DIMENSION TOTAL IRON BINDING CAPACITY (IBCT) CALIBRATOR

K994114 · Dade Behring, Inc. · JIS · Jan 20, 2000 · Clinical Chemistry

Device Facts

• Record ID: K994114
• Device Name: DIMENSION TOTAL IRON BINDING CAPACITY (IBCT) CALIBRATOR
• Applicant: Dade Behring, Inc.
• Product Code: JIS · Clinical Chemistry
• Decision Date: Jan 20, 2000
• Decision: SESE
• Submission Type: Traditional
• Regulation: 21 CFR 862.1150
• Device Class: Class 2

Intended Use

The IBCT Calibrator for the Dimension® Clinical Chemistry System is a device intended to calibrate the Dimension® clinical chemistry system for total iron binding capacity (IBCT) method.

Device Story

Dimension® IBCT Calibrator is a liquid, protein-based product used to calibrate the Total Iron Binding Capacity (IBCT) method on the Dimension® clinical chemistry system. The kit consists of six vials across three levels. It is used in clinical laboratory settings by trained personnel. The calibrator ensures the accuracy of the IBCT assay, which measures the capacity of transferrin to bind iron, aiding in the assessment of iron metabolism. It utilizes NIST Iron Standard SRM 937 as a primary reference standard.

Clinical Evidence

No clinical data provided; bench testing only.

Technological Characteristics

Liquid, protein-based solution; 1.0 mL per vial; 3 levels; traceable to NIST Iron Standard SRM 937. No software or electronic components.

Indications for Use

Indicated for use as a calibrator for the total iron binding capacity (IBCT) method on the Dimension® clinical chemistry system. No specific patient population, age, or gender restrictions are defined.

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

• Dimension® IRN/TIBC Calibrator (K863840)

Submission Summary (Full Text)

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# 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: | Robin O. Norris |
|--------------------------|-----------------------------------------|
| | Dade Behring Inc. |
| | P.O. Box 6101 |
| | Newark, DE 19714-6101 |
| Date of Preparation: | December 2, 1999 |
| Name of Product: | Dimension® IBCT Calibrator |
| FDA Classification Name: | Calibrator |
| Predicate Device: | Dimension® IRN/TIBC Calibrator, K863840 |

Device Description: The Dimension® IBCT Calibrator is a liquid protein based product. The kit consists of six vials; two at each of three levels.

Intended use: The Dimension® IBCT Calibrator is intended to be used to calibrate the Total Iron Binding Capacity (IBCT) method on the Dimension® clinical chemistry system.

### Comparison to Predicate Devices

| Item | Dimension® IRN/TIBC Calibrator | Dimension® IBCT Calibrator |
|--------------|---------------------------------------------------|---------------------------------------------------|
| Intended Use | Calibrator | Calibrator |
| Analytes | iron | human transferrin |
| Matrix | aqueous solution | protein based solution |
| Form | liquid | liquid |
| Volume | 1.0 mL per ampule | 1.0 mL per vial |
| Levels | 3 levels | 3 levels |
| Reference | Primary standard --<br>NIST Iron Standard SRM 937 | Primary standard --<br>NIST Iron Standard SRM 937 |

Comments on Substantial Equivalence: Both the Dimension® IRN/TIBC Calibrator and the Dimension® IBCT Calibrator are intended to be used as calibrators for total iron binding capacity methods.

Conclusion: The Dimension® IBCT Calibrator is substantially equivalent to the Dimension® IRN/TIBC Calibrator based on the comparison discussed abd

Robin O. Norris

bin O. Norris Manager, Quality Assurance and Compliance December 2, 1999

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Public Health Service

Food and Drug Administration 2098 Gaither Road Rockville MD 20850

## JAN 2 0 2000

Ms. Robin O. Norris Manager, Quality Assurance and Compliance Dade Behring, Inc. Building 500, Mailbox 514 P.O. Box 6101 Newark. Delaware 19714-6101

Re: K994114

> Trade Name: Dimension® IBCT Calibrator Regulatory Class: II Product Code: JIS Dated: December 2, 1999 Received: December 6, 1999

Dear Ms. Norris:

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 OS 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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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" (21CFR 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 Autman

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

K994114

Device Name: Dimension® IBCT Calibrator

#### Indications for Use:

ω르=================

The IBCT Calibrator for the Dimension® Clinical Chemistry System is a device intended to calibrate the Dimension® clinical chemistry system for total iron binding capacity (IBCT) method.

Dan Cooper

(Division Sign-Off)
Division of Clinical Laboratory Devices

ivision of Clinical 510(k) Number

Robbi Onons

Robin O. Norris Manager, Quality Assurance and Compliance

December 2, 1999

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Concurrence of CDRH, Office of Device Evaluation (ODE)

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

OR

Over-the-counter Use