VITROS CHEMISTRY PRODUCTS CREA SLIDES,MODEL# 6802584, VITROS CHEMISTRY PRODUCTS CALIBRATOR KIT 1,MODEL#1882208

K063591 · Ortho-Clinical Diagnostics, Inc. · JFY · Dec 15, 2006 · Clinical Chemistry

Device Facts

• Record ID: K063591
• Device Name: VITROS CHEMISTRY PRODUCTS CREA SLIDES,MODEL# 6802584, VITROS CHEMISTRY PRODUCTS CALIBRATOR KIT 1,MODEL#1882208
• Applicant: Ortho-Clinical Diagnostics, Inc.
• Product Code: JFY · Clinical Chemistry
• Decision Date: Dec 15, 2006
• Decision: SESE
• Submission Type: Special
• Regulation: 21 CFR 862.1225
• Device Class: Class 2

Intended Use

For in vitro diagnostic use only. VITROS CREA Slides quantitatively measure creatinine (CREA) concentration in serum, plasma, and urine. 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. For in vitro diagnostic use only. VITROS Calibrator Kit 1 is used to calibrate VITROS Chemistry Systems for the quantitative measurement of BUN/UREA, Ca, CREA, GLU, LAC, LI, Mg, PHOS, SALI, THEO, and URIC.

Device Story

Vitros Chemistry Products Calibrator Kit 1; used for calibration of Vitros Chemistry Systems. Modification involves change in traceability method for creatinine value assignment to GC-IDMS (Gas Chromatography-Isotope Dilution Mass Spectrometry) reference method. Device remains substantially equivalent to previously cleared version; fundamental scientific technology unchanged.

Clinical Evidence

Bench testing only; design control activities and verification/validation performed to confirm impact of traceability method change.

Technological Characteristics

Multilayered analytical slide on polyester support. Principle: two-point colorimetric rate. Instrumentation: VITROS Chemistry Systems. Calibration: traceable to GC/IDMS and NIST SRM 914. Software: two-point rate math model.

Indications for Use

Indicated for patients requiring creatinine measurement for diagnosis/treatment of renal disease or monitoring renal dialysis. Applicable to serum, plasma, and urine samples.

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

• Vitros Chemistry Products Calibrator Kit 1 (K001310)

Submission Summary (Full Text)

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Image /page/0/Picture/0 description: The image shows the logo for Ortho-Clinical Diagnostics. The logo consists of a symbol on the left, followed by the text "Ortho-Clinical Diagnostics" on the right. The text is underlined. The symbol on the left appears to be a stylized caduceus.

Johnson-fohnson company

100 Indigo Creek Drive Rochester, New York 14626-5101

#### DEC 1 5 2006

### 510(k) Summary

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: Kol.359|

- Submitter 1. Ortho-Clinical Diagnostics, Inc. name, ad-100 Indigo Creek Drive MC00881 dress, con-Rochester, New York 14626-5101 tact Phone: [phone] FAX: [phone] Email: [e-mail]
Contact Person: Michael M. Byrne

- 2. Preparation November 29, 2006 date
- 3. Device Trade or Proprietary Name: name VITROS Chemistry Products CREA Slides VITROS Chemistry Products Calibrator Kit 1

Common Name: CREA test Classification Name: Creatinine test system (21 CFR 862.1225).

Common Name: Calibrator Kit 1 Classification Name: Calibrator (21 CFR 862.1150)

- The VITROS CREA assay (modified device) is substantially equivalent to the 4. Predicate device VITROS CREA assay (original). This assay was originally cleared under the VITROS Chemistry Products CREA Slides and VITROS Chemistry Products Calibrator Kit 1 Premarket Notification K001310.
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### 510(k) Summary, Continued

The VITROS CREA assay is performed using the VITROS Chemistry 5. Device description Products CREA Slides, and the VITROS Chemistry Products Calibrator Kit 1 on VITROS Chemistry Systems.

The VITROS CREA Slide is a multilayered, analytical element coated on a polyester support.

A drop of patient sample is deposited on the slide and is evenly distributed by the spreading layer to the underlying layers. Creatinine diffuses to the reagent layer, where it is hydrolyzed to creatine in the rate-determining step. The creatine is converted to sarcosine and urea by creatine amidinohydrolase. The sarcosine, in the presence of sarcosine oxidase, is oxidized to glycine, formaldehyde, and hydrogen peroxide. The final reaction involves the peroxidase-catalyzed oxidation of a leuco dye to produce a colored product.

Following addition of the sample, the slide is incubated. During the initial reaction phase, endogenous creatine in the sample is oxidized. The resulting change in reflection density is measured at 2 time points.

Once a calibration has been performed for each slide lot. creatinine concentration in unknown samples can be determined using the softwareresident two-point rate math model and the change in reflectance calculated for each unknown test slide.

VITROS Calibrator Kit 1 contains three levels of lyophilized standards with corresponding diluents. The standards are prepared from processed bovine serum to which organic analytes, electrolytes, stabilizers, and preservatives have been added. The diluents are prepared from processed water to which inorganic salts have been added. Once reconstituted, the standards are used to calibrate VITROS Chemistry Systems for the quantitative measurement of creatinine in serum, plasma and urine.

Calibration of the VITROS CREA assay requires the use of all three of the calibrator levels (bottles 1, 2 and 3).

6. Device in-For in vitro diagnostic use only. tended use

VITROS CREA Slides quantitatively measure creatinine (CREA) concentration in serum, plasma, and urine.

For in vitro diagnostic use only.

VITROS Calibrator Kit 1 is used to calibrate VITROS Chemistry Systems for the quantitative measurement of BUN/UREA, Ca, CREA, GLU, LAC, Li, Mg, PHOS, SALI, THEO, and URIC.

Continued on next page

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## 510(k) Summary, Continued

- The VITROS CREA assay (modified device) is substantially equivalent to the 7. Comparison to predicate predicate, VITROS CREA assay (original), which was cleared by the FDA device (K001310)) for in vitro diagnostic use.

| Device<br>Characteristic | Modified Device<br>VITROS CREA assay<br>(modified) | Predicate Device<br>VITROS CREA assay (original) |
|----------------------------------------|----------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------|----------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------|
| Intended Use | No change | For <i>in vitro</i> diagnostic use only.<br>VITROS CREA Slides quantitatively<br>measure creatinine (CREA) concentra-<br>tion in serum, plasma, and urine.<br><br>For <i>in vitro</i> diagnostic use only.<br>VITROS Calibrator Kit 1 is used to<br>calibrate VITROS Chemistry Systems<br>for the quantitative measurement of<br>BUN/UREA, Ca, CREA, GLU, LAC,<br>Li, Mg, PHOS, SALI, THEO, and<br>URIC. |
| Calibration trace-<br>ability | The values assigned to the<br>VITROS Chemistry Products Cali-<br>brator Kit 1 for Creatinine are<br>traceable to a Gas Chromatography<br>Isotope Dilution Mass Spectrome-<br>try (GC/IDMS) method1 and NIST<br>SRM®914, creatinine standard ref-<br>erence material. | Traceable to Certified NIST (National<br>Institute of Standards and Technology)<br>Reference Material SRM® (Standard<br>Reference Material) 914a. |
| Reference Interval<br>(Serum) | Males: 0.7 – 1.3 mg/dL<br>Females: 0.6 – 1.0 mg/dL | 0.8 –1.5 mg/dL<br>0.7–1.2 mg/dL |
| Reference Interval<br>(Urine, 24 hour) | Males: 1000 - 2000 mg/day2<br>Females: 800 - 1800 mg/day2 | 800 – 2800 mg/day (Male and Female) |
| Reportable range | | |
| Serum | No Change | 0.05 – 14.0 mg/dL |
| Urine | 1.2 – 346.5 mg/dL (after multiply-<br>ing by a dilution factor of 21) | 1.05 – 346.5 mg/dL (after multiplying<br>by a dilution factor of 21) |
| Sample type | No change | Serum, Plasma, Urine |
| Basic principle | No change | Two point colorimetric rate |
| Instrumentation | No change | VITROS Chemistry Systems |

| | | Table 1 List of Assay Characteristics: Comparison to Predicate Device | | | | |
|--|--|-----------------------------------------------------------------------|--|--|--|--|
|--|--|-----------------------------------------------------------------------|--|--|--|--|

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### 510(k) Summary, Continued

The information presented in the pre-market notification demonstrates that the 8. Conclusions performance of the VITROS CREA assay (modified device) for use with human serum, plasma and urine is substantially equivalent to the cleared predicate device.

> Equivalence was demonstrated using manufactured reagents along with quality control fluids, proficiency samples and human serum, plasma, and urine samples with measured creatinine values spanning the assay range.

> The information presented in the premarket notification provides a reasonable assurance that the VITROS CREA assay (modified device) for use with human serum, plasma, and urine is safe and effective for the stated intended use.

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Food and Drug Administration 2098 Gaither Road Rockville MD 20850

Mr. Michael M. Byrne Regulatory Affairs Associate Ortho-Clinical Diagnostics, Inc. 100 Indigo Creek Drive MC00881 Rochester, NY 14626-5101

DEC 1 5 2006

Re: k063591

> Trade/Device Name: VITROS Chemistry Products CREA Slides and VITROS Chemistry Products Calibrator Kit 1 Regulation Number: 21 CFR 862.1225 Regulation Name: Creatinine test system Regulatory Class: Class II Product Code: JFY, JIX Dated: November 30, 2006 Received: December 1, 2006

Dear Mr. Byrne:

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

Sincerely yours,

Sean M. Cooper MS, Dim.

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

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# Indications for Use

| 510(k) Number (if known): | KU63591 |
|---------------------------|---------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------|
| Device Name: | VITROS Chemistry Products CREA Slides<br>VITROS Chemistry Products Calibrator Kit 1 |
| Indications for Use: | For in vitro diagnostic use only.<br>VITROS CREA Slides quantitatively measure creatinine<br>(CREA) concentration in serum, plasma, and urine. |
| | A creatinine test system is a device intended to measure<br>creatinine levels in plasma and urine. Creatinine measurements<br>are used in the diagnosis and treatment of renal diseases, in<br>monitoring renal dialysis, and as a calculation basis for<br>measuring other urine analytes. |
| | For in vitro diagnostic use only.<br>VITROS Calibrator Kit 1 is used to calibrate VITROS<br>Chemistry Systems for the quantitative measurement of<br>BUN/UREA, Ca, CREA, GLU, LAC, LI, Mg, PHOS, SALI,<br>THEO, and URIC. |

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)

Division Sign-Off

Office of In Vitro Diagnostic Device Evaluation and Safety

063591

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