ELECSYS C-PEPTIDE CALCHECK

K040157 · Roche Diagnostics Corp. · JJX · Feb 25, 2004 · Clinical Chemistry

Device Facts

• Record ID: K040157
• Device Name: ELECSYS C-PEPTIDE CALCHECK
• Applicant: Roche Diagnostics Corp.
• Product Code: JJX · Clinical Chemistry
• Decision Date: Feb 25, 2004
• Decision: SESE
• Submission Type: Traditional
• Regulation: 21 CFR 862.1660
• Device Class: Class 1

Intended Use

The Elecsys® C-Peptide CalCheck is intended for use in the verification of the calibration established by the Elecsys® C-Peptide reagent on the Elecsys® immunoassay systems.

Device Story

Elecsys® C-Peptide CalCheck is a lyophilized quality control material consisting of synthetic human C-Peptide in a buffered equine serum matrix. It is used in clinical laboratory settings to verify the calibration of the Elecsys® C-Peptide reagent on Elecsys® immunoassay systems. The product is provided in three concentration levels. Users reconstitute the lyophilized material with distilled water before use. By comparing the measured values of the CalCheck against established target ranges, healthcare providers verify the accuracy and stability of the immunoassay system's calibration, ensuring reliable patient test results for C-Peptide levels.

Clinical Evidence

No clinical data. Bench testing only. Stability validated via modified accelerated testing (35°C for 3 weeks) and reconstituted stability testing (4 hours at 20-25°C). Traceability established against WHO 1st IRR 84/510.

Technological Characteristics

Lyophilized synthetic human C-peptide in buffered equine serum matrix (HEPES and preservatives). Three concentration levels. Traceable to WHO 1st IRR 84/510. Compatible with Elecsys® 1010/2010 and MODULAR ANALYTICS E170 systems.

Indications for Use

Indicated for use as a calibration verification material for the Elecsys® C-Peptide reagent on Elecsys® immunoassay systems to verify established calibration.

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® SHBG CalCheck (K031698)

Submission Summary (Full Text)

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K040157

FEB 2 5 2004

# 510(k) Summary

| 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<br>9115 Hague Road<br>Indianapolis, IN 46250<br>317-521-3723 |
| | Contact Person: Theresa M. Ambrose |
| | Date Prepared: January 22, 2004 |
| Device Name | Proprietary name: Elecsys® C-Peptide CalCheck |
| | Common name: C-Peptide CalCheck |
| | Classification name: Single (specified) analyte controls (assayed and<br>unassayed) |
| Predicate<br>device | The Elecsys® C-Peptide CalCheck is substantially equivalent to the currently<br>marketed Elecsys® SHBG CalCheck (K031698). |
| Device<br>Description | The Elecsys® C-Peptide CalCheck is a lyophilized product consisting of<br>synthetic human C-Peptide in a buffered equine serum matrix. During<br>manufacture, the analytes are spiked into the matrix at the desired<br>concentration levels. |
| Intended use | The Elecsys® C-Peptide CalCheck is intended for use in the verification of<br>the calibration established by the Elecsys® C-Peptide reagent on the<br>Elecsys® immunoassay systems. |
| | Continued on next page |
| Comparison to | The Elecsys® C-Peptide CalCheck is substantially equivalent to the currently |
| predicate | marketed Elecsys® SHBG CalCheck (K031698). The below tables compare |
| device | Elecsys® C-Peptide CalCheck with the predicate device, Elecsys® SHBG |
| | CalCheck (K031698). |

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## 510(k) Summary, Continued

#### Similarities

| Characteristic | Elecsys® C-Peptide<br>CalCheck | Predicate device:<br>Elecsys® SHBG<br>CalCheck |
|----------------|------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------|-----------------------------------------------------------------------------------------------------------------------------------------------------------------------------------|
| Intended Use | Elecsys® C-Peptide<br>CalCheck is intended for<br>use in the verification of<br>the calibration<br>established by the<br>Elecsys® C-Peptide<br>reagent on the Elecsys®<br>immunoassay systems. | Elecsys® SHBG CalCheck<br>is intended for use in the<br>verification of the<br>calibration established by<br>the Elecsys® SHBG<br>reagent on the Elecsys®<br>immunoassay systems. |
| Levels | Three | same |
| Format | Lyophilized | same |
| Handling | Reconstitute with exactly<br>1.0 mL distilled water<br>and allow to stand closed<br>for 15 minutes. | same |
| Stability | Unopened:<br>• Store at 2-8°C until<br>expiration date<br>Reconstituted:<br>• 20 – 25 °C : 4 hrs | same |

Continued on next page

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## 510(k) Summary, Continued

Differences

| Characteristic | Elecsys® C-Peptide<br>CalCheck | Predicate device:<br>Elecsys® SHBG<br>CalCheck |
|----------------|-----------------------------------------------|------------------------------------------------------------|
| Matrix | Buffered horse serum<br>with added C-Peptide. | Buffered horse serum and<br>human serum with added<br>SHBG |

Performance Characteristics The Elecsys® C-Peptide CalCheck was evaluated for value assignment and stability.

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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" around the perimeter. Inside the circle is an abstract symbol resembling a stylized caduceus or a representation of the human form, with three figures connected at the base.

Food and Drug Administration 2098 Gaither Road Rockville MD 20850

FEB 2 5 2004

Theresa M. Ambrose, Ph.D. Regulatory Principal Centralized Diagnostics Regulatory Submissions Roche Diagnostics Corporation 9115 Hague Road P.O. Box 50457 Indianapolis, IN 46250-0457

Re: k040157

Trade/Device Name: Elecsys® C-Peptide CalCheck Regulation Number: 21 CFR 862.1660 Regulation Name: Quality control material (assayed and unassayed) Regulatory Class: Class I Product Code: JJX Dated: January 22, 2004 Received: January 23, 2004

Dear Dr. Ambrose:

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/dsma/dsmamain.html.

Sincerely yours,

Jean M. Cooper, MS, DVM.

Yean M. Cooper, MS, D.V.M. 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 Statement

K040157 510(k) Number (if known): N/A

Device Name: Elecsys® C-Peptide CalCheck

Indications For Use:

The Elecsys® C-Peptide CalCheck is intended for use in the verification of the calibration The Liccsys® C-Peptide reagent on the Elecsys® immunoassay systems.

Prescription Use (Per 21 CFR 801.109)

OR

Over-The-Counter Use _________________________________________________________________________________________________________________________________________________________

(Optional Format 1-2-96)

Carol C Benson
Division Sign Off

Division Sign-Off

Office of In Vitro Diagnostic Device Evaluation and Safety

510(k) K040157