VITROS CHEMISTRY PRODUCTS URCR SLIDES, VITROS CHEMISTRY PRODUCTS DT CALIBRATOR KIT, MODEL 680 2722, 195 7927

K071215 · Ortho-Clinical Diagnostics, Inc. · JFY · May 25, 2007 · Clinical Chemistry

Device Facts

• Record ID: K071215
• Device Name: VITROS CHEMISTRY PRODUCTS URCR SLIDES, VITROS CHEMISTRY PRODUCTS DT CALIBRATOR KIT, MODEL 680 2722, 195 7927
• Applicant: Ortho-Clinical Diagnostics, Inc.
• Product Code: JFY · Clinical Chemistry
• Decision Date: May 25, 2007
• Decision: SESE
• Submission Type: Special
• Regulation: 21 CFR 862.1225
• Device Class: Class 2

Intended Use

For in vitro diagnostic use only. VITROS Chemistry Products urCR DT Slides quantitatively measure creatinine concentration in urine on the DT60/DT60 II analyzer. 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 Chemistry Products DT Calibrator Kit is specially formulated for use as calibrators for ALB, ALKP, ALT, AMYL, AST, TBIL, NBIL, BUN/UREA, Ca, CHOL, CK, Cl, CO2, CREA, CRSC, Fe, GGT, GLU, HDLC, K+, LAC, LDH, LIPA, Mg, Na+, NH3, PHOS, TP, TRIG, urCR, and URIC on VITROS DT Chemistry Systems.

Device Story

VITROS urCR DT Slides are multilayered analytical elements on polyester support for quantitative creatinine measurement in urine. Sample deposited on slide; distributed by spreading layer; creatinine hydrolyzed to creatine; converted to sarcosine and urea; sarcosine oxidized to glycine, formaldehyde, and hydrogen peroxide; peroxidase-catalyzed oxidation of leuco dye produces colored product. System measures rate of change in reflection density proportional to creatinine concentration. Used on VITROS DT60/DT60II Chemistry Systems in clinical settings. Healthcare providers use results to diagnose/monitor renal disease and dialysis. Calibrator kit uses lyophilized standards from processed bovine serum to calibrate systems.

Clinical Evidence

Bench testing only. Evidence includes linearity, limit of detection (LOD), and limit of quantitation (LOQ) studies to establish the new reportable range. Reference ranges updated based on literature (Henry's Clinical Diagnostics and Management by Laboratory Methods, 21st ed).

Technological Characteristics

Multilayered analytical element on polyester support. Colorimetric rate sensing principle. Uses VITROS DT60/DT60II Chemistry Systems. Calibration traceable to GC/IDMS and NIST SRM 914. Software-resident rate math model used for calculation.

Indications for Use

Indicated for the quantitative determination of creatinine in urine.

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 urCR assay (K934071)

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" in a bold, sans-serif font. Below the text, there is a line, and below the line, there is the text "a Johnson & Johnson company" in a smaller font.

100 Indigo Creek Drive Rochester, New York 14626-5101

MAY 2 5 2007

### 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: K071215

- Ortho-Clinical Diagnostics, Inc. 1. Submitter 100 Indigo Creek Drive MC00881 name, address, con-Rochester, New York 14626-5101 tact Phone: [phone] FAX: [phone] Email: [e-mail] Michael M. Byrne Contact Person:
May 1. 2007 2. Preparation

- date
- Trade or Proprietary Name: 3. Device VITROS Chemistry Products urCR DT Slides name VITROS Chemistry Products DT Calibrator Kit

VITROS urCR assay Common Name: Classification Name: Creatinine test system (21 CFR 862.1225).

VITROS DT Calibrator Kit Common Name: Classification Name: Calibrator (21 CFR 862.1150)

- The VITROS urCR assay (modified device) is substantially equivalent to the Predicate 4. VITROS urCR assay (original device). The FDA cleared the VITROS Chemdevice istry Products urCR DT Slides and VITROS Chemistry Products DT Calibrator Kit on March 21, 1994 (K934071) under the following product names:
KODAK EKTACHEM DT SLIDES (urCR) and

KODAK EKTACHEM DT Calibrator Kit

Note: With the purchase of KODAK Clinical Products Division by Johnson and Johnson, the product branding was revised to VITROS Chemistry Products urCR DT Slides and VITROS Chemistry Products DT Calibrator Kit.

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## 510(k) Summary, Continued

The VITROS urCR assay is performed using the VITROS Chemistry Products 5. Device deurCR DT Slides, and the VITROS Chemistry Products DT Calibrator Kit on scription VITROS DT60/DT60II Chemistry Systems.

The VITROS urCR 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 rate of change in reflection density is proportional to the concentration of creatinine in the sample

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

VITROS DT Calibrator Kit contains four 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 appropriate standards are used to calibrate VITROS DT60/DT60 II Chemistry Systems for the quantitative measurement of creatinine in urine.

Calibration of the VITROS urCR assay requires the use of bottles 1, 2 and 4 of the VITROS DT Calibrator Kit.

6. Device intended use

#### For in vitro diagnostic use only.

VITROS Chemistry Products urCR DT Slides quantitatively measure creatinine concentration in urine.

For in vitro diagnostic use only.

VITROS Chemistry Products DT Calibrator Kit is specially formulated for use as calibrators for ALB, ALKP, ALT, AMYL, AST, TBIL, NBIL, BUN/UREA, Ca, CHOL, CK, Cl, CO2, CREA, CRSC, Fe, GGT, GLU, HDLC, K+, LAC, LDH, LIPA, Mg, Na+, NH3, PHOS, TP, TRIG, urCR, and URIC on VITROS DT Chemistry Systems.

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# 510(k) Summary, Continued

- The VITROS urCR assay (modified device) is substantially equivalent 7. Comparison to the predicate, VITROS urCR assay (original), which was cleared by the to predicate FDA (K934071) for in vitro diagnostic use. device

| Device<br>Characteristic | Modified Device<br>VITROS urCR assay<br>(modified) | Predicate Device<br>VITROS urCR assay (original) |
|-------------------------------|---------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------|-------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------|
| Intended Use | No change | For <i>in vitro</i> diagnostic use only.<br>VITROS urCR DT Slides quantitatively<br>measure creatinine concentration in<br>urine. |
| Calibration trace-<br>ability | The values assigned to the<br>VITROS Chemistry Products DT<br>Calibrator Kit 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. | For <i>in vitro</i> diagnostic use only.<br>VITROS Chemistry Products DT Cali-<br>brator Kit is specially formulated for<br>use as calibrators for ALB, ALKP,<br>ALT, AMYL, AST, TBIL, NBIL,<br>BUN/UREA, Ca, CHOL, CK, Cl., CO₂,<br>CREA, CRSC, Fe, GGT, GLU, HDLC,<br>K+, LAC, LDH, LIPA, Mg, Na+, NH₃,<br>PHOS, TP, TRIG, urCR, and URIC on<br>VITROS DT Chemistry Systems.<br>Traceable to Certified NIST (National<br>Institute of Standards and Technology)<br>Reference Material SRM® (Standard<br>Reference Material) 914a. |
| Reference Interval<br>(Urine) | Males: 1000 – 2000 mg/day²<br>Females: 800 – 1800 mg/day² | 800 – 2800 mg/day |
| Reportable range<br>Urine | 1.0 – 339.2 mg/dL*<br>*After multiplying by a dilution factor of 21 | 2.1 – 346.5 mg/dL*<br>*After multiplying by a dilution factor of 21 |
| Sample type | No change | Urine |
| Basic principle | No change | Colorimetric rate |
| Instrumentation | No change | VITROS DTSC/DTSCII Module |

| 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 The miormation probestical assay (modified device) for use with human urine is substantially equivalent to the cleared predicate device.

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

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

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DEPARTMENT OF HEALTH & HUMAN SERVICES

Image /page/4/Picture/1 description: The image shows the logo for the U.S. Department of Health & Human Services. The logo features a stylized caduceus, which is a symbol often associated with healthcare. The text "DEPARTMENT OF HEALTH & HUMAN SERVICES, USA" is arranged in a circular pattern around the caduceus.

Food and Drug Administration 2098 Gaither Road Rockville MD 20850

MAY 2 5 2007

Ortho-Clinical Diagnostics, Inc. c/o Michael M. Byrne, RAC Regulatory Affairs Associate 100 Indigo Creek Drive Rochester, NY 14626-5101

k071215 Re:

Trade/Device Name: VITROS Chemistry Products urCR DT Slides, VITROS Chemistry Products DT Calibrator Kit Regulation Number: 21 CFR §862.1215 Regulation Name: Creatinine Test System Regulatory Class: Class II Product Code: JFY, JIX Dated: May 1, 2007 Received: May 2, 2007

Dear Mr. Byrne:

We have reviewed your Section 510(k) premarket notification of intent to market the device we nave reviewed your bection of the device is substantially equivalent (for the indications for use stated in the enclosure) to legally marketed predicate devices marketed in interstate for use stated in the encreativent of the enactment date of the Medical Device Amendments, or to conninered prior to May 20, 1978) in accordance with the provisions of the Federal Food, Drug, de ricos mat have been recuire approval of a premarket approval application (PMA). and Cosmetic Act (1107 that de not requently subject to the general controls provisions of the Act. The I ou may, dierelere, mains 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 n may or subject to back and 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) This letter will anow you to begin mailing of substantial equivalence of your device to a legally promation notification - Firesults 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, II you desire specific information association 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.

Jean 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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Indications for Use

| 510(k) Number (if known): | k071215 |
|-----------------------------|----------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------|
| Device Name: | VITROS Chemistry Products urCR DT Slides |
| Indications for Use: | For <i>in vitro</i> diagnostic use only.<br>VITROS urCR DT Slides quantitatively measure creatinine<br>concentration in urine on the DT60/DT60 II analyzer.<br><br>Creatinine measurements are used in the diagnosis and treatment<br>of renal diseases, in monitoring renal dialysis, and as a<br>calculation basis for measuring other urine analytes. |
| Prescription Use | X |
| (Part 21 CFR 801 Subpart D) | AND/OR Over-The-Counter Use<br>(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)

Carol C. Benson
Division Sign-Off

Office of In Vitro Diagnostic Device Evaluation and Safety

071215

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Indications for Use

510(k) Number (if known):

Device Name:

Indications for Use:

For in vitro diagnostic use only. VITROS Chemistry Products DT Calibrator Kit is specially formulated for use as calibrators for ALB, ALKP, ALT, AMYL, AST, TBIL, NBIL, BUN/UREA, Ca, CHOL, CK, CI, CO2, CREA, CRSC, Fe, GGT, GLU, HDLC, K+, LAC, LDH, LIPA, Mg, Na+, NH3, PHOS, TP, TRIG, urCR, and URIC on VITROS DT Chemistry Systems.

VITROS Chemistry Products DT Calibrator Kit

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

KD71215

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)

Carol C. Benam
Sign-Off

Office of In Vitro Diagnostic Device Evaluation and Safety

K09/215

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