ADVIA CHEMISTRY CALCIUM_2 (CA_2) METHOD, MODELS P/M 02189699 (40 ML FILL), P/N 02189915 (70 ML FILL)

K083386 · Siemens Healthcare Diagnostics · CJY · Apr 2, 2009 · Clinical Chemistry

Device Facts

• Record ID: K083386
• Device Name: ADVIA CHEMISTRY CALCIUM_2 (CA_2) METHOD, MODELS P/M 02189699 (40 ML FILL), P/N 02189915 (70 ML FILL)
• Applicant: Siemens Healthcare Diagnostics
• Product Code: CJY · Clinical Chemistry
• Decision Date: Apr 2, 2009
• Decision: SESE
• Submission Type: Traditional
• Regulation: 21 CFR 862.1145
• Device Class: Class 2

Intended Use

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 Story

ADVIA Chemistry Calcium_2 Method is a quantitative, colorimetric in vitro diagnostic assay for use on ADVIA Chemistry systems. Input: human serum, plasma, or urine samples. Principle: sample prediluted 5-fold with saline; calcium ions react with Arsenazo III reagent at pH 5.9 to form a purple complex; absorbance measured at 658 nm. Output: calcium concentration proportional to color intensity. Used in clinical laboratories by trained personnel. Results assist clinicians in diagnosing and managing parathyroid, bone, and renal diseases.

Clinical Evidence

Bench testing only. Precision evaluated per CLSI EP05-A2 (n=40 replicates); total CVs ranged 0.8-2.1% (serum) and 1.6-3.0% (urine). Linearity confirmed across 1-16 mg/dL (serum) and 1-32 mg/dL (urine). Method comparison with predicate (n=172 serum, n=50 urine) showed high correlation (r=0.996 serum, r=0.998 urine). Interference testing showed no significant interference for hemoglobin, bilirubin, triglycerides, or gadolinium contrast agents.

Technological Characteristics

Colorimetric assay; Arsenazo III reagent; single liquid reagent format; measures absorbance at 658/694 nm; automated on ADVIA Chemistry systems.

Indications for Use

Indicated for quantitative determination of calcium in human serum, plasma, and urine for patients requiring assessment of parathyroid disease, bone diseases, chronic renal failure, or tetany.

Regulatory Classification

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).

Predicate Devices

• Calcium method for the Bayer ADVIA 1650 system (k991576)

Submission Summary (Full Text)

{0}------------------------------------------------

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 [phone] Fax: [phone]

### E. Regulatory Information:

ADVIA Chemistry Calcium 2 Method

- 1. Regulation section: 21 CFR § 862.1145 Calcium test system.
- 2. Classification: Class II
- 3. Product Code: CJY, azo dye, calcium
- 4. 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:

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.

{1}------------------------------------------------

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)

# H. Intended Use:

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

## 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(new<br>device) | Bayer (currently Siemens) ADVIA 1650<br>Calcium (predicate device) |
| Intended Use | same | same |
| Sample Type | Serum, plasma (Li-heparin) and<br>urine | Serum, plasma (Li-heparin) and urine |
| Instrument | ADVIA® Chemistry systems | ADVIA® Chemistry systems |
| Calibrators | Siemens Chemistry Calibrator<br>(K030169) | Same (K030169) |
| Controls used | BioRad controls | BioRad controls |
| Method | colorimetry | colorimetry |
| Differences | | |
| Characteristics | Siemens ADVIA Calcium_2(new<br>device) | Bayer (currently Siemens) ADVIA 1650<br>Calcium (predicate device) |
| Assay<br>Protocol | Calcium ions form a colored complex<br>with Arsenazo III, which is measured<br>at 658/694 nm. The amount of<br>calcium present in the sample is<br>directly proportional to the intensity<br>of the colored complex formed.<br>Reaction Equation:<br>$Ca2+ + Arsenazo III -> Ca-ArsenazoIII Complex (purple)$ | Calcium ions form a violet complex<br>with <i>o</i> -cresolphthalein complexone in<br>an alkaline medium. The reaction is<br>measured at 545/658 nm.<br>Reaction Equation:<br>$CPC + 2Ca2+ ->CPC (Ca2+)2 Complex$ |

{2}------------------------------------------------

| Reagents | One liquid reagent | Two liquid reagents |
|--------------------|-------------------------------------------------------|---------------------------------------------------------|
| Expected<br>Values | Serum/Plasma:<br>8.7-10.4 mg/dL (2.18-2.60 mmol/L) | Serum/Plasma:<br>8.3-10.6 mg/dL (2.08-2.65 mmol/L) |
| | Urine:<br>100-300 mg/day (2.5-7.5 mmol/day) | Urine:<br>100-300 mg/day (2.5-7.5 mmol/day) |
| Measuring<br>Range | Serum/Plasma:<br>1.0 - 16.0 mg/dL (0.25 - 4.0 mmol/L) | Serum/ Plasma:<br>1.0 - 15.0 mg/dL (0.25 – 3.75 mmol/L) |
| | Urine<br>1.0-32 mg/dL (0.25 – 8.0 mmol/L) | Urine:<br>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.

{3}------------------------------------------------

#### 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).

{4}------------------------------------------------

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 [phone]. 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 [phone] or [phone] 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

{5}------------------------------------------------

# Indication for Use

510(k) Number (if known): k083386

Device Name: ADVIA® Chemistry Calcium 2 Method

Indication For Use:

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.

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