PRECINORM RF, PRECIPATH RF

K973629 · Boehringer Mannheim Corp. · JJY · Oct 7, 1997 · Clinical Chemistry

Device Facts

• Record ID: K973629
• Device Name: PRECINORM RF, PRECIPATH RF
• Applicant: Boehringer Mannheim Corp.
• Product Code: JJY · Clinical Chemistry
• Decision Date: Oct 7, 1997
• Decision: SESE
• Submission Type: Traditional
• Regulation: 21 CFR 862.1660
• Device Class: Class 1

Intended Use

The Boehringer Mannheim Precinorm and Precipath® RF Controls are used for the quality control of the Boehringer Mannheim Tinaquant RF assay.

Device Story

Precinorm and Precipath RF Controls are in vitro diagnostic quality control materials; manufactured using human serum albumin, Rheumatoid Factor, and stabilizers. Controls are reconstituted with distilled water and used to monitor the performance of the Boehringer Mannheim Tinaquant RF assay. Value assignment is performed by comparison to analyte-specific and chemistry-specific calibrators. Used by laboratory personnel to ensure assay accuracy and precision; results help clinicians verify the reliability of patient Rheumatoid Factor testing.

Clinical Evidence

No clinical data. Performance characteristics established via bench testing, including dose assignment and stability comparisons to the predicate device.

Technological Characteristics

Materials: human serum albumin, Rheumatoid Factor, stabilizers. Form factor: lyophilized powder requiring reconstitution with 1 mL distilled water. Connectivity: none (standalone). Sterilization: not specified.

Indications for Use

Indicated for quality control of the Boehringer Mannheim Tinaquant Rheumatoid Factor assay 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

• Behring N/T Rheumatology Control SL1, SL2 (K962373)

Submission Summary (Full Text)

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OCT - 7 1997

| BOEHRINGER<br>MANNHEIM Summary<br>ORPORATION | | Image: boehringer logo |
|-------------------------------------------------|-------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------|------------------------|
| 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.<br>Submitter<br>name,<br>address,<br>contact | Boehringer Mannheim Corporation<br>4300 Hacienda Drive<br>Pleasanton, CA. 94588-2722<br>[phone]<br><br>Contact Person: Yvette Lloyd<br><br>Date Prepared: September 19, 1997 | |
| 2.<br>Device Name | Proprietary name: Precinorm and Precipath® RF Controls<br><br>Common name: Controls<br><br>Classification name: Single (specified) analyte controls (assayed + unassayed) | |
| 3.<br>Predicate<br>device | The Boehringer Mannheim Precinorm and Precipath® RF Controls are a new<br>product.<br><br>The Boehringer Mannheim Precinorm and Precipath® RF Controls are<br>substantially equivalent to other products in commercial distribution intended<br>for similar use. Most notably it is substantially equivalent to the Behring N/T<br>Rheumatology Control SL1, SL2 (K962373). | |
| 4.<br>Device<br>Description | The Boehringer Mannheim Precinorm and Precipath® RF Controls are<br>manufactured using human serum albumin, Rheumatoid Factor, and<br>stabilizers. The analyte is appropriately spiked into the control matrix to the<br>correct control concentration levels. The controls are in process checked, and a<br>value assignment process is done via a comparison to an analyte specific (and<br>chemistry specific) calibrator. | |

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| | Summary, Continued |
|--|--------------------|
|--|--------------------|

| 5.<br>Intended use | The Boehringer Mannheim Precinorm and Precipath® RF Controls are used<br>for the quality control of the Boehringer Mannheim Tinaquant RF assay. |
|--------------------------------------------|-----------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------|
| 6.<br>Comparison<br>to predicate<br>device | The Boehringer Mannheim Precinorm and Precipath® RF Controls are<br>substantially equivalent to other products in commercial distribution intended<br>for similar use. Most notably it is substantially equivalent to the Behring N/T<br>Rheumatology Control SL1, SL2 (K962373). |

The following table compares the Boehringer Mannheim Precinorm® TDM
Controls with the predicate device, the Behring N/T Rheumatology Control
SL1, SL2. Specific data on the performance of the controls have been
incorporated into the draft labeling in attachment 5. Labeling for the predicate
devices are provided in attachment 6..

**Similarities:**

- Similar intended use
- Similar matrix

Continued on next page

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Image /page/2/Picture/1 description: The image shows a logo with the word "mannheim" written vertically on the left side of a black rectangle. Inside the rectangle is a white circle with the word "boehringer" written in the center. The logo appears to be for a company called "Boehringer Mannheim".

## Differences:

| Feature | Precinorm/Precipath ® RF Control | Behring N/T Rheumatology Control SL1/SL2 |
|--------------------------------|-----------------------------------------------------------------------------|------------------------------------------|
| Analytes | Rheumatoid Factor | Rheumatoid Factor, ASL, CRP |
| Reconstitution<br>Instructions | Add 1 mL of distilled water, then let<br>dissolve with occasional swirling. | Ready for use (liquid stable) |

## Performance Characteristics:

## 6. Comparison to predicate device, (cont.)

· Dose assignment and stability: equivalent performance to the predicate device.

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Image /page/3/Picture/2 description: The image shows the logo for the U.S. Department of Health & Human Services. The logo consists of a circular seal with the words "DEPARTMENT OF HEALTH & HUMAN SERVICES • USA" arranged around the perimeter. Inside the circle is a stylized image of an eagle with its wings spread.

Food and Drug Administration 2098 Gaither Road Rockville MD 20850

OCT - 7 1997

Ms. Yvette Lloyd Regulatory Affairs Specialist Boehringer Mannheim Corporation 4300 Hacienda Drive Pleasanton, California 94588-2722

Re : K973629 Precinorm and Precipath® RF Controls Trade Name: Requlatory Class: I Product Code: JJY Dated: September 22, 1997 Received: September 24, 1997

Dear Ms. Lloyd:

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, listinq of devices, qood manufacturing practice, labeling, 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 requlations affecting your device can be found in the Code of Federal Requlations, 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 regulation (21 CFR Part 820) and that, through periodic (QS) inspections, the Food and Drug Administration (FDA) will verify such Failure to comply with the GMP regulation may result in assumptions. 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 leqally 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 requlation 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): | 7973647 |
|---------------------------|-----------------------------------|
| Device Name: | Precinorm & Precapath RF Controls |
| Indications For Use: | |

The Precinorm and Precipath® RF Controls are used for the quality control of the Boehringer Mannheim Tinaquant Rheumatoid Factor assay.

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

Concurrence of CDRH, Office of Device Evaluation (ODE)

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

Prescription Use ✓
(Per 21 CFR 801.109)
OR
Over-The-Counter Use
(Optional Format 1-2-96)

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