CK CAL is frozen, liquid, bovine serum albumin based product containing creatine kinase from porcine heart. The kit consists of six vials, three vials of Calibrator A, and three vials of Calibrator B. The volume per vial is 1.0 mL.

AI/ML Overview

This document describes the 510(k) submission for the Dimension Vista™ System Creatine Kinase Calibrator (CK CAL - KC340). As such, it focuses on demonstrating substantial equivalence to a predicate device rather than presenting a traditional clinical study with acceptance criteria often seen for diagnostic algorithms.

However, we can extract details about the performance characteristics and the internal studies conducted to ensure the calibrator meets its intended purpose.

1. Table of Acceptance Criteria and Reported Device Performance

Acceptance Criteria (Performance Characteristic)	Reported Device Performance (as described in the document)
Stability (Shelf Life): Allowable shelf life percent change ≤ 5 % (compared to control stored at -70℃).	Target shelf life is 12 months. Shelf-life stability (expiration) dating assigned at commercialization reflects real-time data.
Stability (On-board): Stable for seven days when continuously stored on the instrument after being punctured.	A vial punctured by the instrument and stored on board is stable for seven days.
Stability (Open Vial, Refrigerated): Stable for 30 days when recapped and stored in a refrigerator after opening/puncturing.	An open vial not on instrument, but recapped and stored in a refrigerator is stable for 30 days.
Traceability	The assigned values are traceable to Master Pool, Dimension® clinical chemistry system.
Value Assignment (Master Pool): Concentrations are verified against a previously approved Master Pool lot.	Master Pool concentrations are verified against a previously approved Master Pool lot. Final bottle value assigned by testing N=45 replicates on multiple instruments.
Value Assignment (Stock Solution): Verified by comparing recovery of stock solution versus Master Pool assigned bottle values.	Stock solution verified by comparing recovery versus Master Pool assigned bottle values.
Value Assignment (Commercial Lot): Concentration of each level verified to be within acceptable range using an instrument calibrated with Master Pools. Final bottle value assigned and verified using a released commercial lot of calibrator on multiple instruments.	Commercial calibrator lot levels verified to be within acceptable range using an instrument calibrated with Master Pools. Final bottle value assigned and verified using a released commercial lot of calibrator on multiple instruments for N=45 total replicates.

2. Sample Size Used for the Test Set and Data Provenance

Since this is a calibrator, the "test set" in the context of diagnostic algorithms doesn't directly apply. However, we can analyze the data used for performance characterization.

Stability Studies:
- Shelf-life stability: "Recovery versus time is monitored and percent change over time is determined..." The exact number of samples or data points is not specified, but it's an ongoing monitoring process.
- Open vial stability: Vials are opened/punctured on day zero and tested on days 1, 8, 15, 22, and 32. The number of vials tested on these specific days is not explicitly stated.
Value Assignment:
- Master Pool: N = 45 replicates (measurements) on multiple instruments.
- Commercial Calibrator Lot: N = 45 total replicates (measurements) on multiple instruments.

Data Provenance: The document does not explicitly state the country of origin for the data. However, as Dade Behring Inc. is based in Newark, DE (USA), it is highly likely the studies were conducted within the US. The studies are prospective in the sense that they are specifically designed experiments to characterize the calibrator's performance.

3. Number of Experts Used to Establish Ground Truth and Qualifications

This information is not applicable to a calibrator product. The "ground truth" for a calibrator is its assigned value, which is established through a rigorous, metrologically sound process rather than expert-derived diagnoses.

4. Adjudication Method

Not applicable to a calibrator product. Adjudication is typically used in clinical studies where expert consensus is needed to establish a definitive diagnosis or outcome.

5. Multi-Reader Multi-Case (MRMC) Comparative Effectiveness Study

Not applicable. This is not a diagnostic device that requires human interpretation, nor is it an AI-assisted diagnostic tool.

6. Standalone Performance Study

Yes, the performance characteristics described are for the standalone calibrator device. The stability, traceability, and value assignment studies are all evaluations of the calibrator itself, independent of human intervention other than the procedures for testing it. For example, the stability studies determine how the calibrator's values change over time under various storage conditions.

7. Type of Ground Truth Used

The "ground truth" for the calibrator's assigned values is based on:

Gravimetric addition: For preparing the Master Pool and stock solutions, quantities of creatine kinase are gravimetrically added to the base material to achieve target concentrations. This provides an initial "true" concentration based on precise measurement of mass.
Comparison to previously approved Master Pool lot: The new Master Pool is verified against an existing, approved Master Pool, establishing a reference point.
Dimension® clinical chemistry system values: The assigned values are traceable to the Dimension® clinical chemistry system, implying that the system itself, when properly calibrated, serves as the reference measurement.

Essentially, the ground truth is established through a hierarchical metrological traceability chain, starting with fundamental physical measurements (gravimetric) and then validated against established reference materials and methods within the manufacturer's system.

8. Sample Size for the Training Set

Not applicable. This is a calibrator, not a machine learning algorithm that requires a "training set."

9. How the Ground Truth for the Training Set Was Established

Not applicable, as there is no training set for a calibrator.

Summary

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K061702

510(k) Summary for the Dimension Vista™ System Creatine Kinase Calibrator (CK CAL - KC340)

A. 510(k) Number:

!JUL 1 0 2006

B. Analyte:	Creatine Kinase (CK).
C. Type of Test:	Calibrator Material
D. Applicant:	Dade Behring Inc., P.O. Box 6101, Newark, DE 19714-6101Victor M. Carrio, Regulatory Affairs and Compliance ManagerOffice: (302) 631-0376 Fax: (302) 631-6299

E. Proprietary and Established Names:

Dimension Vista™ System Creatine Kinase Calibrator (CK CAL - KC340)

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 CK CAL is an in vitro diagnostic product for the calibration of G. Intended Use: Creatine Kinase (CK) method on the Dimension Vista™ System.

H. Device Description:

I. Substantial Equivalence Information:

Predicate Device: Dimension® Creatine KinaseVerifier (DC26) and VITROSTM Chemistry Products Calibrator Kit 3.

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Predicate K Number(s): K861700 for Dimension® clinical chemistry system. For the Ortho-Diagnostics VITROS Calibrator Kit 3, a 510(k) was not aveillable.

Comparison
Item	Dimension Vista™System CreatineKinase Calibrator	Dimension®Creatine KinaseVerifier	Otho-ClinicalDiagnosticsVITROSTMCalibrator Kit 3
Intended Use	The CK CAL is an in vitrodiagnostic product for thecalibration of the creatinekinase (CK) method on theDimension Vista™System.	The Dimension® CreatineKinase Verifier is an invitro diagnostic product tobe used to verify theDimension® clinicalchemistry systems for theCreatine Kinase (CK)method.	For in vitro diagnostic useonlv.VITROS Calibrator Kit 3 isintended for use incalibration of the VITROSChemistry Systems for thequantitative measurementof AcP, ALKP, ALT, AST,CK, GGT, LDH and LIPA.
Analytes	Creatine Kinase	Creatine Kinase	Acid Phosphatase (AcP),alanine aminotransferase(ALT), alkalineaminotransferase (ALKP),amylase (AMYL), aspartateaminotransferase (AST),creatine kinase (CK),gamma glutamyltransferase(GGT), lactatedehydrogenase (LDH) andlipase (LIPA).
Form	Liquid	Lyophilized	Lyophilized
Traceability	Master Pool, Dimension®clinical chemistry systemvalues.	Master Pool, Dimension®clinical chemistry systemvalues.	Values assigned toVITROS ChemistryProduct Calibrator Kit 3 aretraceable to high qualitymaterials.
Matrix	Bovine serum albuminbased product containingcreatine kinase fromporcine heart.	Human serum baseproduct containing creatinekinase from simian heart.	Bovine serum and porcineheart based product.
Levels	Two levels.	Three levels.	Three levels.

1. Comparison with Predicate:

J. Standard/Guidance Document Referenced:

l. Guidance: Guidance for Industry - Abbreviated 510(k) Submissions for In 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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1. Standards: CEN 13640 Stability testing of In-Vitro Diagnostic Devices ISO 14971:2000 Medical devices -Application of risk management to medical devices

K. Performance Characteristics:

1. Stability: Target shelf life for the Dimension Vista™ Creatine Kinase Calibrator is 12 months. Calibrator shelf life is determined by comparing results of the product stored at -20°C with control stored at -70℃. The method is calibrated from this stored material. The -20°C material values are recovered versus the calibration. Recovery versus time is monitored and percent change over time is determined where the allowable shelf life percent change should be ≤ 5 %. Shelf-life stability (expiration) dating assignment at commercialization reflects the real-time data on file at Dade Behring, Inc.
  A vial punctured by the instrument and stored on board is stable for seven days.

An open vial not on instrument, but recapped and stored in a refrigerator is stable for 30 days.

For testing, vials are opened /punctured on day zero. A quantity sufficient for multiple calibrations is removed and the vials are recapped and stored at 2 - 8 °C. Opened/punctured vials are tested on days 1, 8, 15, 22, and 32 versus freshly opened vials.

1. Traceability: The assigned values of the Creatine Kinase Calibrator are traceable to Master Pool, Dimension® clinical chemistry system.
1. Value Assignment:

The new calibrator Master Pool is made by gravimetrically adding quantities of creatine kinase to bovine serum albumin base to target concentrations. The concentrations are verified against a previously approved Master Pool lot. The final bottle value for the Master Pool is assigned for each level by testing N = 45 replicates on multiple instruments.

A stock solution is prepared for the new commercial calibrator lot by gravimetrically adding quantities of creatine kinase to bovine serum albumin base to target concentrations. The stock solution is verified by comparing the recovery of the stock solution versus the Master Pool assigned bottle values.

For the commercial calibrator lot, calculated quantities of the stock solution are added to the bovine serum albumin base to target concentrations. The concentration of each level is verified to be

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within acceptable range by using an instrument calibrated with Master Pools. The final bottle value is assigned to each level and verified using a released commercial lot of calibrator on multiple instruments for N = 45 total replicates.

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DEPARTMENT OF HEALTH & HUMAN SERVICES

Image /page/4/Picture/1 description: The image shows the logo for the U.S. Department of Health & Human Services. The logo features a stylized caduceus, a symbol often associated with medicine and healthcare, with three intertwined strands. The text "DEPARTMENT OF HEALTH & HUMAN SERVICES - USA" is arranged in a circular fashion around the caduceus.

Public Health Service

Food and Drug Administration 2098 Gaither Road Rockville MD 20850

JUL 1 0 2006

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

Re: K061702

Trade/Device Name: Dimension Vista™ Creatine Kinase Calibrator (CK Calibrator, KC340) Regulation Number: 21 CFR§862.1150 Regulation Name: Calibrator Regulatory Class: Class II Product Code: JIT Dated: June 15, 2006 Received: June 16, 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. You 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, perceits 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 tolloffree mber (800) 638-2041 or (301) 443-6597 or at its Internet address http://www.fda.gov/cdrh/industry/support/index.html.

Sincerely yours.

Alberto G. A

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:

Dimension VistaTM Creatine Kinase Calibrator (CK Calibrator , KC340)

Indications for Use:

The CK CAL is an in vitro diagnostic product for the calibration of Creatine Kinase (CK) method on the 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)

Carol Benson
Division Sign-Off

Division Sign-Off

Office of In Vitro Diagnostic Device Evaluation and Safety

K061702

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.