ROCHE DIAGNOSTICS COBAS INTEGRA ALBUMIN GEN. 2

K033009 · Roche Diagnostics Corp. · CIX · Oct 16, 2003 · Clinical Chemistry

Device Facts

• Record ID: K033009
• Device Name: ROCHE DIAGNOSTICS COBAS INTEGRA ALBUMIN GEN. 2
• Applicant: Roche Diagnostics Corp.
• Product Code: CIX · Clinical Chemistry
• Decision Date: Oct 16, 2003
• Decision: SESE
• Submission Type: Special
• Regulation: 21 CFR 862.1035
• Device Class: Class 2
• Attributes: Pediatric

Intended Use

The cassette COBAS Integra Albumin Gen.2 (ALB2) contains an in vitro diagnostic reagent system intended for use on COBAS Integra systems for the quantitative determination of the albumin concentration in human serum and plasma.

Device Story

COBAS Integra Albumin Gen.2 is an in vitro diagnostic reagent system for use on COBAS Integra clinical chemistry analyzers. It utilizes a colorimetric assay where albumin at pH 4.1 binds to bromcresol green (BCG) to form a blue-green complex. The intensity of the color, measured photometrically, is directly proportional to albumin concentration. The device is used in clinical laboratory settings by trained technicians. Results are provided to physicians to assist in the diagnosis and management of liver and kidney-related conditions.

Clinical Evidence

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

Technological Characteristics

Colorimetric assay using bromcresol green (BCG) reagent. Operates on COBAS Integra automated analyzer systems. Photometric detection of blue-green complex at pH 4.1. In vitro diagnostic reagent system.

Indications for Use

Indicated for quantitative determination of albumin in human serum and plasma to aid in diagnosis and treatment of liver or kidney diseases. Applicable to adults, newborns, and children.

Regulatory Classification

Identification

An albumin test system is a device intended to measure the albumin concentration in serum and plasma. Albumin measurements are used in the diagnosis and treatment of numerous diseases involving primarily the liver or kidneys.

Predicate Devices

• COBAS Integra Albumin Assay (K951595)

Submission Summary (Full Text)

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OCT 16 2003

K033009

# 510(k) Summary - COBAS Integra Albumin Gen.2

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| Introduction | According to the requirements of 21 CFR 807.92, the following information<br>provides sufficient detail to understand the basis for a determination of<br>substantial equivalence |
|----------------------------------------|------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------|
| Submitter<br>name, address,<br>contact | Roche Diagnostics Corporation<br>9115 Hague Rd<br>Indianapolis IN 46250<br>[phone] |
| | Contact person: Sherri L. Coenen |
| | Date prepared: September 24, 2003 |
| Device Name | Proprietary name: Roche Diagnostics COBAS Integra Albumin Gen.2 |
| | Common name: Albumin Assay |
| | Classification name: Albumin test system |
| Device<br>description | The COBAS Integra Albumin Gen.2 is a colorimetric assay for the<br>determination of albumin concentration in serum or plasma. At a pH value of<br>4.1, albumin displays a sufficiently cationic character to be able to bind with<br>bromcresol green (BCG) to form a blue-green complex. The color intensity is<br>directly proportional to the albumin concentration and can be determined<br>photometrically. |
| Intended use | The cassette COBAS Integra Albumin Gen.2 (ALB2) contains an in vitro<br>diagnostic reagent system intended for use on COBAS Integra systems for the<br>quantitative determination of the albumin concentration in human serum and<br>plasma. |
| Predicate<br>Device | We claim substantial equivalence to the currently marketed COBAS Integra<br>Albumin Assay. (K951595). |

: ·

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

continued

The following table describes the similarities and differences between the Reagent Summary COBAS Integra Albumin Gen.2 and the predicate device.

| Topic | COBAS Integra Albumin<br>(K951595) | COBAS Integra Albumin Gen.2<br>(Modified Device) |
|--------------------|------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------|-------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------|
| Intended Use | The cassette COBAS Integra<br>Albumin (ALB) contains an in vitro<br>diagnostic reagent system intended<br>for use on COBAS Integra systems<br>for the quantitative determination of<br>the albumin concentration in serum<br>and plasma. | The cassette COBAS Integra<br>Albumin Gen.2 (ALB2) contains an<br>in vitro diagnostic reagent system<br>intended for use on COBAS Integra<br>systems for the quantitative<br>determination of the albumin<br>concentration in serum and plasma. |
| Method | BCG colorimetric assay with<br>endpoint method | Same |
| Sample type | Serum<br>Heparin or EDTA plasma | Same |
| Measuring<br>range | 0.08 - 60 g/L | 2 - 60 g/L |
| Expected<br>values | Adults (18-60 yrs): 3.5 - 5.0 g/dL<br>Adults (> 60 yrs): 3.4 - 4.8 g/dL<br>Newborn: 2.8 - 4.4 g/dL<br>Children (4 days - 14 yrs): 3.8 - 5.4<br>g/dL<br>Children (14 - 18 years): 3.2 - 4.5<br>g/dL | Adults: 3.4 - 4.8 g/dL<br>Newborn: 2.8 - 4.4 g/dL<br>Children (4 days - 14 yrs): 3.8 - 5.4<br>g/dL<br>Children (14 - 18 years): 3.2 - 4.5<br>g/dL |

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Image /page/2/Picture/1 description: The image is a black and white seal for the Department of Health & Human Services - USA. The seal is circular with the text "DEPARTMENT OF HEALTH & HUMAN SERVICES - USA" arranged around the perimeter. In the center of the seal are three stylized human profiles facing to the right, with flowing lines extending from the bottom of the profiles.

OCT 1 6 2003

Food and Drug Administration 2098 Gaither Road Rockville MD 20850

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

Re: k033009

> Trade/Device Name: COBAS Integra Albumin Gen.2 Regulation Number: 21 CFR 862.1035 Regulation Name: Albumin test system Regulatory Class: Class II Product Code: CIX Dated: September 24, 2003 Received: September 26, 2003

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). 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/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 K033009

Device Name: COBAS Integra Albumin Gen.2

Indications For Use:

The cassette COBAS Integra Albumin Gen.2 (ALB2) contains an in vitro diagnostic reagent system intended for use on COBAS Integra systems for the quantitative determination of the albumin concentration in human serum and plasma. Albumin measurements are used in the diagnosis and treatment of numerous diseases involving primarily the liver or kidneys.

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| | Concurrence of CDRH, Office of Device Evaluation (ODE) | |
|------------------------------------------|--------------------------------------------------------|--------------------------|
| Prescription Use<br>(Per 21 CFR 801.109) | | Over-The-Counter Use |
| | | (Optional Format 1-2-96) |

Carol C Benson for Jean Cooper, DVM

Division Sign-Off

Office of In Vitro Diagnostic Device Evaluation and Safety

| 510(k) | K033009 | 22 |
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