(58 days)
Not Found
No
The device is a set of calibrators for a chemistry system, which are liquid solutions used for calibration, not a software or hardware device that would typically incorporate AI/ML for analysis or decision-making. The description focuses on the chemical composition and intended use for calibration.
No
This device is for in vitro diagnostic use, specifically for the calibration of chemistry systems to quantitate albumin in urine, which is a diagnostic function, not a therapeutic one.
No
The device is described as "Calibrators" for in vitro diagnostic use, meaning they are used to calibrate other diagnostic systems, not to diagnose conditions themselves.
No
The device description clearly states the device is a liquid aqueous buffered solution containing purified human serum albumin, which is a physical substance, not software.
Yes, this device is an IVD (In Vitro Diagnostic).
The "Intended Use / Indications for Use" section explicitly states:
- "The ADVIA® Chemistry Microalbumin Calibrators are for in vitro diagnostic use..."
- "The ADVIA® Chemistry Microalbumin 2 Calibrators are for in vitro diagnostic use..."
This clearly indicates that the device is intended to be used outside of the body to examine specimens for diagnostic purposes.
N/A
Intended Use / Indications for Use
The ADVIA® Chemistry Microalbumin Calibrators are for in vitro diagnostic use in the calibration of ADVIA Chemistry systems for the ADVIA Chemistry Microalbumin method is used for in vitro quantitation of albumin in urine).
The ADVIA® Chemistry Microalbumin 2 Calibrators are for in vitro diagnostic use in the calibration of ADVIA Chemistry systems for the ADVIA Chemistry Microalbumin 2 method (this method is used for in vitro quantitation of albumin in urine).
Product codes (comma separated list FDA assigned to the subject device)
JIX
Device Description
The ADVIA® Chemistry Microalbumin Calibrators and ADVIA® Chemistry Microalbumin 2 Calibrators are each 5 level liguid aqueous buffered solutions containing varying concentrations of purified human serum albumin. The Microalbumin Calibrators have expected values (lot specific) of 1, 2.5, 5, 10, and 20 mg/dL, and the Microalbumin 2 Calibrators have expected values (lot specific) of 1, 4, 10, 20, and 40 mg/dlL.
The calibrators (2 mL/vial) are liquid and ready to use. Storage is at 2 - 8℃.
CAUTION! POTENTIAL BIOHAZARD: Contains human source material. While each human serum or plasma donor unit used in the manufacture of this product was tested by FDAapproved methods and found nonreactive for hepatitis B surface antigen (HBsAg), antibody to hepatitis C (HCV), and antibody to HIV-1/2, all products manufactured using human source material should be handled as potentially infectious. Because no test method can offer complete assurance that hepatitis B or C viruses, HIV, or other infectious agents are absent, these products should be handled according to established good laboratory practices.
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
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Description of the training set, sample size, data source, and annotation protocol
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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)
The traceability, value assignment, and stability of the ADVIA® Chemistry Microalbumin and ADVIA® Chemistry Microalbumin_2 Calibrators have been validated following procedures of Siemens Medical Solutions Diagnostics. These calibrators are substantially equivalent to currently marketed devices with similar intended uses.
Key Metrics (Sensitivity, Specificity, PPV, NPV, etc.)
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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.
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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
| Submitter information
Contact person: | Philip Liu
Manager, Regulatory Affairs & Compliance |
|-----------------------------------------------------|------------------------------------------------------------------------------------------|
| Address: | Siemens Medical Solutions Diagnostics
511 Benedict Avenue
Tarrytown, NY 10591 |
| Phone: | 914-524-2443
914-524-2500 (fax) |
| Date summary prepared: | August 2, 2007 |
| Device Trade or Proprietary Name: | ADVIA® Chemistry Microalbumin Calibrators
ADVIA® Chemistry Microalbumin_2 Calibrators |
| Device Common/Usual Name or
Classification Name: | Calibrator |
| Classification Number/Class: | JIX / Class II |
| Classification Panel: | Clinical Chemistry (75) |
OCT 5 " 2007
This 510(k) summary of safety and effectiveness is being submitted in accordance with the requirements of 21 CFR 807.92.
The assigned 510(k) number is: k072204____________________________________________________________________________________________________________________________
Predicate Device:
| Device Name | DCL Microalbumin Multi-Calibrator Set |
|---|---|
| Common name | Microalbumin Calibrator |
| 510(k) Number | K042243 |
| Manufacturer | Diagnostic Chemicals Limited |
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Device Description:
The ADVIA® Chemistry Microalbumin Calibrators and ADVIA® Chemistry Microalbumin 2 Calibrators are each 5 level liguid aqueous buffered solutions containing varying concentrations of purified human serum albumin. The Microalbumin Calibrators have expected values (lot specific) of 1, 2.5, 5, 10, and 20 mg/dL, and the Microalbumin 2 Calibrators have expected values (lot specific) of 1, 4, 10, 20, and 40 mg/dlL.
The calibrators (2 mL/vial) are liquid and ready to use. Storage is at 2 - 8℃.
CAUTION! POTENTIAL BIOHAZARD: Contains human source material. While each human serum or plasma donor unit used in the manufacture of this product was tested by FDAapproved methods and found nonreactive for hepatitis B surface antigen (HBsAg), antibody to hepatitis C (HCV), and antibody to HIV-1/2, all products manufactured using human source material should be handled as potentially infectious. Because no test method can offer complete assurance that hepatitis B or C viruses, HIV, or other infectious agents are absent, these products should be handled according to established good laboratory practices.
Statement of Intended Use:
The ADVIA® Chemistry Microalbumin Calibrators are for in vitro diagnostic use in the calibration of ADVIA Chemistry systems for the ADVIA® Chemistry Microalbumin method (for quantitation of albumin in human urine).
The ADVIA® Chemistry Microalbumin_2 Calibrators are for in vitro diagnostic use in the calibration of ADVIA Chemistry systems for the ADVIA® Chemistry Microalbumin 2 method (for quantitation of albumin in human urine).
Performance:
The traceability, value assignment, and stability of the ADVIA® Chemistry Microalbumin and ADVIA® Chemistry Microalbumin_2 Calibrators have been validated following procedures of Siemens Medical Solutions Diagnostics. These calibrators are substantially equivalent to currently marketed devices with similar intended uses.
Comparison to the Predicate Device:
Similarities and Differences between the devices and the predicate are shown below:
2
Comparison Table*
| Device #1 | Device #2 | Predicate | |
|---|---|---|---|
| Item | ADVIA® Chemistry | ||
| Microalbumin Calibrators | ADVIA® Chemistry | ||
| Microalbumin_2 | |||
| Calibrators | DCL Microalbumin | ||
| Multi-Calibrator Set | |||
| Intended Use | For in vitro diagnostic use | ||
| in the calibration of | |||
| ADVIA Chemistry | |||
| systems for the | |||
| Microalbumin method | |||
| (for quantitation of | |||
| albumin in urine) | For in vitro diagnostic use | ||
| in the calibration of | |||
| ADVIA Chemistry | |||
| systems for the | |||
| Microalbumin_2 method | |||
| (for quantitation of | |||
| albumin in urine) | For in vitro diagnostic use | ||
| as a calibrator for the | |||
| DCL Microalbumin Assay | |||
| for quantitation of albumin | |||
| in human urine | |||
| Specimen Type | |||
| (calibrated | |||
| method) | Human Urine | Human Urine | Human Urine |
| Matrix | Liquid | Liquid | Liquid |
| Instructions for | |||
| Use | |||
| (Preparation) | The calibrators are ready | ||
| to use. Mix by inversion | |||
| at least five (5) times to | |||
| ensure homogeneity prior | |||
| to use. | The calibrators are ready | ||
| to use. Mix by inversion | |||
| at least five (5) times to | |||
| ensure homogeneity prior | |||
| to use. | The calibrators are | ||
| provided in a ready to use | |||
| format. | |||
| Calibrator | |||
| Levels | 5 | 5 | 6 |
| Expected | |||
| Values | Lot specific: | ||
| 1, 2.5, 5, 10, and 20 | |||
| mg/dL | Lot specific: | ||
| 1, 4, 10, 20, and 40 | |||
| mg/dL | Lot specific: | ||
| 0.1, 0.5, 1, 5, 10 and 30 | |||
| mg/dL | |||
| Shelf Life | |||
| Stability | 2 years | 2 years | 2 years |
| Open Vial | |||
| Stability | 28 days stored @2-8°C | 60 days stored @2-8°C | 30 days stored @2-8°C |
| Standardization | Internal | Internal | Internal |
- From Instructions for Use
Conclusions:
The ADVIA® Chemistry Microalbumin Calibrators and ADVIA® Chemistry Microalbumin_2 Calibrators are substantially equivalent to other products in commercial distribution intended for similar use. Most notably, it is substantially equivalent to the currently marketed DCL Microalbumin Multi-Calibrator Set (K042243) in intended use, matrix, expected values, and stability.
Siemens Medical Solutions Diagnostics ADVIA Chemistry Microalbumin Calibrators ADVIA Chemistry Microalbumin_2 Calibrators Premarket Notification - Abbreviated 510(k) 510(k) Summary
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Image /page/3/Picture/0 description: The image shows the text "DEPARTMENT OF HEALTH & HUMAN SERVICES" in a bold, sans-serif font. To the left of the text is a stylized graphic consisting of three curved lines. The text is horizontally oriented and centered.
Food and Drug Administration 2098 Gaither Road Rockville MD 20850
OCT 5 2007
Siemens Medical Solutions Diagnostics c/o Philip Liu, Manager, Regulatory Affairs & Compliance 551 Benedict Avenue Tarrytown, NY 10591
Re: K072204
Trade/Device Name: ADVIA® Chemistry Microalbumin Calibrators ADVIA® Chemistry Microalbumin 2 Calibrators Regulation Number: 21 CFR 862.1150 Regulation Name: Calibrator, Multi-Analyte Mixture Regulatory Class: Class II Product Code: JIX Dated: August 6, 2007 Received: August 8, 2007
Dear Mr. Liu:
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 af 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
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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.
Jean 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
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Indications for Use
510(k) Number (if known): K072204
Device Name(s): ADVIA CHEMISTRY Microalbumin Calibrators ADVIA CHEMISTRY Microalbumin Calibrators 2 Calibrators
Indications For Use:
The ADVIA® Chemistry Microalbumin Calibrators are for in vitro diagnostic use in the calibration of ADVIA Chemistry systems for the ADVIA Chemistry Microalbumin method is used for in vitro quantitation of albumin in urine).
The ADVIA® Chemistry Microalbumin 2 Calibrators are for in vitro diagnostic use in the calibration of ADVIA Chemistry systems for the ADVIA Chemistry Microalbumin 2 method (this method is used for in vitro quantitation of albumin in urine).
Prescription Use (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 IF NEEDED)
Concurrence of CDRH, Office of In Vitro Diagnostic Devices (OIVD)
CAC
Division Sign-Off
Division Sign-Off
Office of In Vitro Diagnostic Device Evaluation and Safety
510(k) K072204
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