Predicate Devices

Reference Devices

Not Found

AI/ML (Artificial Intelligence / Machine Learning)

No
The summary describes a chemical calibrator for laboratory instruments and does not mention any computational or algorithmic components, let alone AI/ML.

Therapeutic

No
The device is described as an in vitro diagnostic product for the calibration of alcohol and carbon dioxide methods, not a device used for therapy.

Diagnostic

Yes

Explanation: The "Intended Use / Indications for Use" section explicitly states that the device is "an in vitro diagnostic product."

SaMD (Software as a Medical Device)

No

The device description clearly states it is an "aqueous product containing ethyl alcohol and sodium carbonate" and comes in "six vials." This indicates a physical, chemical product, not software.

IVD (In Vitro Diagnostic)

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

Here's why:

Intended Use: The "Intended Use / Indications for Use" section explicitly states that 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." This directly aligns with the definition of an IVD, which is used to examine specimens derived from the human body to provide information for diagnostic purposes.
Device Description: The description details a product containing substances (ethyl alcohol and sodium carbonate) used in a laboratory setting for calibration, which is a crucial step in ensuring the accuracy of diagnostic tests.
Calibration: The primary function of this device is calibration, which is a process essential for the proper functioning and accuracy of diagnostic instruments used to measure analytes in patient samples.
Traceability: The traceability information indicates that the assigned values are standardized to reference materials (USP Grade Ethyl Alcohol and NIST SRM 351), which is a common practice for IVD calibrators to ensure accuracy and consistency.
Predicate Devices: The mention of predicate devices (K904308 Dimension® ALC Calibrator and K010208 Dimension® ECO2 Calibrator) which are also calibrators for diagnostic tests further supports its classification as an IVD.

Therefore, based on the provided information, the CHEM 3 CAL is clearly an In Vitro Diagnostic device.

PCCP (Predetermined Change Control Plan) Authorized

N/A

Overview

Intended Use / 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.

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 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

Not Found

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

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.

Traceability: The assigned values of the Chemistry 3 Calibrator are standardized to the enclosed table of assigned values:
Constituent: ALC, Traceability: USP Grade Ethyl Alcohol
Constituent: CO2, Traceability: NIST SRM 351

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.

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.

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

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.

Summary

0

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 19714-6101
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) 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 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

Substantial Equivalence Information ட்

.

| Item | New Device
Dimension Vista™ System
Chemistry 3 Calibrator | Predicate Device
Dimension® ALC Calibrator | Dimension® ECO2 Calibrator |
|-----------------------------|--------------------------------------------------------------------------------------------------------------------------------------------------------------------|-----------------------------------------------------------------------------------------------------------------------------------------------------------------------------------|------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------|
| 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. | K904308
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. | K010208
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. |
| 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 ethyl
alcohol and sodium carbonate. | Aqueous product containing ethanol. | Aqueous product containing sodium
carbonate. |
| Number of
Levels | Two levels. | Four levels. | Three levels. |
| United States Pharmacopeia. | | | |

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

:

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:

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.

3

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.

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 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).

5

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

6

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