AMMONIA/ETHANOL/CO2 CALIBRATOR, CONTROL NORMAL, CONTROL ABNORMAL

K031880 · Roche Diagnostics Corp. · JIX · Jul 16, 2003 · Clinical Chemistry

Device Facts

• Record ID: K031880
• Device Name: AMMONIA/ETHANOL/CO2 CALIBRATOR, CONTROL NORMAL, CONTROL ABNORMAL
• Applicant: Roche Diagnostics Corp.
• Product Code: JIX · Clinical Chemistry
• Decision Date: Jul 16, 2003
• Decision: SESE
• Submission Type: Special
• Regulation: 21 CFR 862.1150
• Device Class: Class 2

Intended Use

Ammonia/Ethanol/CO2 Calibrator is for use in the calibration of quantitative Roche methods on Roche clinical chemistry analyzers as specified in the enclosed value sheet. Ammonia/Ethanol/CO2 Control is for use in quality control by monitoring accuracy and precision for the quantitative methods as specified in the enclosed value sheet.

Device Story

Device consists of liquid, ready-to-use buffered aqueous solutions containing ammonia, ethanol, and CO2. Calibrator used to calibrate quantitative Roche clinical chemistry methods; Controls used to monitor accuracy and precision of these methods. Used in clinical laboratory settings by laboratory personnel. Output is a reference value (calibrator) or a quality control result (control) used by the analyzer to ensure assay performance. Benefits include standardized calibration and verification of analytical accuracy/precision for clinical diagnostic testing.

Clinical Evidence

No clinical data provided. Bench testing only.

Technological Characteristics

Liquid, ready-to-use buffered aqueous solution. Multi-analyte mixture (Ammonia, Ethanol, CO2). Designed for use on Roche clinical chemistry analyzers. No specific materials, energy sources, or software algorithms described.

Indications for Use

Indicated for use as a calibrator and quality control material for quantitative Roche clinical chemistry assays on Roche analyzers. No specific patient population, age, or gender is defined as this is an in vitro diagnostic accessory.

Regulatory Classification

Identification

A calibrator is a device intended for medical purposes for use in a test system to establish points of reference that are used in the determination of values in the measurement of substances in human specimens. (See also § 862.2 in this part.)

Special Controls

*Classification.* Class II (special controls). The device is exempt from the premarket notification procedures in subpart E of part 807 of this chapter subject to the limitations in § 862.9.

Predicate Devices

• Ammonia/Ethanol/CO2 Calibrator (K952282)
• Ammonia/Ethanol/CO2 Controls (K951595)

Submission Summary (Full Text)

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# JUL 1 6 2003

## 510(k) Summary - Ammonia/Ethanol/CO2 Calibrator and Controls

. *

| <b>Introduction</b> | 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 |
|-------------------------------------------------|----------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------|
| <b>Submitter<br/>name, address,<br/>contact</b> | Roche Diagnostics Corporation<br>9115 Hague Rd<br>Indianapolis IN 46250<br>[phone]<br><br>Contact person: Sherri L. Coenen<br><br>Date prepared: June 13, 2003 |
| <b>Device Name</b> | Proprietary name:<br>• Roche Diagnostics Ammonia/Ethanol/CO2 Calibrator<br>• Roche Diagnostics Ammonia/Ethanol/CO2 Control Normal<br>• Roche Diagnostics Ammonia/Ethanol/CO2 Control Abnormal<br><br>Common name: Ammonia/Ethanol/CO2 Calibrator and Controls<br><br>Classification name:<br>• Calibrator, Multi-analyte mixture<br>• Multi-analyte controls, all kinds (assayed and unassayed) |
| <b>Device<br/>description</b> | The Ammonia/Ethanol/CO2 Calibrator is a liquid ready-for-use calibrator<br>based on a buffered aqueous solution. The concentration of the calibrator<br>The Ammonia/Ethanol/CO2 Controls are liquid ready-for-use controls based on a buffered aqueous solution. The adjusted concentrations of the control components are in the normal range for the Normal control and the pathological range for the Abnormal control. |

:

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### 510(k) Summary - Ammonia/Ethanol/CO2 Calibrator and Controls, continued

#### Intended use

Ammonia/Ethanol/CO2 Calibrator is for use in the calibration of quantitative Roche methods on Roche clinical chemistry analyzers as specified in the enclosed value sheet.

Ammonia/Ethanol/CO2 Control is for use in quality control by monitoring accuracy and precision for the quantitative methods as specified in the enclosed value sheet.

Predicate Device

We claim substantial equivalence to the currently marketed Ammonia/Ethanol/CO2 Calibrator (K952282) and Ammonia/Ethanol/CO2 Controls (K951595).

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Image /page/2/Picture/1 description: The image shows the logo for the U.S. Department of Health & Human Services. The logo consists of a stylized eagle with three stripes forming its wing, and the words "DEPARTMENT OF HEALTH & HUMAN SERVICES - USA" arranged in a circle around the eagle. The eagle is facing to the right. The logo is black and white.

Food and Drug Administration 2098 Gaither Road Rockville MD 20850

JUL 16 2003

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

Re: k031880

> Trade/Device Name: Ammonia/Ethanol/CO2 Calibrator and Controls Regulation Number: 21 CFR 862.1150 Regulation Name: Calibrator Regulatory Class: Class II Product Code: JIX; JJY Dated: June 13, 2003 Received: June 18, 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

Device Name: Ammonia/Ethanol/CO2 Calibrator and Controls

Indications For Use:

Ammonia/Ethanol/CO2 Calibrator is for use in the calibration of quantitative Roche methods on Roche clinical chemistry analyzers as specified in the enclosed value sheet.

Ammonia/Ethanol/CO2 Control is for use in quality control by monitoring accuracy and precision for the quantitative methods as specified in the enclosed value sheet.

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

(Optional Format 1-2-96)

Division Sign-Off

Office of In Vitro Diagnostic Device Evaluation and Safety

| 510(k) | K031880 |
|--------|---------|
|--------|---------|

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