DIMENSION VISTA FERRITIN FLEX REAGENT CARTRIDGE (FERR)

K070552 · Dade Behring, Inc. · JIT · Apr 30, 2007 · Clinical Chemistry

Device Facts

• Record ID: K070552
• Device Name: DIMENSION VISTA FERRITIN FLEX REAGENT CARTRIDGE (FERR)
• Applicant: Dade Behring, Inc.
• Product Code: JIT · Clinical Chemistry
• Decision Date: Apr 30, 2007
• Decision: SESE
• Submission Type: Traditional
• Regulation: 21 CFR 862.1150
• Device Class: Class 2

Intended Use

The FERR method is an in-vitro diagnostic test for the quantitative measurement of ferritin in human serum and plasma (lithium or sodium heparin and EDTA) on the Dimension Vista™ system. Measurements of ferritin aid in the diagnosis of diseases affecting iron metabolism, such as hemochromatosis (iron overload) and iron deficiency anemia. The LOCI 4 Calibrator is an in vitro diagnostic product for the calibration of the Ferritin (FERR) method on the Dimension Vista™ system.

Device Story

Dimension Vista™ Ferritin Flex® reagent cartridge is a homogenous, sandwich chemiluminescent immunoassay using LOCI™ technology. Input: human serum or plasma sample (2 µL). Process: sample incubated with biotinylated anti-ferritin antibody and Chemibeads (coated with anti-ferritin antibody and chemiluminescent dye); Sensibeads (streptavidin-coated with photosensitizer dye) added to form bead-pair immunocomplexes. Illumination at 680 nm triggers singlet oxygen diffusion from Sensibeads to Chemibeads, inducing chemiluminescence measured at 612 nm. Output: ferritin concentration. Used in clinical laboratory settings by trained technicians. Output aids clinicians in diagnosing iron metabolism diseases. Benefits include rapid, automated quantitative assessment of ferritin levels.

Clinical Evidence

Clinical performance established via split-sample method comparison between the subject device and the predicate. Study included 158 clinical patient samples. Results showed a correlation coefficient (r) of 0.996, a slope of 1.01, and an intercept of 1.48 ng/mL, confirming substantial equivalence.

Technological Characteristics

Sandwich chemiluminescent immunoassay (LOCI™ technology). Reagents: synthetic bead reagents (Sensibeads, Chemibeads) and biotinylated monoclonal antibody fragments. Detection: 680 nm excitation, 612 nm emission. Matrix: bovine serum albumin. Calibrator: 5-level liquid, traceable to WHO standard 3rd IS 94/572. Automated clinical chemistry system platform.

Indications for Use

Indicated for quantitative measurement of ferritin in human serum and plasma to aid in diagnosis of iron metabolism diseases, including hemochromatosis and iron deficiency anemia. Prescription use only.

Regulatory Classification

Identification

A calibrator is a device intended for medical purposes for use in a test system to establish points of reference that are used in the determination of values in the measurement of substances in human specimens. (See also § 862.2 in this part.)

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 § 862.9.

Predicate Devices

• Ferritin (FERR) Flex® reagent cartridge for the Dimension® clinical chemistry system (K963498)
• Dimension FERR Calibrator (K983548)

Submission Summary (Full Text)

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K070552

APR 3 0 2007

### 510(k)Summary of Safety and Effectiveness Information

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: | Lorraine H Piestrak<br>Dade Behring Inc.<br>P.O. Box 6101<br>Newark, DE 19714-6101 |
|----------------------|------------------------------------------------------------------------------------------------|
| Date of Preparation: | February 26, 2007 |
| Name of Product: | Dimension Vista™ Ferritin Flex® reagent cartridge (FERR)<br>Dimension Vista™ LOCI 4 Calibrator |

## FDA Classification Name: Ferritin immunological test system (Class II) Calibrator (Class II)

#### Predicate Device:

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

| New<br>Product | Predicate<br>Device | 510(k)<br>number | Device<br>Class | Regulation | Product<br>Code |
|---------------------------------------------------------------------------------------|-------------------------------------------------------------------------------------------------------|------------------|-----------------|------------|-----------------|
| Ferritin (FERR) Flex® reagent<br>cartridge for the Dimension<br>Vista™ system (K6440) | Ferritin (FERR) Flex®<br>reagent cartridge for the<br>Dimension® clinical<br>chemistry system (RF440) | K963498 | II | 866.5340 | DBF |
| Dimension Vista™ LOCI 4<br>Calibrator | Dimension FERR<br>Calibrator | K983548 | II | 862.1150 | JIT |

#### Device Description:

The Dimension Vista™ FERR Flex® reagent cartridge assay is a homogenous, sandwich chemiluminescent immunoassay based on LOCI™ technology. The LOCT™ reagents include two synthetic bead reagents and a biotinylated anti-ferritin monoclonal antibody fragment. The first bead reagent (Sensibeads) is coated with streptavidin and contains a photosensitizer dye. The second bead reagent (Chemibeads) is coated with a second anti-ferritin monoclonal antibody and contains chemiluminescent dye. Sample is incubated with biotinylated antibody and Chemibeads to form a particle/ferritin/biotinylated antibody sandwich. Sensibeads are added and bind to the biotin to form bead-pair immunocomplexes. Illumination of the complex at 680 nm generates singlet oxygen from Sensibeads which diffuses into the Chemibeads, triggering a chemiluminescent reaction. The resulting signal is measured at 612 mm and is a direct function of the ferritin concentration in the sample.

The Dimension Vista™ LOCI 4 Calibrator is a five level, liquid calibrator. It is packaged as a kit of 10 vials, two vials each of five levels. The product matrix is 6% bovine serum albumin with buffer, stabilizer and preservatives. Level A is zero. Levels B through E contain Ferritin at the following target concentrations :

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| Level | Ferritin<br>concentration |
|-------|---------------------------|
| A | 0 ng/mL |
| B | 26 ng/mL |
| C | 210 ng/mL |
| D | 1050 ng/mL |
| E | 2000 ng/mL |

Values are assigned to new lots from a masterpool that is referenced to the WHO standard for FERR, 3 rd IS 94/572

#### Intended Use:

The FERR method is an in-vitro diagnostic test for the quantitative measurement of ferritin in human serum and plasma (lithium or sodium heparin and EDTA) on the Dimension Vista™ system. Measurements of ferritin aid in the diagnosis of diseases affecting iron metabolism, such as hemochromatosis (iron overload) and iron deficiency anemia.

The LOCI 4 Calibrator is an in vitro diagnostic product for the calibration of the Ferritin (FERR) method on the Dimension Vista™ system.

#### Comparison to Predicate Device:

Both the Dimension Vista™ Flex® reagent cartridge (FERR) assay (catalogue number K6440) and the predicate Dimension® Ferritin Flex® reagent cartridge assay (catalogue number RF440) 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:

| Feature | Dimension Vista™ Ferritin<br>Flex® reagent cartridge<br>(K6440) | Dimension Ferritin Flex®<br>reagent cartridge<br>(RF440) |
|-----------------|-----------------------------------------------------------------|----------------------------------------------------------|
| Intended Use | in vitro diagnostic use | in vitro diagnostic use |
| Sample Type | Serum and Plasma | Serum and Plasma |
| Assay Range | 0- 2000 ng/mL | 0- 1000 ng/mL |
| Technology | Sandwich format monoclonal<br>antibody immunoassay | Sandwich format monoclonal<br>antibody immunoassay |
| Detection | Chemiluminescent reaction<br>measurement at 680 & 612 nm | Colorimetric rate measurement<br>at 577 & 700 nm |
| Sample Size | 2 µL | 40 µL |
| Antibody source | Monoclonal mouse | Monoclonal mouse |

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Both the Dimension Vista™ LOCI 4 Calibrator and the predicate Dimension ® Ferritin Calibrator have the same intended use. A comparison of the important similarities and differences is provided in the following table:

| Feature | Dimension Vista™ LOCI 4<br>Calibrator | Dimension® Ferritin Calibrator |
|---------------|-------------------------------------------------------------------------------------------------------|-------------------------------------------------------------------|
| Intended Use | Calibrate Ferritin on the<br>Dimension Vista™ system | Calibrate Ferritin on the<br>Dimension® clinical chemistry system |
| Analytes | Ferritin | Ferritin |
| Matrix | Bovine Serum Albumin | Bovine Serum Albumin |
| Traceable to: | WHO Standard for ferritin 3rd IS<br>94/572 | WHO Standard for ferritin 3rd IS<br>94/572 |
| Form | Liquid stored @ -10 to -20°C | Liquid stored @ 4 to 8°C |
| Volume | A 2.5 mL per vial<br>B 1.5 mL per vial<br>C 1.0 mL per vial<br>D 1.0 mL per vial<br>E 2.0 mL per vial | 1 ml per vial |
| Levels | 5 levels | 5 levels |

### Comments on Substantial Equivalence:

Split sample comparison between the Dimension Vista™ Ferritin Flex® reagent cartridge assay and the Dimension® Ferritin Flex® reagent cartridge assay gave the following correlation statistics, when tested with clinical patient samples:

| Method Comparison Data<br>Dimension Vista™ FERR vs. Predicate Method | | | | | |
|----------------------------------------------------------------------|-------------------------|-------|------------|--------------------------------|-----|
| Dimension<br>Vista™ | Predicate | Slope | Intercept | Correlation<br>Coefficient (r) | n |
| FERR | Dimension ®<br>Ferritin | 1.01 | 1.48 ng/mL | 0.996 | 158 |

# Conclusion:

The Dimension Vista™ Ferritin Flex® reagent cartridge assay with the associated LOCI 4 Calibrator is substantially equivalent in principle and performance to the Dimension® Ferritin Flex® reagent cartridge assay based on the split sample comparison discussed above.

Lorraine H Piestrak Regulatory Affairs & Compliance Manager March 23, 2007

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DEPARTMENT OF HEALTH & HUMAN SERVICES

Image /page/3/Picture/1 description: The image shows the logo for the U.S. Department of Health & Human Services. The logo consists of a stylized caduceus symbol, which is a staff with two snakes coiled around it, and the words "DEPARTMENT OF HEALTH & HUMAN SERVICES USA" arranged in a circular pattern around the symbol. The logo is black and white.

Public Health Service

APR 3 0 2007

Food and Drug Administration 2098 Gaither Road Rockville MD 20850

Dade Behring Inc. c/o Ms. Lorraine H. Piestrak Regulatory Affairs and Compliance Manager P.O. Box 6101 Newark, DE 19714-6101

Re: k070552

Trade/Device Name: Dimension Vista™ Ferritin Flex® reagent cartridge Dimension Vista™ LOCI 4 Calibrator Regulation Number: 21 CFR 866.5340 Regulation Name: Ferritin Immunological Test System Regulatory Class: Class II Product Code: DBF, JIT Dated: March 26, 2007 Received: March 27, 2007

Dear Ms. Piestrak:

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 either class II (Special Controls) or class III (PMA), it may be subject to such additional controls. Existing major regulations affecting your device can be found in the Code of Federal Regulations, Title 21, Parts 800 to 898. 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 Part 801); 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

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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 information about the application of labeling requirements to your device, or questions on the promotion and advertising of your device, 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). 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,

Robert H. Beakerf

Robert L. Becker, Jr., M.D., 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): Ko 70552

Device Name: Dimension Vista™ Ferritin Flex® reagent cartridge (FERR)

Indications For Use:

The FERR method is an in vitro diagnostic device for the quantitative measurement of ferritin in human serum and plasma (lithium or sodium heparin, and EDTA) on the Dimension Vista® System. Measurements of ferritin aid in the diagnosis of diseases affecting iron metabolism, such as hemochromatosis (iron overload) and iron deficiency anemia.

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

Over-The-Counter Use (21 CFR 801)

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

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

Mari M Clar

Page 1 of

Division Sign-Off

Office of In Vitro Diagnostic Device Evaluation and Safety

510(k) Ko 70572

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# Indications for Use

KO 70552 510(k) Number (if known):

Device Name: Dimension Vista™ LOCI 4 Calibrator

Indications For Use:

The Dimension Vista™ LOCI 4 Calibrator is an in vitro diagnostic device intended to be used to calibrate the ferritin (FERR) assay on the Dimension Vista™ system.

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

Over-The-Counter Use (21 CFR 801)

Page 1 .of

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

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

ia mclam

Division Sign-Off

Office of in Vitro Diagnostic Device Evaluation and Safety

510(k) K070552