LogoFDA 510(k) Search
K Number
K062334
Device Name
DIMENSION VISTA CHEMISTRY 3 CALIBRATOR, MODEL KC130
Manufacturer
DADE BEHRING, INC.
Date Cleared
2006-09-22

(43 days)

Product Code
JIX
Regulation Number
862.1150
AI/MLSaMDIVD (In Vitro Diagnostic)TherapeuticDiagnosticis PCCP Authorized
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.
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.
More Information

K863840, K904308, K010208

Not Found

No
The document describes a chemical calibrator for an in vitro diagnostic system and does not mention any AI or ML components.

No
This device is an in vitro diagnostic product used for the calibration of alcohol, ammonia, and carbon dioxide methods on a specific system, which means it aids in the accuracy of diagnostic tests rather than providing therapy.

No

The device is a calibrator, used to calibrate instruments for measuring certain analytes, not to directly diagnose a patient condition.

No

The device is described as an in vitro diagnostic product consisting of physical vials containing aqueous solutions, which are clearly hardware components.

Yes, this device is an IVD (In Vitro Diagnostic).

Here's why:

  • Intended Use: The "Intended Use / Indications for Use" section explicitly states: "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: The description further clarifies that it's a "multi-analyte, aqueous product" used for calibration, which is a key function in in vitro diagnostic testing.
  • Intended User / Care Setting: This section also lists "in vitro diagnostic product."

The information provided clearly indicates that the CHEM 3 CAL is designed to be used outside of the body to calibrate instruments that perform diagnostic tests on biological samples (specifically for alcohol, ammonia, and carbon dioxide). This aligns with the definition of an in vitro diagnostic device.

N/A

Intended Use / 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.

Product codes (comma separated list FDA assigned to the subject device)

JIX

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.

Mentions image processing

Not Found

Mentions AI, DNN, or ML

Not Found

Input Imaging Modality

Not Found

Anatomical Site

Not Found

Indicated Patient Age Range

Not Found

Intended User / Care Setting

Not Found

Description of the training set, sample size, data source, and annotation protocol

Not Found

Description of the test set, sample size, data source, and annotation protocol

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Summary of Performance Studies (study type, sample size, AUC, MRMC, standalone performance, key results)

  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 Celsius with control stored at -20 Celsius. The method is calibrated from this stored material. The 4 degree Celsius 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 Degrees Celsius. Opened/punctured vials are tested on days 1, 3, and 32 versus freshly opened vials.
  2. Traceability: The assigned values of the Chemistry 3 Calibrator are standardized to the enclosed table of assigned values: USP: United States Pharmacopeia ACS: American Chemical Society NIST-SRM: National Institute of Standards and Technology - Standard Reference Material.
  3. Bottle Value Assignment: Carbon dioxide reference material is weighed into purified water at three levels and stored at -70 Celsius. Ammonia and alcohol reference materials are weighed into purified water at three levels respectively and stored at 4 Celsius. 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.

Key Metrics (Sensitivity, Specificity, PPV, NPV, etc.)

Not Found

Predicate Device(s): If the device was cleared using the 510(k) pathway, identify the Predicate Device(s) K/DEN number used to claim substantial equivalence and list them here in a comma separated list exactly as they appear in the text. List the primary predicate first in the list.

K863840, K904308, K010208

Reference Device(s): Identify the Reference Device(s) K/DEN number and list them here in a comma separated list exactly as they appear in the text.

Not Found

Predetermined Change Control Plan (PCCP) - All Relevant Information for the subject device only (e.g. presence / absence, what scope was granted / cleared under the PCCP, any restrictions, etc).

Not Found

§ 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.

0

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 19714-6101
Victor M. Carrio, Regulatory Affairs and Compliance Manager
Office: (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:

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.

1

| Item | New Device
Dimension Vista™
System Chemistry 3
Calibrator | Dimension® AMON
Calibrator
K863840 | Predicate Devices
Dimension® ALC
Calibrator
K904308 | Dimension® ECO2
Calibrator
K010208 | Constituent | Traceability |
|---------------------|----------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------|----------------------------------------------------------------------------------------------------------------------------------------------------------------------------|-----------------------------------------------------------------------------------------------------------------------------------------------------------------------------------|-----------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------|-------------|-----------------------------|
| 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. | Ammonia Calibrator is an in vitro
diagnostic product to be used for
calibrating the Dimension®
clinical chemistry system for the
ammonia (AMON) method. | The Alcohol Calibrator is an in
vitro diagnostic product to be used
to calibrate the Dimension®
clinical chemistry system for the
Ethyl Alcohol (ALC) method. | The Dimension® ECO2 Calibrator
is an in vitro diagnostics product
to be used to calibrate the
Dimension® clinical chemistry
system for the Enzymatic
Carbonate (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 Ethyl
Alcohol.
AMON – ACS² Grade
Ammonium Sulfate.
CO2 – NIST SRM³ 351. | ACS Grade Ammonium Chloride. | USP Grade Ethyl Alcohol. | NIST SRM 351. | | |
| Matrix | Aqueous product containing
ethyl alcohol, ammonium
bicarbonate and sodium
carbonate. | Aqueous product containing
ammonium chloride. | Aqueous product containing
ethanol. | Aqueous product containing
sodium carbonate. | | |
| Number of
Levels | Two levels. | Three levels. | Four levels. | Three levels. | | |

:

TT

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

2

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.

3

    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.

i

4

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).

5

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

6

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