ELECYS SHBG CALCHECK

K031698 · Roche Diagnostics Corp. · JJX · Aug 20, 2003 · Clinical Chemistry

Device Facts

• Record ID: K031698
• Device Name: ELECYS SHBG CALCHECK
• Applicant: Roche Diagnostics Corp.
• Product Code: JJX · Clinical Chemistry
• Decision Date: Aug 20, 2003
• Decision: SESE
• Submission Type: Traditional
• Regulation: 21 CFR 862.1660
• Device Class: Class 1

Intended Use

The Elecsys® SHBG CalCheck is used in the verification of the calibration established by the Elecsys® SHBG reagent on Elecsys® 1010/2010/MODULAR ANALYTICS E170 immunoassay analyzers.

Device Story

Elecsys SHBG CalCheck is a lyophilized calibration verification product; consists of SHBG spiked into human/horse serum matrix at three defined concentration levels (low, mid, high). Used in clinical laboratory settings by technicians to verify calibration of Elecsys SHBG reagent on Elecsys 1010/2010/MODULAR ANALYTICS E170 immunoassay analyzers. The device provides a mechanism to confirm that the analyzer's calibration remains within established performance specifications across the measuring range. Results from the CalCheck are compared against expected values to ensure assay accuracy and reliability for clinical decision-making.

Clinical Evidence

No clinical data. Bench testing only; traceability established against 1st International Standard for SHBG (NIBSC 95/560).

Technological Characteristics

Lyophilized product; matrix consists of human serum and horse serum; contains SHBG analyte. Designed for use on Elecsys 1010/2010/MODULAR ANALYTICS E170 immunoassay analyzers. No specific energy source or connectivity; standalone calibration verification material.

Indications for Use

Indicated for verification of calibration for Elecsys SHBG reagent on specified Elecsys 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® proBNP CalCheck (K020883)

Submission Summary (Full Text)

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# AUG 2 0 2003 -

## 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 name, address, contact | Roche Diagnostics Corporation<br>9115 Hague Road<br>Indianapolis, IN 46250<br>521 - 3723<br><br>Contact Person: Theresa M. Amrbose<br><br>Date Prepared: May 29, 2003 |
| Device Name | Proprietary name: Elecsys® SHBG CalCheck<br><br>Common name: Calibration Verification Material<br><br>Classification name: Single (specified) analyte controls (assayed + unassayed) |
| Predicate device | The Elecsys® SHBG CalCheck is substantially equivalent to the currently marketed Elecsys® proBNP CalCheck (K020883). |
| Device Description | The Elecsys® SHBG CalCheck is a lyophilized product manufactured using SHBG in human serum/ horse serum matrix. The analyte is appropriately spiked into the CalCheck matrix to the correct concentration levels. |

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and the comments of the comments of

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## 510(k) Summary, Continued

| Intended use | The Elecsys® SHBG CalCheck is used in the verification of the calibration established by the Elecsys® SHBG reagent on Elecsys® 1010/2010/MODULAR ANALYTICS E170 immunoassay analyzers. |
|--------------------------------|------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------|
| Comparison to predicate device | The Elecsys® SHBG CalCheck is substantially equivalent to other products in commercial distribution intended for similar use. Most notably, it is substantially equivalent to the currently marketed Elecsys® proBNP CalCheck (K020883). |
| Performance Characteristics | The Elecsys® SHBG CalCheck was evaluated for value assignment and stability. |

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and the comments of the comments of the comments of

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#### DEPARTMENT OF HEALTH & HUMAN SERVICES

Public Health Service

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AUG 2 0 2003

Food and Drug Administration 2098 Gaither Road Rockville MD 20850

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

Re: k031698

Trade/Device Name: Elecsys® SHBG CalCheck Regulation Number: 21 CFR 862.1660 Regulation Name: Quality control material (assayed and unassayed) Regulatory Class: Class I Product Code: JJX Dated: August 5, 2003 Received: August 6, 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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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,

Steven Sutman

Steven I. Gutman, M.D., M.B.A. Director Office of In Vitro Diagnostic Device Evaluation and Safety Center for Devices and Radiological Health

Enclosure

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#### Indications for Use Statement

K031698 510(k) Number (if known): N/A

Device Name: Elecsys® SHBG CalCheck

Indications For Use:

Elecsys® SHBG CalCheck calibration verification solutions comprise three levels - low, mid, and high - each with a defined SHBG concentration. The low solution concentration is near the lower detection limit of the assay. The middle solution is in the middle or at a clinically critical point of the measuring range. The high solution is near the upper limit of the measuring range.

The Elecsys® SHBG CalCheck is intended for use in the verification of the calibration established by the Elecsys® SHBG reagent on Elecsys® 1010/2010/MODULAR ANALYTICS E170 immunoassay analyzers.

Prescription Use
(Per 21 CFR 801.109)

OR

Over-The-Counter Use _

(Optional Format 1-2-96)

Carol C Benam for Jean Cooper, ORM
**Division Sign-Off**

Office of In Vitro Diagnostic Device Evaluation and Safety

510(k) K 63/698