(78 days)
Not Found
No
The device is a calibrator for an in vitro diagnostic system and the summary does not mention any AI or ML components.
No
This device is an in vitro diagnostic product used for calibrating laboratory equipment, not for treating patients.
Yes
The "Intended Use / Indications for Use" states that it is "an in vitro diagnostic product for the calibration of the Creatine Kinase (CKI) and Creatine Kinase MB (MBI) methods on the Dimension Mista® System." This clearly indicates its role in a diagnostic context, even though it's a calibrator and not a direct measurement device itself.
No
The device is a liquid, multi-analyte product containing biological components, clearly indicating it is a physical in vitro diagnostic product, not software.
Yes, this device is an IVD (In Vitro Diagnostic).
The "Intended Use / Indications for Use" section explicitly states: "The ENZ 6 CAL is an in vitro diagnostic product for the calibration of the Creatine Kinase (CKI) and Creatine Kinase MB (MBI) methods on the Dimension Mista® System."
This statement directly identifies the device as an in vitro diagnostic product.
N/A
Intended Use / Indications for Use
The ENZ 6 CAL is an in vitro diagnostic product for the calibration of the Creatine Kinase (CKI) and Creatine Kinase MB (MBI) methods on the Dimension VIsta® System.
Product codes (comma separated list FDA assigned to the subject device)
JIX
Device Description
The Dimension Vista® System Enzyme 6 Calibrator (Enz 6 CAL) is a liquid, multianalyte, human serum albumin based product containing creatine kinase MM (human source) and creatine kinase MB (porcine source). The kit consists of three vials of Calibrator A, 2.0 ml per vial. Level 1 calibrator for Enz 6 CAL is not included. Purified Water Diluent or reagent grade water is required for use as Calibrator Level 1. Description of the manufacturing, value assignment and stability testing process are provided in this submission report.
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)
Comparative testing described in the protocol included in this submission demonstrates substantial equivalent performance.
Key Metrics (Sensitivity, Specificity, PPV, NPV, etc.)
Not Found
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.
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
§ 862.1150 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
510(k) Summary of Safety and Effectiveness for the Dimension Vista® System Enzyme 6 Calibrator (KC360)
This summary of 510(k) safety and effectiveness information is being submitted in accordance with the requirements of SMDA 1990 and 21 CFR 807.92.
| A. 510(k) Number: | K083579 |
|---|---|
| ------------------- | --------- |
B. Date of Preparation: November 24, 2008
C. Proprietary and Established Names:
Enzyme 6 Calibrator
D. Applicant:
Siemens Healthcare Diagnostics Inc., P.O. Box 6101, Newark, DE 19714-6101 Victor M. Carrio, Senior Manager, Regulatory Affairs Office: (302) 631-0376 Fax: (302) 631-6299
E. Requiatory Information:
Regulation section: 21 CFR § 862.1150 Calibrator Classification: Class II Product Code: JIX, Calibrator, Multi-Analyte Mixture Panel: Clinical Chemistry
F. Predicate Devices: '
Dimension® CKI/MBI Calibrator (K081731)
G. Device Description:
The Dimension Vista® System Enzyme 6 Calibrator (Enz 6 CAL) is a liquid, multianalyte, human serum albumin based product containing creatine kinase MM (human source) and creatine kinase MB (porcine source). The kit consists of three vials of Calibrator A, 2.0 ml per vial. Level 1 calibrator for Enz 6 CAL is not included. Purified Water Diluent or reagent grade water is required for use as Calibrator Level 1. Description of the manufacturing, value assignment and stability testing process are provided in this submission report.
H. Intended Use:
The ENZ 6 CAL is an in vitro diagnostic product for the calibration of the Creatine Kinase (CKI) and Creatine Kinase MB (MBI) methods on the Dimension VIsta® System.
I. Substantial Equivalence Information:
The Dimension Vista® Enzyme 6 Calibrator (KC360) was compared to the Dimension® CKI/MBI Calibrator (K081731). A comparison of the important similarities and differences between the device and the predicate is provided in the following table:
| Feature | Dimension Vista® Enzyme 6
Calibrator | Dimension® CKI/MBI
Calibrator (K081731) |
|--------------|-------------------------------------------------------------------------------------------|---------------------------------------------------------------------------------------------|
| Intended Use | The ENZ 6 CAL is an in vitro
diagnostic product for the
calibration of the Creatine | The CKI/MBI CAL is an in vitro
diagnostic product for the
calibration of the Creatine |
1
| | Kinase (CKI) and Creatine
Kinase MB (MBI) methods on
the Dimension Vista® System. | Kinase (CKI) and Creatine
Kinase MB (MBI) methods on
the Dimension® clinical
chemistry system. |
|---------|-----------------------------------------------------------------------------------------|---------------------------------------------------------------------------------------------------------|
| Analyte | Creatine kinase (human
source) and creatine kinase-MB
(porcine source) | Creatine kinase (human
source) and creatine kinase-MB
(porcine source) |
| Matrix | Human serum albumin | Human serum albumin |
| Form | Liquid | Liquid |
| Levels | CKI — Two levels
MBI — Two levels | CKI - Three levels
MBI - Five levels |
J. Conclusion:
.
.
:
.
。
The Dimension Vista® Enzyme 6 Calibrator (KC360) is substantially equivalent to the Dimension® CKI/MBI Calibrator (K081731). Comparative testing described in the protocol included in this submission demonstrates substantial equivalent performance.
,
2
Image /page/2/Picture/0 description: The image shows the logo for the U.S. Department of Health & Human Services. The logo is circular and contains the words "DEPARTMENT OF HEALTH & HUMAN SERVICES, USA" around the perimeter. In the center of the circle is an abstract symbol that resembles an eagle or other bird-like figure.
DEPARTMENT OF HEALTH & HUMAN SERVICES
Food and Drug Administration 2098 Gaither Road Rockville MD 20850
Siemens Healthcare Diagnostics Inc. c/o Mr. Victor M. Carrio Senior Manager Regulatory Affairs P.O. Box 6101 Newark, DE 19714-6101
FEB 2 0 2009
Re: K083579
Trade/Device Name: Dimension Vista® Enzyme 6 Calibrator Regulation Number: 21 CFR 862.1150 Regulation Name: Calibrator, Multi-Analyte Regulatory Class: Class II Product Code: JIX Dated: December 3, 2008 Received: December 4, 2008
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).
3
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 (301) 594-3084. 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 of the contra ಿ ಮಾರ್ ರೇಸ್ ನಿರ್ವಹಿಸಿ ಪ್ರಮುಖ http://www.fda.gov/cdrh/dsma/dsmamain.html.
Sincerely yours.
Corg C. He
Courtney C. Harper, Ph.D. Acting Director Division of Chemistry and Toxicology Office of In Vitro Diagnostic Device Evaluation and Safety Center for Devices and Radiological Health
4
Indication for Use
K083579 510(k) Number (if known):
Device Name:
Dimension Vista® Enzyme 6 Calibrator
Indication For Use:
The ENZ 6 CAL is an in vitro diagnostic product for the calibration of the Creatine Kinase (CKI) and Creatine Kinase MB (MBI) methods on the Dimension Mista® 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)
Concerrence of CDRH) Office of In Vitro Diagnostic Device Evaluation and Safety (OIVD) 1
Violet May
Division Sign-Off Office of In Vitro Diagnostic Device Evaluation and Safety
510(k) K083579