ROCHE CRP T CONTROL N

K982087 · Roche Diagnostic Systems, Inc. · DCK · Aug 18, 1998 · Immunology

Device Facts

• Record ID: K982087
• Device Name: ROCHE CRP T CONTROL N
• Applicant: Roche Diagnostic Systems, Inc.
• Product Code: DCK · Immunology
• Decision Date: Aug 18, 1998
• Decision: SESE
• Submission Type: Traditional
• Regulation: 21 CFR 866.5270
• Device Class: Class 2

Intended Use

Roche CRP T Control N is an assayed control intended for use to monitor the accuracy and precision at normal concentraion levels in quantitative C-reactive protein (CRP) assays. It is recommended for use with Roche reagents on COBAS® chemistry systems. Roche CRP T Control N is part of a C-reactive protein immunological test system, which is used to measure, by immunochemical techniques, the C-reactive protein in serum and other body fluids. Measurement of C-reactive protein aids in evaluation of the amount of injury to body tissues.

Device Story

Roche CRP T Control N is a liquid human serum-based assayed control; used to monitor accuracy and precision of quantitative C-reactive protein (CRP) assays. Designed for use with Roche reagents on COBAS® chemistry systems. Provides a stable reference point at normal concentration levels (3.44 - 4.66 mg/L) to verify performance of immunochemical test systems. Used by laboratory professionals to ensure reliability of CRP measurements, which aid in evaluating tissue injury. No clinical or nonclinical testing performed; equivalence established via comparison of matrix and intended use to predicate.

Clinical Evidence

No clinical or nonclinical tests were performed for this product.

Technological Characteristics

Liquid human serum-based control. Concentration range: 3.44 - 4.66 mg/L. Designed for use with COBAS® chemistry systems. No specific materials, energy sources, or software algorithms described.

Indications for Use

Indicated for use as an assayed control to monitor accuracy and precision of quantitative C-reactive protein (CRP) assays at normal concentration levels. Used in clinical laboratory settings for monitoring CRP test systems measuring serum or body fluid CRP levels to evaluate tissue injury.

Regulatory Classification

Identification

A C-reactive protein immunological test system is a device that consists of the reagents used to measure by immunochemical techniques the C-reactive protein in serum and other body fluids. Measurement of C-reactive protein aids in evaluation of the amount of injury to body tissues.

Predicate Devices

• Behring Diagnostics N/T Rheumatology Control SL 1 / 2 (K962373)

Submission Summary (Full Text)

{0}------------------------------------------------

AUG 1 8 1998

KG82087

Image /page/0/Picture/2 description: The image shows the logo for Roche, a healthcare company. The logo consists of the word "Roche" in bold, sans-serif font, centered within a hexagon. The hexagon is outlined in black, and the word "Roche" is also in black.

# 510(k) Summary

Roche® CRP T Control N

In accordance with the Safe Medical Devices Act of 1990, a 510(k) summary is provided as outlined in 21 CFR 807.92.

The assigned 510(k) number is: K982087

#### I. Identification of 510(k) Sponsor:

Roche Diagnostic Systems, Inc. a subsidiary of Hoffmann-La Roche, Inc. Branchburg Township 1080 U.S. Highway 202 Somerville, New Jersey 08876-3771

510(k) Submission dated: June 12, 1998

Contact: Rita Smith Senior Regulatory Affairs Associate Phone: [phone] Fax: [phone]

Branchburg Township 1080 U.S. Highway 202 Somerville, New Jersey 08876-3771

{1}------------------------------------------------

#### II. Device Name:

The device name, including both the trade/proprietary name and the classification name are provided in the table below.

## Table I

| Product Name | Classification<br>Name | Product<br>Code | CFR<br>Number and<br>Regulatory Class |
|--------------------------|-------------------------------------------------------|-----------------|---------------------------------------|
| Roche<br>CRP T Control N | C-reactive protein, antigen,<br>antiserum and control | DCK | 866.5270<br>Class II |

### Identification of the legally marketed device to which the 510(k) sponsor claims III. equivalence:

The following table identifies the legally marketed devices to which Roche Diagnostic Systems, Inc. claims equivalence.

## Table 2

| Product Name | Predicate Product<br>Name | Date<br>Predicate<br>Cleared | Predicate<br>510(k)<br>Number |
|--------------------------|----------------------------------------------------------|------------------------------|-------------------------------|
| Roche<br>CRP T Control N | Behring Diagnostics<br>N/T Rheumatology Control SL 1 / 2 | 7/11/96 | K962373 |

#### IV. Description of the Device/Statement of Intended Use:

Roche CRP T Control N is an assayed control intended for use to monitor the accuracy and precision at normal concentraion levels in quantitative C-reactive protein (CRP) assays. It is recommended for use with Roche reagents on COBAS® chemistry systems.

Roche CRP T Control N is part of a C-reactive protein immunological test system, which is used to measure, by immunochemical techniques, the C-reactive protein in serum and other body fluids. Measurement of C-reactive protein aids in evaluation of the amount of injury to body tissues.

{2}------------------------------------------------

## Summary of the technological characteristics of the new device in comparison to V. those of the predicate.

The Roche CRP T Control N and the Behringer N CRP Control are both human serum based controls with assayed values for C-reactive protein and intended for use in monitoring accuracy and precision in quantitative C-reactive protein (CRP) assays.

| | Roche CRP T Control N | Behring Diagnostics<br>N/T Rheumatology Control SL 1/ 2 | |
|----------------------------|-----------------------|---------------------------------------------------------|-------------|
| Matrix/Biological Sources | Liquid human serum | Liquid human serum | |
| Concentration Range (mg/L) | 3.44 - 4.66 | Level 1 | Level 2 |
| | | 9.0 - 12.2 | 40.3 - 54.5 |

### VI. Brief discussion of the clinical and nonclinical tests relied on for a determination of substantial equivalence:

No clinical or nonclinical tests were performed for this product.

{3}------------------------------------------------

## DEPARTMENT OF HEALTH & HUMAN SERVICES

# AUG 1 8 1998

Rita Smith Senior Regulatory Affairs Associate Roche Diagnostic Systems, Inc. Hoffmann-La Roche, Inc. 1080 U.S. Hiqhway 202 Somerville, New Jersey 08876-3771

K982087 Re : Roche® CRP T Control N Trade Name: Requlatory Class: II · · Product Code: DCK Dated: June 12, 1998 Received: June 15, 1998

Dear Ms. Smith:

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, Druq, 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, 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 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 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.

Food and Drug Administration 2098 Gaither Road Rockville MD 20850

{4}------------------------------------------------

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 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 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.qov/cdrh/dsmamain.html"

Sincerely yours,

Steven Sutman

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

{5}------------------------------------------------

Page 1 of 1

510(k) Number (if known) \$K983087

Roche CRP T Control N, Art. No. 07 6632 1 Device Name:

Indications for Use:

Roche CRP T Control N is an assayed control intended for use to monitor the accuracy and precision at normal concentraion levels in quantitative C-reactive protein (CRP) assays. It is recommended for use with Roche reagents on COBAS® chemistry systems.

Roche CRP T Control N is part of a C-reactive protein immunological test system, which is used to measure, by immunochemical techniques, the C-reactive protein in serum and other body fluids. Measurement of C-reactive protein aids in evaluation of the amount of injury to body tissues.

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

Concurrence of CDRH, Office of Device Evaluation (ODE)

Prescription Use (Per 21 CFR 801.109) OR

Over-The-Counter Use (Optional Format 1-2-96)

Peter E. Mayhew

(Divisor
Div
5