VITROS CHEMISTRY PRODUCTS CRSC SLIDES, VITROS CHEMISTRY PRODUCTS DT CALIBRATOR KIT, MODEL 680 2721, 195 7927

K071216 · Ortho-Clinical Diagnostics, Inc. · JFY · May 25, 2007 · Clinical Chemistry

Device Facts

• Record ID: K071216
• Device Name: VITROS CHEMISTRY PRODUCTS CRSC SLIDES, VITROS CHEMISTRY PRODUCTS DT CALIBRATOR KIT, MODEL 680 2721, 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 CRSC DT Slides quantitatively measure creatinine concentration in serum and plasma 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 chemistry products DT calibrator kit used for serum creatinine (CRSC) assay calibration. Modification involves updating traceability method to GC-IDMS reference method; updating reference ranges based on study of 113 males and 195 females (male: 0.7-1.3 mg/dL; female: 0.6-1.0 mg/dL); and updating reportable range to 0.2-11.2 mg/dL based on linearity, LOD, and LOQ studies. Device used in clinical laboratory settings to support diagnostic testing. Fundamental scientific technology remains unchanged from predicate.

Clinical Evidence

Internal study of 113 males and 195 females used to establish new reference ranges. Linearity, LOD, and LOQ studies performed to establish new reportable range of 0.2-11.2 mg/dL.

Technological Characteristics

Multilayered analytical element on polyester support. Colorimetric rate sensing principle. Lyophilized bovine serum-based calibrators. System uses software-resident rate math model for calculation. Connectivity via VITROS DT60/DT60II Chemistry Systems.

Indications for Use

Indicated for the quantitative measurement of creatinine in serum using the VITROS chemistry products DT calibrator kit.

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 CRSC assay (K875191)
• VITROS Chemistry Products DT Calibrator Kit (K934071)

Submission Summary (Full Text)

{0}------------------------------------------------

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

100 Indigo Creek Drive Rochester, New York 14626-5101

# 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: _ Ko 7/2/6

- 1. Submitter 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]
MAY 2 5 2007

Michael M. Byrne Contact Person:

- May 1, 2007 2. Preparation
- date
- Trade or Proprietary Name: 3. Device name VITROS Chemistry Products CRSC DT Slides VITROS Chemistry Products DT Calibrator Kit

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

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

- 4. Predicate The VITROS CRSC assay (modified device) is substantially equivalent to the device VITROS CRSC assay (original device). The FDA cleared the VITROS Chemistry Products CRSC DT Slides on and VITROS Chemistry Products DT Calibrator Kit on February 24, 1988 (K875191) under the product names:
KODAK EKTACHEM DT SLIDES (CRSC) 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 CRSC DT Slides and VITROS Chemistry Products DT Calibrator Kit.

The most recent FDA clearance for the VITROS Chemistry Products DT Calibrator Kit was March 21, 1994 (K934071).

Continued on next page

SPECIAL 510(K) SUBMISSION

VITROS CRSC DT Slides and VITROS DT Calibrator Kit

{1}------------------------------------------------

#### 510(k) Summary, Continued

scription

The VITROS CRSC assay is performed using the VITROS Chemistry 5. Device de-Products CRSC DT Slides and the VITROS Chemistry Products DT Calibrator Kit on VITROS DT60/DT60II Chemistry Systems.

> The VITROS CRSC 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 glvcine, 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 serum and plasma.

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

6. Device in-For in vitro diagnostic use only. tended use VITROS Chemistry Products CRSC DT Slides quantitatively measure creatinine concentration in serum and plasma.

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.

SPECIAL 510(K) SUBMISSION

Continued on next page

13

Ortho-Clinical Diagnostics, Inc.

VITROS CRSC DT Slides and VITROS DT Calibrator Kit

{2}------------------------------------------------

# 510(k) Summary, Continued

- The VITROS CRSC assay (modified device) is substantially equivalent to the 7. Comparison to predicate predicate, VITROS CRSC assay (original), which was cleared by the FDA device (K875191) for in vitro diagnostic use.

| Device<br>Characteristic | Modified Device<br>VITROS CRSC assay<br>(modified) | Predicate Device<br>VITROS CRSC assay (original) |
|--------------------------|----------------------------------------------------|-----------------------------------------------------------------------------------------------------------------------------------------|
| Intended Use | No change | For in vitro diagnostic use only.<br>VITROS CRSC DT Slides quantita-<br>tively measure creatinine concentration<br>in serum and plasma. |
| | | For in vitro diagnostic use only.<br>VITROS Chemistry Products DT Cal<br>ibrator Kit is specially formulated for |

Tahle 1 I ist of A y Characteristics: Comparison to Predicate Devic

| | (modified) | |
|----------------------------|--------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------|-------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------|
| Intended Use | No change | For in vitro diagnostic use only.<br>VITROS CRSC DT Slides quantitatively measure creatinine concentration in serum and plasma.<br><br>For in vitro diagnostic use only.<br>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. |
| Calibration traceability | The values assigned to the VITROS Chemistry Products DT Calibrator Kit for Creatinine are traceable to a Gas Chromatography Isotope Dilution Mass Spectrometry (GC/IDMS) method¹ and NIST SRM®914, creatinine standard reference material. | Traceable to Certified NIST (National Institute of Standards and Technology) Reference Material SRM® (Standard Reference Material) 914a. |
| Reference Interval (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 |
| Reportable range<br>Serum | 0.2-11.2 mg/dL | 0.1 – 16.5 mg/dL |
| Sample type | No change | Serum and Plasma |
| Basic principle | No change | Colorimetric rate |
| Instrumentation | No change | VITROS DTSC/DTSCII Module |

Continued on next page

{3}------------------------------------------------

# 510(k) Summary, Continued

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

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

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

SPECIAL 510(K) SUBMISSION

VITROS CRSC DT Slides and VITROS DT Calibrator Kit

{4}------------------------------------------------

DEPARTMENT OF HEALTH & HUMAN SERVICES

Image /page/4/Picture/1 description: The image shows the logo for the U.S. Department of Health and Human Services. The logo consists of a stylized eagle with its wings spread, and the words "DEPARTMENT OF HEALTH & HUMAN SERVICES • USA" are arranged in a circular pattern around the eagle. The logo is black and white.

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

Re: k071216

> Trade/Device Name: VITROS Chemistry Products CRSC 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 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 (OS) regulation (21 CFR Part 820).

{5}------------------------------------------------

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.

Yean 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

{6}------------------------------------------------

Indications for Use

| 510(k) Number (if known): | k071216 |
|-----------------------------|------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------|
| Device Name: | VITROS Chemistry Products CRSC DT Slides |
| Indications for Use: | For <i>in vitro</i> diagnostic use only. VITROS Chemistry Products CRSC DT Slides quantitatively measure creatinine concentration in serum and plasma on the DT60/DT60 II analyzer.<br>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. |
| 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)

Carol C Benson
Sign-Off

K071216

Page 1 of 2

୍ରାଚe of In Vitro Diagnostic Device los duation and Safety

{7}------------------------------------------------

Indications for Use

510(k) Number (if known):

Device Name:

VITROS Chemistry Products DT Calibrator Kit

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, NBL, BUN/UREA, Ca, CHOL, CK, Cl, C02, CREA, CRSC, Fe, GGT, GLU, HDLC, K+, LAC, LDH, LIPA, Mg, Na+, NH3, PHOS, TP, TRIG, urCR, and URIC on VITROS DT Chemistry Systems.

Prescription Use _ X (Part 21 CFR 801 Subpart D)

AND/OR

1071216

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. Benson

ion Sign-O

Office of In Vitro Diagnostic Device Evaluation and Safety

K071216

Page 2 of 2