The ENZ 2 CAL is an in vitro diagnostic product for the calibration of Alanine Aminotransferase (ALT and ALTI) and Aspartate Aminotransferase (AST) on the Dimension Vista® System.

Device Description

ENZ 2 CAL is a liquid, multi-analyte, bovine serum albumin based product containing alanine aminotransferase and aspartate aminotransferase from porcine heart.

AI/ML Overview

The provided text is a 510(k) summary for the Siemens Dimension Vista ENZ 2 CAL (KC321) and the FDA's clearance letter. This document focuses on establishing substantial equivalence to a predicate device (Dimension Vista ENZ 2 CAL, KC320) rather than presenting a detailed study proving the new device's performance against specific acceptance criteria for analytical validation.

Therefore, much of the requested information regarding acceptance criteria, study details, sample sizes, expert involvement, and ground truth establishment (as typically found in performance studies) is not present in the provided text.

Based on the available information, here's what can be extracted:

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

The document does not explicitly state acceptance criteria in a quantitative manner (e.g., specific accuracy, precision, or linearity targets) for the ENZ 2 CAL (KC321) itself. Instead, it focuses on establishing substantial equivalence based on comparative features to a predicate device.

The "performance" reported is inferred from the statement of "substantial equivalence" and the comparative features, which suggest similar functionality and composition to the legally marketed predicate.

Feature	Acceptance Criteria (Implied)	Reported Device Performance
Intended Use	To be substantially equivalent to the predicate's intended use.	Calibrates ALT, ALTI, and AST methods on Dimension Vista®. (Extended from predicate: ALT and AST only)
Form	Liquid, bovine serum albumin based.	Liquid, bovine serum albumin based. (Identical to predicate)
Constituents	Aspartate aminotransferase and alanine aminotransferase from porcine heart.	Aspartate aminotransferase and alanine aminotransferase from porcine heart. (Identical to predicate)
Traceability of ALT/AST	Traceable to Master pool, Dimension® clinical chemistry system values.	Traceable to Master pool, Dimension® clinical chemistry system values. (Identical to predicate)
Traceability of ALTI	Traceable to IFCC ALT @ 37°C primary reference method.	Traceable to IFCC ALT @ 37°C primary reference method.
Packaging	Glass vials, 1.5 mL/vial, 3 vials of each level/carton.	Glass vials, 1.5 mL/vial, 3 vials of each level/carton. (Identical to predicate)
Levels	2 levels.	2 levels. (Identical to predicate)
Stability and Storage	Stored at 2 to 8°C.	Stored at 2 to 8°C. (Identical to predicate)

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 provide details on a specific "test set" sample size in the context of analytical performance studies.
The data provenance, country of origin, and whether it was retrospective or prospective are not mentioned. The submission is from Siemens Healthcare Diagnostics, Inc. in Newark, DE, USA, suggesting the work was performed domestically, but no explicit statement is made.

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):

This information is not applicable or available in the provided 510(k) summary. "Ground truth" in the context of calibrator performance is typically established through reference methods and internal validation processes by the manufacturer, rather than by an external panel of experts for a test set as might be done for diagnostic image analysis.

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

This information is not applicable or available. Adjudication methods are typically associated with expert review of cases, which is not described for this device's validation.

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:

This information is not applicable or available. The device is a calibrator for laboratory instruments, not an AI-assisted diagnostic tool for human readers.

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

The device is a calibrator, which inherently functions in a standalone manner (it calibrates an instrument). The 510(k) focuses on its equivalence in composition and intended use. There is no explicit "algorithm alone" performance study described beyond the general assurance of substantial equivalence in its function.

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

For the traceability of constituents, the document states:
- "ALT and AST traceable to Master pool, Dimension® clinical chemistry system values."
- "ALTI is traceable to the IFCC ALT@ 37°C primary reference method."
  This indicates that the ground truth for the calibrator's assigned values is based on reference materials and established reference methods (like IFCC standards) and the manufacturer's internal "Master pool" system values, rather than human expert consensus, pathology, or outcomes data.

8. The sample size for the training set:

The document does not explicitly mention a "training set" sample size. As a chemical calibrator, its development involves formulations and reference measurements, not typically machine learning training sets.

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

As a "training set" is not mentioned, the method for establishing its ground truth is not applicable or available. However, as inferred in point 7, the underlying reference values for the calibrator's constituents are based on established reference methods and the manufacturer's internal standards.

Summary

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

SIEMENS

JAN 2 5 2011

510(k) Summary for Dimension Vista ENZ 2 CAL KC321

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.

The assigned 510(k) number is: K103612

1. Manufacturer's Name, Address, Telephone, and Contact Person, Date of Preparation: Manufacturer: Siemens Healthcare Diagnostics, Inc. 500 GBC Drive Newark, DE 19714 Contact Information: Siemens Healthcare Diagnostics, Inc. 500 GBC Drive Newark, DE 19714 Attn: A. Kathleen Ennis Tel: 302-631-9352 Fax: 302-631-6299 Preparation date: December 1, 2010 ENZ 2 CAL (KC321) 2. Device Name: Classification: Class II (21CFR862.1150) JIX: Product Code: Panel: Clinical Chemistry (75) 3. ldentification of the Legally Marketed Device: Dimension Vista® ENZ 2 CAL (KC320) K061390

ব . Device Descriptions:

ENZ 2 CAL is a liquid, multi-analyte, bovine serum albumin based product containing alanine aminotransferase and aspartate aminotransferase from porcine heart.

5. Device Intended Uses:

Dimension Vista® ENZ 2CAL (KC321)

The ENZ 2CAL is an in vitro diagnostic product for the calibration of the alanine aminotransferase (ALT and ALT )) and aspartate aminotransferase (AST) methods on the Dimension® Vista system.

Medical device to which equivalence is claimed and comparison information: 6. The Dimension Vista ENZ 2 CAL (KC321), is substantially equivalent to the Dimension Vistas

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

SIEMENS

ENZ 2 CAL (KC320). Like the predicate, ENZ 2 CAL is an in vitro diagnostic product intended to be used for the calibration of alanine aminotransferase, and aspartate aminotransferase assays.

7. Comparative Features Table

Feature	Current	Modified
	Dimension Vista® ENZ 2Calibrator KC320	Dimension® Vista ENZ 2Calibrator KC321
Similarities
Form:	liquid, bovine serum albuminbased	liquid, bovine serum albuminbased
Constituents:	aspartate aminotransferaseand alanine aminotransferasefrom porcine heart	aspartate aminotransferaseand alanine aminotransferasefrom porcine heart
Traceabilityofconstituents:	ALT and AST traceable toMaster pool, Dimension®clinical chemistry system values	ALT and AST traceable toMaster pool, Dimension®clinical chemistry system values
Packaging:	ENZ 2 CAL is packaged inglass vials containing 1.5mL/vial. Each carton contains 3vials of each level.	ENZ 2 CAL, modified ispackaged in glass vialscontaining 1.5 mL/vial. Eachcarton contains 3 vials of eachlevel.
Levels:	2	2
Stability andstorage	ENZ 2 CAL is stored at 2 to 8°C	ENZ 2 CAL is stored at 2 to 8°C
Differences
Intended Use:	ENZ 2 CAL is an in vitrodiagnostic product forcalibration of the AspartateAminotransferase (AST) andAlanine Aminotransferase(ALT) methods on theDimension Vista® System.	ENZ 2 CAL is an in vitrodiagnostic product forcalibration of the AspartateAminotransferase (AST),Alanine Aminotransferase (ALTand ALTI) methods on theDimension Vista® System.
Traceability ofconstituents:		ALTI is traceable to the IFCCALT@ 37°C primary referencemethod.

8. Conclusion

Dimension Vista® ENZ 2 CAL, KC321, is substantially equivalent in intended use to the legally marketed device, Dimension Vista® ENZ 2 CAL, KC320, based on the information described above.

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

Image /page/2/Picture/1 description: The image shows the logo for the U.S. Department of Health & Human Services. The logo consists of a circular seal with the words "DEPARTMENT OF HEALTH & HUMAN SERVICES • USA" arranged around the perimeter. Inside the circle is an abstract image of an eagle or bird-like figure.

Food and Drug Administration 10903 New Hampshire Avenue Silver Spring, MD 20993

Siemens Healthcare Diagnostics, Inc. c/o Ms. Anna Marie K. Ennis Senior Regulatory Affairs & Compliance Mgr. 500 GBC Drive, PO Box 6101 Newark, Delaware 19714-6101

Re: K103612 Trade Name: Dimension Visa ENZ 2 CAL Regulation Number: 21 CFR 862.1150 Regulation Name: Calibrator Regulatory Class: Class II Product Codes: JIX Dated: December 8, 2010 Received: December 9, 2010

JAN 2 5 201

Dear Ms. Ennis

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); 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).

: : : :

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

Page 2 -

If you desire specific advice for your device on our labeling regulation (21 CFR Parts 801 and 809), 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 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) 796-7100 or at its Internet address http://www.fda.gov/cdrh/industry/support/index.html.

Sincerely yours.

C.C.

Courthey 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): _( ) 03612

Device Name: Dimension Vista® ENZ 2 CAL

Indications for Use:

The ENZ 2 CAL is an in vitro diagnostic product for the calibration of Alanine Aminotransferase (ALT and ALTI) and Aspartate Aminotransferase (AST) on the Dimension Vista® System.

Prescription Use_XX (Part 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 OF NEEDED)

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

Signature

Division Sign-Off Office of In Vitro Diagnostic Device

Evaluation and Safety

K103612 510(k)_

Page 1 of _1

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.