin |
| Form | Liquid | Same |
| Traceability for<br>ferritin analyte | WHO 3rd International Standard<br>IBSC 94/572 | Same |
| Matrix | Buffered base | Same |
| Analyte source | Derived from human source | Same |
| Number of levels | Six (the lowest level is a zero-<br>level) | Same |
| Fill Volume | 1.0 mL each vial | Same |

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## Comments on Substantial Equivalence:

Method Comparison between the ADVIA 1650 Chemistry Ferritin assay and N Latex Ferritin assay gave the following correlation statistics, when tested with patient samples:

# Method Comparison Data ADVIA 1650 Chemistry Ferritin vs. Predicate Method

| New Device | Predicate<br>Device | Slope | Intercept | n |
|-------------------------------------|---------------------|-------------------------------|----------------------------|----|
| ADVIA 1650<br>Chemistry<br>Ferritin | N Latex<br>Ferritin | 1.00<br>(95% CI: 0.97 – 1.03) | 0.00<br>(95% CI: -3.4-3.4) | 47 |

## Conclusion:

The ADVIA Chemistry Ferritin assay with the associated ADVIA Chemistry Liquid Specific Protein Calibrator is substantially equivalent in principle and performance to the N Latex Ferritin assay.

Kira Gordon Regulatory Affairs & Compliance June 24, 2011

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Image /page/5/Picture/1 description: The image shows a logo for the Department of Health & Human Services. The logo consists of a circle with the text "DEPARTMENT OF HEALTH & HUMAN SERVICES. USA" around the perimeter. Inside the circle is an image of an eagle.

Food and Drug Administration 10903 New Hampshire Avenue Silver Spring, MD 20993

Siemens Healthcare Diagnostics, Inc. c/o Dr. Kira Gordon Senior Regulatory Affairs Specialist 511 Benedici Avenue Tarrytown, NY 10591

AUG 1 7 2011

Re: k110736

| K110736 | |
|--------------------|-----------------------------------------------------|
| Trade/Device Name: | ADVIA ® Chemistry Ferritin Reagent |
| | ADVIA® Chemistry Liquid Specific Protein Calibrator |
| Regulation Number: | 21 CFR §866.5340 |
| | 21 CFR §862.1150 |
| Regulation Name: | Ferritin immunological test system |
| | Calibrator |
| Regulatory Class: | Class II |
| Product Code: | DBF, JIX |
| Dated: | July 18, 2011 |
| Received: | July 19, 2011 |
| | |

Dear Dr. Gordon:

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

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Page 2 – Dr. Kira Gordon

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 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,

Qeena Philip

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

510(k) Number (if known): K110736

ADVIA® Chemistry Ferritin Reagent Device Name: ADVIA® Chemistry Liquid Specific Protein Calibrator

Indications For Use:

The ADVIA® 1650 Chemistry Ferritin (FRT) Reagent:

For in vitro diagnostic use in the quantitative determination of ferritin in human serum and plasma on the ADVIA® 1650 Chemistry system. Measurements of ferritin aid in the diagnosis of diseases affecting iron metabolism, such as hemochromatosis (iron overload) and iron deficiency anemia.

The ADVIA® Chemistry Liquid Specific Protein Calibrators: For in vitro diagnostic use in the calibration of ADVIA® Chemistry systems for the Alpha-Acid-Glycoprotein (AAG), Alpha-1-Antitrypsin (AAT), Anti-streptolysin-O 2 (ASO_2), Complement C3 (C3), Complement C4 (C4), Ferritin (FRT), Haptoglobin (HAPT), Immunoglobulin A_2 (IGA_2), Immunoglobulin G 2 (IGG 2), Immunoglobulin M_2 (IGM_2), Prealbumin (PREALB), Rheumatoid Factor (RF), and Transferrin (TRF) methods.

Prescription Use X (Part 21 CFR 801 Subpart D) AND/OR

Over-The-Counter Use (21 CFR 807 Subpart C)

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

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

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Office of In Vitro Diagnostic Device Evaluation and Safety

K 110 510K

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