The Dimension Vista® Cyclosporine Extended Range Calibrator contains cyclosporine in a preserved whole blood hemolysate. The kit consists of three vials of Calibrator A (200 ng/mL) and three vials of Calibrator B (2000 ng/mL). The intermediate calibrator levels (400. 800 and 1400 ng/mL) are prepared on-board the Dimension® Vista analyzer.

AI/ML Overview

Here's an analysis of the provided text regarding the acceptance criteria and study for the Dimension Vista® Cyclosporine Extended Range Calibrator:

Note: This document is a 510(k) summary, which focuses on demonstrating substantial equivalence to a predicate device. It does not contain a detailed formal study report with specific acceptance criteria beyond general statements about "pre-defined acceptance criteria" for stability. The primary "study" described here is a comparison of technological characteristics to a predicate device, rather than a clinical performance study with human subjects or a standalone analytical performance study with specific quantitative acceptance metrics.

Acceptance Criteria and Device Performance

Acceptance Criteria	Reported Device Performance
Intended Use: Calibration of CSAE method on the Dimension Vista® system.	Met: The new device's intended use is identical to its declared intended use for the calibration of the CSAE method on the Dimension Vista® system, and is compared favorably to the predicate device, which also calibrates an extended range cyclosporine method.
Analyte: Cyclosporine.	Met: The device contains cyclosporine.
Matrix: Preserved whole blood hemolysate.	Met: The device contains cyclosporine in a preserved whole blood hemolysate.
Number of levels and target concentrations: Two levels (200 and 2000 ng/mL) with on-board preparation of intermediate levels (400, 800, 1400 ng/mL).	Met: The device provides two primary calibrator levels (200 and 2000 ng/mL) and utilizes the Dimension Vista® analyzer to prepare intermediate levels (400, 800, 1400 ng/mL), which is a technological difference from the predicate but considered equivalent for calibration purposes.
Stability: Established through real-time data on 3 lots of product, passing pre-defined acceptance criteria.	Met: "The stability of the calibrators is established through real-time data on 3 lots of product. Testing is conducted at multiple time points and must pass pre-defined acceptance criteria." Specific quantitative acceptance criteria (e.g., % deviation from target, shelf-life duration, etc.) are not provided in this summary.
Traceability: Traceable to an internal master pool containing USP cyclosporine A, confirmed by LC/MS/MS.	Met: "The calibrator is traceable to an internal master pool containing USP cyclosporine A and whose values are confirmed by LC/MS/MS." This ensures the accuracy and reliability of the calibrator's assigned values, directly supporting the overarching goal of accurate clinical toxicology measurement.

Study Details

Given that this is a 510(k) summary for a calibrator, the "study" is primarily focused on demonstrating substantial equivalence through a comparison of technological characteristics and confirmation of performance aspects like stability and traceability. It is not a traditional clinical study or standalone performance validation with a large test set and ground truth established by experts in the same way a diagnostic algorithm would be evaluated.

Sample size used for the test set and the data provenance:
- Test Set: For stability, testing was conducted on "3 lots of product." The specific number of individual calibrator vials or measurements within each lot is not provided.
- Data Provenance: Not explicitly stated, but assumed to be internal laboratory data generated by the manufacturer (Siemens Healthcare Diagnostics Inc. in Newark, DE, USA). The studies are retrospective from the perspective of this 510(k) submission, as they were conducted to support the submission.
Number of experts used to establish the ground truth for the test set and the qualifications of those experts:
- Not applicable in the context of this device. The "ground truth" for a calibrator is established by its manufacturing process, purity of its components (USP cyclosporine A), and its assigned values confirmed by analytical techniques like LC/MS/MS, not by human expert interpretation of results. Therefore, no external experts were used for this purpose on the test set.
Adjudication method for the test set:
- Not applicable. The "test set" here refers to the calibrator lots themselves and their analytical performance. Adjudication methods are typically relevant for human interpretation tasks or complex diagnostic outcomes.
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:
- No MRMC comparative effectiveness study was done. This device is a calibrator, an in vitro diagnostic product, not a diagnostic algorithm or AI intended for human interpretation or assistance.
If a standalone (i.e., algorithm only without human-in-the-loop performance) was done:
- This is not applicable in the sense of an "algorithm" as commonly understood in AI. However, the performance characteristics (stability, traceability) of the calibrator itself were evaluated in a standalone manner, independent of a specific human operator interpreting patient results. The calibrator's function is purely analytical within the Dimension Vista® system. The analytical performance of the calibrator itself forms the basis of its "standalone" evaluation.
The type of ground truth used (expert consensus, pathology, outcomes data, etc.):
- The ground truth for the calibrator's values is established by analytical measurement and traceability to a primary standard. Specifically, the calibrator is traceable to an internal master pool containing USP (United States Pharmacopeia) cyclosporine A, with values confirmed by LC/MS/MS (Liquid Chromatography-Mass Spectrometry/Mass Spectrometry). This is a highly accurate and precise analytical method for determining concentration.
The sample size for the training set:
- Not applicable. There is no "training set" in the context of a calibrator product. This is not a machine learning model.
How the ground truth for the training set was established:
- Not applicable as there is no training set.

Summary

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AUG 2 2 2008

510(k) Summary of Safety and Effectiveness Dimension Vista® Cyclosporine Extended Range Calibrator

This summary of 510(k) safety and effectiveness information is submitted in accordance with the requirements of SMDA 1990 and 21 CFR §807.92.

KOS2030 The assigned 510(k) number is:

Submitter's Contact Information and Date of Preparation 1.

Contact Information:

Siemens Healthcare Diagnostics Inc. P.O. Box 6101 Newark, DE 19714-6101 Attn: Yuk-Ting Lewis Tel: 302-631-7626

Date of Preparation:

July 10, 2008

Proprietary Device Name / FDA Classification Name 2.

Dimension Vista® Cyclosporine Extended Range Calibrator / Clinical Toxicology Calibrator

Identification of the Predicate Device 3.

Dimension® CSAE Cyclosporine Extended Range Calibrator, K061503

4. Device Description

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Siemens Healthcare Diagnostics Inc.

510(k) Premarket Notification - Dimension Vista® Cyclosporine Extended Range Calibrator

5. Device Intended Use

The CSAE CAL is an in vitro diagnostic product for the calibration of CSAE method on the Dimension Vista® system.

Summary of the devices technological characteristics 6.

A comparison of the Dimension Vista® CSAE Calibrator vs. the predicate device is provided.

	(New Device)	(Predicate)
Characteristic	Dimension Vista®Cyclosporine ExtendedRange Calibrator	Dimension® CSAECyclosporine ExtendedRange Calibrator, K061503
Intended Use	The CSAE CAL is an in vitrodiagnostic product for thecalibration of CSAE methodon the Dimension Vista®system.	The Dimension® CSAECyclosporine Extended RangeCalibrator is an in vitrodiagnostic product intended tobe used to calibrate the CSAECyclosporine Extended rangemethod for the Dimension®clinical chemistry system orthe Syva® Emit® 2000Cyclosporine Specific Assay.
Analyte	Cyclosporine
Matrix	Preserved whole blood hemolysate
Number of levels and targetconcentrations	Two levels: 200 and 2000ng/mL cyclosporine. Theintermediate calibrator levels(400, 800 and 1400 ng/mL)are prepared on-board theDimension® Vista analyzer.	Five levels: 200, 400, 800,1400 and 2000 ng/mLcyclosporine.
Stability	The stability of the calibrators is established through real-timedata on 3 lots of product. Testing is conducted at multiple timepoints and must pass pre-defined acceptance criteria.
Traceability	The calibrator is traceable to an internal master pool containingUSP cyclosporine A and whose values are confirmed byLC/MS/MS.

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7. Conclusion

Based on a review of the devices technological features, the Dimension Vista® Cyclosporine Extended Range Calibrator is substantially equivalent to the legally marketed device, the Dimension® CSAE Cyclosporine Extended Range Calibrator.

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DEPARTMENT OF HEALTH & HUMAN SERVICES

Image /page/3/Picture/1 description: The image shows a black and white logo. The logo is circular in shape and features a stylized eagle head in the center. The eagle's head is composed of three curved lines. The text "U.S. DEPARTMENT OF HEALTH & HUMAN SERVICES" is arranged around the perimeter of the circle.

Public Health Service

Food and Drug Administration 2098 Gaither Road Rockville MD 20850

Siemens Healthcare Diagnostics, Inc. c/o Yuk-Ting Lewis Regulatory Affairs & Compliance Manager P.O. Box 6101, Mail Stop 514 Newark, DE 19714-6101

AUG 2 2 2008

K082030 Re:

Trade Name: Dimension Vista® Cyclosporine Extended Range Calibrator Regulation Number: 21 CFR 862.3200 Regulation Name: Clinical Toxicology Calibrator. Regulatory Class: Class II Product Codes: DLJ Dated: July 15, 2008 Received: July 17, 2008

Dear Ms. Lewis:

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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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) 276-0490. 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 (240) 276-3150 or at its Internet address at http://www.fda.gov/cdrh/industry/support/index.html.

Sincerely yours,

Jean M. Cooper, M.S., D.V.M.

Yean M. Cooper, M.S., D.V.M. 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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Siemens Healthcare Diagnostics Inc.

Stemens Healthoure Diagnostion Vista® Cyclosporine Extended Range Calibrator

Indication for Use

510(k) Number (if known):

Dimension Vista® Cyclosporine Extended Range Calibrator Device Name:

Indications For Use:

The CSAE CAL is an in vitro diagnostic product for the calibration of CSAE method on the Dimension Vista® system.

Prescription Use __ X_____________________________________________________________________________________________________________________________________________________________________________ (21 CFR Part 801 Subpart D) And/Or

Over the Counter Use (21 CFR Part 801 Subpart C)

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

Concurrence of CDRH, Office of In Vitro Diagnostic Device Evaluation and Safety (OIVD)

Division Sign-Off Office of In Vitro Diagnostic Device Evaluation and Safety

510(k) K082030

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.