ELECSYS PTH CALCHECK 5

K103162 · Roche Diagnostics · JJX · Nov 18, 2010 · Clinical Chemistry

Device Facts

• Record ID: K103162
• Device Name: ELECSYS PTH CALCHECK 5
• Applicant: Roche Diagnostics
• Product Code: JJX · Clinical Chemistry
• Decision Date: Nov 18, 2010
• Decision: SESE
• Submission Type: Traditional
• Regulation: 21 CFR 862.1660
• Device Class: Class 1

Intended Use

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

Device Story

Elecsys PTH CalCheck 5 is a lyophilized, human serum-based control containing human parathyroid hormone (PTH). It serves as an assayed control for calibration verification and assay range verification of the Elecsys PTH quantitative assay. The product is reconstituted with distilled or deionized water by laboratory personnel. It is used on Elecsys and cobas e immunoassay analyzers. By providing five concentration levels (1.20–5000 pg/mL), it allows clinicians to verify the accuracy and linearity of the assay across its measuring range. This ensures the reliability of PTH measurements used in clinical decision-making for patients with parathyroid-related conditions.

Clinical Evidence

Bench testing only. Evaluation focused on value assignment and stability of the five-level lyophilized control product.

Technological Characteristics

Lyophilized human serum matrix containing human PTH. Five concentration levels. Reconstituted with 1.0 mL distilled/deionized water. Stability: 2-8°C unopened; 5 hours at 20-25°C after reconstitution. Used 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 PTH quantitative assay on Elecsys and cobas e immunoassay analyzers. For in vitro diagnostic use.

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 PTH CalCheck (K993642)

Submission Summary (Full Text)

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K103162

NOV 1 8 2010

### 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 Roche Diagnostics name, address, 9115 Hague Road, P.O. Box 50416 contact Indianapolis, IN 46250-0416 317-521-3577 Contact Person: Kelly French Phone: [phone] Fax: [phone] Email: [e-mail] Secondary Contact: Stephanie Greeman Phone: [phone] Fax: [phone] Email: [e-mail] Date Prepared: October 11, 2010 Device Name Proprietary name: Elecsys Parathyroid Hormone CalCheck 5 Common name: PTH CalCheck 5 Classification name: Single (specified) analyte controls (assayed and unassaved) Predicate The Elecsys PTH CalCheck 5 is substantially equivalent to other products in device commercial distribution intended for similar use. We claim equivalency to the currently marketed PTH CalCheck (K993642). Device The Elecsys PTH CalCheck 5 is a lyophilized product consisting of human Description PTH in human serum matrix. During manufacture, the analyte is spiked into the matrix at the desired concentration levels. Intended use The Elecsys PTH 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 PTH quantitative assay reagent on the indicated Elecsys and cobas e immunoassay analyzers, for in vitro diagnostic use only.

510(k) Summary

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# 510(k) Summary, Continued

#### Comparison Table

The table below compares Elecsys PTH CalCheck 5 with the predicate device, Elecsys PTH CalCheck (K993642). The predicate shows that PTH CalCheck 5 is substantially equivalent to PTH CalCheck, with several key similarities, especially the analyte. The shaded fields indicate similar characteristics between the candidate device and the predicate device.

| Characteristic | Elecsys PTH CalCheck<br>5<br>(Candidate Device) | Elecsys PTH CalCheck<br>(K993642) |
|--------------------------|----------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------|---------------------------------------------------------------------------------------------------------------------------------------------------------------------------------|
| Intended Use | The Elecsys PTh Calcheck<br>5 is an assayed control for<br>use in calibration<br>verification and for use in<br>the verification of the<br>assay range established by<br>the Elecsys PTH<br>quantitative assay reagent<br>on the indicated Elecsys<br>and cobas e immunoassay<br>analyzers. For in vitro<br>diagnostic use only. | For use in periodic<br>verification of the calibration<br>of the Elecsys Parathyroid<br>Hormone test. |
| Analyte | PTH | PTH |
| Levels | Five | Three |
| Assay Measuring<br>Range | 1.20 - 5000 pg/mL | 1.20 - 5000 pg/mL |
| Check Target<br>Values | Check 1: ≤ 1 pg/mL<br>Check 2: 60 pg/mL<br>Check 3: 2500 pg/mL<br>Check 4: 4000 pg/mL<br>Check 5: 5000 pg/mL | Check 1: < 5 pg/mL<br>Check 2: 60 pg/mL<br>Check 3: 3000 pg/mL |
| 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: 5 hours | Unopened:<br>• Store at 2-8°C until<br>expiration date<br>Reconstituted:<br>• 20-25°C: 4 hours |
| Matrix | Human serum matrix | Human serum matrix |

510(k) Summary, Continued

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

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Image /page/3/Picture/0 description: The image shows the logo for the U.S. Department of Health and Human Services. The logo consists of a stylized eagle with three stripes forming its wing and body. The eagle is encircled by the text "DEPARTMENT OF HEALTH & HUMAN SERVICES - USA" in a circular arrangement.

#### DEPARTMENT OF HEALTH & HUMAN SERVICES

. '

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

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

Re: k103162

NOV 1 8 2010

Trade/Device Name: Elecsys PTH CalCheck 5 Regulation Number: 21 CFR 862.1660 Regulation Name: Quality Control Material (Assayed and Unassayed) Regulatory Class: Class I, reserved Product Code: JJX Dated: 26 October, 2010 Received: 27 October, 2010

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 class II (Special Controls), 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 not 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). 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.

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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.

Signature

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

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## Indication for Use

NQV. 1 8 2010

K103162 510(k) Number (if known):

Device Name: Elecsys PTH CalCheck 5

Indication For Use:

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

Prescription Use X (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 (OVD)

Carol C. Benson

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

510(k) K103162

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