DIMENSION CHEMISTRY III CALIBRATORY

K123321 · Siemens Healthcare Diagnostics · JIX · Feb 15, 2013 · Clinical Chemistry

Device Facts

• Record ID: K123321
• Device Name: DIMENSION CHEMISTRY III CALIBRATORY
• Applicant: Siemens Healthcare Diagnostics
• Product Code: JIX · Clinical Chemistry
• Decision Date: Feb 15, 2013
• Decision: SESE
• Submission Type: Traditional
• Regulation: 21 CFR 862.1150
• Device Class: Class 2

Intended Use

The CHEM III CAL is an in vitro diagnostic product for the calibration of Ammonia (AMM), Carbon Dioxide (ECO2) and Ethyl Alcohol (ETOH) assays on the Dimension® clinical chemistry system.

Device Story

Dimension Chemistry III Calibrator (CHEM III CAL) is a three-level, liquid, aqueous calibrator kit containing ammonium bicarbonate, sodium carbonate, and ethyl alcohol. Used in clinical chemistry laboratories to calibrate Ammonia, Carbon Dioxide, and Ethyl Alcohol assays on the Dimension clinical chemistry system. Provides standardized reference values to ensure accuracy of patient sample measurements. Product is ready-to-use; stored at 2–8°C. Healthcare providers use the calibrated system to obtain quantitative diagnostic results for patient management.

Clinical Evidence

No clinical data. Bench testing only. Stability testing performed per CLSI EP25-A guideline; established 12-month shelf life and open-vial stability (7 days on-system, 30 days refrigerated).

Technological Characteristics

Aqueous multi-analyte calibrator; contains ammonium bicarbonate, ethyl alcohol, sodium carbonate. Traceability: Ammonia (ACS Grade ammonium sulfate), CO2 (NIST SRM 351), Ethyl Alcohol (USP grade). Storage: 2–8°C. Form factor: 6-vial kit (2.5 mL/vial).

Indications for Use

Indicated for the calibration of Ammonia, Carbon Dioxide, and Ethyl Alcohol assays on the Siemens Dimension RxL Max clinical chemistry system.

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

• Dimension Vista® Chemistry 3 Calibrator (CHEM 3 CAL) (k062334)

Submission Summary (Full Text)

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# (123321

## 510k Summary

# FEB 1 5 2013

## Dimension® Chemistry III Calibrator (CHEM III CAL)

This summary of 510(k) safety and effectiveness information is submitted in accordance with the requirements of SMDA 1990 and 21 CFR 807.92.

## 1. 510(k) Number

- 2. Applicant: Rose T. Marinelli Siemens Healthcare Diagnostics, Inc. P.O. Box 6101, Newark, DE 19714-6101. Office Number: 302-631-8805; Fax Number: 302-631-6299
3. Date: October 25, 2012

## 4. Proprietary and Established Names:

Dimension® Chemistry III Calibrator (CHEM III CAL)

## 5. Requlatory Information:

Chemistry III Calibrator (CHEM III CAL)

Requlation section: 21 CFR 862.1150 Calibrator, Multi-Analyte Classification: Class II Product Code: JIX. Panel: Clinical Chemistry

## 6. Predicate Devices:

The predicate device used to demonstrate substantial equivalence to the Dimension® Chemistry III Calibrator (CHEM III CAL) is the Dimension Vista® Chemistry 3 Calibrator (CHEM 3 CAL) previously cleared under k062334.

#### 7. Device Description:

The Chemistry III Calibrator (CHEM III CAL) is a three level, liquid calibrator. It is packaged as a kit of six vials, two vials each of Levels 1, 2 and 3 with 2.5 mL per vial. CHEM III CAL is a multianalyte, aqueous product containing ammonium bicarbonate, sodium carbonate and ethyl alcohol.

## 8. Intended Use:

The CHEM III CAL is an in vitro diagnostic product for the calibration of Ammonia (AMM), Carbon Dioxide (ECO2) and Ethyl Alcohol (ETOH) assays on the Dimension® clinical chemistry svstem.

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## 9. Indication(s) for Use:

The CHEM III CAL is an in vitro diagnostic product for the calibration of Ammonia (AMM), Carbon Dioxide (ECO2) and Ethyl Alcohol (ETOH) assays on the Dimension® clinical chemistry system.

## 10. Substantial Equivalence Information:

Similarities for Dimension® CHEM III CAL

| Feature | New Device: Dimension®<br>Chemistry III Calibrator (CHEM III<br>CAL) (DC130) | Predicate: Dimension Vista®<br>Chem 3 Calibrator (CHEM 3<br>CAL) (KC130) k062334 |
|--------------|-----------------------------------------------------------------------------------------------|-------------------------------------------------------------------------------------------------|
| Preparation | Liquid:<br>Provided ready to use. | Liquid:<br>Provided ready to use. |
| Storage | 2 – 8 °C | 2 - 8 °C |
| Matrix | Aqueous product containing ethyl<br>alcohol, ammonium bicarbonate<br>and sodium carbonate. | Aqueous product containing<br>ethyl alcohol, ammonium<br>bicarbonate and sodium<br>carbonate. |
| Traceability | AMM - ASC Grade Ammonium<br>Sulfate<br>EC02 -- NIST SRM 351<br>ETOH - USP Grade Ethyl Alcohol | AMM - ASC Grade Ammonium<br>Sulfate<br>EC02 - NIST SRM 351<br>ETOH - USP Grade Ethyl<br>Alcohol |

## Differences for Dimension® CHEM III CAL

| Feature | New Device: Dimension®<br>Chemistry III Calibrator (CHEM<br>3 CAL) (DC130) | Predicate: Dimension Vista®<br>Chem 3 Calibrator (CHEM 3 CAL)<br>(KC130) |
|--------------------------------------|---------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------|-----------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------|
| Intended Use | The CHEM III CAL is an in vitro<br>diagnostic product for the<br>calibration of Ammonia (AMM),<br>Carbon Dioxide (EC02) and<br>Ethyl Alcohol (ETOH) assays on<br>the Dimension® clinical<br>chemistry system. | The CHEM 3 CAL is an in vitro<br>diagnostic product for the calibration.<br>of Ammonia (AMON), Carbon<br>Dioxide (C02) and Ethyl Alcohol<br>(ETOH) methods on the Dimension<br>Vista® System. |
| Units | µg/dL and µmol/L | µmol/L |
| Calibrator<br>Levels | 3 levels | 2 levels |
| Calibrator<br>Levels for<br>AMM only | Calibrator Level 3 – 1405 µg/dL<br>[825 µmol/L] | Calibrator Level 3 – 1050 µmol/L |

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## 11. Standard/Guidance Document Reference:

- · CLSI, EP25-A, Evaluation of Stability of In Vitro Diagnostic Reagents; Approved Guideline; 2009.
## 12. Performance Characteristics

## Calibrator

- For opened products, once the cap is removed, assigned values are stable for 7 days . stored on the Dimension® clinical chemistry system.
- . Once cap is removed, assigned values are stable for 30 days when recapped immediately after use and stored at 2-8°C.

The shelf life of the Dimension® CHEM III CAL is 12 months.

13. Conclusion: The Dimension® Chemistry III Calibrator (CHEM III CAL) is substantially equivalent in principle and performance to the Dimension Vista® Chemistry 3 Calibrator.

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Image /page/3/Picture/0 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" around the perimeter. Inside the circle is an abstract symbol resembling an eagle or bird in flight, composed of three curved lines.

#### DEPARTMENT OF HEALTH & HUMAN SERVICES

Food and Drug Administration 10903 New Hampshire Avenue Document Control Center - WO66-G609 Silver Spring, MD 20993-0002

February 15.2013

Siemens Healthcare Diagnostics, Inc. c/o Rose T. Marinelli 500 GBC Drive P.O. Box 6101/MS 514 Newark, DE 19714-6101

Re: k123321

Trade/Device Name: Dimension Chemistry III Calibrator (CHEM III CAL) Regulation Number: 21 CFR 862.1150 Regulation Name: Calibrator Regulatory Class: II Product Code: JIX Dated: February 01, 2013 Received: February 07, 2013

Dear Ms. Marinelli:

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. Please note: CDRH does not evaluate information related to contract liability warranties. We remind you, however, that device labeling must be truthful and not misleading.

If your device is classified (see above) into either class II (Special Controls) or class III (PMA), it may be subject to additional controls. Existing major regulations affecting your device can be found in the Code of Federal Regulations, Title 21, Parts 800 to 898. 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 Part 801); medical device reporting (reporting of medical device-related adverse events) (21 CFR 803); good manufacturing practice requirements as set forth in the quality systems (QS) regulation (21 CFR Part 820); and if applicable, the electronic product radiation control provisions (Sections 531-542 of the Act); 21 CFR 1000-1050.

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Page 2—Ms. Marinelli

If you desire specific advice for your device on our labeling regulation (21 CFR Part 801), please go to http://www.fda.gov/AboutFDA/CentersOffices/CDRH/CDRHOffices/ucm115809.htm for the Center for Devices and Radiological Health's (CDRH's) Office of Compliance. Also, please note the regulation entitled, "Misbranding by reference to premarket notification" (21CFR Part 807.97). For questions regarding the reporting of adverse events under the MDR regulation (21 CFR Part 803), please go to

http://www.fda.gov/MedicalDevices/Safety/ReportaProblem/default.htm for the CDRH's Office of Surveillance and Biometrics/Division of Postmarket Surveillance.

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/MedicalDevices/ResourcesforYou/Industry/default.htm.

Sincerely yours,

## Carol C. Benson for

Courtney H. Lias, Ph.D. Director Division of Chemistry and Toxicology Devices Office of In Vitro Diagnostics and Radiological Health Center for Devices and Radiological Health

Enclosure

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# Indications for Use

510(k) Number (if known): k123321

Device Name: Dimension® Chemistry III Calibrator (CHEM III CAL)

Indications for Use:

The CHEM III CAL is an in vitro diagnostic product for the calibration of Ammonia (AMM), Carbon Dioxide (C02) and Ethyl Alcohol (ETOH) methods on the Dimension® clinical chemistry system.

Prescription Use X (21 CFR Part 801 Subpart D) And/Or

Over the Counter Use (21 CFR Part 801 Subpart C)

(PLEASE DO NOT WRITE BELOW THIS LINE; CONTINUE ON ANOTHER PAGE IF NEEDED)

Concurrence of CDRH, Office of In Vitro Diagnostics and Radiological Health (OIR)

Denise Johnson-lyles -S 2013.02.15 10:17:42 -05'00'

Division Sign-Off Office of In Vitro Diagnostics and Radiological Health

k123321 510(k)