(20 days)
No
The summary describes a lyophilized human serum product used for verifying a clinical chemistry system, with no mention of AI or ML technology.
No
This device is an in vitro diagnostic product used for verifying a laboratory test method, not for treating a condition.
Yes
The "Intended Use / Indications for Use" section explicitly states that the product is an "in vitro diagnostic product."
No
The device description explicitly states it is a "lyophilized human serum base product" and a "kit consists of six vials," indicating it is a physical, in vitro diagnostic product, not software.
Yes, this device is an IVD (In Vitro Diagnostic).
The "Intended Use / Indications for Use" section explicitly states: "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."
This statement directly identifies the device as an in vitro diagnostic product.
N/A
Intended Use / 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.
Product codes
JIT
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.
Mentions image processing
Not Found
Mentions AI, DNN, or ML
Not Found
Input Imaging Modality
Not Found
Anatomical Site
Not Found
Indicated Patient Age Range
Not Found
Intended User / Care Setting
Not Found
Description of the training set, sample size, data source, and annotation protocol
Not Found
Description of the test set, sample size, data source, and annotation protocol
Not Found
Summary of Performance Studies
Not Found
Key Metrics
Not Found
Predicate Device(s)
Reference Device(s)
Not Found
Predetermined Change Control Plan (PCCP) - All Relevant Information
Not Found
§ 862.1150 Calibrator.
(a)
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.)(b)
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.
0
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: (302) 631-0376 Fax: (302) 631-6299
E. Proprietary and Established Names:
Dimension® Creatine Kinase MB Isoenzyme Verifier (CKMB Verifier - DC27)
F. Regulatory Information:
-
- Regulation section: 21 CFR § 862-1150 Calibrator
-
- Classification: Class II
-
- Product Code: JIT Calibrator, Secondary
-
- 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.
1
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 |
| product for verification of the Creatine Kinase MB Isoenzyme | |
| (CKMB) method on the Dimension® clinical chemistry system and | |
| 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 |
| 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 (240) 276-0484. 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 (800) 638-2041 or (301) 443-6597 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):
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