DIMENSION VISTA RF FLEX REAGENT CARTRIDGE; PROTEIN 2 CALIBRATOR AND CONTROL

K062035 · Dade Behring, Inc. · JIX · Oct 4, 2006 · Clinical Chemistry

Device Facts

• Record ID: K062035
• Device Name: DIMENSION VISTA RF FLEX REAGENT CARTRIDGE; PROTEIN 2 CALIBRATOR AND CONTROL
• Applicant: Dade Behring, Inc.
• Product Code: JIX · Clinical Chemistry
• Decision Date: Oct 4, 2006
• Decision: SESE
• Submission Type: Traditional
• Regulation: 21 CFR 862.1150
• Device Class: Class 2

Intended Use

Flex® reagent cartridge: The RF method is an in vitro diagnostic reagent for the quantitative determination of rheumatoid factors (RF) in human serum and lithium heparin plasma on the Dimension Vista™ System. Measurements are used as an aid in the diagnosis of rheumatoid arthritis. Protein 2 Calibrator: PROT2 CAL is an in vitro diagnostic product for the calibration of the C-reactive protein (CRP), high sensitivity CRP (hsCRP) and Rheumatoid Factors (RF) methods on the Dimension Vista™ System. Protein 2 Controls L and H: PROT2 CON L and H are assayed intra-laboratory quality controls for the assessment of precision and analytical bias in the determination of C-reactive protein (CRP) and Rheumatoid Factor (RF) on the Dimension Vista™ System.

Device Story

The Dimension Vista™ RF Flex® reagent cartridge is an in vitro diagnostic reagent used on the Dimension Vista™ System. It utilizes polystyrene particles coated with an immunocomplex (human immunoglobulin and anti-human IgG from sheep). When mixed with patient serum or lithium heparin plasma samples containing RF, the particles aggregate. The system passes a light beam through the sample; the intensity of scattered light is measured, which is proportional to the RF concentration. Results are determined by comparison with a known standard. The system is intended for use in clinical laboratories by trained personnel to aid in the diagnosis of rheumatoid arthritis. The associated Protein 2 Calibrator and Controls (L and H) are used to calibrate the system and assess analytical precision and bias.

Clinical Evidence

Bench testing only. Precision evaluated per CLSI EP5-A2 (repeatability <6%, within-lab ≤6.2%). Linearity confirmed across 10-600 IU/mL range (slope 1.04, r=1.0). Interference testing per CLSI EP7-A2 showed minimal interference (<10%) from common substances. Method comparison with predicate (n=120) yielded slope 0.953, r=0.95. Matrix comparison (serum vs. lithium heparin plasma) showed no significant bias (mean recovery -2.5%). No clinical sensitivity/specificity studies provided.

Technological Characteristics

Immunoturbidimetric assay using polystyrene particles coated with human immunoglobulin and anti-human IgG from sheep. Analyte concentration is proportional to scattered light intensity. System is an automated clinical chemistry analyzer. Reagents are liquid-stable.

Indications for Use

Indicated for quantitative determination of rheumatoid factors (RF) in human serum and lithium heparin plasma to aid in the diagnosis of rheumatoid arthritis. Used on the Dimension Vista™ System.

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

• ROCHE Tina-Quant RF II assay (k032535)
• N Rheumatology Standard SL (k964527)
• N/T Rheumatology Control SL (k962373)

Submission Summary (Full Text)

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# OCT - 4 2006

## 510(k) Summary for Dimension Vista™ RF Flex® reagent cartridge Dimension Vista™ Protein 2 Calibrator Dimension Vista™ Protein 2 Control L Dimension Vista™ Protein 2 Control H

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.

The assigned 510(k) number is: Ko 62035

- 1. Manufacturer's Name, Address, Telephone, and Contact Person, Date of Preparation:
- Manufacturer: Dade Behring Marburg GmbH Emil-von-Behring Str. 76 D-35001 Marburg, Germany Dade Behring Inc. Contact Information: P.O. Box 6101 Newark, Delaware 19714-6101 Attn: Kathleen Dray-Lyons Tel: [phone] Fax: [phone] Preparation date: September 11, 2006 2. Device Name: Dimension Vista™ Rheumatoid Factors Flex® reagent cartridge (RF) Dimension Vista™ Protein 2 Calibrator Dimension Vista™ Protein 2 Control L Dimension Vista™ Protein 2 Control H Classification: Class II; Class II; Class I Product Code: DHR: JIX: JJY Panel: Immunology (82) and Clinical Chemistry (75)

#### 3. ldentification of the Legally Marketed Device:

ROCHE Tina-Quant RF II assay - K032535 N Rheumatology Standard SL - K964527 N/T Rheumatology Control SL - K962373

#### 4. Device Description:

## Dimension Vista™ RF Flex® reagent cartridge

Polystyrene particles coated with an immunocomplex consisting of human immunoglobulin and anti-human IgG from sheep are aggregated when mixed with samples containing RF. These aggregates scatter a beam of light passed through the sample. The intensity of the scattered light is proportional to the concentration of the

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respective protein in the sample. The result is evaluated by comparison with a standard of known concentration.

### Dimension Vista™ Protein 2 Calibrator

PROT2 CAL is a liquid, human serum based product containing C-reactive protein and Rheumatoid Factors.

### Dimension Vista™ Protein 2 Control L and H

PROT2 CON L and H are liquid, multi-analyte, human serum based products containing C-reactive protein and Rheumatoid Factors.

#### 5. Device Intended Use:

### Dimension Vista™ RF Flex® reagent cartridge:

The RF method is an in vitro diagnostic reagent for the quantitative determination of rheumatoid factors (RF) in human serum and lithium heparin plasma on the Dimension Vista™ System. Measurements of RF are used as an aid in the diagnosis of rheumatoid arthritis.

### Dimension Vista™ Protein 2 Calibrator:

PROT2 CAL is an in vitro diagnostic product for the calibration of the C-reactive protein (CRP), high sensitivity CRP (hsCRP) and Rheumatoid Factors (RF) methods on the Dimension Vista™ System.

### Dimension Vista™ Protein 2 Controls L and H:

PROT2 CON L and H are assayed intralaboratory quality controls for the assessment of precision and analytical bias in the determination of C-reactive protein (CRP) and Rheumatoid Factors (RF) on the Dimension Vista™ System.

#### Medical device to which equivalence is claimed and comparison information: 6.

The Dimension Vista™ RF Flex® reagent cartridge, Dimension Vista™ Protein 2 Calibrator and Dimension Vista™ Protein 2 Controls L and H are substantially equivalent to the ROCHE Tina-Quant RF II assay (K032535), N Rheumatology Standard SL (K964527) and N/T Rheumatology Control SL (K962373), respectively. The Dimension Vista™ RF assay, like the ROCHE Tina-Quant RF II assay is an in vitro diagnostic test for the quantitative determination of Rheumatoid Factors in human serum and heparinized plasma.

#### Device Performance Characteristics: 7.

The Dimension Vista™ RF assay was compared to the ROCHE Tina-Quant RF II on the Hitachi 917 Analyzer by evaluating serum samples with concentrations ranging from 10 to 520 IU/ML. Regression analysis of these results yielded the following equation:

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### Method Comparison Study

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Food and Drug Administration 2098 Gaither Road Rockville MD 20850

# OCT - 4 2006

Dade Behring. Inc. c/o Ms. Kathleen Dray-Lyons Regulatory Affairs and Compliance Manager Glasgow Site P.O. Box 6101 Newark. DE 19714

Re: k062035

Trade/Device Name: Dimension Vista™ Rheumatoid Factors Flex® reagent cartridge Dimension Vista™ Protein 2 Calibrator Dimension Vista™ Protein 2 Control L., Dimension Vista™ Protein 2 Control H Regulation Number: 21 CFR 866.5775 Regulation Name: Rheumatoid Factor Immunological Test System Regulatorv Class: Class II Product Code: DHR, JIX, JJY Dated: July 13, 2006 Received: July 19, 2006

Dear Ms. Dray-Lyons:

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 Mav 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

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systems (QS) regulation (21 CFR Part 820); and if applicable, the electronic product radiation control provisions (Sections 531-542 of the Act): 21 CFR 1000-1050.

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 Part 801), please contact the Office of Compliance at [phone]. Also, please note the regulation entitled, "Misbranding by reference to premarket notification" (21CFR 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 Becker

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 Statement

### Device Name: Dimension Vista™ RF Flex® reagent cartridge Dimension Vista™ Protein 2 Calibrator Dimension Vista™ Protein 2 Control L Dimension Vista™ Protein 2 Control H

### Indications for Use:

## Dimension Vista™ RF Flex® reagent cartridge:

The RF method is an in vitro diagnostic reagent for the quantitative determination of rheumatoid factors (RF) in human serum and lithium heparin plasma on the Dimension Vista ™ System. Measurements of RF are used as an aid in the Dinemistori
adhritis arthritis.

# Dimension Vista™ Protein 2 Calibrator:

PROT2 CAL is an in vitro diagnostic product for the calibration of the C-reactive protein (CRP), high sensitivity CRP (hsCRP) and Rheumatord Factors (RF) methods on the Dimension Vista™ System.

# Dimension Vista™ Protein 2 Controls L and H:

PROT2 CON L and H are assayed intralaboratory quality controls for the assessment of precision and analytical bias in the determination of C-reactive protein (CRP) and Rheumatoid Factor (RF) on the Dimension Vista™ System.

Prescription Use X (Per 21 CFR 801 Subpart D)

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)

Marisa Chan
Division Sign-Off

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Office of In Vitro Digana Device Evaluation and Safety

510(k) K062035