PRECICONTROL TUMOR MARKER 1 AND 2

K972235 · Boehringer Mannheim Corp. · JJY · Aug 12, 1997 · Clinical Chemistry

Device Facts

• Record ID: K972235
• Device Name: PRECICONTROL TUMOR MARKER 1 AND 2
• Applicant: Boehringer Mannheim Corp.
• Product Code: JJY · Clinical Chemistry
• Decision Date: Aug 12, 1997
• Decision: SESE
• Submission Type: Traditional
• Regulation: 21 CFR 862.1660
• Device Class: Class 1

Intended Use

PreciControl Tumor Marker is used for quality control of Elecsys immunoassays using the Elecsys immunoassay systems (Elecsys 2010, 1010 and others of the Elecsys family of instruments). PreciControl Tumor Marker contains lyophilized control serum based on human serum. The concentrations are in two clinically relevant ranges. The controls are used for monitoring the accuracy and precision of Elecsys immunoassays.

Device Story

PreciControl Tumor Marker is a lyophilized control serum derived from human serum; provided in two clinically relevant concentration ranges. Used by laboratory personnel on Elecsys immunoassay systems (e.g., 2010, 1010) to monitor analytical accuracy and precision. The control is processed alongside patient samples; results are compared against expected values to detect systematic analytical deviations. This ensures the reliability of tumor marker immunoassay results, supporting clinical decision-making regarding patient diagnosis and monitoring.

Technological Characteristics

Lyophilized control serum based on human serum. Formulated in two clinically relevant concentration ranges. Designed for use with Elecsys immunoassay systems. No specific materials standards or software algorithms described.

Indications for Use

Indicated for use as a quality control material for monitoring the accuracy and precision of Elecsys immunoassay systems in a clinical laboratory setting.

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

• Bio-Rad Lyphochek Immunoassay Plus Control

Submission Summary (Full Text)

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## 510(k) Summary

K972235

| 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. |
|-------------------------------------------|------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------|
| 1) Submitter<br>name, address,<br>contact | Boehringer Mannheim Corporation<br>9115 Hague Rd.<br>Indianapolis, IN 46250<br>[phone] |
| | Contact Person: LeeAnn Chambers, RAC |
| | Date Prepared: June 13, 1997 |
| 2) Device name | Proprietary name: PreciControl Tumor Marker |
| | Common name: Quality Control Material |
| | Classification name: Multi-Analyte Control, all kinds, (assayed + unassayed) |
| 3) Predicate<br>device | We claim substantial equivalence to Bio-Rad Lyphochek Immunoassay Plus<br>Control. |
| 4) Device<br>Description | PreciControl Tumor Marker contains lyophilized control serum based on<br>human serum. The concentrations are in two clinically relevant ranges. The<br>controls are used for monitoring the accuracy and precision of Elecsys<br>immunoassays. |
| | Continued on next page |

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## 510(k) Summary, Continued

1

f

## K972235

| 5) Intended use | PreciControl Tumor Marker is used for quality control of Elecsys immunoassays using the Elecsys immunoassay systems. |
|-----------------------------------|-----------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------|
| 6) Comparison to predicate device | The Boehringer Mannheim PreciControl Tumor Marker is substantially equivalent to other products in commercial distribution intended for similar use. Most notably it is substantially equivalent to the currently marketed Bio-Rad Lyphochek Immunoassay Plus Control.<br>The intended use of both the PreciControl Tumor Marker and the predicate device are the same in that they are intended to estimate test precision and detect systematic analytical deviations on automated immunoassay systems. |

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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 and Human Services. The logo features a stylized image of an eagle with three lines representing its body and wings. The text "DEPARTMENT OF HEALTH & HUMAN SERVICES • USA" is arranged in a circular fashion around the eagle image.

Food and Drug Administration 2098 Gaither Road Rockville MD 20850

Ms. LeeAnn Chambers, RAC Program Manager, Regulatory Affairs Boehringer Mannheim Corporation 9115 Haque Road Indianapolis, Indiana 46250

AUG 1 2 1997

Re: K972235 Trade Name: PreciControl Tumor Marker Requlatory Class: I Product Code: JJY Dated: June 13, 1997 Received: June 16, 1997

Dear Ms. Chambers:

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, 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, labelinq, and prohibitions aqainst 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 requirement, as set forth in the Quality System Regulation (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 requlatory 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 at [phone] or at its internet address "http://www.fda.gov/cdrh/dsmamain.html"

Sincerely yours,

Steven Putman

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): K972235 Device Name: PreciControl Tumor Marker Indications for Use:

PreciControl Tumor Marker is used for quality control of Elecsys immunoassays using the Elecsys immunoassay systems (Elecsys 2010, 1010 and others of the Elecsys family of instruments).

PreciControl Tumor Marker contains lyophilized control serum based on human serum. The concentrations are in two clinically relevant ranges. The controls are used for monitoring the accuracy and precision of Elecsys immunoassays.

ﺮ ﺍﻟﻤﺴﺎﺑﻘﺎﺕ ﺍﻟﻤﺘﺤﺪﺓ ﺍﻟﻤﺘﺤﺪﺓ ﺍﻟﺘﻲ ﺗﺮﺗﺒﺎﺕ ﺍﻟﻤﺘﺤﺪﺓ ﺍﻟﺘﻲ ﺗﺮﺗﺒﺎﺕ ﺍﻟﻤﺘﺤﺪﺓ ﺍﻟﺘﻲ ﺗﺮﺗﺒﺎﺕ ﺍﻟﻤﺘﺤﺪﺓ ﺍﻟﺘﻲ ﺗﺮﺗﺒﺎﺕ ﺍﻟﻤﺘﺤﺪﺓ ﺍﻟﺘﻲ ﺍﻟﺘﻲ ﺗﺮﺗﺒﺎﺕ ﺍﻟﻤﺘﺤﺪﺓ ﺍﻟﺘﻲ ﺍﻟﺘﻲ ﺍﻟﺘﻲ ﺍﻟﺘﻲ ﺍﻟﺘﻲ ﺍﻟﺘﻲ ﺍﻟﺘﻲ ﺍﻟﺘﻲ ﺍ

Peter E. Machin
(Division Sign Off)

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

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Concurrence of CDRH, Office of Device Evaluation (ODE)

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Prescription Use
(Per 21 CFR 801.109)

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Over-The-Counter Use

(Optional Format 1-2-96)