DIMENSION VISTA ENZYMATIC CREATININE FLEX REAGENT CARTRIDGE, AND ENZYMATIC CREATININE CALIBRATOR, MODELS K1270, KC270

K090330 · Siemens Healthcare Diagnostics, Inc. · JFY · May 22, 2009 · Clinical Chemistry

Device Facts

• Record ID: K090330
• Device Name: DIMENSION VISTA ENZYMATIC CREATININE FLEX REAGENT CARTRIDGE, AND ENZYMATIC CREATININE CALIBRATOR, MODELS K1270, KC270
• Applicant: Siemens Healthcare Diagnostics, Inc.
• Product Code: JFY · Clinical Chemistry
• Decision Date: May 22, 2009
• Decision: SESE
• Submission Type: Traditional
• Regulation: 21 CFR 862.1225
• Device Class: Class 2

Intended Use

The ECREA method is an in vitro diagnostic test for the quantitative measurement of creatinine in human serum, plasma and urine on the Dimension Vista® System. Creatinine measurements are used in the diagnosis and treatment of renal diseases, in monitoring renal dialysis, and as a calculation basis for other urine analytes. The ECREA CAL is an in vitro diagnostic product for the calibration of the Enzymatic Creatinine (ECREA) method on the Dimension Vista® System.

Device Story

Dimension Vista® ECREA Flex® reagent cartridge is an in vitro diagnostic test for quantitative creatinine measurement in human serum, plasma, and urine. The system uses a bichromatic end-point enzymatic method; reagents include TAPS buffer, creatinase, sarcosine oxidase, HTIB, creatininase, horseradish peroxidase, 4-aminophenazone, and potassium hexacyanoferrate (II). The device is used on the Dimension Vista® System in clinical laboratory settings by trained technicians. The system processes samples automatically; results are provided to clinicians to assist in diagnosing and treating renal disease or monitoring dialysis. The ECREA CAL is a liquid, bovine serum albumin-based calibrator used to calibrate the ECREA method on the system.

Clinical Evidence

Bench testing only. Precision evaluated via 20-day ANOVA (CLSI EP5-A); total CVs ranged 1.7-4.4% for serum and 2.8-3.97% for urine. Linearity assessed (EP6-A) with serum range 0.14-20 mg/dL and urine 2.8-400 mg/dL. Method comparison (EP9-A2) against predicate (n=130 serum, n=126 urine) showed high correlation (r=1.00 and 0.999). Commutability evaluated against ID-GC/MS reference method (r=0.9985 serum, r=0.998 urine). Interference testing (EP7-A) defined thresholds for bilirubin, hemolysis, and lipemia.

Technological Characteristics

Enzymatic, quantitative assay. Reagents: TAPS buffer, creatinase, sarcosine oxidase, HTIB, creatininase, horseradish peroxidase, 4-aminophenazone, potassium hexacyanoferrate (II). Bichromatic end-point detection at 540/770 nm. Calibrator: liquid bovine serum albumin-based. Traceable to NIST SRM914. System: Dimension Vista 1500. Standards: CLSI EP5-A, EP7-A, EP17-A, EP9-A, EP6-A.

Indications for Use

Indicated for quantitative measurement of creatinine in human serum, plasma, and urine to aid in diagnosis and treatment of renal diseases, monitoring renal dialysis, and as a calculation basis for other urine analytes. Intended for use on the Dimension Vista® System.

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

• Roche Creatinine Plus Reagent (k003261)
• Dimension Chem I Cal (k860021)

Submission Summary (Full Text)

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# 510(k) Summary of Safety and Effectiveness for the

# Dimension Vista® Enzymatic Creatinine (ECREA) Flex® Reagent Cartridge

# Dimension Vista® Enzymatic Creatinine (ECREA CAL) Calibrator

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.

A. 510(k) Number: k090330 ____________

B. Date of Preparation: January 27, 2009

# C. Proprietary and Established Names:

Dimension Vista® Enzymatic Creatinine Flex® Reagent Cartridge

Dimension Vista® Enzymatic Creatinine Calibrator

## D. Applicant:

Siemens Healthcare Diagnostics Inc.

P.O. Box 6101, Newark, DE 19714-6101

Rose T. Marinelli, Regulatory Technical Specialist

Office Number: [phone] Fax Number: [phone]

# E. Regulatory Information:

Dimension Vista® ECREA Flex® Reagent Cartridge:

1. Requlation section: 21 CFR § 862.1225 Creatinine Test System

- 2. Classification: Class II
- 3. Product Code: JFY Enzymatic Method, Creatinine
- 4. Panel: Clinical Chemistry

Dimension Vista® ECREA CAL:

1. Regulation section: 21 CFR § 862.1150 Calibrator

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- 2. Classification: Class II
- 3. Product Code: JIT Calibrator, Secondary
- 4. Panel: Clinical Chemistry

## F. Predicate Device:

The predicate device used to demonstrate substantial equivalence to the Dimension Vista® ECREA Flex® reagent cartridge is the Roche Creatinine Plus Reagent previously cleared under K003261.

The predicate device used to demonstrate substantial equivalence to the Dimension® Chem I Cal (DC18B) previously cleared under K860021.

## G. Device Description:

The Dimension Vista® ECREA Flex® reagent cartridge is a prepackaged in-vitro diagnostic test method that is specifically designed to be used on the Dimension Vista® System. The reagents contained in the Dimension Vista® ECREA Flex® reagent cartridge are: Reagent 1 - TAPS buffer, creatinase, sarcosine oxidase, HTIB; Reagent 2 - TAPS buffer, creatininase, horseradish peroxidase, 4aminophenazone, and potassium hexacyanoferrate (II),

The Dimension Vista® ECREA CAL is an ECREA CAL is a liquid, bovine serum albumin, based product containing creatinine. The kit consists of six vials, three vials per level (A, B), 2.5 mL per vial. Description of the manufacturing, value assignment and stability testing process are provided in this submission report.

#### H. Intended Use:

The ECREA method is an in vitro diagnostic test for the quantitative measurement of creatinine in human serum, plasma and urine on the Dimension Vista® System. Creatinine measurements are used in the diagnosis and treatment of renal diseases, in monitoring renal dialysis, and as a calculation basis for other urine analytes.

The ECREA CAL is an in vitro diagnostic product for the calibration of the Enzvmatic Creatinine (ECREA) method on the Dimension Vista® System.

# l. Substantial Equivalence Information:

The Dimension Vista® ECREA Flex® reagent cartridge and the predicate, Roche Creatinine Plus reagent, were compared. The following table provides a comparison of the important similarities and differences:

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| Feature | Dimension Vista® ECREA<br>Flex® reagent cartridge | Creatinine Plus Reagent<br>(K003261) |
|--------------------|-------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------|-------------------------------------------------------------------------------------------------------------------------------------------------------------------------|
| Intended Use | The ECREA method is an in vitro<br>diagnostic test for the quantitative<br>measurement of creatinine in<br>human serum, plasma, and urine<br>on the Dimension Vista® System.<br>Creatinine measurements are used<br>in the diagnosis and treatment of<br>renal diseases, in monitoring renal<br>dialysis, and as a calculation basis<br>for other urine analytes. | Enzymatic in vitro assay for the<br>direct quantitative determination of<br>creatinine in human serum, plasma<br>and urine using Roche clinical<br>chemistry analyzers. |
| Sample Type | Plasma, serum, and urine | Plasma, serum and urine |
| Measuring<br>Range | Serum, Plasma - 0.14 - 20.0 mg/dL<br>Urine - 2.80 - 400 mg/dL | Serum, Plasma - 0.03 - 30 mg/dL<br>Urine - 0.3 - 400 mg/dL |
| Sample Size | 2.7 µL | 6 µL |
| Measurement | Bichromatic end point | Bichromatic end point |

The Dimension Vista® ECREA CAL and the predicate, Dimension® Chem I CAL (DC18B), were compared. The following table provides a comparison of the important similarities and differences:

| Feature | ECREA CAL | Dimension® Chem I CAL<br>(DC18B) K860021 |
|-----------------|-------------------------------------------------------------------------------------------------------------------------------------------------------------------|----------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------|
| Intended<br>Use | The ECREA CAL is an <i>in vitro</i><br>diagnostic product for the<br>calibration of the Enzymatic<br>Creatinine (ECREA) method on<br>the Dimension Vista® System. | The Dimension® Chemistry I<br>Calibrator is an <i>in vitro</i> diagnostic<br>product to be used to calibrate the<br>Dimension® clinical chemistry<br>system for the Calcium (CA),<br>Creatinine (CREA/ECRE),<br>Glucose (GLU/GLUC), Urea<br>Nitrogen (BUN), and Uric Acid<br>(URCA) methods. |
| Analyte | Creatinine | Calcium, Creatinine, Glucose,<br>Urea Nitrogen, Uric Acid |
| Matrix | Bovine Albumin | Bovine Albumin |
| Form | Liquid | Lyophilized |
| Volume | Six vials, three vials per level (A,<br>B), 2.5 mL per vial. | Six vials, two vials per level (1, 2,<br>3), 2.0 mL per vial |
| Levels | Three levels: 0.0*, 0.95, 22.0<br>mg/dL<br>*Level 1 is System Water | Three levels: 0.0, 11.1, 22.4 mg/dL |

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#### J. Conclusion:

The Dimension Vista® ECREA Flex® reagent cartridge is substantially equivalent to Roche's Creatinine Plus Reagent (K003261). Comparative testing described in the submission report demonstrates substantial equivalent performance.

The Dimension Vista® ECREA CAL is substantially equivalent to the Dimension® Chem I CAL CREA (K860021). Comparative testing described in the submission report demonstrates substantial equivalent performance.

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Image /page/4/Picture/0 description: The image shows the logo for the U.S. Department of Health & Human Services. The logo consists of a stylized eagle with three stripes forming its body and wing. The eagle faces to the right. The text "DEPARTMENT OF HEALTH & HUMAN SERVICES • USA" is arranged in a circular fashion around the eagle.

Food and Drug Administration 2098 Gaither Road Rockville MD 20850

Siemens Healthcare Diagnostics Inc. c/o Ms. Rose Marinelli PO Box 6101 MS 514 Newark, DE 19714-6101

MAY 22 2009

Re: k090330

> Trade/Device Name: Dimension Vista Enzymatic Creatinine Flex Reagent Cartridge and Dimension Vista Enzymatic Creatinine Calibrator Regulation Number: 21 CFR 862.1225 Regulation Name: Creatinine Test System Regulatory Class: Class II Product Code: JFY and JIT Dated: April 24, 2009 Received: April 27, 2009

Dear Ms. Marinelli:

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); medical device 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).

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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 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 postmarket surveillance, please contact CDRH's Office of Surveillance and Biometric's (OSB's) Division of Postmarket Surveillance at [phone]. For questions regarding the reporting of device adverse events (Medical Device Reporting (MDR)), please contact the Division of Surveillance Systems at [phone]. For more information regarding the reporting of adverse events, please go to http://www.fda.gov/cdrl/mdr/.

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 vours.

G.C.H.

Courtney C. Harper, Ph.D. Acting 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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#### Indications For Use Statement

510(k) Number (if known): KOQO330

Device Name:

Dimension Vista® Enzymatic Creatinine Flex® Reagent Cartridge

Indications for Use:

The ECREA method is an in vitro diagnostic test for the quantitative measurement of creatinine in human serum, plasma and urine on the Dimension Vista® System. Creatinine measurements are used in the diagnosis and treatment of renal diseases, in monitoring renal dialysis, and as a calculation basis for other urine analytes.

Prescription Use X (Per 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 IF NEEDED)

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

Division Sign-Off

Office of In Vitro Dlagn Device Evalue

510(k) k090330

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#### Indications For Use Statement

14090330 510(k) Number (if known):

Device Name:

Dimension Vista® Enzymatic Creatinine Calibrator

Indications for Use:

The ECREA CAL is an in vitro diagnostic product for the calibration of the Enzymatic Creatinine (ECREA) method on the Dimension Vista® System.

Prescription Use X (Per 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 IF NEEDED)

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

Division Sign-Off

Office of In Vitro Diagnostic Device Evaluation and Safety

510(k) k090330

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