(36 days)
Not Found
No
The summary describes a calibrator for an in vitro diagnostic test, which is a chemical reagent product, not a software or imaging device typically associated with AI/ML. The "Mentions AI, DNN, or ML" section is explicitly marked as "Not Found".
No
The device is described as an in vitro diagnostic product for the calibration of a method, not for direct therapeutic treatment.
Yes
Explanation: The "Intended Use / Indications for Use" section explicitly states, "The CSAE CAL is an in vitro diagnostic product..." which directly identifies it as a diagnostic device.
No
The device description explicitly states it is an in vitro diagnostic product containing physical components (vials of calibrator) and is used for calibration on a hardware system (Dimension Vista® system). It is not solely software.
Yes, this device is an IVD (In Vitro Diagnostic).
The "Intended Use / Indications for Use" section explicitly states: "The CSAE CAL is an in vitro diagnostic product for the calibration of CSAE method on the Dimension Vista® system."
This statement directly identifies the device as an in vitro diagnostic product.
N/A
Intended Use / Indications for Use
The CSAE CAL is an in vitro diagnostic product for the calibration of CSAE method on the Dimension Vista® system.
Product codes
DLJ
Device Description
The Dimension Vista® Cyclosporine Extended Range Calibrator contains cyclosporine in a preserved whole blood hemolysate. The kit consists of three vials of Calibrator A (200 ng/mL) and three vials of Calibrator B (2000 ng/mL). The intermediate calibrator levels (400. 800 and 1400 ng/mL) are prepared on-board the Dimension® Vista analyzer.
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
The stability of the calibrators is established through real-time data on 3 lots of product. Testing is conducted at multiple time points and must pass pre-defined acceptance criteria.
Key Metrics
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.
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AUG 2 2 2008
510(k) Summary of Safety and Effectiveness Dimension Vista® Cyclosporine Extended Range Calibrator
This summary of 510(k) safety and effectiveness information is submitted in accordance with the requirements of SMDA 1990 and 21 CFR §807.92.
KOS2030 The assigned 510(k) number is:
Submitter's Contact Information and Date of Preparation 1.
Contact Information:
Siemens Healthcare Diagnostics Inc. P.O. Box 6101 Newark, DE 19714-6101 Attn: Yuk-Ting Lewis Tel: 302-631-7626
Date of Preparation:
July 10, 2008
Proprietary Device Name / FDA Classification Name 2.
Dimension Vista® Cyclosporine Extended Range Calibrator / Clinical Toxicology Calibrator
Identification of the Predicate Device 3.
Dimension® CSAE Cyclosporine Extended Range Calibrator, K061503
4. Device Description
The Dimension Vista® Cyclosporine Extended Range Calibrator contains cyclosporine in a preserved whole blood hemolysate. The kit consists of three vials of Calibrator A (200 ng/mL) and three vials of Calibrator B (2000 ng/mL). The intermediate calibrator levels (400. 800 and 1400 ng/mL) are prepared on-board the Dimension® Vista analyzer.
1
Siemens Healthcare Diagnostics Inc.
510(k) Premarket Notification - Dimension Vista® Cyclosporine Extended Range Calibrator
5. Device Intended Use
The CSAE CAL is an in vitro diagnostic product for the calibration of CSAE method on the Dimension Vista® system.
Summary of the devices technological characteristics 6.
A comparison of the Dimension Vista® CSAE Calibrator vs. the predicate device is provided.
| (New Device) | (Predicate) | |
|---|---|---|
| Characteristic | Dimension Vista® | |
| Cyclosporine Extended | ||
| Range Calibrator | Dimension® CSAE | |
| Cyclosporine Extended | ||
| Range Calibrator, K061503 | ||
| Intended Use | The CSAE CAL is an in vitro | |
| diagnostic product for the | ||
| calibration of CSAE method | ||
| on the Dimension Vista® | ||
| system. | 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 or | ||
| the Syva® Emit® 2000 | ||
| Cyclosporine Specific Assay. | ||
| Analyte | Cyclosporine | |
| Matrix | Preserved whole blood hemolysate | |
| Number of levels and target | ||
| concentrations | Two levels: 200 and 2000 | |
| ng/mL cyclosporine. The | ||
| intermediate calibrator levels | ||
| (400, 800 and 1400 ng/mL) | ||
| are prepared on-board the | ||
| Dimension® Vista analyzer. | Five levels: 200, 400, 800, | |
| 1400 and 2000 ng/mL | ||
| cyclosporine. | ||
| Stability | The stability of the calibrators is established through real-time | |
| data on 3 lots of product. Testing is conducted at multiple time | ||
| points and must pass pre-defined acceptance criteria. | ||
| Traceability | The calibrator is traceable to an internal master pool containing | |
| USP cyclosporine A and whose values are confirmed by | ||
| LC/MS/MS. |
2
7. Conclusion
Based on a review of the devices technological features, the Dimension Vista® Cyclosporine Extended Range Calibrator is substantially equivalent to the legally marketed device, the Dimension® CSAE Cyclosporine Extended Range Calibrator.
3
DEPARTMENT OF HEALTH & HUMAN SERVICES
Image /page/3/Picture/1 description: The image shows a black and white logo. The logo is circular in shape and features a stylized eagle head in the center. The eagle's head is composed of three curved lines. The text "U.S. DEPARTMENT OF HEALTH & HUMAN SERVICES" is arranged around the perimeter of the circle.
Public Health Service
Food and Drug Administration 2098 Gaither Road Rockville MD 20850
Siemens Healthcare Diagnostics, Inc. c/o Yuk-Ting Lewis Regulatory Affairs & Compliance Manager P.O. Box 6101, Mail Stop 514 Newark, DE 19714-6101
AUG 2 2 2008
K082030 Re:
Trade Name: Dimension Vista® Cyclosporine Extended Range Calibrator Regulation Number: 21 CFR 862.3200 Regulation Name: Clinical Toxicology Calibrator. Regulatory Class: Class II Product Codes: DLJ Dated: July 15, 2008 Received: July 17, 2008
Dear Ms. Lewis:
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).
4
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) 276-0490. 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 (240) 276-3150 or at its Internet address at http://www.fda.gov/cdrh/industry/support/index.html.
Sincerely yours,
Jean M. Cooper, M.S., D.V.M.
Yean M. Cooper, M.S., D.V.M. Director Division of Chemistry and Toxicology Office of In Vitro Diagnostic Device Evaluation and Safety Center for Devices and Radiological Health
Enclosure
5
Siemens Healthcare Diagnostics Inc.
Stemens Healthoure Diagnostion Vista® Cyclosporine Extended Range Calibrator
Indication for Use
510(k) Number (if known):
Dimension Vista® Cyclosporine Extended Range Calibrator Device Name:
Indications For Use:
The CSAE CAL is an in vitro diagnostic product for the calibration of CSAE method on the Dimension Vista® system.
Prescription Use __ X_____________________________________________________________________________________________________________________________________________________________________________ (21 CFR Part 801 Subpart D) And/Or
Over the Counter Use (21 CFR Part 801 Subpart C)
(PLEASE DO NOT WRITE BELOW THIS LINE; CONTINUE ON ANOTHER PAGE IF NEEDED)
Concurrence of CDRH, Office of In Vitro Diagnostic Device Evaluation and Safety (OIVD)
Division Sign-Off Office of In Vitro Diagnostic Device Evaluation and Safety
510(k) K082030