(47 days)
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No
The summary describes a chemical calibrator product and its performance characteristics, with no mention of AI or ML technology.
No
This device is an in vitro diagnostic product used for the calibration of laboratory instruments, not for direct therapeutic use on a patient.
No.
The CHEM 2 CAL is described as an "in vitro diagnostic product for the calibration" of methods, not for diagnosing conditions itself. It is a calibrator, used to ensure the accuracy of diagnostic tests.
No
The device is a liquid, multi-analyte, bovine serum albumin based product, which is a physical substance, not software.
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 2 CAL is an "in vitro diagnostic product for the calibration of Phosphorus (PHOS), Salicylate (SAL), and Triglycerides (TRIG) methods on the Dimension Vista™ System." This directly aligns with the definition of an in vitro diagnostic device, which is used to examine specimens taken from the human body to provide information for diagnosis, treatment, or prevention of disease.
- Device Description: The description details a product used in a laboratory setting (on the Dimension Vista™ System) to calibrate tests for specific analytes (Phosphorus, Salicylate, and Triglycerides) found in biological samples.
- Performance Studies: The "Summary of Performance Studies" describes stability and traceability testing, which are standard evaluations for IVD products to ensure their reliability and accuracy in a diagnostic context.
- Predicate Devices: The mention of "Predicate Device(s)" with K numbers (K861700 and K904307) indicates that this device is being compared to previously cleared IVD devices, further confirming its classification as an IVD.
Therefore, based on the provided information, the CHEM 2 CAL is clearly intended and described as an in vitro diagnostic device.
N/A
Intended Use / Indications for Use
The CHEM 2 CAL is an in vitro diagnostic product for the calibration of Phosphorus (PHOS), Salicylate (SAL), and Triglycerides (TRIG) methods on the Dimension Vista " System.
Product codes
JIX
Device Description
CHEM 2 CAL is a liquid, multi-analyte, bovine serum albumin based product containing phosphorus, salicylate and glycerol. 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 2.0 mL.
Mentions image processing
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Mentions AI, DNN, or ML
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Input Imaging Modality
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Anatomical Site
Not Found
Indicated Patient Age Range
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Intended User / Care Setting
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Description of the training set, sample size, data source, and annotation protocol
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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)
Stability: Target shelf life for the Dimension Vista™ Chemistry 2 Calibrator is 12 months. Calibrator shelf life is determined by comparing results of the product stored at 4°C with control stored at -20°C. 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 7 days. 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, 8, 15, 22, 31, and 32 versus freshly opened vials.
Traceability: The assigned values of the Chemistry 2 Calibrator are traceable to:
- PHOS: NISTa SRM 2186I
- SAL: Sodium Salicylate ACSb grade
- TRIG: Glycerol Anhydrous (ACS grade)
- NIST-SRM: National Institute of Standards and Technology- Standard a. Reference Material.
- ACS: American Chemical Society.
Bottle Value Assignment: The new calibrator is made by adding weighed in aqueous solutions of potassium dihydrogen phosphate, sodium salicylate, and glycerol reference materials to a stock solution at target concentrations. The concentration is verified using an instrument calibrated with primary standards. The stock solutions are added to base matrix in appropriate concentrations and verified using an instrument calibrated with primary standards. The final bottle assignment for each level of the commercial lot is tested N = 45 replicates, with multiple reagent lots on multiple instruments.
Key Metrics (Sensitivity, Specificity, PPV, NPV, etc.)
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Predicate Device(s)
Reference Device(s)
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Predetermined Change Control Plan (PCCP) - All Relevant Information
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§ 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
AUG 0 2 2006
510(k) Summary for the Dimension Vista™ System Chemistry 2 Calibrator (CHEM 2 CAL - KC120)
A. 510(k) Number:
| B. Analytes: | Phosphorus (PHOS), Salicylate (SAL), and Triglycerides (TRIG) |
|---|---|
| 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 2 Calibrator (CHEM 2 CAL - KC120)
F. Regulatory Information:
-
- Regulation section: 21 CFR § 862-1150 Calibrator
-
- Classification: Class II
-
- Product Code: JIX Calibrator, Multi-Analyte Mixture
-
- Panel: Clinical Chemistry
- G. Intended Use: The CHEM 2 CAL is an in vitro diagnostic product for the calibration of Phosphorus (PHOS), Salicylate (SAL), and Triglycerides (TRIG) methods on the Dimension Vista " System.
H. Device Description:
CHEM 2 CAL is a liquid, multi-analyte, bovine serum albumin based product containing phosphorus, salicylate and glycerol. 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 2.0 mL.
1
| Item | Device
Dimension Vista™ System
Chemistry 2 Calibrator | Predicates
Chemistry II Calibrator
K861700 | Predicates
Salicylate Calibrator
K904307 |
|---------------------|-------------------------------------------------------------------------------------------------------------------------------------------------------------------------------|---------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------|---------------------------------------------------------------------------------------------------------------------------------------------------------------|
| Intended Use | The CHEM 2 CAL is an in vitro diagnostic product for the calibration of Phosphorus (PHOS), Salicylate (SAL), and Triglycerides (TRIG) methods on the Dimension Vista™ System. | CHEM II Calibrator is an in vitro diagnostic product to be used to calibrate the Dimension® clinical chemistry system for the magnesium (MG), phosphorus (PHOS) and triglycerides (TRIG) methods. | The Salicylate Calibrator is an in vitro diagnostic product to be used to calibrate the Dimension® clinical chemistry system for the Salicylate (SAL) method. |
| Analytes | Phosphorus (PHOS), Salicylate (SAL), and Triglycerides (TRIG). | Phosphorus (PHOS) and Triglycerides (TRIG). | Salicylate (SAL). |
| Form | Liquid. | Liquid. | Liquid. |
| Traceability | PHOS – NIST SRM 2186I.
SAL – Sodium Salicylate ACS grade.
TRIG - Glycerol Anhydrous ACS grade. | PHOS - NIST SRM 2186I.
TRIG - Glycerol Anhydrous ACS grade. | SAL - Sodium Salicylate ACS grade. |
| Matrix | Bovine serum albumin based product. | Pure magnesium dissolved in a dilute solution of HCL, reagent grade potassium dihydrogen phosphate and reagent grade glycerol. | Aqueous solution of ACS grade sodium salicylate. |
| Number of
Levels | Two levels. | Three levels. | Three levels. |
:
·
:
Substantial Equivalence Information 'I
2
J. Standard/Guidance Document Referenced:
-
- 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.
-
- 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™ Chemistry 2 Calibrator
is 12 months. Calibrator shelf life is determined by comparing
results of the product stored at 4°C with control stored at -20°C.
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 7 days.
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, 8, 15, 22, 31, and 32 versus freshly opened vials. |
|------------------|----------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------|
| 2. Traceability: | The assigned values of the Chemistry 2 Calibrator are traceable to: |
| Constituent | Traceability |
|---|---|
| PHOS | NISTa SRM 2186I |
| SAL | Sodium Salicylate ACSb grade |
| TRIG | Glycerol Anhydrous (ACS grade) |
- NIST-SRM: National Institute of Standards and Technology- Standard a. Reference Material.
- b. ACS: American Chemical Society.
3
-
- Bottle Value Assignment:
The new calibrator is made by adding weighed in aqueous solutions of potassium dihydrogen phosphate, sodium salicylate, and glycerol reference materials to a stock solution at target concentrations. The concentration is verified using an instrument calibrated with primary standards. The stock solutions are added to base matrix in appropriate concentrations and verified using an instrument calibrated with primary standards. The final bottle assignment for each level of the commercial lot is tested N = 45 replicates, with multiple reagent lots on multiple instruments.
- Bottle Value Assignment:
4
DEPARTMENT OF HEALTH & HUMAN SERVICES
Image /page/4/Picture/1 description: The image shows the logo for the U.S. Department of Health and Human Services. The logo consists of a stylized eagle with three lines representing its wings. The eagle is facing to the right. The text "DEPARTMENT OF HEALTH & HUMAN SERVICES USA" is arranged in a circle around the eagle.
Public Health Service
Food and Drug Administration 2098 Gaither Road Rockville MD 20850
Mr. Victor M. Carrio RA/QS Compliance Manager Dade Behring, Inc. 500 GBC Drive PO Box 6101, Mail Stop 514 Newark, DE 19714-6101
AUG 0 2 2006
Re: K061703
Trade/Device Name: CHEM 2 CAL Regulation Number: 21 CFR§ 862.1150 Regulation Name: Calibrator Regulatory Class: Class II Product Code: JIX Dated: June 15, 2006 Received: June 16, 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 misbanding 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, percoits 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 not 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 Guti
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): K061703
Device Name: CHEM 2 CAL
Indications For Use:
The CHEM 2 CAL is an in vitro diagnostic product for the calibration of Phosphorus (PHOS), Salicylate (SAL), and Triglycerides (TRIG) methods on the Dimension Vista™ System.
Prescription Use × (Part 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)
CDRH, Office of I
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