For in vitro diagnostic use in the quantitative determination of calcium in human serum, plasma, and urine on the ADVIA Chemistry systems. Such measurements are used in the diagnosis and treatment of parathyroid disease, a variety of bone diseases, chronic renal failure, and tetany.

Device Description

Summary and Explanation: the Calcium 2 (CA 2) method is based on the work of Michaylova and Illkova, (Anal Chem Acta 1971; 53: 194), who found that Arsenazo III could form a stable complex with calcium with high selectivity at low pH.

Principles of the Procedure: Calcium ions form a colored complex with Arsenazo III, which is measured at 658/694 nm. The amount of calcium present in the sample is directly proportional to the intensity of the colored complex formed.

Reaction Equation: Ca2+ + Arsenazo III ---> Ca-Arsenazo III Complex (purple)

AI/ML Overview

The provided document is a 510(k) summary for the ADVIA® Chemistry Calcium 2 Method, which is an in vitro diagnostic device for quantitative determination of calcium. It aims to demonstrate substantial equivalence to a predicate device. The document describes the device, its intended use, and a comparison with the predicate. However, it does not contain specific acceptance criteria, detailed study results (like sample sizes for test/training sets, data provenance, expert details, or MRMC studies), or a comprehensive description of how ground truth was established, beyond stating "comparative testing described in the protocol included in this submission demonstrates substantially equivalent performance."

Therefore, much of the requested information cannot be extracted from this document.

Here's what can be extracted and what is missing:

1. Table of Acceptance Criteria and Reported Device Performance

This information is not provided in the document. The document states that "Comparative testing described in the protocol included in this submission demonstrates substantially equivalent performance," but it does not present the acceptance criteria for that testing or the specific performance metrics achieved against those criteria.

Acceptance Criteria	Reported Device Performance
Not specified in this document	Not specified in this document

2. Sample size used for the test set and the data provenance

This information is not provided in the document.

3. Number of experts used to establish the ground truth for the test set and the qualifications of those experts

This information is not provided in the document. Establishing ground truth for a clinical chemistry assay typically involves reference methods or certified reference materials, not human experts in the same way as imaging analysis. However, the document does not specify how ground truth was established for the comparative performance study.

4. Adjudication method for the test set

This information is not provided in the document.

5. If a multi reader multi case (MRMC) comparative effectiveness study was done, If so, what was the effect size of how much human readers improve with AI vs without AI assistance

This is not applicable to this type of chemical assay device. MRMC studies are typically used for imaging or diagnostic devices where human interpretation is involved. This device is an automated quantitative chemical analysis system.

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

This device is essentially a standalone algorithm/system. Its performance is measured independently of human interpretation in the analytical sense. The document implicitly supports this by describing it as a "quantitative determination of calcium" on automated chemistry systems. However, a formal "standalone study" in the context of an algorithm's performance vs. a human reader for a specific diagnostic task (like in imaging AI) is not relevant here. The comparison is between the new device and a predicate device, both automated diagnostic tests.

7. The type of ground truth used (expert consensus, pathology, outcomes data, etc)

This information is not explicitly stated. For quantitative chemical assays, ground truth is typically established using:

Reference methods (e.g., atomic absorption spectroscopy for calcium)
Certified reference materials with known analyte concentrations
Comparative analysis against a legally marketed predicate device (as done here, for substantial equivalence)

The document refers to "comparative testing" against the predicate device (ADVIA Chemistry 1650 Calcium method), implying that the predicate's results might serve as a form of reference or comparison for the new device's accuracy and precision.

8. The sample size for the training set

This information is not provided in the document. Algorithms for chemical assays like this are typically developed and validated using calibration materials and quality control samples, rather than a "training set" in the machine learning sense.

9. How the ground truth for the training set was established

This information is not provided in the document. As mentioned for #8, the concept of a "training set" with established ground truth is less directly applicable for this type of device. Calibration and quality control procedures involve materials with known concentrations, but these are part of the operational system rather than a "training set" for a learning algorithm.

Summary

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15083386

510(k) Summary of Safety and Effectiveness for the

ADVIA® Chemistry Calcium 2 Method

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.

A. 510(k) Number: K083386

APR - 2 2009

B. Date of Preparation: September 29, 2008

C. Proprietary and Established Names:

ADVIA® Chemistry Calcium 2 Method

D. Applicant:

Siemens Healthcare Diagnostics Inc., 511 Benedict Ave, Tarrytown, NY 10591

Carol Bianca, Sr. Manager, Regulatory Affairs

Office (914) 524-2531 Fax: (914) 524-2500

E. Regulatory Information:

ADVIA Chemistry Calcium 2 Method

1. Regulation section: 21 CFR § 862.1145 Calcium test system.
1. Classification: Class II
1. Product Code: CJY, azo dye, calcium
1. Panel: Clinical Chemistry

F. Predicate Device:

ADVIA Chemistry Calcium 2 Method is substantially equivalent to the ADVIA Chemistry 1650 Calcium method cleared under K991576.

G. Device Description:

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Reaction Equation: Ca2+ + Arsenazo III ---> Ca-Arsenazo III Complex (purple)

H. Intended Use:

I. Substantial Equivalence Information:

The ADVIA Chemistry Calcium 2 Method and ADVIA 1650 Calcium methods were compared. A comparison of the important similarities and differences between the device and the predicate is provided in the following tables:

Similarities
Characteristics	Siemens ADVIA Calcium_2(newdevice)	Bayer (currently Siemens) ADVIA 1650Calcium (predicate device)
Intended Use	same	same
Sample Type	Serum, plasma (Li-heparin) andurine	Serum, plasma (Li-heparin) and urine
Instrument	ADVIA® Chemistry systems	ADVIA® Chemistry systems
Calibrators	Siemens Chemistry Calibrator(K030169)	Same (K030169)
Controls used	BioRad controls	BioRad controls
Method	colorimetry	colorimetry
Differences
Characteristics	Siemens ADVIA Calcium_2(newdevice)	Bayer (currently Siemens) ADVIA 1650Calcium (predicate device)
AssayProtocol	Calcium ions form a colored complexwith Arsenazo III, which is measuredat 658/694 nm. The amount ofcalcium present in the sample isdirectly proportional to the intensityof the colored complex formed.Reaction Equation:$Ca2+ + Arsenazo III -> Ca-ArsenazoIII Complex (purple)$	Calcium ions form a violet complexwith o -cresolphthalein complexone inan alkaline medium. The reaction ismeasured at 545/658 nm.Reaction Equation:$CPC + 2Ca2+ ->CPC (Ca2+)2 Complex$

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Reagents	One liquid reagent	Two liquid reagents
ExpectedValues	Serum/Plasma:8.7-10.4 mg/dL (2.18-2.60 mmol/L)	Serum/Plasma:8.3-10.6 mg/dL (2.08-2.65 mmol/L)
	Urine:100-300 mg/day (2.5-7.5 mmol/day)	Urine:100-300 mg/day (2.5-7.5 mmol/day)
MeasuringRange	Serum/Plasma:1.0 - 16.0 mg/dL (0.25 - 4.0 mmol/L)	Serum/ Plasma:1.0 - 15.0 mg/dL (0.25 – 3.75 mmol/L)
	Urine1.0-32 mg/dL (0.25 – 8.0 mmol/L)	Urine:1.0 - 30.0 mg/dL (0.25 - 7.50 mmol/L)

J. Conclusion:

The ADVIA Chemistry Calcium_2 Method is substantially equivalent to the ADVIA 1650 Calcium method cleared under K991576. Comparative testing described in the protocol included in this submission demonstrates substantially equivalent performance.

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DEPARTMENT OF HEALTH & HUMAN SERVICES

Image /page/3/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 text "DEPARTMENT OF HEALTH & HUMAN SERVICES • USA" around the perimeter. Inside the circle is an emblem of an eagle with its wings spread, symbolizing the department's mission to protect the health of all Americans.

Public Health Service

Food and Drug Administration 2098 Gaither Road Rockville MD 20850

Siemens Healthcare Diagnostics c/o Philip Liu, Ph.D. Manager, Regulatory Affairs and Compliance 511 Benedict Ave. Tarrytown, NY 10591

Re: K083386

Trade Name: ADVIA Chemistry Calcium 2 Method Regulation Number: 21 CFR 862.1145 Regulation Name: Calcium test system Regulatory Class: Class II Product Codes: CJY Dated: February 27, 2009 Received: March 4, 2009

APR - 2 2009

Dear Dr. 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. Iisting 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); and good manufacturing practice requirements as set forth in the quality systems (OS) regulation (21 CFR Part 820).

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Page - 2

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 (301) 594-3084. 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 (301) 443-6597 or at its Internet address http://www.fda.gov/cdrh/dsma/dsmamain.html.

Sincerely yours,

Corg C. He

Courtney C. Harper, Ph.D. Acting Director Division of Chemistry and Toxicology Office of In Vitro Diagnostic Device Evaluation and Safety Center for Devices and Radiological Health

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Indication for Use

510(k) Number (if known): K083386

Device Name: ADVIA® Chemistry Calcium 2 Method

Indication For Use:

Prescription Use X (21 CFR Part 801 Subpart D) And/Or

Over the Counter Use (21 CFR Part 801 Subpart C)

(PLEASE DO NOT WRITE BELOW THIS LINE; CONTINUE ON ANOTHER PAGE IF NEEDED)

Concurrence of CDRH, Office of In Vitro Diagnostic Device Evaluation and Safety (OIVD)

Carol C. Benson

Division Sign-Of Office of In Vitro Diagnostic Device Evaluation and Safety

510(k) K083386

Regulation Number and Section

§ 862.1145 Calcium test system.

(a)
Identification. A calcium test system is a device intended to measure the total calcium level in serum. Calcium measurements are used in the diagnosis and treatment of parathyroid disease, a variety of bone diseases, chronic renal disease and tetany (intermittent muscular contractions or spasms).(b)
Classification. Class II.