(100 days)
Not Found
No
The summary describes a calibration product for in vitro diagnostic tests and does not mention any AI or ML components or functionalities.
No
The device is an in vitro diagnostic product used for calibration of laboratory methods, not for direct treatment or therapy of a medical condition.
No
Explanation: This device is a calibrator, used to ensure the accuracy of diagnostic methods. It is not itself a diagnostic device that performs a diagnosis, but rather a tool to support the proper functioning of diagnostic devices.
No
The device description explicitly states it is a "liquid, frozen bovine serum albumin based product containing ferritin from human liver, Vitamin B12 and Folate," indicating it is a physical reagent, not software.
Yes, this device is an IVD (In Vitro Diagnostic).
Here's why:
- Intended Use: The "Intended Use / Indications for Use" section explicitly states that ANEMIA CAL is an "in vitro diagnostic product".
- Function: The device is used for the calibration of methods that measure Vitamin B12, Folate, and Ferritin, which are analytes measured in vitro (outside the body) to aid in the diagnosis of conditions like anemia.
- Device Description: The description confirms it's a "liquid, frozen bovine serum albumin based product containing ferritin from human liver, Vitamin B12 and Folate," indicating it's a reagent used in laboratory testing.
The information provided clearly aligns with the definition of an in vitro diagnostic device.
N/A
Intended Use / Indications for Use
ANEMIA CAL is an in vitro diagnostic product for the calibration of the LOCI Vitamin B12 (B12)and LOCI Folate(FOL) methods on the Dimension(r) EXI(tm) integrated chemistry system and the Ferritin(FERR) method on the Dimension(r) clinical chemistry system.
Product codes (comma separated list FDA assigned to the subject device)
JIX
Device Description
ANEMIA CAL is a multi-analyte, liquid, frozen bovine serum albumin based product containing ferritin from human liver, Vitamin B12 and Folate
Mentions image processing
Not Found
Mentions AI, DNN, or ML
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Input Imaging Modality
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Anatomical Site
Not Found
Indicated Patient Age Range
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Intended User / Care Setting
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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
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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
510(k) Summary for Anemia Calibrator
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: (0936465
Manufacturer's Name, Address, Telephone, and Contact Person, Date of Preparation: 1.
Siemens Healthcare Diagnostics, Inc. Manufacturer:
500 GBC Drive
Newark, DE 19714
Siemens Healthcare Diagnostics, Inc. Contact Information:
500 GBC Drive
Newark, DE 19714
Attn: A. Kathleen Ennis
Tel: 302-631-9352
Fax: 302-631-6299
November 23, 2009 Preparation date:
- Anemia Calibrator 2. Device Name:
Classification: Class II
Product Code: JIX;
Clinical Chemistry (75) Panel:
Identification of the Legally Marketed Device: 3.
Dimension Vista ® LOCI 4 Calibrator K071224
Device Descriptions: 4.
ANEMIA CAL is a multi-analyte, liquid, frozen bovine serum albumin based product containing ferritin from human liver, Vitamin B12 and Folate
MAR - 5 2010
1
Device Intended Uses: 5.
Dimension Anemia Calibrator
The ANEMIA CAL is an in vitro diagnostic product for the calibration of Ferritin (FERR), LOCI Vitamin B12 (B12) and LOCI Folate (FOL) methods on the Dimension ® EXL™ integrated chemistry system.
- Medical device to which equivalence is claimed and comparison information: 6. The ANEMIA CAL is substantially equivalent to the Dimension Vista® LOCI 4 Calibrator. ANEMIA CAL, like the predicate, is an in vitro diagnostic product intended to be used for the calibration of Ferritin, Vitamin B12 and Folate assays.
| Feature | Predicate Device
Dimension Vista® LOCI 4 Calibrator | New Device
Dimension® Anemia Calibrator |
|----------------------------------|------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------|----------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------|
| Similarities | | |
| Intended Use: | LOCI 4 CAL is an in vitro diagnostic
product for calibration of the Ferritin
(FERR), Vitamin B12 (B12) and Folate
(FOL) methods on the Dimension Vista®
System. | ANEMIA CAL is an in vitro
diagnostic product for calibration of
the Vitamin B12 (B12) and Folate
(FOL) methods on the Dimension®
EXLTM integrated chemistry system
and the Ferritin (FERR) method on
the Dimension® clinical chemistry
system. |
| Form: | frozen liquid, bovine serum albumin | frozen liquid, bovine serum albumin |
| Constituents: | ferritin from human liver, vitamin B12
and folate | ferritin from human liver, vitamin
B12 and folate |
| Traceability of
constituents: | ferritin - human serum based anchor
pool containing WHO Standard for
Ferritin, 3rd IS 94/572 | ferritin - human serum based anchor
pool containing WHO Standard for
Ferritin, 3rd IS 94/572 |
| | vitamin B12 - Human serum based
anchor pool containing USP grade
Vitamin B12 | vitamin B12 - Human serum based
anchor pool containing USP grade
Vitamin B12 |
| | folate - human serum based anchor pool
containing USP grade folic acid | folate - human serum based anchor
pool containing USP grade folic acid |
| Levels: | 5 | 5 |
| Stability and storage | LOCI 4 CAL is stored at -20 to -10 °C | ANEMIA CAL is stored at -25 to -
15 °C |
| | LOCI 4 CAL is stable, thawed and
unopened for 30 days @ 2 - 8 °C | ANEMIA CAL is stable, thawed and
unopened for 30 days @ 2 - 8 °C |
| Differences | LOCI 4 Cal is for use on the Dimension
Vista® System. | ANEMIA CAL is for use on the
Dimension® EXLTM integrated
chemistry system. |
Comparative Features Table 7.
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Image /page/2/Picture/0 description: The image shows the logo for the Department of Health & Human Services - USA. The logo consists of a stylized eagle with three wing segments, representing health, services, and people. The text "DEPARTMENT OF HEALTH & HUMAN SERVICES - USA" is arranged in a circular fashion around the eagle.
DEPARTMENT OF HEALTH & HUMAN SERVICES
Siemens Healthcare Diagnostics c/o Anna M. Kathleen Ennis 500 GBC Drive M/S 514 PO Box 6101 Newark, Delaware 19714
Food and Drug Administration 10903 New Hampshire Avenue Document Mail Center - WO66-0609 Silver Spring, MD 20993-0002
Har 0 5 2010
Re: K093645
Trade Name: Anemia Calibrator Regulation Number: 21 CFR §862.1150 Regulation Name: Calibrator. Regulatory Class: Class II Product Codes: JIX Dated: January 20, 2010 Received: January 21, 2010
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).
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If you desire specific advice for your device on our labeling regulation (21 CFR Part 801), 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 postmarket surveillance, please contact CDRH's Office of Surveillance and Biometric's (OSB's) Division of Postmarket Surveillance at (301) 796-5760. 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 ) 796-5680 or at its Internet address http://www.fda.gov/MedicalDevices/Resourcesfor You/Industry/default.htm.
Sincerely yours,
CA
Courtney C. 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
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Indications for Use Form
510(k) Number (if known): ko 93 64 5
Anemia Calibrator Device Name:
Indications for Use:
ANEMIA CAL is an in vitro diagnostic product for the calibration of the LOCI Vitamin B12 (B12)and LOCI Folate(FOL) methods on the Dimension(r) EXI(tm) integrated chemistry system and the Ferritin(FERR) method on the Dimension(r) clinical chemistry system.
XXXXX Over-The-Counter Use Prescription Use AND/OR (Part 21 CFR 801 Subpart D) (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)
Carol Benson
Division Sign-Off Office of In Vitro Diagnostic Device Evaluation and Safety
510(k) K093645
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