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

Device Description

CHEM 3 CAL is a multi-analyte, aqueous product containing ethyl alcohol 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 submission is for a calibrator device, not an AI/ML diagnostic. Therefore, many of the requested fields are not applicable to this type of device. I will address the relevant sections based on the information provided in the 510(k) summary.

Here's an analysis of the Dimension Vista™ System Chemistry 3 Calibrator (CHEM 3 CAL - KC130) based on the provided document:

1. Table of Acceptance Criteria and Reported Device Performance

Performance Characteristic	Acceptance Criteria	Reported Device Performance
Stability (Shelf Life)	Percent change should be less than or equal to 5% when comparing product stored at 4°C with control stored at -20°C. Target shelf life is 12 months.	"Shelf-life stability (expiration) dating assignment at commercialization reflects the real-time data on file at Dade Behring, Inc." (Implies criteria were met or will be met).
Stability (On-Board)	A vial punctured by the instrument and stored on board is stable for 24 hours.	Not explicitly reported as a measured performance value in this summary, but stated as a characteristic.
Stability (Open Vial)	An open vial not on instrument, but recapped and stored in a refrigerator is stable for 30 days. Tested on days 1, 3, and 32 versus freshly opened vials.	Not explicitly reported as a measured performance value in this summary, but stated as a characteristic.
Bottle Value Assignment Verification	The final bottle values for each level of the commercial lot are assigned and verified using multiple instruments by testing N = 45 replicates per level. The reference states "verified," implying it met the internal criteria.	"The final bottle values for each level of the commercial lot is assigned and verified using multiple instruments by testing N = 45 replicates per level." (Implies successful verification).
Traceability	ALC: USP Grade Ethyl Alcohol; CO2: NIST SRM 351.	Confirmed that the calibrator is traceable to these standards.

Regarding the sections that are not applicable to this device type:

2. Sample size used for the test set and the data provenance: For calibrators, "test sets" in the context of diagnostic accuracy are not applicable. The performance is assessed through stability studies and value assignment verification.
- Stability Studies: Vials are opened/punctured on day zero and tested on days 1, 3, and 32 for open-vial stability. The number of replicates per time point for stability testing is not specified beyond "sufficient for multiple calibrations."
- Bottle Value Assignment: N = 45 replicates per level were used for final bottle value assignment verification.
- Data Provenance: Not explicitly stated, implied to be internal laboratory data generated by Dade Behring, Inc.
3. Number of experts used to establish the ground truth for the test set and the qualifications of those experts: Not applicable. Ground truth for a calibrator concerns its inherent value and traceability to reference materials.
4. Adjudication method (e.g. 2+1, 3+1, none) for the test set: Not applicable.
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: Not applicable. This is a calibrator, not an AI diagnostic device.
6. If a standalone (i.e. algorithm only without human-in-the-loop performance) was done: Not applicable.
7. The type of ground truth used:
- ALC (Alcohol): USP Grade Ethyl Alcohol.
- CO2 (Carbon Dioxide): NIST SRM 351.
- Bottle Value Assignment: Verification against previously approved Master Pools, which themselves are traced to the primary reference materials (USP and NIST SRM).
8. The sample size for the training set: Not applicable. This is not an AI/ML device.
9. How the ground truth for the training set was established: Not applicable.

Study That Proves the Device Meets Acceptance Criteria:

The 510(k) summary describes internal studies conducted by Dade Behring, Inc. to establish the performance characteristics of the Dimension Vista™ System Chemistry 3 Calibrator. These studies are designed to demonstrate the calibrator's suitability for its intended use and its substantial equivalence to predicate devices.

The key studies mentioned are:

Stability Studies: These studies evaluate the calibrator's stability over its proposed shelf life (12 months) and its stability after opening/puncturing (24 hours on-board, 30 days open vial in refrigerator). The acceptance criterion is a percent change less than or equal to 5%. The submission states that "Shelf-life stability (expiration) dating assignment at commercialization reflects the real-time data on file at Dade Behring, Inc.," indicating that internal data supports meeting these criteria. For open-vial stability, vials are tested on days 1, 3, and 32 versus freshly opened vials.
Traceability and Value Assignment Studies:
- The calibrator's values for ALC are traceable to USP Grade Ethyl Alcohol, and for CO2 to NIST SRM 351. This establishes the fundamental accuracy of the calibrator's assigned values.
- The "Bottle Value Assignment" process involves a multi-step verification process:
  - Preparation of carbon dioxide and alcohol reference materials.
  - Verification of "Master Pool" values against previously approved Master Pools.
  - Validation of "stock solution" values using instruments calibrated with approved Master Pools.
  - Final verification of commercial lot bottle values: "The final bottle values for each level of the commercial lot is assigned and verified using multiple instruments by testing N = 45 replicates per level." This extensive testing (N=45 replicates per level on multiple instruments) confirms that the assigned values for the commercial product are accurate and consistent within acceptable limits as determined by Dade Behring's internal quality standards.

In summary, the device meets its acceptance criteria through robust internal studies demonstrating its stability, traceability to recognized standards, and accurate value assignment through meticulous calibration and verification processes.

Summary

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K062122
AUG 25 2006

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

A. 510(k) Number:

B. Analytes:	Alcohol (ALC) 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) and carbon dioxide (CO2) methods on the Dimension Vista" System.

H. Device Description:

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Substantial Equivalence Information ட்

Item	New DeviceDimension Vista™ SystemChemistry 3 Calibrator	Predicate DeviceDimension® ALC Calibrator	Dimension® ECO2 Calibrator
IntendedUse	The CHEM 3 CAL is an in vitrodiagnostic product for thecalibration of Alcohol (ALC) andCarbon Dioxide (CO2) methods onthe Dimension Vista™ System.	K904308The Alcohol Calibrator is an in vitrodiagnostic product to be used to calibratethe Dimension® clinical chemistry systemfor the Ethyl Alcohol (ALC) method.	K010208The Dimension® ECO2 Calibrator is anin vitro diagnostics product to be used tocalibrate the Dimension® clinicalchemistry system for the EnzymaticCarbonate (ECO2) method.
Analytes	Alcohol and carbon dioxide.	Alcohol.	Carbon Dioxide.
Form	Liquid.	Liquid.	Liquid.
Traceability	ALC – USP Grade Ethyl Alcohol.CO2 - NIST SRM² 351.	USP Grade Ethyl Alcohol.	NIST SRM 351.
Matrix	Aqueous product containing ethylalcohol and sodium carbonate.	Aqueous product containing ethanol.	Aqueous product containing sodiumcarbonate.
Number ofLevels	Two levels.	Four levels.	Three levels.
United States Pharmacopeia.

omica States I harmatopena:
National Institute of Standards and Technology Standard Reference Material

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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:

Constituent	Traceability
ALC	USP1 Grade Ethyl Alcohol
CO2	NIST SRM2 351

'USP: United States Pharmacopeia

2NIST-SRM: National Institute of Standards and Technology -- Standard Reference Material.

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3. Bottle Value Assignment:

Carbon dioxide reference material is weighed into purified water at three levels and stored at -70°C. Alcohol reference material is weighed into purified water at three levels and stored at 4°C. The verification of the Master Pool values are compared against previously approved Master Pool values. The stock solution is made by adding alcohol 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 and verified 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 features a stylized eagle with its wings spread, along with the text "DEPARTMENT OF HEALTH & HUMAN SERVICES - USA" arranged in a circular fashion around the eagle. The text is in all caps and appears to be in a sans-serif font.

Public Health Service

Food and Drug Administration 2098 Gaither Road Rockville MD 20850

AUG 2 5 2006

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

K062122 Re:

Trade/Device Name: Dimension Vista™ Chem 3 Calibrator (KC 130) Regulation Number: 21 CFR 862.1150 Regulation Name: Calibrator Regulatory Class: Class II Product Code: JIX Dated: July 24, 2006 Received: July 25, 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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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 G

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

510(k) Number (if known): K062122

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), and carbon dioxide (CO2) methods on the Dimension Vista™ System.

Prescription Use _____________________________________________________________________________________________________________________________________________________________

AND/OR

Over-The-Counter Use

(Part 21 CFR 801 Subpart D)

(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)

C.C.H.
Division Sign-Off

Office of In Vitro Diagnostic Device Evaluation and Safety

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K042122

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.