ELECSYS PARATHYROID HORMONE CALCHECK

K993642 · Roche Diagnostics Corp. · JJX · Nov 30, 1999 · Clinical Chemistry

Device Facts

• Record ID: K993642
• Device Name: ELECSYS PARATHYROID HORMONE CALCHECK
• Applicant: Roche Diagnostics Corp.
• Product Code: JJX · Clinical Chemistry
• Decision Date: Nov 30, 1999
• Decision: SESE
• Submission Type: Traditional
• Regulation: 21 CFR 862.1660
• Device Class: Class 1

Intended Use

The Elecsys® Parathyroid Hormone CalCheck is used to verify the calibration of the Elecsys® Parathyroid Hormone assay.

Device Story

Elecsys® Parathyroid Hormone CalCheck is a lyophilized calibration verification product consisting of three levels (low, mid, high) of parathyroid hormone in a human serum base with synthetic PTH and preservative. Used by laboratory professionals to verify the calibration of Elecsys® Immunoassay Analyzers. The device provides known concentration levels—near the lower detection limit, at the clinically critical point, and near the upper limit of the assay range—to ensure the accuracy of the analyzer's calibration curve. This verification process helps maintain the reliability of patient test results, supporting clinical decision-making regarding parathyroid hormone levels.

Clinical Evidence

Bench testing only. Evaluation focused on value assignment and stability of the lyophilized product.

Technological Characteristics

Lyophilized product; human serum base; synthetic parathyroid hormone; preservative. Three-level concentration set (low, mid, high). Designed for use with Elecsys® Immunoassay Analyzers.

Indications for Use

Indicated for periodic calibration verification of the Elecsys® Parathyroid Hormone assay. Intended for prescription use in clinical laboratory settings.

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® CalCheck™ TSH

Submission Summary (Full Text)

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| 510(k) Summary | NOV 30 1999 |
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| 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) 576 - 3723 |
| | Contact Person: Priscilla A. Hamill |
| | Date Prepared: October 26, 1999 |
| Device Name | Proprietary name: Elecsys® Parathyroid Hormone CalCheck |
| | Common name: Calibration Verification Material |
| | Classification name: Single (specified) analyte controls (assayed +<br>unassayed) |
| Predicate<br>device | The Elecsys® Parathyroid Hormone CalCheck is substantially equivalent to<br>the currently marketed Elecsys CalCheck TSH. |
| Device ®<br>Description | The Elecsys® Parathyroid Hormone CalCheck is a lyophilized product<br>manufactured using a human serum base, synthetic PTH, and preservative.<br>The analyte is appropriately spiked into the CalCheck matrix to the correct<br>CalCheck concentration levels. |
| Intended use | The Elecsys® Parathyroid Hormone CalCheck is used to verify the calibration of the Elecsys® Parathyroid Hormone assay. |
| Comparison to predicate device | The Elecsys® Parathyroid Hormone 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® CalCheck™ TSH.<br><br>Both products are intended to be used for the verification of calibration for analytes on the Elecsys® Immunoassay Analyzers. |
| Performance Characteristics | The Elecsys® Parathyroid Hormone CalCheck was evaluated for value assignment and stability. |

NOV 300 1999

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## 510(k) Summary, Continued

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NOV 300 1999

Food and Drug Administration 2098 Gaither Road Rockville MD 20850

Ms. Priscilla A. Hamill Regulatory Affairs, Laboratory Systems Roche Diagnostics Corporation 9115 Hague Road Indianapolis, Indiana 46250-0457

K993642 Re:

Trade Name: Elecsys® Parathyroid Hormone CalCheck Regulatory Class: I Product Code: JJX Dated: October 26, 1999 Received: October 28, 1999

## Dear Ms. Hamill:

We have reviewed your Section 510(k) notification of intent to market the device referenced above and we 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). 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 (Premarket Approval), it may be subject to such additional controls. Existing major regulations affecting your device can be found in the Code of Federal Regulations, Title 21, Parts 800 to 895. A substantially equivalent determination assumes compliance with the Current Good Manufacturing Practice requirements, as set forth in the Quality System Regulation (QS) for Medical Devices: General regulation (21 CFR Part 820) and that, through periodic OS inspections. the Food and Drug Administration (FDA) will verify such assumptions. Failure to comply with the GMP regulation may result in regulatory action. In addition, FDA may publish further announcements concerning your device in the Federal Register. Please note: this response to your premarket notification submission does not affect any obligation you might have under sections 531 through 542 of the Act for devices under the Electronic Product Radiation Control provisions, or other Federal laws or regulations.

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Under the Clinical Laboratory Improvement Amendments of 1988 (CLIA-88), this device may require a CLIA complexity categorization. To determine if it does, you should contact the Centers for Disease Control and Prevention (CDC) at [phone].

This letter will allow you to begin marketing your device as described in your 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 advice for your device on our labeling regulation (21 CFR Part 801 and additionally 809.10 for in vitro diagnostic devices), please contact the Office of Compliance at [phone]. Additionally, for questions on the promotion and advertising of your device, please contact the Office of Compliance at [phone]. Also, please note the regulation entitled, "Misbranding by reference to premarket notification" (21 CFR 807.97). Other general information on your responsibilities under the Act may be obtained from the Division of Small Manufacturers Assistance at its toll free number [phone] or at [phone] or at its internet address "http://www.fda.gov/cdrh/dsmamain.html"

Sincerely yours,

Steven Autman

Steven I. Gutman, M.D., M.B.A. Director Division of Clinical Laboratory Devices Office of Device Evaluation 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® Parathyroid Hormone CalCheck

Indications For Use:

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

The Elecsys® Parathyroid Hormone CalCheck is intended for use in periodic verification of the calibration of the Elecsys® Parathyroid Hormone test.

V Prescription Use (Per 21 CFR 801.109)

OR

Over-The-Counter Use

(Optional Format 1-2-96)

Peter E. Madeni

(Division Sign-Off)
Division of Clinical Laboratory Devices K993642
510(k) Number

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