CREATININE KINASE MB ISOENZYME VERIFIER, MODEL DC27

K062152 · Dade Behring, Inc. · JIT · Aug 16, 2006 · Clinical Chemistry

Device Facts

• Record ID: K062152
• Device Name: CREATININE KINASE MB ISOENZYME VERIFIER, MODEL DC27
• Applicant: Dade Behring, Inc.
• Product Code: JIT · Clinical Chemistry
• Decision Date: Aug 16, 2006
• Decision: SESE
• Submission Type: Traditional
• Regulation: 21 CFR 862.1150
• Device Class: Class 2

Intended Use

The Creatine Kinase MB Isoenzyme Verifier is an in vitro diagnostic product for verification of the Creatine Kinase MB Isoenzyme (CKMB) method on the Dimension® clinical chemistry system and Dimension Vista™ System.

Device Story

The CKMB Verifier is a lyophilized human serum-based product used as a calibrator/verifier for CKMB assays. It consists of three levels: Level 1 (no CKMB) and Levels 2 and 3 (containing CKMB derived from simian heart source). The product is intended for professional use in clinical laboratory settings to verify the accuracy of CKMB method performance on Dimension and Dimension Vista clinical chemistry systems. The healthcare provider reconstitutes the lyophilized material and runs it on the clinical chemistry system; the system compares the measured values against established target concentrations to ensure the assay is performing within acceptable parameters.

Clinical Evidence

No clinical data; bench testing only.

Technological Characteristics

Lyophilized human serum-based matrix containing simian heart-derived CKMB. Three-level configuration. Traceable to Dimension clinical chemistry system values. Complies with ISO 14971:2000 for risk management.

Indications for Use

Indicated for use as an in vitro diagnostic calibrator/verifier for the Creatine Kinase MB Isoenzyme (CKMB) method on Dimension® clinical chemistry and Dimension Vista™ systems.

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® CKMB Verifier (K863840)

Submission Summary (Full Text)

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K062/52

### 510(k) Summary for the Dimension® Clinical Chemistry System Dimension Vista™ System Creatine Kinase MB Isoenzyme Verifier (CKMB Verifier - DC27)

AUG 16 2006

### A. 510(k) Number:

- B. Analyte: Creatine Kinase MB Isoenzyme (CKMB) C. Type of Test: Calibrator Material D. Applicant: Dade Behring Inc., P.O. Box 6101, Newark, DE 19714-6101 Victor M. Carrio, Regulatory Affairs and Compliance Manager Office: [phone] Fax: [phone]
### E. Proprietary and Established Names:

Dimension® Creatine Kinase MB Isoenzyme Verifier (CKMB Verifier - DC27)

#### F. Regulatory Information:

- 1. Regulation section: 21 CFR § 862-1150 Calibrator
- 2. Classification: Class II
- 3. Product Code: JIT Calibrator, Secondary
- 4. Panel: Clinical Chemistry
- The Creatine Kinase MB Isoenzyme Verifier is an in vitro G. Intended Use: diagnostic product for verification of the Creatine Kinase MB Isoenzyme (CKMB) method on the Dimension® clinical chemistry system and Dimension Vista™ System.

#### H. Device Description:

CKMB Verifier is a lyophilized human serum base product. Level 1 contains no CKMB, Levels 2 and 3 contain CKMB from a simian heart source. The kit consists of six vials, two vials per level. The volume per vial is 1.0 mL.

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# I. Substantial Equivalence Information:

The intended use of the Dimension® CKMB Verifier has been expanded beyond the intended use stated for this product in a previous 510(k) submission (see K863840). All features of the product remain the same as described in K863840 except that now the product will be used for verification of the Creatine Kinase MB Isoenzyme (CKMB) method on the Dimension® clinical chemistry system and Dimension Vista™ System.

| Item | Dimension® CKMB Verifier |
|--------------|----------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------|
| Intended Use | The Creatine Kinase MB Isoenzyme Verifier is an in vitro diagnostic<br>product for verification of the Creatine Kinase MB Isoenzyme<br>(CKMB) method on the Dimension® clinical chemistry system and<br>Dimension Vista™ System. |
| Analytes | Creatine Kinase MB Isoenzyme |
| Form | Lyophilized |
| Traceability | Dimension® clinical chemistry system values. |
| Matrix | Human serum based product containing CKMB from simian heart<br>source. |
| Levels | Three levels. |

# J. Standard/Guidance Document Referenced:

- Guidance for Industry Abbreviated 510(k) Submissions for In 1. Guidance: Vitro Diagnostic Calibrators; Final, 02/22/1999 Guidance for Industry and FDA Staff - Use of Symbols on Labels and in Labeling of In Vitro Diagnostic Devices Intended for Professional Use, 11/30/2004

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## DEPARTMENT OF HEALTH & HUMAN SERVICES

Image /page/2/Picture/1 description: The image shows the seal of the Department of Health & Human Services - USA. The seal features an eagle with its wings spread, and the words "DEPARTMENT OF HEALTH & HUMAN SERVICES - USA" are written in a circular pattern around the eagle. The seal is black and white and appears to be a scanned image.

Public Health Service

Food and Drug Administration 2098 Gaither Road Rockville MD 20850

Mr. Victor M. Carrio RA/QS Compliance Manager Dade Behring, Inc. 500 GBC Drive Mailstop 514 Newark, DE 19714-6101

AUG 16 2006 .

Re: k062152

> Trade/Device Name: Creatine Kinase MB Isoenzyme Verifier (DC27) Regulation Number: 21 CFR§862.1150 Regulation Name: Calibrator Regulatory Class: Class II Product Code: JIT Dated: July 26, 2006 Received: July 27, 2006

Dear: Mr. Carrio

We have reviewed your Section 510(k) premarket notification of intent to market the device referenced above and 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) that do not require approval of a premarket approval application (PMA). 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 (PMA), it may be subject to such additional controls. Existing major regulations affecting your device, can be found in Title 21, Code of Federal Regulations (CFR), Parts 800 to 895. In addition, FDA may publish further announcements concerning your device in the Federal Register.

Please be advised that FDA's issuance of a substantial equivalence determination does not mean that FDA has made a determination that your device complies with other requirements of the Act or any Federal statutes and regulations administered by other Federal agencies. Your must comply with all the Act's requirements, including, but not limited to: registration and listing (21 CFR Part 807); labeling (21 CFR Parts 801 and 809); and good manufacturing practice requirements as set forth in the quality systems (QS) regulation (21 CFR Part 820).

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### Page 2 -

This letter will allow you to begin marketing your device as described in your Section 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 information about the application of labeling requirements to your device, or questions on the promotion and advertising of your device, please contact the Office of In Vitro Diagnostic Device Evaluation and Safety at [phone]. Also, please note the regulation entitled, "Misbranding by reference to premarket notification" (21CFR Part 807.97). You may obtain other general information on your responsibilities under the Act from the Division of Small Manufacturers, International and Consumer Assistance at its toll-free number [phone] or [phone] or at its Internet address http://www.fda.gov/cdrh/industry/support/index.html.

Sincerely yours,

Alberto Gutierrez, Ph.D.

Alberto Gutierrez, Ph.D. Director Division of Chemistry and Toxicology Office of In Vitro Diagnostic Device Evaluation and Safety Center for Devices and Radiological Health

Enclosure

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Indications For Use Statement

510(k) Number (if known):

K062152

Device Name:

Creatine Kinase MB Isoenzyme Verifier (DC27)

#### Indications for Use:

The Creatine Kinase MB Isoenzyme Verifier is an in vitro diagnostic product for verification of the Creatine Kinase MB Isoenzyme (CKMB) method on the Dimension® clinical chemistry system and Dimension Vista™ System

Prescription Use X (Per 21 CFR 801 Subpart D) AND/OR

Over-the-counter Use (21 CFR 801 Subpart C)

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

Concurrence of CDRH, Office of -In Vitro Diagnostic Devices (OIVD)

AC

Division Sigh-Off

Office of In Vitro Diagnostic Device Evaluation and Safety

510(k) K062152