DIMENSION SPECIAL PROTEIN CALIBRATOR

K990554 · Dade Behring, Inc. · JIT · Mar 22, 1999 · Clinical Chemistry

Device Facts

• Record ID: K990554
• Device Name: DIMENSION SPECIAL PROTEIN CALIBRATOR
• Applicant: Dade Behring, Inc.
• Product Code: JIT · Clinical Chemistry
• Decision Date: Mar 22, 1999
• Decision: SESE
• Submission Type: Traditional
• Regulation: 21 CFR 862.1150
• Device Class: Class 2

Intended Use

The Dimension® Special Protein Calibrator is intended to be used to calibrate the Immunoglobulin G (IGG), Immunoglobulin A (IGA), and Immunoglobulin M (IGM) methods on the Dimension® clinical chemistry system.

Device Story

Dimension® Special Protein Calibrator is a liquid, human serum-based product; kit contains ten vials at five concentration levels. Used in clinical laboratory settings by trained personnel to calibrate IgG, IgA, and IgM assays on the Dimension® clinical chemistry system. Provides reference points for instrument calibration; ensures accuracy of patient sample measurements. Benefits patient by maintaining analytical performance of diagnostic tests.

Clinical Evidence

No clinical data; bench testing only.

Technological Characteristics

Liquid human serum-based calibrator; 5 levels; 1.5 mL per vial. Calibrates IgG, IgA, and IgM methods. Traceable to IFCC/CRM 470 reference materials.

Indications for Use

Indicated for use as an in vitro diagnostic calibrator to establish points of reference for the measurement of Immunoglobulin G (IgG), Immunoglobulin A (IgA), and Immunoglobulin M (IgM) in human serum using the Dimension® clinical chemistry system.

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

• Beckman CAL I

Reference Devices

• IFCC
• CRM 470

Submission Summary (Full Text)

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3/22/99

K990554

# Dade Behring

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: | Cathy P. Craft<br>Dade Behring Inc.<br>P.O. Box 6101<br>Newark, DE 19714-6101 |
|--------------------------|-------------------------------------------------------------------------------|
| Date of Preparation: | February 3, 1999 |
| Name of Product: | Dimension® Special Protein Calibrator |
| FDA Classification Name: | Calibrator |
| Predicate Device: | Beckman CAL I |

Device Description: The Dimension® Special Protein Calibrator is a liquid human serum-based product. The kit consists of ten vials; two at each of five levels.

Intended use: The Dimension® Special Protein Calibrator is intended to be used to calibrate the Immunoglobulin G (IGG), Immunoglobulin A (IGA), and Immunoglobulin M (IGM) methods on the Dimension® clinical chemistry system.

### Comparison to Predicate Device:

| Item | Beckman CAL I | Dimension® Special Protein Calibrator |
|--------------|-----------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------|----------------------------------------------------------------------------|
| Intended Use | Calibrator | Calibrator |
| Analytes | Immunoglobulin G (IgG)<br>Immunoglobulin A (IgA)<br>Immunoglobulin M (IgM)<br>Alpha1-acid glycoprotein (AAG)<br>Complement C3 (C3)<br>Complement C4 (C4)<br>Haptoglobin (HPT)<br>Kappa light chain (KAP)<br>Lambda light chain (CAM)<br>Transferrin (TRF) | Immunoglobulin G (IgG)<br>Immunoglobulin A (IgA)<br>Immunoglobulin M (IgM) |
| Matrix | Human serum base | Human serum base |
| Form | Liquid | Liquid |
| Volume | 3.0 mL per vial, reconstituted | 1.5 mL per vial |
| Levels | 1 level | 5 levels |
| Reference | IFCC, CRM 470 | IFCC, CRM 470 |

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Comments on Substantial Equivalence: Both the Beckman CAL I and the Dimension® Special Protein Calibrator are intended to be used as calibrators for IGG, IGA, and IGM methods.

Conclusion: The Dimension® Special Protein Calibrator is substantially equivalent to the Beckman Immunoglobulin Calibrator based on the comparison discussed above.

Cathy P. Craft

Regulatory Affairs and Compliance Manager Date: February 8, 1999

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MAR 2 2 1999

Food and Drug Administration 2098 Gaither Road Rockville MD 20850

Cathy P. Craft Regulatory Affairs and Compliance Manager Dade Behring Inc. P.O. Box 6101 Newark, DE 19714-6101

Re: K990554

> Trade Name: Dimension® Special Protein Calibrator Regulatory Class: II Product Code: JIT Dated: February 8, 1999 Received: February 22, 1999

Dear Ms. Craft:

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 Requlations, 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 (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.

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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 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

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## Indications For Use Statement

Device Name: Dimension® Special Protein Calibrator

### Indications for Use:

The Special Protein Calibrator for the Dimension® Clinical Chemistry System is an in vitro diagnostic device intended for use in an in vitro test system to establish points of reference that are used in determination of values in the measurement of human substances.

> Cathy P. Craft Regulatory Affairs and Compliance Manager

February 8, 1999

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

Concurrence of CDRH, Office of Device Evaluation (ODE)

Peter E. Makim

ion Sign-Off 510(k) Num

**Prescription Use**
(Per 21 CFR 801.109)

OR

Over-the-counter Use_

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