(21 days)
No
The device is a calibrator for a clinical chemistry system and does not describe any computational or analytical functions that would involve AI/ML.
No
This device is an in vitro diagnostic product used to calibrate a clinical chemistry system, not to treat a condition or disease directly.
No
This product is a calibrator, used to calibrate methods for measuring cyclosporine. It is not intended to diagnose a patient's condition.
No
The device is a calibrator containing cyclosporine in a preserved whole blood hemolysate, which is a physical substance, 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 and the Syva® Emit® 2000 Cyclosporine assay."
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 and the Syva® Emit® 2000 Cyclosporine assay.
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 vial of sample diluent (0.0 ng/ml of cyclosporine ) and one vial of levels 1 through 5. Target concentrations for 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 results within the assay range; it is not used in calibration. Levels 1 thru 5 are used for calibration of the CSAE method.
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 testing was conducted to determine the target shelf life of 12 months for the Dimension® CSAE Calibrator (DC108A). Studies required 13 months of real-time testing on three lots of product. Calibrator shelf life is determined by comparing results of the product stored at -15 to -25℃ (recommended storage temperature) with product stored at -70°C (reference storage temperature) to ensure that analytical system drift is dissociated with calibrator drift. Product is tested at days 0, 7, 14, 30, 90, 120, 150, 180, 210, 240, 270, 300, 330, 360, 390.
Key Metrics (Sensitivity, Specificity, PPV, NPV, etc.)
Not Found
Predicate Device(s)
Reference Device(s)
Not Found
Predetermined Change Control Plan (PCCP) - All Relevant Information
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
JUN 222 2006
510(k) Summary for the Dimension® Extended Range Cyclosporine Calibrator Catalog # DC108A
A. 510(k) Number: K061503
B. Analyte: Cyclosporine Calibrator
C. Type of Test: Calibrator Material
D. Applicant:
Manufacturer: Dade Behring Inc., P.O. Box 6101, Newark, DE 19714-6101
Contact: Andrea M. Tasker, Regulatory Affairs and Compliance Manager (302) 631-9454
Date of Preparation: May 31, 2006
E. Proprietary and Established Names:
Dimension® Extended Range Cyclosporine Calibrator (DC108A)
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:
-
- 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 and the Syva® Emit® 2000 Cyclosporine assay.
- Intended use(s):
- 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 and the Syva® Emit® 2000 Cyclosporine assay.
1
-
- Special condition for use statement(s): none
-
- Special instrument Requirements: none
H. 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 vial of sample diluent (0.0 ng/ml of cyclosporine ) and one vial of levels 1 through 5. Target concentrations for 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 results within the assay range; it is not used in calibration. Levels 1 thru 5 are used for calibration of the CSAE method.
I. Substantial Equivalence Information:
-
Predicate device name(s): Dimension® CSAE Cyclosporine Extended Range Calibrator (DC108)
-
Predicate K number(s): K052015, Dimension® Cyclosporine Extended Range Calibrator (CSAE CAL - DC108) cleared on September 12, 2005 for the Dimension® system intended use
K053108, Dimension® Cyclosporine Extended Range Calibrator (CSAE CAL - DC108) cleared on January 12, 2006 for new Syva® Emit® 2000 intended use
| Item | New Device | Predicate |
|---|---|---|
| Dimension® CSAE | ||
| Cyclosporine Calibrator | ||
| DC108A | Dimension® CSAE | |
| Cyclosporine Calibrator | ||
| DC108 | ||
| Intended 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 and | 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 and |
3. Comparison with predicate:
2
| | the Syva® Emit® 2000
Cyclosporine assay. | the Syva® Emit® 2000
Cyclosporine assay. |
|------------------------------------------------|-----------------------------------------------------------------------------------------------------------------------------------------------------------|-----------------------------------------------------------------------------------------------------------------------------------------------------------------|
| Matrix | Preserved whole blood
hemolysate | Preserved whole blood
hemolysate |
| Number of levels
used for calibration | 5 Levels | 5 Levels |
| Target
Concentrations | 200, 400, 800, 1400 and 2000
ng/ml of cyclosporine | 200, 400, 800, 1400 and 2000
ng/ml of cyclosporine |
| Storage | This is a frozen product | This is a frozen product |
| Differences | | |
| Item | New Device | Predicate |
| | Dimension® CSAE
Cyclosporine Calibrator
DC108A | Dimension® CSAE
Cyclosporine Calibrator
DC108 |
| Packaging | The kit consists of 6 glass
Vials (Level 0 - Level 5),
2.0 mL each. | The kit consists of 6 plastic
Vials (Level 0 - Level 5),
2.0 mL each. |
| Storage
Temperature | Unopened vials should be
stored between -15 and -25°C. | Unopened vials should be
stored between -17 and -27°C. |
| Traceability
(Reference lot
Formulation) | Reference lot stock solution
formulated
Final Reference lot sent to
external reference lab for
LC/MS/MS value assignment | Reference lot stock solution
formulated and tested by
LC/MS
Final Reference lot sent to
external reference lab for
LC/MS/MS value assignment |
| Value
Assignment
(New Calibrator
Lot) | Stock solution for new
Calibrator Lot formulated | Stock solution for new
Calibrator Lot formulated and
tested by LC/MS |
| | New Calibrator Lot recovery
verses the Reference Lot and
verses Control Calibrator lot
(Control Calibrator Lot =
Any Approved Calibrator Lot) | New Calibrator Lot recovery
verses the Reference Lot and
verses Control Calibrator lot
(Control Calibrator Lot =
Any Approved Calibrator Lot) |
| Production
Site | Calibrator manufactured by
Dade Behring Inc. in Glasgow
Delaware | Calibrator prepared by an
OEM Manufacturer for Dade
Behring Inc. |
. . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . .
3
J. Standard/Guidance Document Referenced:
1. Guidance;
Class II Special Controls Guidance Document: Cyclosporine and Tacrolimus Assays; Guidance for Industry and FDA, Document issued on: September 16, 2002.
| 2. Standards; | |
|---|---|
| GP22-A | Continuous Quality Improvement Essential Management Approaches |
| CEN 13640 | Stability testing of In-Vitro Diagnostic Devices |
| ISO 14971:2000 | Medical devices -Application of risk management to medical |
| devices | |
| ISO 15223 | Medical devices - Symbols to be used with medical device labeling |
| and information to be supplied |
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 and the Syva® Emit® 2000 Cyclosporine assay.
4
L. Performance Characteristics:
1. Stability
Target shelf life for the Dimension® CSAE Calibrator (DC108A) is 12 months. Studies require 13 months of real time testing on three lots of product. Calibrator shelf life is determined by comparing results of the product stored at -15 to -25℃ (recommended storage temperature) with product stored at -70°C (reference storage temperature) to ensure that analytical system drift is dissociated with calibrator drift. Product is tested at days 0, 7, 14, 30, 90, 120, 150, 180, 210, 240, 270, 300, 330, 360, 390.
2. Traceability:
Novartis Pharmaceutical USP Grade CSA powder is used to formulate a reference stock solution. A reference lot is formulated by diluting the stock into whole blood hemolysate with preservatives at six different levels and stored -70°C. The reference lot is assigned by LC/MS/MS.
3. Value Assignment
A cyclosporine stock solution is prepared using standard gravimetric procedure. Aliquots of the stock solution are added to measured amounts of calibrator matrix to vield 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 the frozen reference lot.
M. Comments on Substantial Equivalence/Conclusion
The performance testing according to the verification and validation test protocols demonstrate that the Dimension® CSAE Calibrator (DC108A) is substantially equivalent to the designated predicate device.
5
DEPARTMENT OF HEALTH & HUMAN SERVICES
Image /page/5/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 its wings spread, and the words "DEPARTMENT OF HEALTH & HUMAN SERVICES - USA" are arranged in a circular pattern around the eagle. The logo is black and white.
Public Health Service
JUN 222 2006
Food and Druq Administration 2098 Gaither Road Rockville MD 20850
Ms. Andrea M. Tasker Regulatory Affairs and Compliance Manager Dade Behring Inc. Glasgow Business Community PO Box 6101 MS 514 Newark, DE 19714-6101
Re: K061503
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: May 31, 2006 Received: June 1, 2006
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).
6
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 vours.
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
7
Indications For Use Statement
510(k) Number (if known):
06/503
Device Name:
Dimension® CSAE Cyclosporine Extended Range Calibrator
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 and the Syva® Emit® 2000 Cyclosporine assay.
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)
GAC
Division Sign-Off
Office of the Vitro Diagnostic Device Evaluation and Safet
100k) K061503