(48 days)
Not Found
No
The summary describes a calibrator for a clinical chemistry system, which is a standard laboratory reagent, and contains no mention of AI or ML.
No
The device is described as an "in vitro diagnostic product for the calibration of Alanine Aminotransferase (ALTI) on the Dimension® clinical chemistry system." It is a calibrator used for diagnostic testing, not a device intended to treat, cure, prevent, or mitigate disease.
Yes
The "Intended Use / Indications for Use" section explicitly states that "The Enzyme II Calibrator is an in vitro diagnostic product".
No
The device description clearly states it is a liquid, multi-analyte product, indicating it is a physical reagent, not software.
Yes, this device is an IVD (In Vitro Diagnostic).
The "Intended Use / Indications for Use" section explicitly states: "The Enzyme II Calibrator is an in vitro diagnostic product for the calibration of Alanine Aminotransferase (ALTI) on 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 Enzyme II Calibrator is an in vitro diagnostic product for the calibration of Alanine Aminotransferase (ALTI) on the Dimension® clinical chemistry system.
Product codes (comma separated list FDA assigned to the subject device)
JIX, JIT
Device Description
ENZ II CAL is a liquid, multi-analyte, bovine serum albumin based product containing alanine 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): 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
SIEMENS
510(k) Summary for Dimension ® ENZ II CAL
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: _ K |03836
-
- 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: November 15, 2010 -
- Device Name: ENZ II CAL
Classification: Class II
- Device Name: ENZ II CAL
Product Code: JIX;
Panel: Clinical Chemistry (75)
-
- Identification of the Legally Marketed Device:
Dimension Vista® ENZ 2 CAL K061390
- Identification of the Legally Marketed Device:
4. Device Descriptions:
ENZ II CAL is a liquid, multi-analyte, bovine serum albumin based product containing alanine aminotransferase from porcine heart.
5. Device Intended Uses:
Dimension Vista ® ENZ 2CAL
1
SIEMENS
The ENZ II CAL is an in vitro diagnostic product for the calibration of the alanine aminotransferase (ALT I) method on the Dimension® clinical chemistry system.
6. Medical device to which equivalence is claimed and comparison information:
The Dimension® ENZ II CAL, modified, is substantially equivalent to the Dimension Vista® ENZ 2 CAL. ENZ II CAL like the predicate, is an in vitro diagnostic product intended to be used for the calibration of the alanine aminotransferase assay.
7. Comparative Features Table
| Feature | Predicate Device
Dimension Vista® ENZ 2 Calibrator | New Device
Dimension® ENZ II Calibrator |
|----------------------------------|------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------|-----------------------------------------------------------------------------------------------------------------------------------------------------------------------------|
| Similarities | | |
| Intended Use: | ENZ 2 CAL is an in vitro diagnostic
product for calibration of automated
clinical chemistry analyzers. | ENZ II CAL is an in vitro
diagnostic product for calibration
of automated clinical chemistry
analyzers |
| Form: | liquid, bovine serum albumin based | liquid, bovine serum albumin
based |
| Packaging: | ENZ 2 CAL is packaged in plastic
vials containing 1.5 mL/vial. Each
carton contains 2 vials of each level. | ENZ II CAL is packaged in plastic
vials containing 1.5 mL/vial. Each
carton contains 2 vials of each
level. |
| Stability and
storage | ENZ 2 CAL is stored at 2 to 8 °C | ENZ II 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 II CAL is an in vitro
diagnostic product for calibration
of the Alanine Aminotransferase
(ALTI) method on the Dimension
® clinical chemistry system. |
| Assigned
Constituents: | aspartate aminotransferase and
alanine aminotransferase from
porcine heart | alanine aminotransferase from
porcine heart |
| Traceability of
constituents: | ALT and AST traceable to Master
pool, Dimension® clinical chemistry
system values | ALT I traceable to the IFCC
ALT @ 37°C primary reference
method. |
| Levels: | 2 levels
Level 1 - 0 U/L
Level 2 - 1047 U/L | 3 levels
Level 1 - 0 U/L
Level 2 - 550 U/L
Level 3 - 1100 U/L |
2
SIEMENS
8. Conclusion
Dimension ENZ II CAL is substantially equivalent in intended use to the legally marketed device, Dimension Vista® ENZ 2 Calibrator based on the information described above.
3
Public Health Service
Image /page/3/Picture/2 description: The image shows the logo for the U.S. Department of Health & Human Services. The logo consists of a stylized caduceus symbol, which is a staff with two snakes coiled around it, and the text "DEPARTMENT OF HEALTH & HUMAN SERVICES • USA" arranged in a circular fashion around the symbol. The text is in all caps and is evenly spaced around the circle.
Food and Drug Administration 10903 New Hampshire Avenue Silver Spring, MD 20993
FEB 1 6 2011
Siemens Healthcare Diagnostics, Inc. c/o Anna Marie Kathleen Ennis. Regulatory Affairs Manager 500 GBC Drive PO Box 6101 Newark, DE 19714-6101, USA
Re: K103836
Trade Name: Siemens Dimension® ENZ II Calibrator Regulation Number: 21 CFR §862.1150 Regulation Name: Calibrators Regulatory Class: Class II Product Codes: JIT Dated: February 9, 2011 Received: February 10, 2011
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).
4
If you desire specific advice for your device on our labeling regulation (21 CFR Parts 801 and 809), please contact the Office of In Viro 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.
Courtney 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
5
Indications for Use Form
510(k) Number (if known): K1038360 Device Name: Dimension® ENZ II CAL Indications for Use:
The Enzyme II Calibrator is an in vitro diagnostic product for the calibration of Alanine Aminotransferase (ALTI) on the Dimension® clinical chemistry 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)
District Court Officer
Division Sign-Off Office of In Vitro Diagnostic Device Evaluation and Safety 510(k) 12/0383
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