REVISED C-REACTIVE PROTEIN CALIBRATOR

K990824 · Dade Behring, Inc. · JIT · Apr 16, 1999 · Clinical Chemistry

Device Facts

• Record ID: K990824
• Device Name: REVISED C-REACTIVE PROTEIN CALIBRATOR
• Applicant: Dade Behring, Inc.
• Product Code: JIT · Clinical Chemistry
• Decision Date: Apr 16, 1999
• Decision: SESE
• Submission Type: Traditional
• Regulation: 21 CFR 862.1150
• Device Class: Class 2

Intended Use

The Dimension® Revised C-Reactive Protein Calibrator is intended to be used to calibrate the Revised C-Reactive Protein (RCRP) method on the Dimension® clinical chemistry system.

Device Story

Dimension® Revised C-Reactive Protein Calibrator is a liquid, multi-level (5 levels) calibration product used in clinical laboratory settings. It is designed for use with the Dimension® clinical chemistry system to establish the calibration curve for the Revised C-Reactive Protein (RCRP) assay. The calibrator utilizes a bovine serum albumin base for Level 1 and a human serum base with added human C-Reactive Protein for Levels 2-5. The product is traceable to the IFCC CRM 470 primary standard. Laboratory technicians use the calibrator to ensure the accuracy and reliability of the Dimension® system's CRP measurements, which are used by clinicians to assess patient inflammatory states. The device is provided in a ten-vial kit format.

Clinical Evidence

No clinical data provided; bench testing only.

Technological Characteristics

Liquid calibrator kit consisting of 10 vials (2 vials at each of 5 levels). Matrix: bovine serum albumin (Level 1) and human serum base with human CRP (Levels 2-5). Traceability: IFCC CRM 470. Designed for use with the Dimension® clinical chemistry system.

Indications for Use

Indicated for use as a calibrator for the Revised C-Reactive Protein (RCRP) method on the Dimension® clinical chemistry system. No specific patient population, age, or gender restrictions are defined for this in vitro diagnostic calibrator.

Regulatory Classification

Identification

A calibrator is a device intended for medical purposes for use in a test system to establish points of reference that are used in the determination of values in the measurement of substances in human specimens. (See also § 862.2 in this part.)

Special Controls

*Classification.* Class II (special controls). The device is exempt from the premarket notification procedures in subpart E of part 807 of this chapter subject to the limitations in § 862.9.

Predicate Devices

• Dade Behring N CRP Standard SY (K962406)

Submission Summary (Full Text)

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4/16/99

DADE BEHR

DADE BEHRING INC. P.O. Box 6101 Newark, DE 19714

## Summary of Safety and Effectiveness Information

This summary of 510(k) safety and effectiveness information is being submitted in accordance with the requirements of SMDA 1990 and 21 CFR 807.92.

| Submitter's Name: | Lorraine Piestrak<br>Dade Behring Inc.<br>P.O. Box 6101<br>Newark, DE 19714-6101 |
|--------------------------|----------------------------------------------------------------------------------|
| Date of Preparation: | March 11, 1999 |
| Name of Product: | Dimension® Revised C-Reactive Protein Calibrato |
| FDA Classification Name: | Calibrator |
| Predicate Device: | Dade Behring N CRP Standard SY, K962406 |

Device Description: The Dimension® Revised C-Reactive Protein Calibrator is a liquid product. Level 1 contains bovine serum albumin. Levels 2-5 contain human serum base product with added human C-Reactive Protein. The kit consists of ten vials; two at each of five levels.

Intended use: The Dimension® Revised C-Reactive Protein Calibrator is intended to be used to calibrate the Revised C-Reactive Protein (RCRP) method on the Dimension® clinical chemistry system.

### Comparison to Predicate Device:

| Item | N CRP Standard SY | Revised C-Reactive Protein Calibrator |
|--------------------|----------------------------------------------|----------------------------------------------------------------------------------|
| Intended Use | Calibrator | Calibrator |
| Analytes<br>Matrix | C-Reactive Protein (CRP)<br>human serum base | C-Reactive Protein (CRP)<br>L-1: bovine serum albumin<br>L 2-5: human serum base |
| Form | lyophilized | liquid |
| Volume | 0.5 mL per vial, reconstituted | 1.0 mL per vial |
| Levels | 1 levels | 5 levels |
| Reference | Primary standard --<br>IFCC CRM 470 | Primary standard --<br>IFCC CRM 470 |

Comments on Substantial Equivalence: Both the N CRP Standard SY and the Dimension® Revised C-Reactive Protein Calibrator are intended to be used as calibrators for C-Reactive Protein.

Conclusion: The Revised C-Reactive Protein Calibrator is substantially equivalent to the N CRP Standard SY based on the comparison discussed above.

Lorraine Piestrak

Quality Assurance and Compliance Manager March 11, 1999

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APR 1 6 1999

Food and Drug Administration 9200 Corporate Boulevard Rockville MD 20850

Ms. Lorraine Piestrak Quality Assurance and Compliance Manager Dade Behring Inc. P.O. Box 6101 Newark, Delaware 19714-6101

Re: K990824

Trade Name: Dimension® Revised C-Reactive Protein Calibrator Regulatory Class: I Product Code: JIT Dated: March 11, 1999 Received: March 12, 1999

Dear Ms. Piestrak:

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 legally marketed predicate 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 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.

Image /page/1/Picture/10 description: The image is a black and white logo for the Department of Health & Human Services - USA. The logo features a circular border with the text "DEPARTMENT OF HEALTH & HUMAN SERVICES - USA" arranged around the perimeter. Inside the circle is a stylized symbol consisting of three abstract human profiles facing to the right, with flowing lines suggesting movement or connection.

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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 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 [phone], or at its internet address "http://www.fda.gov/cdrh/dsma/dsmamain.html".

Sincerely yours,

Steven Dutman

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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#### Indications For Use Statement

Device Name: Revised C-Reactive Protein Calibrator

### Indications for Use:

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The Revised C-Reactive Protein Calibrator for the Dimension® Clinical Chemistry System is a device intended to calibrate the Dimension® clinical chemistry system for the Revised C-Reactive Protein (RCRP) method.

Lorraine Pustiak

Lorraine Piestrak Quality Assurance and Compliance Manager

March 11, 1999

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

Concurrence of CDRH, Office of Device Evaluation (ODE)

Ketu E. Maher

-Prescription Use (Per 21 CFR 801.109)

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OR

Over-the-counter Use_ ___________