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 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.

AI/ML Overview

The provided text describes a 510(k) submission for the Dimension® Creatine Kinase MB Isoenzyme Verifier (CKMB Verifier - DC27). This product is a calibrator material used for verifying the CKMB method on Dimension® and Dimension Vista™ clinical chemistry systems.

It's crucial to understand that this submission is for a calibrator material, not a diagnostic device that directly measures a patient's CKMB levels or diagnoses a condition. Therefore, the "acceptance criteria" and "device performance" in this context refer to the performance of the verifier itself in its intended role of QC/calibration, not the diagnostic accuracy of a clinical test. The study described focuses on demonstrating substantial equivalence to a predicate device, and the specifics around clinical performance (e.g., sensitivity, specificity, accuracy against a gold standard in patient samples) are not applicable or detailed for a calibrator.

Based on the provided information, here's an attempt to answer your questions:

1. A table of acceptance criteria and the reported device performance

The document does not explicitly state quantitative acceptance criteria or a direct "performance" study in the sense of a diagnostic device. The primary "performance" aspect highlighted is its substantial equivalence to a previously cleared device (K863840) with an expanded intended use. For calibrators, performance is typically tied to stability, homogeneity, and its ability to act as a stable reference for the assay.

Acceptance Criteria	Reported Device Performance
Intended Use: Verification of CKMB method on Dimension® and Dimension Vista™ Systems.	The device meets this intended use, which is an expansion of the previous 510(k) (K863840) without changes to the product features.
Analyte: Creatine Kinase MB Isoenzyme	Contains CKMB.
Form: Lyophilized	The device is lyophilized.
Traceability: Dimension® clinical chemistry system values.	The device traces to Dimension® clinical chemistry system values.
Matrix: Human serum based product containing CKMB from simian heart source.	The device is a human serum based product containing CKMB from simian heart source.
Levels: Three levels.	The device has three levels (Level 1: no CKMB, Levels 2 & 3: with CKMB).
Substantial Equivalence: To predicate device K863840, with expanded intended use.	The FDA found the device substantially equivalent to the predicate device (K863840) for its expanded intended use. This implies the device performs comparably to the predicate in its role as a verifier.

2. Sample size used for the test set and the data provenance (e.g. country of origin of the data, retrospective or prospective)

The document does not specify a "test set" or a quantified sample size for a performance study in the way one would for a diagnostic device. The assessment is based on the characteristics of the calibrator material itself and its comparison to the predicate device. Therefore, details about data provenance (country, retrospective/prospective) are not provided as it's not a clinical data-driven submission in that sense.

3. Number of experts used to establish the ground truth for the test set and the qualifications of those experts

Not applicable. For a calibrator material, "ground truth" doesn't involve clinical expert consensus. Its value is established through manufacturing processes, analytical testing, and traceability to reference methods or standards, usually by the manufacturer's own qualified personnel using established laboratory practices.

4. Adjudication method (e.g. 2+1, 3+1, none) for the test set

Not applicable. No expert adjudication method is described as this is not a diagnostic device relying on interpretation of clinical data.

5. If a multi-reader multi-case (MRMC) comparative effectiveness study was done, If so, what was the effect size of how much human readers improve with AI vs without AI assistance

Not applicable. This device is a calibrator material, not an AI-powered diagnostic tool, and involves no human interpretation of images or clinical cases.

6. If a standalone (i.e. algorithm only without human-in-the-loop performance) was done

Not applicable. This is a physical calibrator material, not an algorithm.

7. The type of ground truth used (expert consensus, pathology, outcomes data, etc)

For a calibrator like the CKMB Verifier, the "ground truth" or reference values are established through:

Analytical methods and certified reference materials: The concentrations of CKMB in the verifier levels are determined by rigorous analytical testing using validated methods and, ideally, traceable to established reference materials or methods.
Manufacturer's internal quality control and validation: The manufacturer performs extensive testing to ensure the lot-to-lot consistency, stability, and assigned values of the calibrator material.

8. The sample size for the training set

Not applicable. There is no training set as described for an AI/algorithm-based device.

9. How the ground truth for the training set was established

Not applicable. There is no training set for this type of device.

Summary

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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: (302) 631-0376 Fax: (302) 631-6299

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
1. Classification: Class II
1. Product Code: JIT Calibrator, Secondary
1. 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:

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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 diagnosticproduct for verification of the Creatine Kinase MB Isoenzyme(CKMB) method on the Dimension® clinical chemistry system andDimension Vista™ System.
Analytes	Creatine Kinase MB Isoenzyme
Form	Lyophilized
Traceability	Dimension® clinical chemistry system values.
Matrix	Human serum based product containing CKMB from simian heartsource.
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):

K062152

Device Name:

Creatine Kinase MB Isoenzyme Verifier (DC27)

Indications for Use:

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)

Division Sigh-Off

Office of In Vitro Diagnostic Device Evaluation and Safety

510(k) K062152

Regulation Number and Section

§ 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.