ELECSYS IGE CALCHECK

K984419 · Boehringer Mannheim Corp. · JJY · Feb 2, 1999 · Clinical Chemistry

Device Facts

• Record ID: K984419
• Device Name: ELECSYS IGE CALCHECK
• Applicant: Boehringer Mannheim Corp.
• Product Code: JJY · Clinical Chemistry
• Decision Date: Feb 2, 1999
• Decision: SESE
• Submission Type: Traditional
• Regulation: 21 CFR 862.1660
• Device Class: Class 1

Intended Use

The Elecsys® CalCheck IgE is used to verify the calibration assignment for the Elecsys IgE assay.

Device Story

Elecsys CalCheck IgE is a calibration verification material used in clinical laboratory settings to ensure the accuracy of Elecsys IgE assays on immunoassay analyzers. The device consists of three levels of human serum-based solutions spiked with human IgE, stabilizers, and preservatives. These solutions are processed by the analyzer to verify that the calibration remains within the clinically critical measuring range. By comparing the analyzer's measured values against the assigned concentration levels, laboratory personnel can confirm the validity of the assay calibration, thereby supporting reliable clinical decision-making for patients undergoing IgE testing.

Clinical Evidence

Bench testing only. The device was evaluated for value assignment and stability.

Technological Characteristics

Calibration verification material consisting of human serum matrix, human IgE, stabilizers, and preservatives. Three-level concentration form factor (low, mid, high). Designed for use with Elecsys immunoassay analyzers.

Indications for Use

Indicated for periodic verification of the calibration of the Elecsys IgE assay. Comprises three levels (low, mid, high) covering the measuring range of the assay.

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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· FEB 2 1999

ﺮ ﺍﻟﻤﺴﺎﺣﺔ ﺍﻟﻤﺘﻮﻗﻊ ﺍﻟﻤﺘﻮﻗﻊ ﺍﻟﻤﺘﻮﻗﻊ ﺍﻟﻤﺘﻮﻗﻊ ﺍﻟﻤﺘﻮﻗﻊ ﺍﻟﻤﺘﻮﻗﻊ ﺍﻟﻤﺘﻮﻗﻊ ﺍﻟﻤﺘﻮﻗﻊ ﺍﻟﻤﺘﻮﻗﻊ ﺍﻟﻤﺘﻮﻗﻊ ﺍﻟﻤﺘﻮﻗﻊ ﺍﻟﻤﺘﻮﻗﻊ ﺍﻟﻤﺘﻮﻗﻊ ﺍﻟﻤﺘﻮﻗﻊ ﺍﻟﻤﺘﻮﻗﻊ ﺍﻟﻤﺘﻮﻗﻊ ﺍﻟﻤﺘﻮﻗﻊ ﺍﻟﻤﺘﻮﻗﻊ ﺍﻟﻤﺘﻮﻗﻊ ﺍﻟﻤﺘﻮﻗﻊ ﺍﻟﻤ

. K9 84419

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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. |
| Submitter name, address, contact | Boehringer Mannheim Corporation<br>9115 Hague Road<br>Indianapolis, IN 46250<br>(317) 845 - 3723 |
| | Contact Person: Priscilla A. Hamill |
| | Date Prepared: December 9, 1998 |
| Device Name | Proprietary name: Elecsys CalCheck IgE |
| | Common name: Calibration Verification Material |
| | Classification name: Single (specified) analyte controls (assayed + unassayed) |
| Predicate device | The Elecsys CalCheck IgE is substantially equivalent to the currently marketed Elecsys CalCheck TSH. |
| Device Description | The Elecsys CalCheck IgE is manufactured using a human serum matrix, human IgE, stabilizers, and preservatives. The analyte is appropriately spiked into the CalCheck matrix to the correct CalCheck concentration levels. |

Continued on next pageﺮ ﺍﻟﻤﺴﺘﻘﻠﺔ ﺍﻟﻤﺴﺘﻘﺒﺔ ﺍﻟﻤﺴﺘﻘﺒﺔ ﺍﻟﻤﺘﺤﺪﺓ ﺍﻟﻤﺘﺤﺪﺓ ﺍﻟﻤﺘﺤﺪﺓ ﺍﻟﻤﺘﺤﺪﺓ ﺍﻟﻤﺘﺤﺪﺓ ﺍﻟﻤﺘﺤﺪﺓ ﺍﻟﻤﺘﺤﺪﺓ ﺍﻟﻤﺘﺤﺪﺓ ﺍﻟﻤﺘﺤﺪﺓ ﺍﻟﻤﺘﺤﺪﺓ ﺍﻟﻤﺘﺤﺪﺓ ﺍﻟﻤﺘﺤﺪﺓ ﺍﻟﻤﺘﺤﺪﺓ ﺍﻟﻤﺘﺤﺪﺓ ﺍﻟﻤﺘﺤﺪﺓ ﺍﻟﻤﺘﺤﺪﺓ ﺍﻟﻤﺘﺤﺪﺓ ﺍﻟﻤﺘﺤﺪﺓ

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## 510(k) Summary, Continued

| Intended use | The Elecsys® CalCheck IgE is used to verify the calibration assignment for<br>the Elecsys IgE assay. |
|--------------------------------------|---------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------|
| Comparison to<br>predicate<br>device | The Elecsys® CalCheck™ IgE is substantially equivalent to other products in<br>commercial distribution intended for similar use. Most notably, it is<br>substantially equivalent to the currently marketed Elecsys® CalCheck™<br>TSH. |
| | Both products are intended to be used for the verification of calibration for<br>analytes on the Elecsys immunoassay analyzers. |
| Performance<br>Characteristics | The Elecsys® CalCheck IgE was evaluated for value assignment and<br>stability. |

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Image /page/2/Picture/2 description: The image shows the logo for the U.S. Department of Health and Human Services. The logo features a stylized depiction of an eagle or bird-like figure with three curved lines representing its head and wings. The logo is surrounded by the text "DEPARTMENT OF HEALTH & HUMAN SERVICES • USA" in a circular arrangement.

## FEB ■ 2 1999

Food and Drug Administration 2098 Gaither Road Rockville MD 20850

Ms. Priscilla A. Hamill Regulatory Affairs Consultant Boehringer Mannheim Corporation 9115 Hague Road P.O. Box 50457 Indianapolis, Indiana 46250-0457

K984419 Re: Trade Name: Elecsys CalCheck IgE Regulatory Class: I Product Code: JJY Dated: January 20, 1999 Received: January 25, 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 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 regulations.

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## Page 2

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/dsma/dsmamain.html".

Sincerely yours,

Steven Butman

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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## 8984419 510(k) Number (if known): N/A

Device Name: Elecsys® CalCheck IgE

Indications For Use:

Elecsys CalCheck IgE calibration verification solutions comprise three levels - low, mid, and Elecsys CalCheck IgE concentration. The low solution concentration is near the lower mgn - cach with a domicalle 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 IgE is intended for use in periodic verification of the calibration of the Elecsys IgE assay.

Prescription Use
(Per 21 CFR 801.109)

OR

Over-The-Counter Use _________________________________________________________________________________________________________________________________________________________

(Optional Format 1-2-96)

(Division Sign-Off)
Division of Clinical Laboratory Devices ¥984419
510(k) Number