ELECSYS SHBG CALCHECK 5

K111349 · Roche Diagnostics · JJX · Jun 9, 2011 · Clinical Chemistry

Device Facts

• Record ID: K111349
• Device Name: ELECSYS SHBG CALCHECK 5
• Applicant: Roche Diagnostics
• Product Code: JJX · Clinical Chemistry
• Decision Date: Jun 9, 2011
• Decision: SESE
• Submission Type: Traditional
• Regulation: 21 CFR 862.1660
• Device Class: Class 1

Intended Use

The Elecsys SHBG 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 SHBG quantitative assay reagent on the indicated Elecsys and cobas e immunoassay analyzers, for in vitro diagnostic use only.

Device Story

Elecsys SHBG CalCheck 5 is a lyophilized, assayed control material containing SHBG in a human and equine serum matrix; used for calibration verification and assay range verification of Elecsys SHBG quantitative assays on Elecsys and cobas e immunoassay analyzers. Device is intended for professional use in clinical laboratory settings. Healthcare providers use the output to verify that the immunoassay analyzer is performing within established measurement ranges, ensuring accuracy of patient SHBG test results. Benefits include improved reliability of diagnostic testing for SHBG levels.

Clinical Evidence

No clinical data. Bench testing only. Value assignment performed on E170 and 2010 analyzers; stability studies (shelf-life and open-vial) performed on cobas e 601.

Technological Characteristics

Lyophilized human and equine serum matrix; spiked with SHBG analyte. Reconstituted with 1.0 mL distilled/deionized water. Traceable to NIBSC 95/560. Stability: 18-month shelf-life at 2-8°C; 4-hour open-vial stability at 20-25°C. Compatible with Elecsys 2010, MODULAR ANALYTICS E170, cobas e 411, cobas e 601, and cobas e 602.

Indications for Use

Indicated for use as an assayed control for calibration verification and assay range verification of the Elecsys SHBG quantitative assay 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 SHBG CalCheck (K031698)

Submission Summary (Full Text)

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KI1349

| 510(k) Summary | JUN - 9 2011 |
|----------------------------------------|------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------|
| 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, P.O. Box 50416<br>Indianapolis, IN 46250-0416<br>317-521-3577 |
| | Contact Person: Kelly French<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: May 11, 2011 |
| Device Name | Proprietary name: Elecsys SHBG CalCheck 5<br>Common name: SHBG CalCheck 5<br>Classification name: Single (specified) analyte controls (assayed and<br>unassayed) |
| Predicate<br>device | The Elecsys SHBG CalCheck 5 is substantially equivalent to other products<br>in commercial distribution intended for similar use. We claim equivalency to<br>the currently marketed SHBG CalCheck (K031698). |
| Device<br>Description | The Elecsys SHBG CalCheck 5 is a lyophilized product consisting of SHBG<br>in human and equine (horse) serum matrix. During manufacture, the analyte<br>is spiked into the matrix at the desired concentration levels. |
| Intended use | The Elecsys SHBG 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 SHBG quantitative assay reagent on the indicated Elecsys and<br>cobas e immunoassay analyzers, for in vitro diagnostic use only. |
| | Continued on next page |

# 510(k) Summary

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## 510(k) Summary, Continued

#### Comparison Table

The table below compares Elecsys SHBG CalCheck 5 with the predicate device, Elecsys SHBG CalCheck (K031698). The predicate shows that SHBG CalCheck 5 is substantially equivalent to SHBG CalCheck, with several key similarities, especially the analyte. The shaded fields indicate similar characteristics between the candidate device and the predicate device.

| Characteristic | Elecsys SHBG<br>CalCheck 5<br>(Candidate Device) | Elecsys SHBG CalCheck<br>(K031698) |
|--------------------------|-----------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------|---------------------------------------------------------------------------------------------------------------------------------------------------------------------------------|
| Intended Use | The Elecsys SHBG<br>Calcheck 5 is an assayed<br>control for use in<br>calibration verification and<br>for use in the verification<br>of the assay range<br>established by the Elecsys<br>SHBG quantitative assay<br>reagent on the indicated<br>Elecsys and cobas e<br>immunoassay analyzers. | For use in the verification of<br>the calibration established by<br>the Elecsys SHBG regent on<br>Elecsys<br>1010/2010/MODULAR<br>ANALYTICS E170<br>immunoassay analyzers. |
| Analyte | SHBG | SHBG |
| Levels | Five | Three |
| Assay Measuring<br>Range | $0.800-200$ nmol/L | $0.350 - 200$ nmol/L |
| Check Target<br>Values | Check 1: $< 5$ nmol/L<br>Check 2: $20$ nmol/L<br>Check 3: $80$ nmol/L<br>Check 4: $150$ nmol/L<br>Check 5: $200$ nmol/L | Check 1: $20$ nmol/L<br>Check 2: $80$ nmol/L<br>Check 3: $150$ nmol/L |
| Format | Lyophilized | Lyophilized |
| Handling | Reconstitute Check 1,<br>Check 2, Check 3, Check<br>4, and Check 5 with<br>exactly 1.0 mL distilled or<br>deionized water. Allow to<br>stand closed for 15<br>minutes, then mix gently<br>by inversion. | Reconstitute Check 1, Check<br>2, and Check 3 with exactly<br>1.0 mL distilled or deionized<br>water. Allow to stand closed<br>for 15 minutes, then mix<br>gently by inversion. |
| Stability | Unopened:<br>• Store at 2-8°C until<br>expiration date<br>Reconstituted:<br>• 20-25°C: 4 hours | Unopened:<br>• Store at 2-8°C until<br>expiration date<br>Reconstituted:<br>• 20-25°C: 4 hours |
| Matrix | Human serum/Horse<br>serum matrix | Human serum/Horse serum<br>matrix |

Continued on next page

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## 510(k) Summary, Continued

The Elecsys SHBG CalCheck 5 was evaluated for value assignment and Performance Characteristics stability.

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Image /page/3/Picture/1 description: The image shows the seal of the Department of Health & Human Services - USA. The seal is circular and contains the department's name around the perimeter. In the center of the seal is an abstract emblem featuring three stylized lines, resembling an eagle or bird-like figure.

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

Roche Diagnostics c/o Ms. Kelly French Manager, Regulatory Affairs 9115 Hague Road, PO Box 50416 Indianapolis, IN 46250-0416

JUN - 9 2011

Re: k111349 Trade Name: Elecsys SHBG 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: May 12, 2011 Received: May 13, 2011

Dear Ms. French:

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); medical device 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).

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If you desire specific advice for your device on our labeling regulation (21 CFR Parts 801 and 809), 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 the reporting of adverse events under the MDR regulation (21 CFR Part 803), please go to

http://www.fda.gov/MedicalDevices/Safety/ReportalProblem/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/cdrh/industry/support/index.html.

Sincerely yours,

CJC.

Courtney 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

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## Indication for Use

510(k) Number (if known):

Device Name: Elecsys SHBG CalCheck 5

Indication For Use:

The Elecsys SHBG 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 SHBG reagent on the indicated Elecsys and cobas e immunoassay analyzers.

Prescription Use _____________________________________________________________________________________________________________________________________________________________ י (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 Diagnostic Device Evaluation and Safety (OIVD)

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

510(k) K111349