(36 days)
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No
The description focuses on the chemical composition and physical properties of a calibration product for a diagnostic system. The mention of "corresponding values calculated by the Dimension Vista™ System" refers to standard analytical calculations, not AI/ML. There are no mentions of AI, ML, or related concepts.
No
This device is an in vitro diagnostic product used for calibration of a method to measure cyclosporine levels, not for treating a condition directly.
No
This device is described as a "calibration product" or "calibrator," meaning it is used to set or adjust the accuracy of a diagnostic method or system (the Cyclosporine (CSA) method on the Dimension Vista™ System). It does not directly diagnose a condition or disease in a patient.
No
The device is a physical in vitro diagnostic product consisting of frozen liquid calibrators, 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 DRUG 3 CAL is an "in vitro diagnostic product for the calibration of Cyclosporine (CSA) method on the Dimension Vista™ System." This directly aligns with the definition of an IVD, which are used to examine specimens taken from the human body to provide information for diagnosis, monitoring, or treatment.
- Device Description: The description details a product used in a laboratory setting (on the Dimension Vista™ System) to calibrate a test for Cyclosporine in human whole blood. This is a typical application for an IVD.
- Calibration: The primary function of this device is calibration, which is a crucial step in ensuring the accuracy and reliability of an in vitro diagnostic test.
The other sections, while providing important information about the device, do not contradict its classification as an IVD. The absence of image processing, AI, or specific patient information doesn't preclude it from being an IVD.
N/A
Intended Use / Indications for Use
The DRUG 3 CAL is an in vitro diagnostic product for the calibration of Cyclosporine (CSA) method on the Dimension Vista™ System.
Product codes (comma separated list FDA assigned to the subject device)
DLJ
Device Description
DRUG 3 CAL is a frozen, liquid, human whole blood hemolysate containing cyclosporine.
The kit consists of six vials, three vials of Calibrator A, and three vials of Calibrator B which are frozen. The volume for Calibrator A is 2.0 mL per vial and for Calibrator B is 1.5 mL per vial. Intermediate levels are automatically prepared and corresponding values calculated by the Dimension Vista™ System.
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™ System Drug 3 Calibrator is 12 months. Calibrator shelf life is determined by comparing results of the product stored at -20°C with control stored at -70°C. The method is calibrated from this stored material. The -20℃ 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 seven days. An open vial not on instrument, but recapped and stored in a refrigerator is stable for 31 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 8, 15, 22 and 32 versus freshly opened vials.
-
Traceability: The assigned values of the DRUG 3 CAL are traceable to United States Pharmacopeia Cyclosporine A Reference Material.
-
Bottle Value Assignment: Cyclosporine Reference Material is weighed into drug free whole blood hemolysate at five levels and stored at -70℃. The verification of the Master Pool values are compared against weighed in Master Pool values and LC/MS testing. The stock solution is made by adding Cyclosporine Reference Material gravimetrically to stock solution at target concentrations. The commercial lot is made by adding calculated quantities of stock solution to drug free whole blood hemolysate to target concentrations for each of the calibrator levels. The concentration of each level is verified by using an instrument. Nominal values are assigned to the commercial lot.
The nominal values for each level of the commercial lot are verified using an instrument calibrated with Master Pools.
Key Metrics (Sensitivity, Specificity, PPV, NPV, etc.)
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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.
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.
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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).
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§ 862.3200 Clinical toxicology calibrator.
(a)
Identification. A clinical toxicology 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. A clinical toxicology calibrator can be a mixture of drugs or a specific material for a particular drug (e.g., ethanol, lidocaine, etc.). (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
510(k) Summary for the Dimension VistaTM System Drug 3 Calibrator (DRUG 3 CAL - KC430)
SEP - 6 2006
A. 510(k) Number:
| B. Analytes: | Cyclosporine (CSA) |
|---|---|
| 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 Drug 3 Calibrator (DRUG 3 CAL - KC430)
F. Regulatory Information:
-
- Regulation section: 21 CFR § 862-3200 Clinical Toxicology Calibrator
-
- Classification: Class II
-
- Product Code: DLJ Calibrator, Drug Specific
-
- Panel: Clinical Chemistry
- G. Intended Use: The DRUG 3 CAL is an in vitro diagnostic product for the calibration of Cyclosporine (CSA) method on the Dimension Vista™ System.
H. Device Description:
DRUG 3 CAL is a frozen, liquid, human whole blood hemolysate containing cyclosporine.
The kit consists of six vials, three vials of Calibrator A, and three vials of Calibrator B which are frozen. The volume for Calibrator A is 2.0 mL per vial and for Calibrator B is 1.5 mL per vial. Intermediate levels are automatically prepared and corresponding values calculated by the Dimension Vista™ System.
1
I. Substantial Equivalence Information:
| New Device | Predicate Device | |
|---|---|---|
| Item | Dimension Vista™ System | |
| Drug 3 Calibrator | Dimension® CSA Calibrator | |
| K011112 | ||
| Intended | ||
| Use | The DRUG 3 CAL is an in vitro diagnostic | |
| product for the calibration of Cyclosporine | ||
| (CSA) method on the Dimension Vista™ | ||
| System. | The CSA Calibrator is an in vitro diagnostic | |
| product intended to be used to calibrate the | ||
| Cyclosporine (CSA) method for the | ||
| Dimension® clinical chemistry system. | ||
| Analytes | Cyclosporine. | Cyclosporine. |
| Form | Frozen. | Frozen. |
| Traceability | USP1 Cyclosporine A. | USP Cyclosporine A. |
| Matrix | Human whole blood containing | |
| cyclosporine. | Human whole blood containing | |
| cyclosporine. | ||
| Number of | ||
| Levels | Two levels2. | Five levels. |
1 United States Pharmacopeia.
2 Intermediate levels are automatically prepared and corresponding values calculated by the Dimension Vista™ System.
J. Standard/Guidance Document Referenced:
medical devices
| 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 |
| | Class II Special Controls Guidance Document: Cyclosporine and
Tacrolimus Assays; Guidance for Industry and FDA |
| 2. Standards: | CEN 13640 Stability testing of In-Vitro Diagnostic Devices |
| | ISO 14971:2000 Medical devices -Application of risk management to |
K. Performance Characteristics:
Target shelf life for the Dimension Vista™ System Drug 3 1. Stability: Calibrator is 12 months. Calibrator shelf life is determined by comparing results of the product stored at -20°C with control stored at -70°C. The method is calibrated from this stored material. The -20℃ 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 seven days.
2
An open vial not on instrument, but recapped and stored in a refrigerator is stable for 31 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 8, 15, 22 and 32 versus freshly opened vials.
2. Traceability: The assigned values of the DRUG 3 CAL are traceable to United States Pharmacopeia Cyclosporine A Reference Material.
-
- Bottle Value Assignment:
Cyclosporine Reference Material is weighed into drug free whole blood hemolysate at five levels and stored at -70℃. The verification of the Master Pool values are compared against weighed in Master Pool values and LC/MS testing. The stock solution is made by adding Cyclosporine Reference Material gravimetrically to stock solution at target concentrations. The commercial lot is made by adding calculated quantities of stock solution to drug free whole blood hemolysate to target concentrations for each of the calibrator levels. The concentration of each level is verified by using an instrument. Nominal values are assigned to the commercial lot.
- Bottle Value Assignment:
The nominal values for each level of the commercial lot are verified using an instrument calibrated with Master Pools.
3
DEPARTMENT OF HEALTH & HUMAN SERVICES
Public Health Service
Food and Drug Administration 2098 Gaither Road Rockville MD 20850
Mr. Victor M. Carrio RAC/OC Compliance Manager Dade Behring, Inc. 500 GBC Drive Mailstop 514 Newark, DE 19714
SEP - 6 2006
Re: K062199
Trade/Device Name: Dimension Vista™ System Drug 3 Calibrator (DRUG 3 CAL - KC430) Regulation Number: 21 CFR 862.3200 Regulation Name: Clinical toxicology calibrator Regulatory Class: Class II Product Code: DLJ Dated: July 28, 2006 Received: August 1, 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).
Image /page/3/Picture/11 description: The image shows the logo for the U.S. Department of Health & Human Services. The logo features a stylized eagle or bird-like symbol with flowing lines, representing the department's mission. The text "DEPARTMENT OF HEALTH & HUMAN SERVICES - USA" is arranged in a circular pattern around the symbol.
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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 Statement
510(k) Number (if known):
Device Name:
Dimension Vista™ System Drug 3 Calibrator (DRUG 3 CAL - KC430)
Indications for Use:
The DRUG 3 CAL is an in vitro diagnostic product for the calibration of the cyclosporine (CSA) method on the Dimension Vista™ System.
Prescription Use __ X (Per 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)
Carol C. Benem
Division Sign-Off
Office of In Vitro Diagnostic Device Evaluation and Safety