The CHEM 3 CAL is an in vitro diagnostic product for the calibration of alcohol (ALC), ammonia (AMON) and carbon dioxide (CO2) methods on the Dimension Vista" System.

Device Description

CHEM 3 CAL is a multi-analyte, aqueous product containing ethyl alcohol, ammonium bicarbonate and sodium carbonate. 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 2.5 mL.

AI/ML Overview

The provided document is a 510(k) Summary for a calibrator device, not a diagnostic device that performs clinical measurements or predictions. Therefore, many of the typical AI/ML-related acceptance criteria and study descriptions (like MRMC studies, human reader improvement, standalone algorithm performance, or ground truth for a test set) are not applicable to this type of product.

This document describes the validation of a calibrator's stability and its ability to assign accurate values for three analytes on a specific instrument system.

Here's the relevant information based on the provided text:

1. Table of Acceptance Criteria and Reported Device Performance

The core "performance" for a calibrator relates to its stability and its ability to be accurately assigned values for the analytes it is meant to calibrate.

Acceptance Criteria Category	Specific Criteria	Reported Device Performance
Shelf-life Stability	Percent change should be less than or equal to 5% when comparing product stored at 4°C with control stored at -20°C over the intended shelf life.	Target shelf life is 12 months. (The document states "Shelf-life stability (expiration) dating assignment at commercialization reflects the real-time data on file at Dade Behring, Inc.," indicating this criterion was met, but does not provide the specific percentage change results in this summary).
On-board Stability	Vials punctured by the instrument and stored on-board should be stable for 24 hours.	Stated as "stable for 24 hours." (No specific data presented in the summary, but implies compliance).
Open-vial Stability	Open vials (re-capped and stored in a refrigerator) should be stable for 30 days. Tested on days 1, 3, and 32 versus freshly opened vials.	Stated as "stable for 30 days." (No specific data presented in the summary, but implies compliance).
Traceability	Analytes must be traceable to established reference materials.	ALC traced to USP Grade Ethyl Alcohol. AMON traced to ACS Grade Ammonium Sulfate. CO2 traced to NIST SRM 351.
Bottle Value Assignment	Final bottle values for each level of the commercial lot are assigned using multiple instruments.	Final bottle values assigned using multiple instruments by testing N = 45 replicates per level. (Implies method is robust and accurate, though no specific numerical acceptance range for the assigned values is given in this summary).

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

Test Set Description: The "test set" for a calibrator's performance primarily refers to the samples used to demonstrate its stability and the accuracy of its assigned values.
- Stability Testing: Vials are opened/punctured and tested on days 1, 3, and 32 against freshly opened vials. The number of samples per test point is not explicitly stated in this summary, but would typically involve multiple vials or measurements.
- Bottle Value Assignment: N = 45 replicates per level were tested for final bottle value assignment. There are two levels of calibrator (Calibrator A and Calibrator B).
Data Provenance: The study was conducted by Dade Behring Inc. (now Siemens Healthineers) for the Dimension Vista™ System. The data is retrospective relative to the submission date and originates from internal testing by the manufacturer. No country of origin for the data is explicitly stated beyond the manufacturer being in the US (Newark, DE).

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

Not Applicable. This is a calibrator, not a diagnostic device requiring expert interpretation of clinical images or data. "Ground truth" for calibrators is established via metrological traceability to reference materials (USP, ACS, NIST SRM) and gravimetric preparation, followed by instrumental verification.

4. Adjudication Method for the Test Set

Not Applicable. As above, this is not a diagnostic device requiring adjudication of clinical interpretations.

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

No, this was not done. This type of study is for comparing human performance with and without AI assistance for tasks like diagnosis or detection from clinical images, which is irrelevant for a chemical calibrator.

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

Not Applicable in the traditional AI/ML sense. While the calibrator itself functions "standalone" in its role within the instrument system, there is no "algorithm only" performance study in the context of an AI/ML diagnostic device without human intervention. The calibrator's performance is intrinsically linked to the Dimension Vista™ System's ability to accurately measure analytes based on the calibration curve.

7. The Type of Ground Truth Used

The "ground truth" for this calibrator is established by:

Gravimetric Preparation: Alcohol, ammonia, and carbon dioxide reference materials are weighed into purified water at specific concentrations.
Traceability to Reference Standards:
- Alcohol (ALC) is traceable to USP Grade Ethyl Alcohol.
- Ammonia (AMON) is traceable to ACS Grade Ammonium Sulfate.
- Carbon Dioxide (CO2) is traceable to NIST SRM 351.
Master Pool Verification: Master Pool values are verified by comparing against previously approved Master Pool values.

8. The Sample Size for the Training Set

Not Applicable in the AI/ML sense. There is no "training set" as this is not an AI/ML algorithm that learns from data. The calibrator's formulation and verification are based on established chemical and analytical principles.

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

Not Applicable. As there is no AI/ML training set, there is no ground truth established for one. The "truth" for the calibrator's assigned values comes from its manufacturing process using traceable reference materials and subsequent instrumental verification.

Summary

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K062334

510(k) Summary for the Dimension Vista™ System Chemistry 3 Calibrator (CHEM 3 CAL - KC130)

SEP 2 2 2006

A. 510(k) Number:

B. Analytes:	Alcohol (ALC), ammonia (AMON) and carbon dioxide (CO2).
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 Chemistry 3 Calibrator (CHEM 3 CAL-KC130)

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 CHEM 3 CAL is an in vitro diagnostic product for the calibration of alcohol (ALC), ammonia (AMON) and carbon dioxide (CO2) methods on the Dimension Vista" System.

H. Device Description:

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Item	New DeviceDimension Vista™System Chemistry 3Calibrator	Dimension® AMONCalibratorK863840	Predicate DevicesDimension® ALCCalibratorK904308	Dimension® ECO2CalibratorK010208	Constituent	Traceability
IntendedUse	The CHEM 3 CAL is an in vitro diagnostic product forthe calibration of Alcohol(ALC), Ammonia (AMON)and Carbon Dioxide (CO2)methods on the DimensionVista™ System.	Ammonia Calibrator is an in vitrodiagnostic product to be used forcalibrating the Dimension®clinical chemistry system for theammonia (AMON) method.	The Alcohol Calibrator is an invitro diagnostic product to be usedto calibrate the Dimension®clinical chemistry system for theEthyl Alcohol (ALC) method.	The Dimension® ECO2 Calibratoris an in vitro diagnostics productto be used to calibrate theDimension® clinical chemistrysystem for the EnzymaticCarbonate (ECO2) method.	ALC	USP1 Grade Ethyl Alcohol
Analytes	Alcohol (ALC), Ammonia(AMON) and Carbon Dioxide(CO2).	Ammonia.	Alcohol.	Carbon Dioxide.	AMON	ACS2 Grade Ammonium Sulfate
Form	Liquid.	Liquid.	Liquid.	Liquid.	CO2	NIST SRM3 351
Traceability	ALC – USP¹ Grade EthylAlcohol.AMON – ACS² GradeAmmonium Sulfate.CO2 – NIST SRM³ 351.	ACS Grade Ammonium Chloride.	USP Grade Ethyl Alcohol.	NIST SRM 351.
Matrix	Aqueous product containingethyl alcohol, ammoniumbicarbonate and sodiumcarbonate.	Aqueous product containingammonium chloride.	Aqueous product containingethanol.	Aqueous product containingsodium carbonate.
Number ofLevels	Two levels.	Three levels.	Four levels.	Three levels.

Substantial Equivalence Information I

| Levels
| United States Pharmacopeia.
² American Chemical Society
² National Institute of Standards and Technology Standard Reference Material.
² National Institute of Stand

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J. Standard/Guidance Document Referenced:

1. Guidance: Guidance for Industry - Abbreviated 510(k) Submissions for In Vitro Diagnostic Calibrators; 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

K. Performance Characteristics:

1. Stability: Target shelf life for the Dimension Vista™ System Chemistry 3 Calibrator is 12 months. Calibrator shelf life is determined by comparing results of the product stored at 4℃ with control stored at -20℃. The method is calibrated from this stored material. The 4°C 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 24 hours. An open vial not on instrument, but recapped and stored in a refrigerator is stable for 30 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 1, 3, and 32 versus freshly opened vials.
1. Traceability: The assigned values of the Chemistry 3 Calibrator are standardized to the enclosed table of assigned values:
  ¹USP: United States Pharmacopeia

2ACS: American Chemical Society

3 NIST-SRM: National Institute of Standards and Technology - Standard Reference Material.

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1. Bottle Value Assignment:
  Carbon dioxide reference material is weighed into purified water at three levels and stored at -70°C. Ammonia and alcohol reference materials are weighed into purified water at three levels respectively and stored at 4℃. The Master Pool values are verified by comparing against previously approved Master Pool values.

The stock solution is made by adding alcohol, ammonia and carbon dioxide reference materials gravimetrically to stock solution at target concentrations. The stock solution values are verified on an instrument calibrated with a previously approved Master Pool.

The commercial lot is made by adding calculated quantities of stock solution to purified water in appropriate concentrations for each of the calibrator levels. The concentration of each level is verified by using an instrument calibrated with Master Pools. The final bottle values for each level of the commercial lot is assigned using multiple instruments by testing N = 45 replicates per level.

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DEPARTMENT OF HEALTH & HUMAN SERVICES

Image /page/4/Picture/1 description: The image shows the logo for the U.S. Department of Health & Human Services. The logo consists of a stylized eagle with three stripes forming its body and wing. The eagle is positioned to the right of a circular inscription that reads "DEPARTMENT OF HEALTH & HUMAN SERVICES. USA".

Public Health Service

Food and Drug Administration 2098 Gaither Road Rockville MD 20850

Mr. Victor M. Carrio RA/QS Compliance Manager Dade Behring, Inc. P.O. Box 6101, M/S 514 Newark, DE 19714

SEP 2 2 2006

K062334 Re:

Trade/Device Name: Dimenston Vista"™ Chem 3 Catiorator (KC130) Regulation Number: 21 CFR 862.1150 Regulation Name: Calibrator Regulatory Class: Class II Product Code: JIX Dated: August 9, 2006 Received: August 10, 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).

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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 Gutz

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™ Chem 3 Calibrator (KC130)

Indications for Use:

The CHEM 3 CAL is an in vitro diagnostic product for the calibration of alcohol (ALC), ammonia (AMON) and carbon dioxide (CO2) methods on the Dimension Vista" System.

Prescription Use X (Pcr 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)

Division Sign-Off for Carol Bonson

Office of In Vitro Diagnostic Device Evaluation and Safety

510(k) K062334

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.