ISE COMPENSATOR

K052193 · Roche Diagnostics · JIT · Oct 3, 2005 · Clinical Chemistry

Device Facts

• Record ID: K052193
• Device Name: ISE COMPENSATOR
• Applicant: Roche Diagnostics
• Product Code: JIT · Clinical Chemistry
• Decision Date: Oct 3, 2005
• Decision: SESE
• Submission Type: Traditional
• Regulation: 21 CFR 862.1150
• Device Class: Class 2

Intended Use

ISE Compensator is for use in the calibration of Ion Selective Electrodes on Roche/Hitachi analyzers.

Device Story

ISE Compensator is a ready-to-use liquid calibrator for Ion Selective Electrodes (ISE) on Roche/Hitachi analyzers. It consists of a buffered human serum matrix containing defined concentrations of sodium, potassium, and chloride, plus stabilizers. The device is used by laboratory personnel to calibrate ISE modules on compatible analyzers. It provides a reference point for measuring electrolyte concentrations in patient samples. The human serum matrix is screened for HBsAg, HCV, and HIV. The product is supplied in 1 mL bottles.

Clinical Evidence

No clinical data. Performance was established through bench testing, specifically evaluating value assignment and stability of the calibrator.

Technological Characteristics

Liquid calibrator; buffered human serum matrix; active ingredients: Na+, K+, Cl-. Ready-to-use format. Stability: 2 weeks at 2-8 °C after opening. Designed for use with Roche/Hitachi analyzer ISE modules.

Indications for Use

Indicated for the calibration of Ion Selective Electrodes on Roche/Hitachi analyzers. For prescription use only.

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

• ISE Compensation Sera (K870379)

Submission Summary (Full Text)

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510(k) Summary

K052193

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, and contact | Roche Diagnostics<br>9115 Hague Road<br>Indianapolis, IN 46250<br>317-521-3723 |
|--------------------------------------|--------------------------------------------------------------------------------|
| Contact Person: | Corina Harper |
| Date Prepared: | August 9, 2005 |

| Device name | |
|----------------------|-----------------------------------|
| Proprietary name: | ISE Compensator |
| Common name: | Calibrator |
| Classification name: | Calibrator, Multi-Analyte mixture |

| Predicate device | The ISE Compensator is substantially equivalent to the cleared ISE Compensation Sera (K870379). |
|------------------|-------------------------------------------------------------------------------------------------|
|------------------|-------------------------------------------------------------------------------------------------|

| Intended use | ISE Compensator is for use in the calibration of Ion Selective Electrodes on Roche/Hitachi analyzers. |
|--------------|-------------------------------------------------------------------------------------------------------|
|--------------|-------------------------------------------------------------------------------------------------------|

Continued on next page

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## 510(k) Summary, Continued

The ISE Compensator is substantially equivalent to other products in Substantial equivalence commercial distribution intended for similar use. We claim equivalency to the currently marketed ISE Compensation Sera (K870379).

The below tables compare ISE Compensator with the predicate device, ISE Substantial equivalence: Compensation Sera (K870379). Similarities

| Characteristic | Predicate Device<br>ISE Compensation<br>Sera (K870379) | ISE Compensator |
|----------------|---------------------------------------------------------------------------------------------------------------------------------------------------------------------------|------------------------------------------------------------------------------------------------|
| Intended Use | For use in the<br>calibration of Sodium,<br>Potassium, and<br>Chloride on the<br>Boehrienger Mannheim<br>diagnostics/Hitachi<br>Systems with Ion<br>Selective Electrodes. | For use in the<br>calibration of Ion<br>Selective Electrodes on<br>Roche/Hitachi<br>analyzers. |
| Levels | One | Same |
| Format | Lyophilized | Liquid |
| Handling | Add 5.0 mL distilled or<br>deionized water. Allow<br>to stand for 30 minutes.<br>Mix carefully, avoiding<br>the formation of the<br>foam. | Ready to use. Mix well<br>prior to use, avoiding<br>the formation of the<br>foam. |
| Stability | Unopened:<br>• Store at 2-8 °C until<br>expiration date<br>Reconstituted:<br>• 5 days at 2-8 °C<br>• 5 days at -20 °C | Unopened:<br>• Same<br>After opening:<br>• 2 weeks at 2-8 °C |

Continued on next page

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## 510(k) Summary, Continued

| Characteristic | Predicate Device<br>ISE Compensation<br>Sera (K870379) | ISE Compensator |
|----------------|---------------------------------------------------------------------------------------------------|--------------------------------------------------------------------------------------------------------|
| Matrix | Human serum matrix<br>with added Sodium<br>carbonate, Potassium<br>chloride,, Sodium<br>chloride. | Human serum matrix<br>preparation with<br>defined Sodium,<br>Potassium and Chloride<br>concentrations. |

Substantial equivalence: Similarities (continued)

## The table below lists all active ingredients for ISE Compensator. Matrix The active ingredients are spiked into a buffered human serum matrix. composition

1. 1

| | Components | Concentration |
|---------------------|------------------|---------------------------------------------------|
| Reactive Components | Na+<br>K+<br>Cl- | Refer to target value<br>sheet of package insert. |

The ISE Compensator was evaluated for value assignment and stability. Performance characteristics

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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 circular seal with the text "DEPARTMENT OF HEALTH & HUMAN SERVICES USA" arranged around the perimeter. Inside the circle is an abstract symbol resembling an eagle or bird in flight, composed of three curved lines above a wavy base.

Public Health Service

OCT 3 - 2005

Food and Drug Administration 2098 Gaither Road Rockville MD 20850

Ms. Corina Harper, RAC Regulatory Affairs Consultant Roche Diagnostics 9115 Hague Road PO Box 50416 Indianapolis, IN 46250-0416

k052193 Re:

> Trade/Device Name: ISE Compensator Regulation Number: 21 CFR 862.1150 Regulation Name: Calibrator Regulatory Class: Class II Product Code: JIT Dated: September 13, 2005 Received: September 15, 2005

Dear Ms. Harper:

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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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 http://www.fda.gov/cdrh/industry/support/index.html.

Sincerely yours,

Carol C. Benam

Carol C. Benson, M.A. Acting 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):

K052193

Device Name: ISE Compensator

Indications For Use:

ISE Compensator is for use in the calibration of Ion Selective Electrodes on Roche/Hitachi analyzers.

Prescription Use XXXX (Part 21 CFR 801 Subpart D)

AND/OR

Over-The-Counter Use (21 CFR 801 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)

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Office of In Vitro Diagnostic Device Evaluation and Safety

510(k

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