ADVIA CHEMISTRY CYSTATIN C REAGENT, ADVIA CHEMISTRY CYSTATIN C CALIBRATOR, MODELS P/N 04851534, P/N 10376487

K083906 · Siemens Healthcare Diagnostics · NDY · Mar 11, 2009 · Clinical Chemistry

Device Facts

• Record ID: K083906
• Device Name: ADVIA CHEMISTRY CYSTATIN C REAGENT, ADVIA CHEMISTRY CYSTATIN C CALIBRATOR, MODELS P/N 04851534, P/N 10376487
• Applicant: Siemens Healthcare Diagnostics
• Product Code: NDY · Clinical Chemistry
• Decision Date: Mar 11, 2009
• Decision: SESE
• Submission Type: Traditional
• Regulation: 21 CFR 862.1225
• Device Class: Class 2

Intended Use

Reagent: For in vitro diagnostic use in the quantitative determination of Cystatin-C (CYSC) in human serum or plasma (lithium heparin, potassium EDTA) on the ADVIA Chemistry systems. Measurement of Cystatin C aids in the diagnosis and treatment of renal disease. Calibrator: For in vitro diagnostic use in the calibration of Cystatin C method on ADVIA Chemistry systems.

Device Story

Device is an in vitro diagnostic latex-enhanced turbidimetric assay for measuring Cystatin C in human serum or plasma. Input: patient serum or plasma sample mixed with latex particles coated with rabbit anti-cystatin-C antibodies. Operation: agglutination of latex particles occurs in presence of Cystatin C, increasing turbidity; measured at 571 and 805 nm. Output: Cystatin C concentration calculated via calibration curve. Used in clinical laboratory settings on ADVIA Chemistry systems; operated by laboratory technicians. Results assist clinicians in diagnosing and monitoring renal disease.

Clinical Evidence

Bench testing only. Precision evaluated per CLSI EP05-A2 (n=40 per sample). Linearity assessed across 0.1–8.0 mg/L range (r=0.99). Limit of Blank (0.07 mg/L), Limit of Detection (0.10 mg/L), and Limit of Quantitation (0.10 mg/L) established per CLSI EP17-A. Interference testing showed no significant impact (≤10%) from hemoglobin, bilirubin, lipemia, RF, or common medications. Method comparison against predicate (n=55) yielded y=1.003x+0.021 (r=0.986). Reference range established using 121 healthy adult samples (0.56–0.95 mg/dL).

Technological Characteristics

Latex-enhanced turbidimetric assay. Reagents: buffer, sodium azide, latex particles coated with rabbit anti-cystatin C antibody. Calibrators: recombinant human Cystatin C in serum. Measurement: turbidity at 571 and 805 nm. Compatible with ADVIA Chemistry 1200, 1650/1800, and 2400 systems. Traceable to internal standard of purified human Cystatin C.

Indications for Use

Indicated for the quantitative determination of Cystatin-C in human serum or plasma to aid in the diagnosis and treatment of renal disease. For prescription use only.

Regulatory Classification

Identification

A creatinine test system is a device intended to measure creatinine levels in plasma and urine. Creatinine measurements are used in the diagnosis and treatment of renal diseases, in monitoring renal dialysis, and as a calculation basis for measuring other urine analytes.

Predicate Devices

• Siemens N Latex Cystatin C reagent kit (k041878)

Submission Summary (Full Text)

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#### 510(k) Summary of Safety and Effectiveness for the

#### ADVIA® Chemistry Cystatin C Method

# MAR 1 1 2009

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:

B. Date of Preparation: December 22, 2008

## C. Proprietary and Established Names:

ADVIA® Chemistry Cystatin C Reagent ADVIA® Chemistry Cystatin C Calibrator

#### D. Applicant:

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

Kira Gordon, Sr. Regulatory Affairs Specialist

Office: [phone] Fax: [phone]

#### E. Regulatory Information:

ADVIA Chemistry Cystatin C Reagent

- 1. Regulation section: 21 CFR § 862.1225 Creatinine, test system.
- 2. Classification: Class II
- 3. Product Code: NDY, Test, Cystatin C
- 4. Panel: Clinical Chemistry

#### ADVIA Chemistry Cystatin C Calibrator

- 1. Regulation section: 21 CFR § 862.1150 Calibrator
- 2. Classification: Class II
- 3. Product Code: JIT, calibrator secondary
- 4. Panel: Clinical Chemistry

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#### F. Predicate Device:

ADVIA Chemistry Cystatin C reagent is substantially equivalent to the Dade Behring N Latex Cystatin C reagent cleared under k041878

ADVIA Chemistry Cystatin C calibrator is substantially equivalent to the Dade Behring N Protein Standard UY cleared under K003501.

#### G. Device Description:

The CYSC latex reagent is a suspension of uniform latex particles coated with anticystatin-C antibody. When serum or plasma containing cystatin C is mixed with the latex reagent, agglutination takes place resulting in an increase in turbidity. This turbidity is measured at 571 and 805 nm. The cystatin C concentration in serum or plasma is determined from a calibration curve that is generated with the calibrators.

#### H. Intended Use:

Reagent: For in vitro diagnostic use in the quantitative determination of Cystatin C (CYSC) in human serum or plasma on the ADVIA Chemistry systems. Measurement of Cystatin C aids in the diagnosis and treatment of renal disease.

Calibrator: For in vitro diagnostic use in the calibration of Cystatin C method on ADVIA Chemistry systems.

#### I. Substantial Equivalence Information:

The ADVIA Chemistry Cystatin C Method and (formerly) Dade Behring, Inc., N Latex Cystatin C methods were compared. A comparison of the important similarities and differences between the devices and the predicates is provided in the following tables:

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|-----------------------------------|-----------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------|-------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------|
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| A 46-44-4844<br>na Vit | 44-4-4-448-1-800-<br><br>. | Company Control Concession Company of Children<br>. |

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| Intended Use | Reagent: for in vitro diagnostic<br>use in the quantitative<br>determination of cystatin C in<br>human serum and plasma on the<br>ADVIA Chemistry<br>systems.Measurement of cystatin<br>C aids in the diagnosis and<br>treatment of renal diseases.<br><br>Calibrator: For in vitro diagnostic<br>use in the calibration of the<br>Cystatin C method on ADVIA<br>Chemistry systems. | Reagent: N Latex CYSC method is<br>an in vitro diagnostic kit for the<br>quantitative determination of<br>cystatin C in human serum and<br>heparinized plasma. Cystatin C<br>measurements are used in the<br>diagnosis and treatment of renal<br>diseases.<br><br>Calibrator: For preparing reference<br>curves for the<br>immunonephelometric<br>determinations of a-1-micorglobulin<br>and Cystatin C using the BN<br>systems. |
|-----------------------------|-------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------|----------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------|
| Antibody | Rabbit Polyclonal antibodies to<br>human Cystatin C | Rabbit Polyclonal antibodies to<br>human Cystatin C |
| Format | Liquid | Liquid |
| Use of<br>Calibrators | Yes | Yes |
| Traceability | internal standard of highly purified<br>human cystatin C | internal standard of highly purified<br>human cystatin C |
| Reference<br>range | 0.56-0.95 mg/L | 0.53 -0.95 mg/L |
| Differences | | |
| Item | Device | Predicate |
| Sample<br>Matrix | Serum , Heparinized Plasma,<br>EDTA plasma | Serum or Heparinized Plasma |
| Reagents | Two: R1 (buffer), R2 (latex coated<br>with anti-cystatin C antibody from<br>rabbit) contained in system<br>specific packaging | Three: (1) latex coated with anti-<br>cystatin C antibody from rabbit, (2)<br>Supplementary A (rabbit antibody),<br>(3) Supplementary B (polyethylene<br>glycol) in system specific packaging |
| Technology /<br>Methodology | Latex enhanced<br>turbidimetric assay | Particle enhanced<br>immunonephelometric assay |
| Number of<br>Calibrators | 6 (5 provided in package and<br>zero-calibrator - DI water) | 1 (diluted on system to 6 levels) |
| Calibrators | Recombinant Cystatin C in human<br>serum base (liquid) | Urinary proteins of human origin<br>polygeline and preservatives<br>(lyophilized) |
| Reportable<br>range | 0.1 - 8.0 mg/L | 0.05 - 8.0 mg/L |

and the state of the states and

:

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### J. Conclusion:

The ADVIA Chcmistry Cystatin C Method is substantially equivalent to the A Dade Behring, Inc., N Latex Cystatin C method cleared under K041878. Comparative testing described in the protocol included in this submission demonstrates substantial equivalent performance.

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Image /page/4/Picture/1 description: The image shows the seal for the Department of Health & Human Services. The seal is circular and contains the words "DEPARTMENT OF HEALTH & HUMAN SERVICES. USA" around the edge. In the center of the seal is an abstract image of an eagle.

MAR 1 1 2009

Food and Drug Administration 2098 Gaither Road Rockville MD 20850

Siemens Healthcare Diagnostics c/o Dr. Kira Gordon 511 Benedict Avenue Tarrytown, New York 10591

Re: k083906 Trade/Device Name: ADVIA Chemistry Cystatin C Reagent Regulation Number: 21CFR 862.1225 Regulation Name: Creatinine, test system Regulatory Class: Class II Product Code: NDY, JIT Dated: December 23, 2008 Received: December 30, 2008

Dear Dr. Gordon:

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); and good manufacturing practice requirements as set forth in the quality systems (QS) 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 [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

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# Indication for Use

510(k) Number (if known): k083906

Device Name:

ADVIA® Chemistry Cystatin C Reagent

ADVIA® Chemistry Cystatin C Calibrator

Indication For Use:

Reagent: For in vitro diagnostic use in the quantitative determination of Cystatin-C (CYSC) in human serum or plasma (lithium heparin, potassium EDTA) on the ADVIA Chemistry systems. Measurement of Cystatin C aids in the diagnosis and treatment of renal disease.

Calibrator: For in vitro diagnostic use in the calibration of Cystatin C method on ADVIA Chemistry systems.

Prescription Use
(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)

Rute Chealer

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

510(k) K 083906