ELECSYS INSULIN CALCHECK 5

K101075 · Roche Diagnostics Corp. · JJX · Jun 11, 2010 · Clinical Chemistry

Device Facts

• Record ID: K101075
• Device Name: ELECSYS INSULIN CALCHECK 5
• Applicant: Roche Diagnostics Corp.
• Product Code: JJX · Clinical Chemistry
• Decision Date: Jun 11, 2010
• Decision: SESE
• Submission Type: Traditional
• Regulation: 21 CFR 862.1660
• Device Class: Class 1

Intended Use

The Elecsys Insulin CalCheck 5 is an assayed control for use in calibration verification and for use in the verification of the assay range established by the Elecsys Insulin reagent on the indicated Elecsys and cobas e immunoassay analyzers. The Elecsys Insulin CalCheck 5 is not intended to be used as a primary calibrator or routine control material.

Device Story

Elecsys Insulin CalCheck 5 is a lyophilized, bovine serum-based control material containing recombinant human insulin. It is used by laboratory personnel on MODULAR ANALYTICS E170, Elecsys 2010, cobas e 601, and cobas e 411 analyzers. The device provides five concentration levels to verify the assay range and calibration of the Elecsys Insulin reagent. It is not a primary calibrator or routine control. Users reconstitute the material with distilled or deionized water before use. The device ensures the accuracy and linearity of insulin measurements within the clinical laboratory setting.

Clinical Evidence

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

Technological Characteristics

Lyophilized product; recombinant human insulin in bovine serum matrix. Five-level concentration format. Reconstituted with 1.0 mL distilled or deionized water. Stability: 2-8°C unopened; 4 hours at 20-25°C after reconstitution. Designed for use on Elecsys and cobas e immunoassay analyzers.

Indications for Use

Indicated for use as an assayed control for calibration verification and assay range verification of the Elecsys Insulin reagent on specified Elecsys and cobas e immunoassay analyzers.

Regulatory Classification

Identification

A quality control material (assayed and unassayed) for clinical chemistry is a device intended for medical purposes for use in a test system to estimate test precision and to detect systematic analytical deviations that may arise from reagent or analytical instrument variation. A quality control material (assayed and unassayed) may be used for proficiency testing in interlaboratory surveys. This generic type of device includes controls (assayed and unassayed) for blood gases, electrolytes, enzymes, multianalytes (all kinds), single (specified) analytes, or urinalysis controls.

Predicate Devices

• Elecsys HCG+β CalCheck 5 (K092168)

Submission Summary (Full Text)

{0}------------------------------------------------

K101075

### Roche Diagnostics

# Elecsys® Insulin CalCheck 5

| 510(k) Summary | | | |
|----------------------------------------|-------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------|--|--|
| 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<br>name, address,<br>contact | Roche Diagnostics<br>9115 Hague Road<br>Indianapolis, IN 46250<br>JUN 11 2010 | | |
| | Contact Person: Sarah Baumann<br>Phone: [phone]<br>Fax: [phone]<br>Email: [e-mail] | | |
| | Secondary Contact: Stephanie Greeman<br>Phone: [phone]<br>Fax: [phone]<br>Email: [e-mail] | | |
| | Date Prepared: April 16, 2010 | | |
| Device Name | Proprietary name: Elecsys® Insulin CalCheck 5<br>Common name: Insulin CalCheck 5<br>Classification name: Single (specified) analyte controls (assayed and<br>unassayed) | | |
| Predicate<br>device | The Elecsys Insulin CalCheck 5 is substantially equivalent to other products<br>in commercial distribution intended for similar use. We claim equivalency to<br>the currently marketed Elecsys HCG+B CalCheck 5 (K092168). | | |
| Device<br>Description | The Elecsys Insulin CalCheck 5 is a lyophilized product consisting of<br>recombinant human insulin in bovine serum matrix. During manufacture, the<br>analyte is spiked into the matrix at the desired concentration levels. | | |
| Intended use | The Elecsys Insulin CalCheck 5 is an assayed control for use in calibration<br>verification and for use in the verification of the assay range established by<br>the Elecsys Insulin reagent on the indicated Elecsys and cobas e<br>immunoassay analyzers. | | |
| | | | |

Continued on next page

Confidential

Page 1 of 2

{1}------------------------------------------------

### Roche Diagnostics

## 510(k) Summary, Continued

| Comparison | The table below compares Elecsys Insulin CalCheck 5 with the predicate |
|------------|------------------------------------------------------------------------|
| Table | device, Elecsys HCG+B Calcheck 5 (K092168). |

| Characteristic | Elecsys HCG+β CalCheck 5<br>(K092168) | Elecsys Insulin CalCheck 5 |
|--------------------------|------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------|----------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------|
| Intended Use | The Elecsys HCG+β CalCheck 5 is<br>an assayed control for use in<br>calibration verification and for use in<br>the verification of the assay range<br>established by the Elecsys HCG+β<br>reagent on the indicated Elecsys and<br>cobas e immunoassay analyzers. | The Elecsys Insulin CalCheck 5 is<br>an assayed control for use in<br>calibration verification and for use in<br>the verification of the assay range<br>established by the Elecsys Insulin<br>reagent on the indicated Elecsys and<br>cobas e immunoassay analyzers. |
| Matrix | Human serum matrix | Bovine serum matrix |
| Levels | Five | Same |
| Format | Lyophilized | Same |
| Handling<br>instructions | Reconstitute the contents of<br>each vial with exactly 1.0 mL distilled<br>or deionized water.<br><br>Allow the bottle to stand closed for 15<br>minutes. Mix gently by inversion to<br>ensure homogeneity. | Same |
| Stability | Unopened:<br>• Store at 2-8°C until expiration date<br><br>Reconstituted:<br>• 20 – 25°C : 4 hrs | Same |

The Elecsys Insulin CalCheck 5 was evaluated for value assignment and Performance Characteristics stability. Conclusion The data demonstrate that the performance of the Elecsys Insulin CalCheck 5 is substantially equivalent to that of the predicate device, Elecsys HCG+β CalCheck 5 (K092168).

{2}------------------------------------------------

DEPARTMENT OF HEALTH & HUMAN SERVICES.USA

#### DEPARTMENT OF HEALTH & HUMAN SERVICES

Public Health Service

Food & Drug Administration 10903 New Hampshire Avenue Building 66 Silver Spring, MD 20993

Roche Diagnostics Corp. c/o Ms. Sarah Baumann Regulatory Affairs Consultant 9115 Hague Road, PO Box 50410 Indianapolis, IN 46250-0416

JUN 1 1 2010

k101075 Re: Trade Name: Elecsys® Insulin CalCheck 5 Regulation Number: 21 CFR §862.1660 Regulation Name: Quality control material (assayed and unassayed). Regulatory Class: Class I, reserved Product Codes: JJX Dated: April 16, 2010 Received: April 19, 2010

Dear Ms. Baumann:

We have reviewed your Section 510(k) premarket notification of intent to market the we have formed your ood have determined the device is substantially equivalent (for de recolorenene 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 marketed in meetstate ovents, 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 with the provisions of thapproval application (PMA). You may, therefore, market the approvide of a promazions provisions of the Act. The general controls actives, subject to Act include requirements for annual registration, listing of devices, provisions of the ing 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 (1 Wrift), It may of basice 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 I fouse oo aa ADDA has made a determination that your device complies with other not firements 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 I coderal agencies: "Fou mast compy 1 CFR Part 807); labeling (21 CFR Parts 801 and 1111164 to: reporting (reporting (reporting of medical device-related adverse events) (21 CFR 803); and good manufacturing practice requirements as set forth in the quality systems (QS) regulation (21 CFR Part 820).

{3}------------------------------------------------

#### Page 2

If you desire specific advice for your device on our labeling regulation (21 CFR Part 801), 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" (21 CFR Part 807.97). For questions regarding postmarket surveillance, please contact CDRH's Office of Surveillance and Biometric's (OSB's) Division of Postmarket Surveillance at [phone]. 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 ( 301 ) 796-5680 or at its Internet address http://www.fda.gov/MedicalDevices/ResourcesforYou/Industry/default.htm.

Sincerely yours,

CA

Courtney C. Harper, Ph.D. Director Division of Chemistry and Toxicology Office of In Vitro Diagnostic Device Evaluation and Safety Center for Devices and Radiological Health

Enclosure

{4}------------------------------------------------

## Indications for Use Form

510(k) Number (if known): ____________________________________________________________________________________________________________________________________________________

Device Name: Elecsys Insulin CalCheck 5

Indications for Use: The Elecsys Insulin CalCheck 5 is an assayed control for use in calibration verification and for use in the verification of the assay range established by the Elecsys Insulin reagent on the indicated Elecsys and cobas e immunoassay analyzers.

Over-The-Counter Use Prescription Use Prescription Use _____________________________________________________________________________________________________________________________________________________________

(PLEASE DO NOT WRITE BELOW THIS LINE-CONTINUE ON ANOTHER PAGE OF NEEDED) .

Concurrence of CDRH, Office of In Vitro Diagnostic Devices (OIVD)

Carol C. Benson

Division Sign-Off Office of In Vitro Diagnostic Device Evaluation and Safety

510(k) K101075

Page 1 of