The Enzyme 2 Calibrator is an in vitro diagnostic product for the calibration of alanine aminotransferase (ALT) and aspartate aminotransferase (AST) on the Dimension Vista™ System.

Device Description

The Enzyme 2 Calibrator is a liquid, multi-analyte, bovine serum albumin based product containing alanine aminotransferase (ALT) and aspartate aminotransferase (AST) from porcine heart. The kit consists of six vials, three vials of Calibrator A and three vials of Calibrator B which are ready for use (no preparation is required). The volume per vial is 1.5 mL.

AI/ML Overview

Here's an analysis of the provided text regarding the acceptance criteria and study for the Dimension Vista™ Enzyme 2 Calibrator (ENZ 2 CAL - KC320), formatted as requested:

Acceptance Criteria and Study for Dimension Vista™ Enzyme 2 Calibrator (ENZ 2 CAL - KC320)

1. Table of Acceptance Criteria and Reported Device Performance:

Performance Characteristic	Acceptance Criteria	Reported Device Performance
Shelf-Life Stability	Percent change over time should be ≤ 5% (when compared to control at -70°C).	Determined to be 12 months when stored at 4℃. The actual shelf-life dating at commercialization reflects real-time data.
On-Board Stability	Not explicitly stated as a numerical criterion for acceptance in the document.	A vial punctured by the instrument and stored on board has a seven day stability claim. This implies that performance within acceptable limits (likely the ≤ 5% change, though not explicitly stated for this specific condition) is achieved for 7 days.
Opened Vial Stability (Recapped & Refrigerated)	Not explicitly stated as a numerical criterion for acceptance in the document.	A vial that is uncapped, recapped, and stored in a refrigerator (not on instrument) has a stability claim of 31 days. This implies that performance within acceptable limits (likely the ≤ 5% change, though not explicitly stated for this specific condition) is achieved for 31 days.
Traceability	Standardized to a master pool assigned by the Dimension® clinical chemistry system.	The assigned values of the Enzyme 2 Calibrator are standardized to a master pool that is assigned by the Dimension® clinical chemistry system. Manufacturer's verification process involves adding verified stock solution to a bovine serum albumin base, and the concentration of each level is verified on an instrument calibrated with an approved Master Pool. Master Pool values are assigned for each level on multiple Dimension® instruments.
Value Assignment	Calculated quantities of verified stock solution achieve target concentrations; verified on an instrument calibrated with an approved Master Pool.	To manufacture a calibrator lot, calculated quantities of a verified stock solution are added to a bovine serum albumin base at target concentrations. The concentration of each level is verified on an instrument calibrated with an approved Master Pool. The Master Pool values are assigned for each level on multiple Dimension® instruments.

2. Sample Size and Data Provenance:

Test Set Sample Size: The document does not explicitly state the number of individual calibrator vials or batches used in the stability studies. It mentions "a quantity sufficient for multiple calibrations" being removed for the opened vial stability tests. This is a common practice for stability studies, where multiple units are tested over time.
Data Provenance: The data is described as "real-time data on file at Dade Behring, Inc." This indicates the studies were prospective in nature, conducted by the manufacturer, Dade Behring Inc., in Newark, DE, USA.

3. Number of Experts and Qualifications for Ground Truth:

The document does not mention the use of human experts to establish ground truth for the performance characteristics of this calibrator device. Calibrator performance is typically assessed by instrumental measurements against established reference materials or methods, not by expert consensus.

4. Adjudication Method for the Test Set:

None. As the device is a calibrator and its performance is evaluated by quantitative analytical methods and comparison to a Master Pool, an adjudication method involving human interpretation is not applicable or described.

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

No. An MRMC study is not applicable for a diagnostic calibrator device. These studies are typically used for imaging or diagnostic interpretation devices where human readers assess cases. The calibrator's function is to standardize measurements, which is an analytical performance characteristic.

6. Standalone Performance:

Yes. The performance characteristics described (stability, traceability, value assignment) represent the standalone performance of the calibrator device itself. These studies evaluate the calibrator's properties (e.g., how long it remains stable, how accurately its values are assigned) independent of a human operator's interpretation. The calibrator's "performance" is its ability to accurately set the measurement scale for the Dimension Vista™ System.

7. Type of Ground Truth Used:

The ground truth used is primarily instrumental measurement against a Master Pool. Specifically:
- For stability, results are compared to a "control stored at -70℃" which serves as a stable reference.
- For traceability and value assignment, the calibrator is standardized to a "Master Pool that is assigned by the Dimension® clinical chemistry system." The Master Pool itself would have its values established through a rigorous process, likely involving primary reference materials or highly accurate reference methods. This indicates a hierarchical traceability chain where the Master Pool is the ultimate "ground truth" reference for this specific system.

8. Sample Size for the Training Set:

The concept of a "training set" is not applicable for this device. This is a calibrator, not an algorithm or an AI model that requires a training set for machine learning. Its manufacturing process involves adding stock solutions and verifying concentrations, not learning from data.

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

Not applicable. As there is no training set for this calibrator device, no ground truth for a training set was established.

Summary

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K061390

JUL - 5 2006

510(k) Summary for the Dimension Vista™ System Enzyme 2 Calibrator (ENZ 2 CAL - KC320)

A. 510(k) Number:

B. Analytes:	Alanine aminotransferase (ALT) and aspartate aminotransferase(AST)
C. Type of Test:	Calibrator Material
D. Applicant:	Dade Behring Inc., P.O. Box 6101, Newark, DE 19714-6101Contact: Victor M. Carrio, Regulatory Affairs and ComplianceManagerOffice: (302) 631-0376 Fax: (302) 631-6299

E. Proprietary and Established Names:

Dimension Vista™ Enzyme 2 Calibrator (ENZ 2 Cal - KC320) - m 1-1)

F. Regulatory Information:

1. Regulation section: 21 CFR § 862-1150 Calibrator
1. Classification: Class II
1. Product Code: JIX Calibrator, Multi-Analyte Mixture
1. Panel: Clinical Chemistry
G. Intended Use: The Enzyme 2 Calibrator is an in vitro diagnostic product for the calibration of alanine aminotransferase (ALT) and aspartate aminotransferase (AST) on the Dimension Vista™ System.

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H. Device Description:

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I. Substantial Equivalence Information:

1. Predicate Device: Dimension® Enzyme Verifier (DC19).
1. Predicate K Number: K860021 for Dimension® clinical chemistry system.
1. Comparison with Predicate:

Item	Dimension Vista™Enzyme 2 Calibrator	Dimension®Enzyme Verifier
IntendedUse	The Enzyme 2 Calibrator is an in vitro diagnostic product for thecalibration of alanineaminotransferase (ALT) andaspartate aminotransferase (AST)on the Dimension Vista™System.	Enzyme Verifier is an in vitro diagnosticproduct to be used to verify alkalinephosphatase (ALP), amylase (AMY), g-glutamyl transferase (GGT), aspartameaminotransferase (AST), alanineaminotransferase (ALT) and lacticdehydrogenase (LDH) methodperformance on the Dimension® clinicalchemistry system.
Analytes	Alanine aminotransferase (ALT)Aspartate aminotransferase (AST)	Alkaline phosphatase (ALP), Amylase(AMY)g-glutamyl transferase (GGT), Aspartameaminotransferase (AST),Alanine aminotransferase (ALT), Lacticdehydrogenase (LDH)
Form	Liquid	Lyophilized
Traceability	ALT/AST Master Pool,Dimension® clinical chemistrysystem values.	ALT/AST Master Pool, Dimension®clinical chemistry system values.
Matrix	Bovine serum and porcine heartbased product.	Human serum and porcine heart basedproduct
Levels	Two calibration levels	Three verification levels

J. Standard/Guidance Document Referenced:

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

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K. Performance Characteristics:

Calibrator shelf life for the Dimension Vista™ Enzyme 2 1. Stability: Calibrator is determined to be 12 months. Calibrator shelf life is determined by comparing results of the product stored at 4℃ with control stored at -70℃. The method is calibrated from this stored material. The 4℃ material values are recovered versus the

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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 that is punctured (opened) by the instrument and stored on board has a seven day stability claim.

An vial that is uncapped, recapped and stored in a refrigerator, not on instrument, has a stability claim of 31 days.

Both opened and punctured vials are tested 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 Enzyme 2 Calibrator are standardized to a master pool that is assigned by the Dimension® clinical chemistry system.
1. Value Assignment:

To manufacture a calibrator lot, calculated quantities of a verified stock solution are added to a bovine serum albumin base at target concentrations. The concentration of each level is verified on an instrument calibrated with an approved Master Pool. The Master Pool values are assigned for each level on multiple Dimension® instruments.

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Public Health Service

Food and Drug Administration 2098 Gaither Road Rockville MD 20850

JUL - 5 2006

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

Re: K061390

Trade/Device Name: Dimension Vista™ Enzyme 2 Calibrator (AST/ALT Calibrator-KC320) Regulation Number: 21 CFR§ 862.1150 Regulation Name: Calibrator Regulatory Class: Class II Product Code: JIX Dated: May 17, 2006 Received: May 18, 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 Foeld, Or to 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 misbaranding 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 dctermination 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 manufagturing 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, permite 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 80 .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 tolli-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 Gutierrez

Alberto Guticarez, 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): CX0(390

Device Name:

Dimension Vista™ Enzyme 2 Calibrator (AST/ALT Calibrator , KC320)

Indications for Use:

The Enzyme 2 Calibrator is an in vitro diagnostic product for the calibration of alanine aminotransferase (ALT) and aspartate aminotransferase (AST) 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)
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Division Sign Off
Office of In Vitro Diagnostic Device
Evaluation and Safety

510(k)	K061320
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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.