COBAS INTEGRA CREATININE PLUS VER.2 ASSAY

K024098 · Roche Diagnostics Corp. · JFY · Dec 19, 2002 · Clinical Chemistry

Device Facts

• Record ID: K024098
• Device Name: COBAS INTEGRA CREATININE PLUS VER.2 ASSAY
• Applicant: Roche Diagnostics Corp.
• Product Code: JFY · Clinical Chemistry
• Decision Date: Dec 19, 2002
• Decision: SESE
• Submission Type: Special
• Regulation: 21 CFR 862.1225
• Device Class: Class 2
• Attributes: Pediatric

Intended Use

The cassette COBAS INTEGRA Creatinine plus ver.2 (CREP2) contains an in vitro diagnostic reagent system intended for use on COBAS INTEGRA systems for the quantitative determination of the creatinine concentration in serum, plasma, and urine.

Device Story

The COBAS Integra Creatinine plus ver.2 is an in vitro diagnostic reagent system used on COBAS Integra clinical chemistry analyzers. It utilizes an enzymatic colorimetric method; creatinine is converted via creatininase, creatinase, and sarcosine oxidase to produce hydrogen peroxide. This hydrogen peroxide reacts to form a quinone imine dye. The intensity of the dye color is measured photometrically and is directly proportional to the creatinine concentration in the sample. The device is operated by laboratory professionals in clinical settings. The quantitative results provided to clinicians assist in the assessment of renal function and patient management. The system supports testing across a broad range of patient ages, from neonates to adults.

Clinical Evidence

No clinical data provided; substantial equivalence is based on analytical performance and comparison of reagent characteristics to the predicate device.

Technological Characteristics

Enzymatic colorimetric assay; reagents include creatininase, creatinase, and sarcosine oxidase. Designed for use on automated COBAS Integra clinical chemistry systems. Measures creatinine concentration via quinone imine dye color intensity. No specific materials of construction or connectivity standards provided.

Indications for Use

Indicated for the quantitative determination of creatinine concentration in serum, plasma, and urine for clinical diagnostic purposes. Applicable to adult and pediatric populations, including neonates.

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

• COBAS Integra Creatinine plus Assay (K003261)

Submission Summary (Full Text)

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K024098

# 510(k) Summary - COBAS Integra Creatinine plus ver.2 Assay

| Introduction | According to the requirements of 21 CFR 807.92, the following information provides sufficient detail to understand the basis for a determination of substantial equivalence |
|----------------------------------|----------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------|
| Submitter name, address, contact | Roche Diagnostics Corporation<br>9115 Hague Rd<br>Indianapolis IN 46250<br>[phone]<br><br>Contact person: Sherri L. Coenen<br><br>Date prepared: December 11, 2002 |
| Device Name | Proprietary name: COBAS Integra Creatinine plus ver.2<br><br>Common name: creatinine reagent<br><br>Classification name: enzymatic Method, Creatinine |
| Device description | The COBAS Integra Creatinine plus ver. 2 Assay is an enzymatic method based on the determination of hydrogen peroxide after conversion of creatinine with the aid of creatininase, creatinase, and sarcosine oxidase. The liberated hydrogen peroxide reacts to form a quinone imine dye, the color intensity of which is directly proportional to the creatinine concentration. |
| Intended use | The cassette COBAS INTEGRA Creatinine plus ver.2 (CREP2) contains an in vitro diagnostic reagent system intended for use on COBAS INTEGRA systems for the quantitative determination of the creatinine concentration in serum, plasma, and urine. |
| Predicate Device | We claim substantial equivalence to the currently marketed COBAS Integra Creatinine plus Assay. (K003261). |

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# 510(k) Summary - COBAS Integra Creatinine plus ver.2,

continued

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#### Reagent Summary

The following table describes the similarities and differences between the COBAS Integra Creatinine plus ver.2 assay and the predicate device.

| Topic | COBAS Integra<br>Creatinine plus<br>(K003261) | COBAS Integra<br>Creatinine plus ver.2<br>(Modified Device) |
|--------------------|------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------|--------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------|
| Intended Use | The cassette COBAS INTEGRA<br>Creatinine plus (CREAP)<br>contains an in vitro diagnostic<br>reagent system intended for use<br>on COBAS INTEGRA systems<br>for the quantitative determination<br>of the creatinine concentration in<br>serum, plasma, and urine. | The cassette COBAS INTEGRA Creatinine<br>plus ver.2 (CREP2) contains an in vitro<br>diagnostic reagent system intended for use on<br>COBAS INTEGRA systems for the<br>quantitative determination of the creatinine<br>concentration in serum, plasma, and urine. |
| Method | Enzymatic colorimetric | Same |
| Sample type | serum, plasma (Li-heparin, K3-<br>EDTA), urine | Same |
| Measuring<br>range | Serum/Plasma: 0 - 2700 µmol/L<br>Urine: 0 - 40 mmol/L | Same |
| Expected<br>values | Serum/Plasma:<br>Females: 45 - 84 µmol/L<br>Males: 59 - 104 µmol/L | Serum/Plasma:<br><i>Adults</i><br>Females: 45 - 84 µmol/L<br>Males: 59 - 104 µmol/L<br><i>Children</i><br>Neonates (premature): 29 - 87 µmol/L<br>Neonates (full term): 27 - 77 µmol/L<br>2 - 12 m: 14 - 34 µmol/L<br>1 - <3y: 15 - 31 µmol/L<br>3 - <5y: 23 - 37 µmol/L<br>5 - <7y: 25 - 42 µmol/L<br>7 - <9y: 30 - 47µmol/L<br>9 - <11y: 29 - 56 µmol/L<br>11- <13y: 39 - 60 µmol/L<br>13 - <15y: 40 - 68 µmol/L |

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## 510(k) Summary - COBAS Integra Creatinine plus ver.2,

continued

| Reagent<br>Summary,<br>continued | | |
|----------------------------------|--------------------------------------------------------|---------------------------------------------------------------|
| Topic | COBAS Integra<br>Creatinine plus<br>(K003261) | COBAS Integra<br>Creatinine plus ver.2<br>(Modified Device) |
| Expected<br>values,<br>continued | Urine:<br>First morning urine:<br>Females: 2.55 - 20.0 | Urine:<br>First morning urine:<br>Females: 2.55 - 20.0 mmol/L |

Males: 3.54 - 24.6 mmol/L

Females: 6 - 13 mmol/24h

Males: 9 - 19 mmol/24h

Creatinine clearance: 66 - 143 mL/min

24-hour urine:

mmol/L

24-hour urine:

mL/min

Males: 3.54 - 24.6 mmol/L

Females: 6 - 13 mmol/24h

Males: 9 - 19 mmol/24h

Creatinine clearance: 66 - 143

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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 stylized image of an eagle with three lines representing its wings and head. The text "DEPARTMENT OF HEALTH & HUMAN SERVICES - USA" is arranged in a circular fashion around the eagle image.

Food and Drug Administration 098 Gaither Road Rockville MD 20850

Ms. Sherri L. Coenen Regulatory Submissions, Centralized Diagnostics Roche Diagnostics Corporation 9115 Hague Road P.O. Box 50457 Indianapolis, IN 46250-0457

k024098 Re:

> Trade/Device Name: COBAS Integra Creatinine plus ver.2 Assay Regulation Number: 21 CFR 862.1225 Regulation Name: Creatinine Test System Regulatory Class: Class II Product Code: JFY Dated: December 11, 2002 Received: December 12, 2002

Dear Ms. Coenen:

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). Other general information on your responsibilities under the Act may be obtained 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/dsma/dsmamain.html.

Sincerely yours,

Steven Sutman

Steven I. Gutman, M.D., M.B.A. Director 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): N/A

Device Name: COBAS Integra Creatinine plus ver.2 Assay

Indications For Use:

The cassette COBAS INTEGRA Creatinine plus ver.2 (CREP2) contains an in vitro diagnostic reagent system intended for use on COBAS INTEGRA systems for the quantitative determination of the creatinine concentration in serum, plasma, and urine.

Dean Cooper

(Division Sign-Off) (Division of Clinical Laboratory Devices 以 510(k) Number ..

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Concurrence of CDRH, Office of Device Evaluation (ODE) Prescription Use OR Over-The-Counter Use (Per 21 CFR 801.109)

(Optional Format 1-2-96)