ELECSYS CALCHECK FERRITIN

K981281 · Roche Diagnostics GmbH · JJX · Apr 24, 1998 · Clinical Chemistry

Device Facts

• Record ID: K981281
• Device Name: ELECSYS CALCHECK FERRITIN
• Applicant: Roche Diagnostics GmbH
• Product Code: JJX · Clinical Chemistry
• Decision Date: Apr 24, 1998
• Decision: SESE
• Submission Type: Traditional
• Regulation: 21 CFR 862.1660
• Device Class: Class 1

Intended Use

The Roche Diagnostics/Boehringer Mannheim Elecsys® CalCheck™ Ferritin is used to verify the calibration assignment for the Roche Diagnostics/Boehringer Mannheim Corporation Elecsys Ferritin assay.

Device Story

Elecsys® CalCheck™ Ferritin is a calibration verification material used in clinical laboratory settings to verify the calibration of the Elecsys Ferritin assay on automated immunoassay analyzers. The device consists of three levels of solutions (low, mid, high) with defined Ferritin concentrations. The low level is near the assay's lower detection limit; the mid level is at a clinically critical point; the high level is near the upper limit. The product is manufactured using human serum albumin, Ferritin, stabilizers, and preservatives. Quality control is performed against ID-GC/MS. Healthcare providers use the output to confirm that the assay's calibration remains accurate, ensuring reliable patient test results for Ferritin levels.

Clinical Evidence

Bench testing only. Evaluation focused on value assignment and stability of the calibration verification material.

Technological Characteristics

Materials: human serum albumin, Ferritin, stabilizers, preservatives. Form factor: three-level liquid solution set (low, mid, high). Principle: calibration verification for automated immunoassay analyzers. Quality control: ID-GC/MS.

Indications for Use

Indicated for use in periodic verification of the calibration of the Elecsys Ferritin assay. Comprises three levels (low, mid, high) with defined Ferritin concentrations spanning the assay's measuring range.

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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K981281

APR 2 4 1998

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| 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. |
| 1.<br>Submitter<br>name,<br>address,<br>contact | Roche Diagnostics/Boehringer Mannheim Corporation<br>4300 Hacienda Drive<br>Pleasanton, CA 94566-0900<br>(925) 730 - 8215<br>Fax number: (925) 225 - 0654<br>Contact Person: Patricia M. Klimley<br>Date Prepared: April 6, 1998 |
| 2.<br>Device Name | Proprietary name: Elecsys® CalCheckTM Ferritin<br>Common name: Calibration Verification Material<br>Classification name: Single (specified) analyte controls (assayed + unassayed) |
| 3.<br>Predicate<br>device | The Roche Diagnostics/Boehringer Mannheim Elecsys® CalCheckTM Ferritin is substantially equivalent to the currently marketed Elecsys® CalCheckTM TSH. |
| 4.<br>Device<br>Description | The Roche Diagnostics/Boehringer Mannheim Elecsys® CalCheckTM Ferritin is manufactured using human serum albumin, Ferritin, stabilizers, and preservatives. The analyte is appropriately spiked into the calcheck matrix to the correct calcheck concentration levels. The calcheck are in process checked and quality controlled against ID-GC/MS. |

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## 510(k) Summary, Continued

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| 5. Intended use | The Roche Diagnostics/Boehringer Mannheim Elecsys® CalCheck™ Ferritin is used to verify the calibration assignment for the Roche Diagnostics/Boehringer Mannheim Corporation Elecsys Ferritin assay. |
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| 6. Comparison to predicate device | The Roche Diagnostics/Boehringer Mannheim Corporation Elecsys® CalCheck™ Ferritin is substantially euivalent to other products in commercial distribution intended for similar use. Most notably, it is substantially equivalent to the currently marketed Elecsys® CalCheck™ TSH.<br>Both products are intended to be used for the verification of calibration for analytes on automated immunoassay analyzers. |

The Elecsys® CalCheck™ Ferritin was evaluated for value assignment and 7. Performance Characteristics stability.

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Image /page/2/Picture/1 description: The image is a black and white logo for the U.S. Department of Health & Human Services. The logo features a stylized depiction of a human figure with three wavy lines representing the body. The figure is enclosed within a circular border, with the text "DEPARTMENT OF HEALTH & HUMAN SERVICES • USA" arranged around the upper portion of the circle.

Food and Drug Administration 2098 Gaither Road Rockville MD 20850

APR 2 4 1998

Patricia M. Klimley Manager, Elecsys Regulatory Affairs Roche Diagnostics/Boehringer Mannheim Corporation 4300 Hacienda Drive P.O. Box 9002 Pleasanton, California 94566-0900

K981281 Re : Elecsys® CalCheck™ Ferritin Requlatory Class: I Product Code: JJX Dated: April 7, 1998 Received: April 8, 1998

Dear Ms. Klimley:

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 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, Druq, and Cosmetic Act (Act). You may, therefore, market the device; subject to the general controls provisions The general controls provisions of the Act 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 requlations affecting your device can be found in the Code of Federal Requlations, Title 21, Parts 800 to 895. ਦੇ substantially equivalent determination assumes compliance withthe Current Good Manufacturing Practice requirements, as set forth in the Quality System Requlation (QS) for Medical Devices: General requlation (21 CFR Part 820) and that, through periodic QS 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 requlations.

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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 [phone] or at its internet address "http://www.fda.gov/cdrh/dsmamain.html".

Sincerely yours,
Steven Gutman

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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## 510(k) Number (if known):

Device Name: Roche Diagnostics/Boehringer Mannheim Elecsys® CalCheck™ Ferritin

Indications For Use:

Elecsys CalCheck Ferritin calibration verification solutions comprise three levels - low, mid, and high - each with a defined Ferritin concentration. The low solution concentration is near the lower detection limit of the assay. The mid 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 CalCheck Ferritin is intended for use in periodic verification of the calibration of the Elecsys Ferritin assay.

(Division Sign-Off)
Division of Clinical Laboratory Devices
510(k) Number. K981281

(PLEASE DO NOT WRITE BELOW THIS LINE - CONTINUE ON ANOTHER PAGE IF NEEDED)

Concurrence of CDRH, Office of Device Evaluation (ODE)

Prescription Use ﺮ ﺍﻟﻤﺮﺍﺟﻊ ﺍﻟﻤﺮﻛﺰ ﺍﻟﻤﺮﺍﺟﻊ (Per 21 CFR 801.109)

OR

Over-The-Counter Use

(Optional Format 1-2-96)

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