OPUS HLH CONTROLS

K973832 · Behring Diagnostics, Inc. · JJX · Oct 27, 1997 · Clinical Chemistry

Device Facts

• Record ID: K973832
• Device Name: OPUS HLH CONTROLS
• Applicant: Behring Diagnostics, Inc.
• Product Code: JJX · Clinical Chemistry
• Decision Date: Oct 27, 1997
• Decision: SESE
• Submission Type: Traditional
• Regulation: 21 CFR 862.1660
• Device Class: Class 1

Indications for Use

OPUS hLH controls are intended for use as an assayed quality control material in the clinical laboratory to assess or verify the performance of the OPUS hLH assay.

Device Story

OPUS hLH Controls are tri-level, serum-based matrix quality control materials; used in clinical laboratories to monitor performance of OPUS hLH assays on OPUS analyzers. Controls contain known levels of LH; provided with lot-specific values for the Behring OPUS Immunoassay System. Laboratory personnel use these materials to verify assay accuracy and precision; results help ensure reliability of patient diagnostic testing.

Clinical Evidence

Bench testing only. Precision evaluated using three levels of control material. Intra-assay precision (n=20) showed %CV of 4.51% to 6.48%. Inter-assay precision (n=20 over 5 days) showed %CV of 2.48% to 6.41%.

Technological Characteristics

Tri-level, serum-based matrix control material. Designed for use with the Behring OPUS Immunoassay System. No specific materials of construction, energy sources, or software algorithms described.

Indications for Use

Indicated for use in clinical laboratories as an assayed quality control material to monitor the accuracy and precision of the OPUS hLH assay performed on OPUS analyzers.

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

• OPUS hCG Controls

Submission Summary (Full Text)

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K9138832

510(k) Notification Dade-Behring Inc. OPUS hLH Controls

OCT 27 1997

## Summary for 510(k) OPUS hLH Controls

## Manufactures Name, Address, Telephone, and contact person, date of 1 . preparation:

Manufacturer:

Dade-Behring Inc. 151 University Avenue Westwood, MA 02090 617-320-3117 Attn: Ruth Forstadt

Preparation date:

October 6, 1997

### Device Name/ Classification: 2 .

OPUS hLH Controls: Classification Number: Quality Control Material Class | (862.1660)

### Identification of the legally marketed device: 3 .

OPUS® hCG

#### Device Description: 4 . Proposed

OPUS hLH Controls are intended for use as quality control material to monitor the accuracy and precision of the OPUS hLH assay run on the OPUS analyzers.

#### Proposed Device Intended Use: 5 .

OPUS hLH controls are intended for use as an assayed quality control material in the clinical laboratory to assess or verify the performance of the OPUS hLH assay.

## 6 . Medical device to which equivalence is claimed and comparison information:

The OPUS hLH Controls are substantially equivalent in intended use to the OPUS hCG Controls. Both products arein vitro diagnostic reagents intended for use as a quality control material to monitor specific laboratory procedures. The OPUS hLH Controls, like the OPUS hCG Controls, are a tri-level serum-based matrix controls for specific OPUS assays only. Both controls are provided with lot specific values for the Behring OPUS Immunoassay System.

The OPUS hLH Controls differ from the OPUS hCG Controls in that the OPUS hLH Controls are for use with the OPUS hLH assay and contain known levels of LH, while the OPUS hCG Controls are for use with the OPUS hCG assay and contain known levels of hCG.

Image /page/0/Picture/21 description: The image contains the word "CONFIDENTIAL" in large, bold, black letters. The word is written in all capital letters and is slightly angled upwards from left to right. The font appears to be a sans-serif typeface, and the overall impression is one of emphasis and importance.

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510(k) Notification Dade-Behring Inc. OPUS hLH Controls

## 7. Device Performance Characteristics:

## Precision

Intra-assay precision was determined by the evaluation of three levels of control material in replicates of twenty (20) each. %CV ranged from 4.51% to 6.48%.

Inter-assay precision was determined by the evaluation of three levels of control material in duplicate, assayed over a five day period to total 20 replicates. %CV ranged from 2.48% to 6.41%.

# CONFIDENTIAL

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Image /page/2/Picture/2 description: The image shows the logo for the U.S. Department of Health & Human Services. The logo features a stylized caduceus symbol, which is a staff with two snakes entwined around it. The text "DEPARTMENT OF HEALTH & HUMAN SERVICES • USA" is arranged in a circular fashion around the symbol.

Food and Drug Administration 2098 Gaither Road Rockville MD 20850

OCT 2 7 1997

Ruth Forstadt . Regulatory Affairs Associate Behring Diagnostics, Inc. 151 University Avenue Westwood, Massachusetts 02090

Re : K973832 OPUS hLH Controls Requlatory Class: I Product Code: JJX Dated: October 6, 1997 Received: October 7, 1997

Dear Ms. Forstadt:

requlations.

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, 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 Requlation (OS) 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

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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 requlation (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 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.qov/cdrh/dsmamain.html".

Sincerely yours,
Steven Sitman

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) Notification Dade-Behring Inc. OPUS hLH Controls

Page of

510(k) Number (if known): J

Device Name:_

OPUS hLH Controls

# Indications For Use:

OPUS hLH Controls are quality control materials intended for use in the clinical laboratory to assess or verify the performance of the OPUS hLH assay, run on the OPUS analyzers.

(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 K973832

Prescription Use_y (Per 21 CFR 801.109)

PAFIDENTIAL

OR

Over-The-Counter Use_

(Optional Format 1-2-96)

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