(47 days)
Not Found
No
The summary describes a calibration product for in vitro diagnostic tests, not a device that processes data or images using AI/ML. There are no mentions of AI, ML, or related concepts.
No.
The device is described as an "in vitro diagnostic product for the calibration of Alanine Aminotransferase (ALT and ALTI) and Aspartate Aminotransferase (AST) on the Dimension Vista® System," which means it is used for diagnostic testing and not for treating a disease or condition.
No
The device is a calibrator for in vitro diagnostic products, not a diagnostic device itself. It is used to calibrate other diagnostic tests (ALT and AST measurements).
No
The device description clearly states it is a liquid, multi-analyte, bovine serum albumin based product, indicating it is a physical reagent, not software.
Yes, based on the provided information, this device is an IVD (In Vitro Diagnostic).
Here's why:
- Intended Use / Indications for Use: The very first sentence explicitly states, "The ENZ 2 CAL is an in vitro diagnostic product..." This is the most direct confirmation.
- Function: The intended use describes its function as a calibrator for specific enzymes (ALT and AST) on a diagnostic system (Dimension Vista® System). Calibrators are essential components in many in vitro diagnostic tests to ensure accurate measurements of analytes in biological samples.
- Device Description: The description mentions it's a "liquid, multi-analyte, bovine serum albumin based product containing alanine aminotransferase and aspartate aminotransferase from porcine heart." This describes a reagent or material used in a laboratory setting for diagnostic testing.
The information provided strongly indicates that this device is designed to be used outside of the body (in vitro) to aid in the diagnosis or monitoring of medical conditions by calibrating diagnostic tests.
N/A
Intended Use / Indications for Use
The ENZ 2CAL is an in vitro diagnostic product for the calibration of the alanine aminotransferase (ALT and ALT )) and aspartate aminotransferase (AST) methods on the Dimension® Vista system.
Product codes
JIX
Device Description
ENZ 2 CAL is a liquid, multi-analyte, bovine serum albumin based product containing alanine aminotransferase and aspartate aminotransferase from porcine heart.
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)
Not Found
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
§ 862.1150 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
SIEMENS
JAN 2 5 2011
510(k) Summary for Dimension Vista ENZ 2 CAL KC321
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.
The assigned 510(k) number is: K103612
1. Manufacturer's Name, Address, Telephone, and Contact Person, Date of Preparation: Manufacturer: Siemens Healthcare Diagnostics, Inc. 500 GBC Drive Newark, DE 19714 Contact Information: Siemens Healthcare Diagnostics, Inc. 500 GBC Drive Newark, DE 19714 Attn: A. Kathleen Ennis Tel: 302-631-9352 Fax: 302-631-6299 Preparation date: December 1, 2010 ENZ 2 CAL (KC321) 2. Device Name: Classification: Class II (21CFR862.1150) JIX: Product Code: Panel: Clinical Chemistry (75) 3. ldentification of the Legally Marketed Device: Dimension Vista® ENZ 2 CAL (KC320) K061390
ব . Device Descriptions:
ENZ 2 CAL is a liquid, multi-analyte, bovine serum albumin based product containing alanine aminotransferase and aspartate aminotransferase from porcine heart.
5. Device Intended Uses:
Dimension Vista® ENZ 2CAL (KC321)
The ENZ 2CAL is an in vitro diagnostic product for the calibration of the alanine aminotransferase (ALT and ALT )) and aspartate aminotransferase (AST) methods on the Dimension® Vista system.
Medical device to which equivalence is claimed and comparison information: 6. The Dimension Vista ENZ 2 CAL (KC321), is substantially equivalent to the Dimension Vistas
.
1
SIEMENS
ENZ 2 CAL (KC320). Like the predicate, ENZ 2 CAL is an in vitro diagnostic product intended to be used for the calibration of alanine aminotransferase, and aspartate aminotransferase assays.
7. Comparative Features Table
| Feature | Current | Modified |
|---|---|---|
| Dimension Vista® ENZ 2 | ||
| Calibrator KC320 | Dimension® Vista ENZ 2 | |
| Calibrator KC321 | ||
| Similarities | ||
| Form: | liquid, bovine serum albumin | |
| based | liquid, bovine serum albumin | |
| based | ||
| Constituents: | aspartate aminotransferase | |
| and alanine aminotransferase | ||
| from porcine heart | aspartate aminotransferase | |
| and alanine aminotransferase | ||
| from porcine heart | ||
| Traceability | ||
| of | ||
| constituents: | ALT and AST traceable to | |
| Master pool, Dimension® | ||
| clinical chemistry system values | ALT and AST traceable to | |
| Master pool, Dimension® | ||
| clinical chemistry system values | ||
| Packaging: | ENZ 2 CAL is packaged in | |
| glass vials containing 1.5 | ||
| mL/vial. Each carton contains 3 | ||
| vials of each level. | ENZ 2 CAL, modified is | |
| packaged in glass vials | ||
| containing 1.5 mL/vial. Each | ||
| carton contains 3 vials of each | ||
| level. | ||
| Levels: | 2 | 2 |
| Stability and | ||
| storage | ENZ 2 CAL is stored at 2 to 8° | |
| C | ENZ 2 CAL is stored at 2 to 8° | |
| C | ||
| Differences | ||
| Intended Use: | ENZ 2 CAL is an in vitro | |
| diagnostic product for | ||
| calibration of the Aspartate | ||
| Aminotransferase (AST) and | ||
| Alanine Aminotransferase | ||
| (ALT) methods on the | ||
| Dimension Vista® System. | ENZ 2 CAL is an in vitro | |
| diagnostic product for | ||
| calibration of the Aspartate | ||
| Aminotransferase (AST), | ||
| Alanine Aminotransferase (ALT | ||
| and ALTI) methods on the | ||
| Dimension Vista® System. | ||
| Traceability of | ||
| constituents: | ALTI is traceable to the IFCC | |
| ALT@ 37°C primary reference | ||
| method. |
8. Conclusion
Dimension Vista® ENZ 2 CAL, KC321, is substantially equivalent in intended use to the legally marketed device, Dimension Vista® ENZ 2 CAL, KC320, based on the information described above.
2
Image /page/2/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 words "DEPARTMENT OF HEALTH & HUMAN SERVICES • USA" arranged around the perimeter. Inside the circle is an abstract image of an eagle or bird-like figure.
Food and Drug Administration 10903 New Hampshire Avenue Silver Spring, MD 20993
Siemens Healthcare Diagnostics, Inc. c/o Ms. Anna Marie K. Ennis Senior Regulatory Affairs & Compliance Mgr. 500 GBC Drive, PO Box 6101 Newark, Delaware 19714-6101
Re: K103612 Trade Name: Dimension Visa ENZ 2 CAL Regulation Number: 21 CFR 862.1150 Regulation Name: Calibrator Regulatory Class: Class II Product Codes: JIX Dated: December 8, 2010 Received: December 9, 2010
JAN 2 5 201
Dear Ms. Ennis
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); medical device reporting (reporting of medical device-related adverse events) (21 CFR 803); and good manufacturing practice requirements as set forth in the quality systems (QS) regulation (21 CFR Part 820).
: : : :
3
Page 2 -
If you desire specific advice for your device on our labeling regulation (21 CFR Parts 801 and 809), please contact the Office of In Vitro Diagnostic Device Evaluation and Safety at (301) 796-5450. Also, please note the regulation entitled, "Misbranding by reference to premarket notification" (21 CFR Part 807.97). For questions regarding the reporting of adverse events under the MDR regulation (21 CFR Part 803), please go to
http://www.fda.gov/MedicalDevices/Safety/ReportaProblem/default.htm for the CDRH's Office of Surveillance and Biometrics/Division of Postmarket Surveillance.
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) 796-7100 or at its Internet address http://www.fda.gov/cdrh/industry/support/index.html.
Sincerely yours.
C.C.
Courthey Harper, Ph.D. Director Division of Chemistry and Toxicology Office of In Vitro Diagnostic Device Evaluation and Safety Center for Devices and Radiological Health
Enclosure
4
Indications for Use Form
510(k) Number (if known): _( ) 03612
Device Name: Dimension Vista® ENZ 2 CAL
Indications for Use:
The ENZ 2 CAL is an in vitro diagnostic product for the calibration of Alanine Aminotransferase (ALT and ALTI) and Aspartate Aminotransferase (AST) on the Dimension Vista® System.
| Prescription Use_XX (Part 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 OF NEEDED)
Concurrence of CDRH, Office of In Vitro Diagnostic Devices (OIVD)
Signature
Division Sign-Off Office of In Vitro Diagnostic Device
Evaluation and Safety
K103612 510(k)_
Page 1 of _1