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).

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℃.

AI/ML Overview

This submission describes a calibration device, not an AI/ML powered diagnostic device. As such, the information typically requested for AI/ML device evaluations (e.g., sample sizes for test and training sets, ground truth establishment, MRMC studies, standalone performance) is not applicable or provided in this document.

However, I can extract the acceptance criteria as presented in the comparative table, which focuses on device characteristics and performance related to its function as a calibrator, and then summarize the study's conclusions regarding these criteria.

Here's the closest interpretation of your request based on the provided text, focusing on the "acceptance criteria" through comparison to a predicate device:

1. Table of Acceptance Criteria (Inferred from Comparison) and Reported Device Performance

For this type of device (calibrators), "acceptance criteria" are implicitly met if the new device demonstrates substantial equivalence to a legally marketed predicate device across key performance characteristics. The table below outlines these characteristics and how the new devices compare to the predicate, demonstrating their "performance" relative to these criteria.

Characteristic (Inferred Acceptance Criterion)	ADVIA® Chemistry Microalbumin Calibrators	ADVIA® Chemistry Microalbumin_2 Calibrators	Predicate Device (DCL Microalbumin Multi-Calibrator Set)
Intended Use	For in vitro diagnostic use in calibration of ADVIA Chemistry systems for Microalbumin method (quantitation of albumin in urine)	For in vitro diagnostic use in calibration of ADVIA Chemistry systems for Microalbumin_2 method (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)	Ready to use. Mix by inversion at least five (5) times.	Ready to use. Mix by inversion at least five (5) times.	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

Study Proving Device Meets Acceptance Criteria:

The study involved demonstrating "traceability, value assignment, and stability" of the ADVIA® Chemistry Microalbumin and ADVIA® Chemistry Microalbumin_2 Calibrators. These validations followed "procedures of Siemens Medical Solutions Diagnostics." The conclusion drawn from this internal validation and comparative analysis is that:

"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."

2. Sample Size Used for the Test Set and Data Provenance:

Sample Size: Not explicitly mentioned in terms of a "test set" as for a diagnostic device. The "performance" assessment is based on the characteristics of the calibrators themselves (e.g., stability over time, value assignment) rather than clinical samples.
Data Provenance: The study was conducted internally by Siemens Medical Solutions Diagnostics. Information regarding country of origin or whether it was retrospective/prospective is not provided, but given it's a calibrator, it would involve laboratory-based testing rather than patient data.

3. Number of Experts Used to Establish the Ground Truth for the Test Set and Qualifications of Those Experts:

This is not applicable as the device is a calibrator, not a diagnostic device that requires expert ground truth for interpretation of results. The "ground truth" for a calibrator relates to its assigned values and stability, which are determined through metrological principles and internal validation processes, likely by qualified scientists or chemists within Siemens.

4. Adjudication Method for the Test Set:

Not applicable for a calibrator device.

5. If a Multi Reader Multi Case (MRMC) Comparative Effectiveness Study was done:

No, an MRMC study was not done. This type of study is relevant for diagnostic devices where human readers interpret results, typically from medical images, and an AI assists in that interpretation. This device is a calibrator, which is a reagent used to standardize other assays.

6. If a Standalone (i.e. algorithm only without human-in-the loop performance) was done:

Not applicable. This is not an algorithm-based device. Its performance is inherent to its chemical properties and manufacturing consistency.

7. The Type of Ground Truth Used:

The "ground truth" for a calibrator refers to its assigned concentration values and its consistent performance over time (stability). This is likely established through:

Reference Methods/Materials: Traceability to established reference methods or certified reference materials for human serum albumin.
Analytical Validation: Rigorous analytical testing to confirm the stated concentrations and assess the stability of the calibrator solutions under various conditions.

8. The Sample Size for the Training Set:

Not applicable. This device is a calibrator, not an AI/ML model that requires a training set.

9. How the Ground Truth for the Training Set was Established:

Not applicable as there is no training set for this type of device.

Summary

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510(k) Summary

Submitter informationContact person:	Philip LiuManager, Regulatory Affairs & Compliance
Address:	Siemens Medical Solutions Diagnostics511 Benedict AvenueTarrytown, NY 10591
Phone:	914-524-2443914-524-2500 (fax)
Date summary prepared:	August 2, 2007
Device Trade or Proprietary Name:	ADVIA® Chemistry Microalbumin CalibratorsADVIA® Chemistry Microalbumin_2 Calibrators
Device Common/Usual Name orClassification Name:	Calibrator
Classification Number/Class:	JIX / Class II
Classification Panel:	Clinical Chemistry (75)

K072204

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 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:

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Comparison Table*

	Device #1	Device #2	Predicate
Item	ADVIA® ChemistryMicroalbumin Calibrators	ADVIA® ChemistryMicroalbumin_2Calibrators	DCL MicroalbuminMulti-Calibrator Set
Intended Use	For in vitro diagnostic usein the calibration ofADVIA Chemistrysystems for theMicroalbumin method(for quantitation ofalbumin in urine)	For in vitro diagnostic usein the calibration ofADVIA Chemistrysystems for theMicroalbumin_2 method(for quantitation ofalbumin in urine)	For in vitro diagnostic useas a calibrator for theDCL Microalbumin Assayfor quantitation of albuminin human urine
Specimen Type(calibratedmethod)	Human Urine	Human Urine	Human Urine
Matrix	Liquid	Liquid	Liquid
Instructions forUse(Preparation)	The calibrators are readyto use. Mix by inversionat least five (5) times toensure homogeneity priorto use.	The calibrators are readyto use. Mix by inversionat least five (5) times toensure homogeneity priorto use.	The calibrators areprovided in a ready to useformat.
CalibratorLevels	5	5	6
ExpectedValues	Lot specific:1, 2.5, 5, 10, and 20mg/dL	Lot specific:1, 4, 10, 20, and 40mg/dL	Lot specific:0.1, 0.5, 1, 5, 10 and 30mg/dL
Shelf LifeStability	2 years	2 years	2 years
Open VialStability	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:

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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Regulation Number and Section

§ 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.