(48 days)
Not Found
No
The device description and performance studies focus on the chemical composition, stability, traceability, and value assignment of a calibrator solution for a clinical chemistry system. There is no mention of AI or ML in the intended use, device description, or performance data.
No.
This device is an in vitro diagnostic product used to calibrate a clinical chemistry system, not to treat a condition or disease in a patient.
No
Explanation: This device is a calibrator for a diagnostic test, not a diagnostic device itself. It is used to ensure the accuracy of a clinical chemistry system that measures cyclosporine levels.
No
The device description clearly states it is an in vitro diagnostic product containing cyclosporine in a preserved whole blood hemolysate, which are physical components, not software.
Yes, this device is an IVD (In Vitro Diagnostic).
The "Intended Use / Indications for Use" section explicitly states: "The Dimension® CSAE Cyclosporine Extended Range Calibrator is an in vitro diagnostic product intended to be used to calibrate the CSAE Cyclosporine Extended range method for the Dimension® clinical chemistry system."
This statement directly identifies the device as an in vitro diagnostic product.
N/A
Intended Use / Indications for Use
The Dimension® CSAE Cyclosporine Extended Range Calibrator is an in vitro diagnostic product intended to be used to calibrate the CSAE Cyclosporine Extended range method for the Dimension® clinical chemistry system.
Product codes
DLJ
Device Description
The Dimension® CSAE Cyclosporine Extended Range Calibrator contains cyclosporine in a preserved whole blood hemolysate. The kit consists of 2 sets of the following: one ni a of sample diluent (0.0 ng/ml of cyclosporine ) and one vial of levels 1 through 5. vial of sample antacht (or the five calibrator levels are approximately 200, 400, 800, 1400 and 2000 ng/ml of cyclosporine. Level 0 is included for dilution of over-range samples (>2000 ng/mL) in order to obtain Ecvel o is metaded for unance it is not used in calibration. Levels 1 thru 5 are used for calibration of the CSAE method. Refer to the method insert sheet for instructions on calibration and making appropriate manual dilutions.
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
Not Found
Key Metrics
Not Found
Predicate Device(s)
Reference Device(s)
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
§ 862.3200 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
SEP 1 2 2005
K052.015
510(k) Summary for the
Dimension® Extended Range Cyclosporine Calibrator Catalog # DC108
A. 510(k) Number:
B. Analyte: Cyclosporine Calibrator
C. Type of Test: Calibrator Material
D. Applicant: Dade Behring Inc., P.O. Box 6101, Newark, DE 19714-6101 (302) 631-9454 Contact: Andrea M. Tasker, Regulatory Affairs and Compliance Manager
E. Proprietary and Established Names:
Dimension® Extended Range Cyclosporine Calibrator (DC108)
F. Regulatory Information:
-
Regulation section: 862.3200 - CLINICAL TOXICOLOGY CALIBRATOR
-
Classification: Class II
-
Product Code: DLJ - CALIBRATORS, DRUG SPECIFIC
-
Panel: CLINICAL TOXICOLOGY
G. Intended Use:
l. Intended use(s):
The Dimension® CSAE Cyclosporine Extended Range Calibrator is an in vitro diagnostic product intended to be used to calibrate the CSAE Cyclosporine Extended range method for the Dimension® clinical chemistry system.
2. Indication(s) for use:
The Dimension® CSAE Cyclosporine Extended Range Calibrator is an in vitro diagnostic product intended to be used to calibrate the CSAE Cyclosporine Extended range method for the Dimension® clinical chemistry system.
-
Special condition for use statement(s): none
-
Special instrument Requirements: none
1
H. Device Description:
The Device Description.
The Dimension® CSAE Cyclosporine Extended Range Calibrator contains cyclosporine in a preserved whole blood hemolysate. The kit consists of 2 sets of the following: one ni a of sample diluent (0.0 ng/ml of cyclosporine ) and one vial of levels 1 through 5. vial of sample antacht (or the five calibrator levels are approximately 200, 400, 800, 1400 and 2000 ng/ml of cyclosporine.
and 2000 ng/m or of eyeresponsive
Level 0 is included for dilution of over-range samples (>2000 ng/mL) in order to obtain Ecvel o is metaded for unance it is not used in calibration. Levels 1 thru 5 are used for calibration of the CSAE method. Refer to the method insert sheet for instructions on calibration and making appropriate manual dilutions.
I. Substantial Equivalence Information:
-
- Substantian Dquivated Information Cyclosporine Calibrator Catalog # DC89
. . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . .
- Substantian Dquivated Information Cyclosporine Calibrator Catalog # DC89
2. Predicate K number(s): K011112
3. Comparison with predicate:
| Item | Device
Dimension® CSAE
Cyclosporine Calibrator | Predicate
Dimension® CSA
Cyclosporine Calibrator |
|--------------------------|--------------------------------------------------------------------------------------------------------------------|-------------------------------------------------------------------------------------------------|
| Intended Use | To calibrate the CSAE
Cyclosporine Extended
range method for the
Dimension® clinical
chemistry system. | To calibrate the CSA
Cyclosporine method for the
Dimension® clinical
chemistry system. |
| Matrix | Preserved whole blood
hemolysate | Preserved whole blood
hemolysate |
| Number of levels | 5 | 5 |
| Target
Concentrations | 200, 400, 800, 1400 and
2000 ng/ml of cyclosporinea | 0, 80, 180, 300 and 500 ng/ml
of cyclosporine |
a. This calibrator material is similar to the predicate in terms of intended use, matrix, and number of levels. Cyclosporine calibrator levels are different compared to the predicate in order to accommodate a higher assay range.
2
J. Standard/Guidance Document Referenced:
Class II Special Controls Guidance Document: Cyclosporine and Tacrolimus Assays; Cuidance for Industry and FDA, Document issued on: September 16, 2002.
K. Test Principle:
The Dimension® CSAE Cyclosporine Extended Range Calibrator contains cyclosporine in a preserved whole blood hemolysate. It is intended to be used to calibrate the high range cyclosporine assay on the Dimension® clinical chemistry systems.
L. Performance Characteristics:
1. Stability
Product is stored at -20℃ and throughout testing cycle and tested at days 0, 7, 14, 30, 1 roduct is stored at - 2 - 40, 270, 300, 330, 390. The control material is stored at -70 °C and tested at the same frequency.
Acceptance Criteria: Allowable drift is less than or equal to the total precision % CV at the test concentration.
2. Traceability:
Novartis Pharmaceutical Grade CSA powder used to formulate a reference stock solution. The concentration of the stock solution is assigned by HPLC. A reference lot is formulated by diluting the stock into whole blood hemolysate with preservatives at six different levels and stored -20° C. The reference lot is assigned by LC/MS/MS.
3. Value Assignment
A cyclosporine stock solution is prepared using standard gravimetric procedure and the concentration of the stock solution is established with high performance liquid chromatography (HPLC). Aliquots of the stock solution are added to measured amounts of calibrator matrix to yield the desired concentration for each calibrator level. Cyclosporine calibrators are prepared in preserved whole blood hemolysate. The recovery of the six levels are verified verses a control calibrator lot (control calibrator = any approved calibrator lot) and verses a frozen reference lot.
Final: September 2, 2005
3
Image /page/3/Picture/1 description: The image shows the logo for the U.S. Department of Health & Human Services. The logo consists of a circular seal with the text "DEPARTMENT OF HEALTH & HUMAN SERVICES - USA" around the perimeter. Inside the circle is an abstract symbol resembling an eagle or bird in flight, composed of three curved lines.
SEP 1 2 2005
Food and Drug Administration 2098 Gaither Road Rockville MD 20850
Ms. Andrea M. Tasker Regulatory Affairs and Compliance Manager Dade Behring, Inc. P.O. Box 6101 Glasgow Bldg. 500 Newark, DE 19714
Re: K052015
Trade/Device Name: Dimension® CSAE Cyclosporine Extended Range Calibrator Regulation Number: 21 CFR 862.3200 Regulation Name: Clinical toxicology calibrator Regulatory Class: Class II Product Code: DLJ Dated: August 30, 2005 Received: September 1, 2005
Dear Ms. Tasker:
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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Page 2 -
This letter will allow you to begin marketing your device as described in your Section 5 [0(k) This letter whi anow you to oegin mancetting your and equivalence of your device to a legally premarket notification: "The PDT Internation 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 (c.vice, If you desire specific information acourtising of your device, please contact the Office of In
or questions on the promotion and advertising of your and advertising office of of questions on the promotion and Safety at (240) 276-0484. Also, please note the VITO Diagnostic Device Developments and reacle to premarket notification" (21CFR Part 807.97). Tegulation childed, "Misording of Priser on your responsibilities under the Act from the I bu may obtain only general mornational 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,
Carol C. Benson
Carol C. Benson, M.A. Acting Director Division of Chemistry and Toxicology Office of In Vitro Diagnostic Device Evaluation and Safety Center for Devices and Radiological Health
Enclosure
5
Indications For Use Statement
510(k) Number (if known):
Device Name:
Dimension® CSAE Cyclosporine Extended Range Calibrator
Indications for Use:
The CSAE Calibrator is an in vitro diagnostic product intended to be used to calibrate the Cyclosporine Extended Range (CSAE) method for the Dimension® clinical chemistry system.
Jan M. Tauer
Andrea M. Tasker Regulatory Affairs and Compliance Manager June 27, 2005
P Prescription Use (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)
AFC
Division Sign-Off
Office of In Vitro Diagnostic Device Evaluation and Safety
510(k) K052015