The provided 510(k) summary for the Dimension Vista® DGTX CAL is for a calibrator device for an in vitro diagnostic system, not a device that involves image analysis or human interpretation. Therefore, many of the typical acceptance criteria and study components related to machine learning performance (e.g., sample size for test sets, data provenance, ground truth experts, MRMC studies, standalone performance, training set details) are not applicable to this type of medical device submission.

This submission focuses on demonstrating substantial equivalence to a predicate calibrator device (Dimension® Drug Calibrator II) by comparing their features, intended use, and formulation. The "study" here is essentially a comparison of product characteristics rather than a clinical performance study.

Here's a breakdown of the requested information, adapted for this specific device type:

1. Table of Acceptance Criteria and Reported Device Performance

For calibrators, the primary "acceptance criterion" is typically substantial equivalence to a legally marketed predicate device. Performance is demonstrated by showing that the new device has comparable characteristics and performs its intended function (calibration) in a similar manner.

Acceptance Criteria (Implied)	Reported Device Performance
Substantial Equivalence to Predicate Device:
- Intended Use matches	The DGTX CAL is for calibration of digitoxin on the Dimension Vista® System. The predicate calibrates digitoxin (among others) for Dimension Flex® cartridges. The digitoxin calibration function is equivalent.
- Matrix is the same	Both DGTX CAL and predicate use Bovine Serum base.
- Number of levels is the same	Both DGTX CAL and predicate have 5 levels.
- Preparation is the same	Both DGTX CAL and predicate are liquid.
- Storage conditions are the same	Both DGTX CAL and predicate are stored at 2 – 8 °C.
Formulation Equivalence:	The Dimension Vista® DGTX CAL product is stated to be the exact same formulation as Dimension® Drug Cal II.

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

Sample Size: Not applicable in the context of a clinical test set. The "test" here involves comparing the characteristics of the new calibrator to the predicate device. This is a descriptive comparison, not a statistical sampling of patient data.
Data Provenance: Not applicable. The "data" are the specifications and formulation details of the new device and the predicate device.

3. Number of Experts Used to Establish the Ground Truth for the Test Set and Qualifications

Number of Experts: Not applicable. Ground truth in the sense of clinical interpretations or diagnoses is not involved. The "truth" here is the chemical composition and physical properties of the calibrator.
Qualifications of Experts: Not applicable.

4. Adjudication Method for the Test Set

Adjudication Method: Not applicable. There is no ambiguous clinical data requiring expert adjudication.

5. If a Multi-Reader Multi-Case (MRMC) Comparative Effectiveness Study was Done

MRMC Study: No. This type of study is relevant for diagnostic devices where human readers interpret output, often with AI assistance. A calibrator does not involve human interpretation in this manner.
Effect Size of Human Readers Improvement with AI vs. without AI assistance: Not applicable.

6. If a Standalone (i.e., algorithm only without human-in-the-loop performance) Study was Done

Standalone Study: No. This concept is for AI algorithms. A calibrator is a chemical reagent, not an algorithm.

7. The Type of Ground Truth Used

Type of Ground Truth: The "ground truth" for this submission is the physical and chemical specifications, intended use, and formulation details of both the new calibrator and the legally marketed predicate device. The claim is that they are identical or highly similar in relevant aspects.

8. The Sample Size for the Training Set

Sample Size for Training Set: Not applicable. Calibrators are not "trained" like AI algorithms.

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

How Ground Truth for Training Set Was Established: Not applicable.

Summary

{0}------------------------------------------------

510(k) Summary of Safety and Effectiveness for the Dimension Vista® DGTX CAL

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

A. 510(k) Number: K103360

B. Date of Preparation:

C. Proprietary and Established Names:

Dimension Vista® DGTX CAL

D. Applicant:

Siemens Healthcare Diagnostics Inc.

P.O. Box 6101, Newark, DE 19714-6101

Rose T. Marinelli, Regulatory Technical Specialist

Office Number: (302) 631-8805 fax Number: (302) 631-6299

E. Regulatory Information:

Drug Calibrator II:

Regulation section: 21 CFR § 862.1150 Calibrator
Classification: Class II
Product Code: JIT - Calibrator, Secondary
Panel: Immunology

F. Predicate Device:

The predicate device used to demonstrate substantial equivalence to the Dimension Vista® DGTX CAL is the Dimension® Drug Calibrator 11 cleared under K033809.

G. Device Description:

The DGTX CAL is a liquid bovine serum based product containing digitoxin.

H. Intended Use:

The DGTX CAL is an in vitro diagnostic product for the calibration of digitoxin on the Dimension Vista® System.

{1}------------------------------------------------

I. Substantial Equivalence Information:

The Dimension Vista® DGTX CAL was compared to the predicate, Dimension® Drug Calibrator II. The following table provides a comparison of the important similarities and differences:

Feature	Dimension Vista® DGTX CAL	Drug Calibrator II (DC49D)(K033809) (predicate device)
Intended Use	The DGTX CAL is an in vitrodiagnostic product for thecalibration of digitoxin on theDimension Vista® System.	Drug Calibrator II is an in vitrodiagnostic product intended for thecalibration of the following methodspackaged in Flex® reagentcartridges:Acetaminophen (ACTM) Carbamazepine (CRBM) Digitoxin (DGTX) Gentamicin (GENT) Lidocaine (LIDO) N-acetylprocainamide (NAPA) Procainamide (PROC) Tobramycin (TOBR) Valproic Acid (VALP) Vancomycin (VANC)
Matrix	Bovine Serum base	Bovine Serum base
Levels	5 Levels	5 Levels
Preparation	Liquid	Liquid
Storage	2 – 8 °C	2 – 8 °C

J. Conclusion:

The Dimension Vista® DGTX CAL is substantially equivalent to the current Dimension® Drug Calibrator II cleared under K033809. The Dimension Vista® DGTX CAL product is the exact same formulation as Dimension® Drug Cal II.

{2}------------------------------------------------

Public Health Service

Siemens Healthcare Diagnostics Inc. c/o Ms. Rose Merinelli, Regulatory Technical Specialist PO Box 6101 MS 514 Newark, DE 19714-6101

Food & Drug Administration 10903 New Hampshire Avenue Building 66 Silver Spring, MD 20993

DEC 1 7 2010

Re: K103360

Trade/Device Name: Dimension Vista® Digitoxin Calibrator – DGTX CAL Regulation Number: 21 CFR 862.1150 Regulation Name: Calibrator Regulatory Class: Class II Product Code: JIT Dated: November 12, 2010 Received: November 16, 2010

Dear Ms. Merinelli:

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., Orug. 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 class II (Special Controls), 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); medical device reporting (reporting of medical device-related adverse events) (21 CFR 803); and good manufacturing practice requirements as set forth in the quality systems (QS) regulation (21 CFR Part 820). 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.

{3}------------------------------------------------

Page 2

If you desire specific advice for your device on our labeling regulation (21 CFR Part 801), please contact the Office of In Vitro Diagnostic Device Evaluation and Safety at (301) 796-5450. Also, please note the regulation entitled, "Misbranding by reference to premarket notification" (21 CFR Part 807.97). For questions regarding postmarket surveillance, please contact CDRH's Office of Surveillance and Biometric's (OSB's) Division of Postmarket Surveillance at (301) 796-5760. For questions regarding the reporting of adverse events under the MDR regulation (21 CFR Part 803), please go to http://www.fda.gov/MedicalDevices/Safety/ReportaProblem/default.htm for the CDRH's Office of Surveillance and Biometrics/Division of Postmarket Surveillance.

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 ) 796-5680 or at its Internet address http://www.fda.gov/MedicalDevices/ResourcesforYou/Industry/default.htm.

Sincerely yours,

Courtney C. Harper, Ph.D. Director Division of Chemistry and Toxicology Office of In Vitro Diagnostic Device Evaluation and Safety Center for Devices and Radiological Health

Enclosure

{4}------------------------------------------------

Indications for Use Form

510(k) Number (if known): 103360

Device Name: _________________________________________________________________________________________________________________________________________________________________

Indications for Use: The DGTX CAL is an in vitro diagnostic product for the calibration of digitoxin on the Dimension Vista® System.

Prescription Use X (Part 21 CFR 801 Subpart D)

AND/OR

Over-The-Counter Use (21 CFR 801 Subpart C)

Page 1 of

(PLEASE DO NOT WRITE BELOW THIS LINE-CONTINUE ON ANOTHER PAGE OF NEEDED)

Concurrence of CDRH, Office of In Vitro Diagnostic Devices (OIVD)

Carol C. Benson

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

510(k) K103360

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.