DIMENSION VISTA CYSC FLEX REAGENT CARTRIDGE, PROTEIN 3 CALIBRATOR AND CYSTATIN CONTROL LOW AND HIGH

K063351 · Dade Behring, Inc. · NDY · Jan 22, 2007 · Clinical Chemistry

Device Facts

• Record ID: K063351
• Device Name: DIMENSION VISTA CYSC FLEX REAGENT CARTRIDGE, PROTEIN 3 CALIBRATOR AND CYSTATIN CONTROL LOW AND HIGH
• Applicant: Dade Behring, Inc.
• Product Code: NDY · Clinical Chemistry
• Decision Date: Jan 22, 2007
• Decision: SESE
• Submission Type: Traditional
• Regulation: 21 CFR 862.1225
• Device Class: Class 2
• Attributes: Pediatric

Intended Use

The CYSC method is an in vitro diagnostic test for the quantitative determination of cystatin C in human serum, heparinized plasma or EDTA plasma on the Dimension Vista® System. Cystatin C measurements are used in the diagnosis and treatment of renal diseases. The PROT3 CAL is an in vitro diagnostic product to the calibration of the Cyatatin C (CYSC) and Microalbumin (MALB) methods on the Dimension Vista® System. CYSC CON L and H are assayed intralaboratory quality controls for the assessment of precision and analytical bias in determination of cystatin C (CYSC) on the Dimension Vista® System. For in vitro diagnostic use.

Device Story

Device uses particle-enhanced immunonephelometry to quantify cystatin C in human serum or plasma samples. Polystyrene particles coated with rabbit polyclonal antibodies to human cystatin C aggregate upon binding to cystatin C in the sample; aggregates scatter light. Scattered light intensity is proportional to cystatin C concentration. System is an automated clinical chemistry analyzer (Dimension Vista® System) operated by laboratory personnel. Output is a quantitative concentration value (mg/L) used by clinicians to assess renal function and manage renal disease. System includes reagent cartridges, calibrators, and controls.

Clinical Evidence

Bench testing only. Precision evaluated per CLSI EP5-A2 (n=80 per level). Linearity confirmed across 0.23–8.0 mg/L range (slope 1.018, r=0.999). Method comparison against predicate (n=160) showed high correlation (r=0.998). Interference testing (hemoglobin, bilirubin, lipemia) met acceptance criteria (bias <±10%). Reference range established using 413 subjects (ages 1-78) as 0.53–0.95 mg/L.

Technological Characteristics

Particle-enhanced immunonephelometry. Reagents: polystyrene particles coated with rabbit anti-cystatin C antibodies, phosphate buffer, PEG. Calibrators/Controls: lyophilized, polygeline-based human-origin proteins. Traceable to ERM®-DA470 (CRM 470). Automated analysis on Dimension Vista® System. Reportable range: 0.23–8.0 mg/L.

Indications for Use

Indicated for quantitative determination of cystatin C in human serum, heparinized plasma, or EDTA plasma to aid in the diagnosis and treatment of renal diseases in patients.

Regulatory Classification

Identification

A creatinine test system is a device intended to measure creatinine levels in plasma and urine. Creatinine measurements are used in the diagnosis and treatment of renal diseases, in monitoring renal dialysis, and as a calculation basis for measuring other urine analytes.

Predicate Devices

• N Latex Cystatin C Kit (k041878)

Submission Summary (Full Text)

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## 510(k) Summary for Dimension Vista™ CYSC Flex® reagent cartridge
Dimension Vista" Cystatin C Control L and 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.

er is: K06335|

- The assigned 510(k) number is: 10(03335
- 1. Manufacturer's Name, Address, Telephone, and Contact Person, Date of Preparation:

| Manufacturer: | Dade Behring Marburg GmbH Emil-von-Behring Str. 76 35041 Marburg, Germany |
|---------------|-----------------------------------------------------------------------------|
|---------------|-----------------------------------------------------------------------------|

- Contact Information: Dade Behring Inc. P.O. Box 6101 Newark, Delaware 19714-6101 Attn: Kathleen Dray-Lyons Tel: [phone] Fax: [phone]
Preparation date: November 3, 2006

- Dimension Vista™ CYSC Flex® reagent cartridge 2. Device Name: ionsholor Vista" Protein 3 Californian 3 Calibration
Dimension Vista", "Protein 3 Calibration Claiman
Dimension Vista", "Cystation Coontrol L

| Classification: | Class II; Class II; Class I |
|-----------------|-----------------------------|
| Product Code: | NDY; JIX; JJY |
| Panel: | Clinical Chemistry (75) |

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

Dade Behring N Latex Cystatin C Kit- K041878 Dade Behring N Protein Standard UY - K003501

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#### Device Description: 4.

## Dimension Vista" CYSC Flex® reagent cartridge

Proteins contained in human body fluids form immune complexes in an immunochemical reaction with specific antibodies. These complexes scatter a beam of light passed through the sample. The intensity of the scattered light is proportional to the concentration of the respective protein in the sample. The result is evaluated by comparison with a standard of known concentration

### Dimension Vista™ Protein 3 Calibrator

PROT3 CAL is a multi-analyte, lyophilized, polygeline based product containing urinary cystatin C and serum albumin of human origin.

### Dimension Vista" Cystatin C Control L and H

CYSC CON L and H are lyophilized, polygeline based product with urinary proteins of human origin containing cystatin C.

#### 5. Device Intended Use:

## Dimension Vista" CYSC Flex® reagent cartridge:

The CYSC method is an in vitro diagnostic test for the quantitative determination of cystatin C in human serum, heparinized plasma or EDTA plasma on the Dimension Vista System. Cystatin C measurements are used in the diagnosis and treatment of renal diseases.

## Dimension Vista™ Protein 3 Calibrator:

The PROT3 CAL is an in vitro diagnostic product for the calibration of the Cystatin C (CYSC) and Microalbumin (MALB) methods on the Dimension Vista® System.

### Dimension Vista" Cystatin C Control L and H:

CYSC CON L and H are assayed intralaboratory quality control for assessment of precision and analytical bias in determination of cystatin C (CYSC) on the Dimension Vista" System.

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

The Dimension Vista "CYSC assay, like the Dade Behring N Latex Cystatin C Kit is an in vitro diagnostic test for the quantitative measurement of cystatin C in human serum and plasma.

#### 7. Device Performance Characteristics:

The Dimension Vista" CYSC assay was compared to the Dade Behring N Latex Cystatin C Kit on the BN ProSpec® System by evaluating serum and plasma samples with concentrations ranging from 0.33 to 7.46 mg/L. Regression analysis of these results yielded the following equation:

| Comparative Method | n | Slope | Intercept | Correlation Coefficient |
|------------------------------------------|-----|-------|-----------|-------------------------|
| N Latex Cystatin C on the BN<br>ProSpec® | 160 | 1.005 | 0.005 | 0.998 |

### Method Comparison Study

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Dade Behring Inc.
Dimension Vista 510(k) Notification

#### 8. Conclusion:

.

These studies demonstrate correlation and equivalent performance between the Dade
Behring N Latex Cystatin C Kit and the Dimension Vista" CYSC assay.

.

# 000096

.

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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 circular seal with the words "DEPARTMENT OF HEALTH & HUMAN SERVICES - USA" arranged around the perimeter. Inside the circle is a stylized representation of an eagle or other bird-like figure with three wing-like shapes extending upwards.

Public Health Service

Food and Drug Administration 2098 Gaither Road Rockville MD 20850

Dade Behring, Inc. Glasgow Site P.O. Box 6101 Newark, DF 19714

JAN 2 2 2007

Attn: Kathleen A. Dray-Lyons

Re: k063351

> Trade/Device Name: Dimension Vista™ CYSC Flex® reagent cartridge, Dimension Vista™ Protein 3 Calibrator, Dimension Vista™ Cystatin C Control M & Dimension Vista™ Cystatin C Control H Regulation Numbers: 21 CFR 862.1225 Regulation Names: Creatinine test system Regulatory Class: Class II Product Code: NDY, JIX & JJY Dated: November 3, 2006 Received: November 6, 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 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 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); and good manufacturing practice requirements as set forth in the quality systems (QS) regulation (21 CFR Part 820).

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Page 2 -

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 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" (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 at http://www.fda.gov/cdrh/industry/support/index.html.

Sincerely yours,

Jean M. Cooper, M.S., D.V.M.

Yéan M. Cooper, M.S., D.V.M. Director Division of Chemistry and Toxicology Office of In Vitro Diagnostic Device Evaluation and Safety Center for Devices and Radiological Health

Enclosure

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Dade Behring Inc., Dimension Vista 510(k) Notification

# Indications Statement

K0463351/

Device Name:

"" CYSC Flex® reagent cartridge Dimension Vista Dimension Vista - CrSC Frex - Protein 3 Calibrant C
Dimension Vista - Protein 3 Calibraon Mistan M
Dimension Vista - Cystating Control M
Dimension Vista - Cystating Control M Dimension Vista" Cystatin C Control M
Dimension Vista" Cystatin C Control H

## Indications for Use:

## Dimension Vista™ CYSC Flex® reagent cartridge:

The CYSC method is an in vitro diagnostic test for the quantitative determination of cystatin C in human serum, heparinized plasma or EDTA plasma on the Dimension Vista System. Cystatin C measurements are used in the diagnosis and treatment of renal diseases.

# Dimension Vista™ Protein 3 Calibrator:

The PROT3 CAL is an in vitro diagnostic product for the calibration of the Cystatin C (CYSC) and Microalbumin (MALB) methods on the Dimension Vista® System.

# Dimension Vista™ Cystatin C Control L and H:

CYSC CON L and H are assayed intralaboratory quality controls for assessment of precision and analytical bias in determination of cystatin C (CYSC) on the Dimension Vista® System.

Prescription Use × (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)

Page 1 of _

Carol Benson
Division Sign off

Division Sign-Off

Office of In Vitro Diagnostic Device Evaluation and Safety

3199(k) K063351

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