DRUG 3 CAL is a frozen, liquid, human whole blood hemolysate containing cyclosporine. The kit consists of six vials, three vials of Calibrator A, and three vials of Calibrator B which are frozen. The volume for Calibrator A is 2.0 mL per vial and for Calibrator B is 1.5 mL per vial. Intermediate levels are automatically prepared and corresponding values calculated by the Dimension Vista™ System.

AI/ML Overview

Here's an analysis of the provided information regarding the Dimension Vista™ System Drug 3 Calibrator (DRUG 3 CAL - KC430), broken down by your requested categories:

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

Acceptance Criteria (Stability)	Reported Device Performance (Stability)
Shelf life: 12 months (at -20°C)	Shelf life stability (expiration) dating assignment at commercialization reflects the real-time data on file, where "Percent change should be less than or equal to 5%."
On-board stability (after puncture): 7 days	"A vial punctured by the instrument and stored on board is stable for seven days."
Recapped and refrigerated stability (off-instrument): 31 days	"An open vial not on instrument, but recapped and stored in a refrigerator is stable for 31 days."
% Change over time for shelf life: ≤ 5%	"Recovery versus time is monitored and percent change over time is determined. Percent change should be less than or equal to 5%."

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

Sample Size for Test Set: The document does not explicitly state the specific numerical sample size for the stability testing (e.g., number of vials, number of runs). It mentions "vials are opened/punctured on day zero" and testing on "days 8, 15, 22 and 32 versus freshly opened vials." This implies a prospective design for the open-vial stability studies. For the 12-month shelf life, it refers to "real-time data on file," suggesting a prospective study conducted over time.
Data Provenance: The document does not specify the country of origin for the data. Given Dade Behring Inc.'s location in Newark, DE, USA, the testing was likely conducted in the United States. The studies are described as prospective, with real-time data for shelf life and specific timelines for open-vial stability.

3. Number of experts used to establish the ground truth for the test set and the qualifications of those experts (e.g. radiologist with 10 years of experience)

Not Applicable: This device is a calibrator material, not an AI/imaging diagnostic device that requires expert interpretation for ground truth. The "ground truth" here is the assigned value of Cyclosporine A, which is established gravimetrically against a reference material (USP Cyclosporine A Reference Material) and verified by LC/MS testing and instrument-based verification.

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

Not Applicable: Adjudication methods like 2+1 or 3+1 are typically used for establishing ground truth in medical imaging or clinical assessment where subjective interpretation is involved. For a calibrator, the "truth" is based on the traceable reference material and quantitative analytical methods, not human consensus.

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 for an in vitro diagnostic test, not an AI-powered diagnostic tool requiring human readability or interpretation. Therefore, MRMC studies and "human readers improve with AI" metrics are irrelevant.

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

Yes (inherently): The performance of the calibrator itself is standalone. It's a physical material with defined properties. Its "performance" refers to its stability and its ability to properly calibrate the associated Cyclosporine (CSA) method on the Dimension Vista™ System. The characteristics reported (stability, traceability, bottle value assignment) are intrinsic to the calibrator material and not dependent on human intervention during its use in calibrating the instrument.

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

Traceable Reference Material and Analytical Methods: The ground truth for the calibrator's values is established through traceability to United States Pharmacopeia (USP) Cyclosporine A Reference Material. This involves:
- Gravimetric weighing of Cyclosporine Reference Material into drug-free whole blood hemolysate.
- Verification against weighed-in Master Pool values.
- Verification by LC/MS testing (Liquid Chromatography-Mass Spectrometry).
- Verification using an instrument calibrated with Master Pools.

8. The sample size for the training set

Not Applicable: As a calibrator material, there is no "training set" in the context of machine learning or AI. The product manufacturing involves creating stock solutions and commercial lots using established gravimetric and analytical methods. The stability studies and value assignments are performance validations, not training.

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

Not Applicable: See point 8. There is no training set for this type of device. The "ground truth" for the calibrator's assigned values is established through the robust analytical methods and traceability described in point 7.

Summary

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510(k) Summary for the Dimension VistaTM System Drug 3 Calibrator (DRUG 3 CAL - KC430)

SEP - 6 2006

A. 510(k) Number:

B. Analytes:	Cyclosporine (CSA)
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 Drug 3 Calibrator (DRUG 3 CAL - KC430)

F. Regulatory Information:

1. Regulation section: 21 CFR § 862-3200 Clinical Toxicology Calibrator
1. Classification: Class II
1. Product Code: DLJ Calibrator, Drug Specific
1. Panel: Clinical Chemistry
G. Intended Use: The DRUG 3 CAL is an in vitro diagnostic product for the calibration of Cyclosporine (CSA) method on the Dimension Vista™ System.

H. Device Description:

DRUG 3 CAL is a frozen, liquid, human whole blood hemolysate containing cyclosporine.

The kit consists of six vials, three vials of Calibrator A, and three vials of Calibrator B which are frozen. The volume for Calibrator A is 2.0 mL per vial and for Calibrator B is 1.5 mL per vial. Intermediate levels are automatically prepared and corresponding values calculated by the Dimension Vista™ System.

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I. Substantial Equivalence Information:

	New Device	Predicate Device
Item	Dimension Vista™ SystemDrug 3 Calibrator	Dimension® CSA CalibratorK011112
IntendedUse	The DRUG 3 CAL is an in vitro diagnosticproduct for the calibration of Cyclosporine(CSA) method on the Dimension Vista™System.	The CSA Calibrator is an in vitro diagnosticproduct intended to be used to calibrate theCyclosporine (CSA) method for theDimension® clinical chemistry system.
Analytes	Cyclosporine.	Cyclosporine.
Form	Frozen.	Frozen.
Traceability	USP1 Cyclosporine A.	USP Cyclosporine A.
Matrix	Human whole blood containingcyclosporine.	Human whole blood containingcyclosporine.
Number ofLevels	Two levels2.	Five levels.

1 United States Pharmacopeia.

2 Intermediate levels are automatically prepared and corresponding values calculated by the Dimension Vista™ System.

J. Standard/Guidance Document Referenced:

medical devices

1. Guidance:	Guidance for Industry - Abbreviated 510(k) Submissions for InVitro Diagnostic Calibrators; Final, 02/22/1999
	Guidance for Industry and FDA Staff - Use of Symbols on Labelsand in Labeling of In Vitro Diagnostic Devices Intended forProfessional Use, 11/30/2004
	Class II Special Controls Guidance Document: Cyclosporine andTacrolimus Assays; Guidance for Industry and FDA
2. Standards:	CEN 13640 Stability testing of In-Vitro Diagnostic Devices
	ISO 14971:2000 Medical devices -Application of risk management to

K. Performance Characteristics:

Target shelf life for the Dimension Vista™ System Drug 3 1. Stability: Calibrator is 12 months. Calibrator shelf life is determined by comparing results of the product stored at -20°C with control stored at -70°C. The method is calibrated from this stored material. The -20℃ material values are recovered versus the calibration. Recovery versus time is monitored and percent change over time is determined. Percent change should be less than or equal to 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.

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An open vial not on instrument, but recapped and stored in a refrigerator is stable for 31 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 8, 15, 22 and 32 versus freshly opened vials.

2. Traceability: The assigned values of the DRUG 3 CAL are traceable to United States Pharmacopeia Cyclosporine A Reference Material.

1. Bottle Value Assignment:
  Cyclosporine Reference Material is weighed into drug free whole blood hemolysate at five levels and stored at -70℃. The verification of the Master Pool values are compared against weighed in Master Pool values and LC/MS testing. The stock solution is made by adding Cyclosporine Reference Material gravimetrically to stock solution at target concentrations. The commercial lot is made by adding calculated quantities of stock solution to drug free whole blood hemolysate to target concentrations for each of the calibrator levels. The concentration of each level is verified by using an instrument. Nominal values are assigned to the commercial lot.

The nominal values for each level of the commercial lot are verified using an instrument calibrated with Master Pools.

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DEPARTMENT OF HEALTH & HUMAN SERVICES

Public Health Service

Food and Drug Administration 2098 Gaither Road Rockville MD 20850

Mr. Victor M. Carrio RAC/OC Compliance Manager Dade Behring, Inc. 500 GBC Drive Mailstop 514 Newark, DE 19714

SEP - 6 2006

Re: K062199

Trade/Device Name: Dimension Vista™ System Drug 3 Calibrator (DRUG 3 CAL - KC430) Regulation Number: 21 CFR 862.3200 Regulation Name: Clinical toxicology calibrator Regulatory Class: Class II Product Code: DLJ Dated: July 28, 2006 Received: August 1, 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).

Image /page/3/Picture/11 description: The image shows the logo for the U.S. Department of Health & Human Services. The logo features a stylized eagle or bird-like symbol with flowing lines, representing the department's mission. The text "DEPARTMENT OF HEALTH & HUMAN SERVICES - USA" is arranged in a circular pattern around the symbol.

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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 G

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 Vista™ System Drug 3 Calibrator (DRUG 3 CAL - KC430)

Indications for Use:

The DRUG 3 CAL is an in vitro diagnostic product for the calibration of the cyclosporine (CSA) 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 C. Benem
Division Sign-Off

Office of In Vitro Diagnostic Device Evaluation and Safety

K062199

Regulation Number and Section

§ 862.3200 Clinical toxicology calibrator.

(a)
Identification. A clinical toxicology 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. A clinical toxicology calibrator can be a mixture of drugs or a specific material for a particular drug (e.g., ethanol, lidocaine, etc.). (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.