ELECSYS C-PEPTIDE CALSET

K033873 · Roche Diagnostics Corp. · JIX · Feb 13, 2004 · Clinical Chemistry

Device Facts

• Record ID: K033873
• Device Name: ELECSYS C-PEPTIDE CALSET
• Applicant: Roche Diagnostics Corp.
• Product Code: JIX · Clinical Chemistry
• Decision Date: Feb 13, 2004
• Decision: SESE
• Submission Type: Traditional
• Regulation: 21 CFR 862.1150
• Device Class: Class 2

Intended Use

The Elecsys® C-Peptide CalSet is used to calibrate the quantitative Elecsys C-Peptide assay on the Elecsys immunoassay systems.

Device Story

Elecsys® C-Peptide CalSet is a lyophilized calibrator consisting of synthetic human C-Peptide in a buffered horse serum matrix. It is used in clinical laboratory settings to calibrate quantitative C-Peptide assays on Elecsys immunoassay systems. The product is provided in two levels and requires reconstitution with distilled water before use. By establishing a calibration curve on the immunoassay analyzer, the device enables the accurate quantification of C-Peptide levels in patient samples, which assists healthcare providers in assessing pancreatic beta-cell function and insulin secretion.

Clinical Evidence

No clinical data. Performance evaluation was limited to bench testing, specifically focusing on value assignment and stability testing of the calibrator.

Technological Characteristics

Lyophilized product; matrix consists of buffered horse serum with synthetic human C-Peptide. Two-level format. Reconstitution requires 1.0 mL distilled water. Intended for use on Elecsys immunoassay systems. Storage: 2-8°C unopened; -20°C reconstituted.

Indications for Use

Indicated for use as a calibrator for the quantitative Elecsys C-Peptide assay on Elecsys immunoassay systems (1010, 2010, and Modular Analytics E170) in a clinical laboratory setting.

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

• Elecsys® LH CalSet II (K031299)

Submission Summary (Full Text)

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K033873

FEB 1 3 2004

く、

| 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 Corporation<br>9115 Hague Road<br>Indianapolis, IN 46250<br>317-521-3723<br><br>Contact Person: Theresa M. Ambrose<br><br>Date Prepared: December 12, 2003 |
| Device Name | Proprietary name: Elecsys® C-Peptide CalSet<br><br>Common name: Calibrator<br><br>Classification name: Calibrator, secondary |
| Predicate<br>device | The Elecsys® C-Peptide CalSet is substantially equivalent to the currently<br>marketed Elecsys® LH CalSet II (K031299). |
| Device<br>Description | The Elecsys® C-Peptide CalSet is a lyophilized product consisting of<br>synthetic human C-Peptide in a buffered horse serum matrix. During<br>manufacture, the analyte is spiked into the matrix at the desired concentration<br>levels. |
| Intended use | The Elecsys® C-Peptide CalSet is used to calibrate the quantitative Elecsys<br>C-Peptide assay on the Elecsys immunoassay systems. |

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# 510(k) summary, continued

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| Comparison to<br>predicate | The Elecsys® C-Peptide CalSet is substantially equivalent to the currently<br>marketed Elecsys® LH CalSet II (K031299). The below tables compare |
|----------------------------|--------------------------------------------------------------------------------------------------------------------------------------------------|
| device | Elecsys® C-Peptide CalSet with the predicate device, Elecsys® LH CalSet II |
| Similarities | |

| Characteristic | Elecsys® C-Peptide<br>CalSet | Predicate device<br>Elecsys® LH CalSet II |
|----------------|----------------------------------------------------------------------------------------------------------------------------------------------------------------|------------------------------------------------------------------------------------------------|
| Intended Use | For calibrating the<br>quantitative Elecsys C-<br>Peptide assay on the<br>Elecsys immunoassay<br>systems. | For calibrating the<br>quantitative Elecsys LH<br>assay on the Elecsys<br>immunoassay systems. |
| Levels | Two | Same |
| Format | Lyophilized | Same |
| Handling | Add exactly 1.0 mL<br>distilled water and<br>allow to stand closed<br>for 15 minutes to<br>reconsititute. Mix<br>carefully, avoiding the<br>formation of foam. | Same |

## Differences

| Characteristic | Elecsys® C-Peptide<br>CalSet | Predicate device<br>Elecsys® LH CalSet II |
|----------------|-------------------------------------------------------------------------------------------------------------------------------------------------------------|--------------------------------------------------------------------------------------------------------------------------------------------------------------|
| Matrix | Equine serum with<br>added synthetic human<br>C-peptide | Human serum with<br>added human LH |
| Stability | Unopened:<br>• Store at 2-8°C until<br>expiration date<br>Reconstituted:<br>• -20°C : 1 month<br>(freeze only once)<br>• On the analyzers: use<br>only once | Unopened:<br>• Store at 2-8°C until<br>expiration date<br>Reconstituted:<br>• -20°C : 3 months<br>(freeze only once)<br>• On the analyzers: use<br>only once |

### Performance Characteristics

The Elecsys® C-Peptide CalSet was evaluated for value assignment and stability.

21

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#### DEPARTMENT OF HEALTH & HUMAN SERVICES

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 lines representing its wings and body. The eagle is facing to the right. The text "DEPARTMENT OF HEALTH & HUMAN SERVICES USA" is arranged in a circular pattern around the eagle.

#### Public Health Service

Food and Drug Administration 2098 Gaither Road Rockville MD 20850

FEB 1 3 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: k033873

> Trade/Device Name: Elecsys® C-Peptide CalSet Regulation Number: 21 CFR 862.1150 Regulation Name: Calibrator Regulatory Class: Class II Product Code: JIX Dated: December 12, 2003 Received: December 15, 2003

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

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

Device Name: Elecsys® C-Peptide CalSet

Indications For Use:

The Elecsys® C-Peptide CalSet is used for calibrating the quantitative C-Peptide assay on the Elecsys immunoassay systems.

Prescription Use (Per 21 CFR 801.109)

OR

Over-The-Counter Use _

(Optional Format 1-2-96)

Alberto Sati'

Revision Sign-Off

Office of In Vitro Diagnostic Device _valuation and Safety

10(k) K 033873