BOEHRINGER MANNHEIM PRECINORM PRECIPATH PROTEIN CONTROLS

K981401 · Boehringer Mannheim Corp. · JJY · May 18, 1998 · Clinical Chemistry

Device Facts

• Record ID: K981401
• Device Name: BOEHRINGER MANNHEIM PRECINORM PRECIPATH PROTEIN CONTROLS
• Applicant: Boehringer Mannheim Corp.
• Product Code: JJY · Clinical Chemistry
• Decision Date: May 18, 1998
• Decision: SESE
• Submission Type: Traditional
• Regulation: 21 CFR 862.1660
• Device Class: Class 1

Intended Use

Boehringer Mannheim Precinorm ® Protein Precipath ® Protein Controls are intended for use as a control in the immunoturbidimetric assay of serum proteins.

Device Story

Device consists of two-level liquid preparation of pooled human sera; contains constituents in normal (Precinorm Protein) and pathological (Precipath Protein) ranges. Used as control in immunoturbidimetric assays of serum proteins. Operated by laboratory personnel in clinical settings. Assigned values for constituents obtained on Boehringer Mannheim/Hitachi systems. Provides quality control for analytical procedures; ensures accuracy and reliability of serum protein measurements; benefits patients by verifying assay performance.

Clinical Evidence

No clinical data. Bench testing only.

Technological Characteristics

Liquid preparation of pooled human sera. Two-level control (normal and pathological ranges). Designed for immunoturbidimetric assays. Compatible with automated analytical systems (Boehringer Mannheim/Hitachi).

Indications for Use

Indicated for use as a control in the immunoturbidimetric assay of serum proteins. Suitable for automated analytical procedures.

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

• Precinorm ® Protein control (K871027)
• Precipath® Protein (K933589)

Submission Summary (Full Text)

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MAY 18 1998

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## 510(k) Summary

| 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: Priscilla A. Hamill |
| | Date prepared: April 1, 1998 |
| 2) Device name | Proprietary name: Boehringer Mannheim Precinorm ® Protein Precipath ®<br>Protein Controls |
| | Common name: Precinorm ® Protein Precipath ® Protein Controls |
| | Classification name: Multi-analyte Controls, All Kinds (assayed and<br>unassayed) |
| 3) Predicate<br>device | We claim substantial equivalence to Precinorm ® Protein control (K871027)<br>and Precipath® Protein (K933589) control |
| 4) Device<br>description | Boehringer Mannheim Precinorm ® Protein Precipath ® Protein Controls are<br>a two-level liquid preparation of pooled human sera with constituents in the<br>normal (Precinorm ® Protein) and pathological (Precipath ® Protein) ranges. |
| | Continued on next page |

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## 510(k) Summary, Continued

5) Intended use Boehringer Mannheim Precinorm ® Protein Precipath ® Protein Controls are intended for use as a control in the immunoturbidimetric assay of serum proteins. 6) Comparison Boehringer Mannheim Precinorm ® Protein Precipath ® Protein Controls are to the predicate substantially equivalent to other products in commercial distribution intended device for similar use. Most notably, it is substantially equivalent to the currently Precinorm ® Protein and Precipath ® Protein controls marketed by Boehringer Mannheim Corporation. These controls were cleared by the FDA based on a 510(k) submissions by Boehringer Mannheim. The 510(k) number for the Precinorm ® Protein submission is K871027. The 510(k) number for the Precipath ® Protein submission is K933589. The intended use of this BM control and the predicate devices is the same in that they are intended to be used for the control of immunoturbidimetric assay of serum proteins. The only significant difference is the inclusion of additional constitutent analytes.

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Food and Drug Administration 2098 Gaither Road Rockville MD 20850

MAY 1 8 1998

Patricia A. Hamill · Regulatory Affairs Consultant Boehringer Mannheim Corporation 9115 Haque Road P.O. Box 50457 Indianapolis, Indiana 46250-0457

K981401 Re : Precinorm® Protein Precipath® Protein Controls Requlatory Class: I Product Code: JJY Dated: April 15, 1998 Received: April 17, 1998

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 devices marketed in interstate commerce prior to May 28, 1976, the enactment date of the Medical Device Amendments, or to devices that have been arr 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 The general controls provisions of the Act of the Act. include requirements for annual registration, listing of devices, qood 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 Requlations, Title 21, Parts 800 to 895. ਰੇ 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 requlatory In addition, FDA may publish further announcements action. 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 Other qeneral 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 Litman

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: Boehringer Mannheim Precinorm ® Protein Precipath ® Protein Controls

Indications for Use: For use as a control in the immunoturbidimetric assay of serum proteins. It is well suited for automated analytical procedures. The assigned values for each constituent are obtained on Boehringer Mannheim/Hitachi systems.

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Concurrence of CDRH, Office of Device Evaluation (ODE)

| Prescription Use<br>(Per 21 CFR 801.109) | OR | Over-the-Counter Use |
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(Optional format 1-2-96)

(Division Sign-Off)

Division of Clinical Laboratory Devices

| 510(k) Number | K981401 |
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