CYSTATIN C IMMUNOPARTICLES, CONTROL SET, CALIBRATOR

K041627 · Dako A/S · NDY · Sep 3, 2004 · Clinical Chemistry

Device Facts

• Record ID: K041627
• Device Name: CYSTATIN C IMMUNOPARTICLES, CONTROL SET, CALIBRATOR
• Applicant: Dako A/S
• Product Code: NDY · Clinical Chemistry
• Decision Date: Sep 3, 2004
• Decision: SESE
• Submission Type: Traditional
• Regulation: 21 CFR 862.1225
• Device Class: Class 2

Intended Use

Cystatin C Immunoparticles are intended for the quantitative determination of cystatin C in human serum, heparinized plasma and EDTA plasma by turbidimetry and nephelometry. Cystatin C measurements are used as an aid in the diagnosis and treatment of renal diseases. For In Vitro Diagnostic Use. For Professional Use Only. Cystatin C Control Set is an assayed bi-level control intended to monitor and evaluate the precision and accuracy of the quantitative immunological determination of human cystatin C by turbidimetry of nephelometry. For In Vitro Diagnostic Use. For Professional Use Only. Cystatin C Calibrator is intended for establishing calibration curves for the quantitative immunological determination of human cystatin C by turbidimetry of nephelometry. For In Vitro Diagnostic Use. For Professional Use Only.

Device Story

Device system comprises Cystatin C Immunoparticles, Control Set, and Calibrator. Immunoparticles consist of rabbit anti-cystatin C antibodies covalently coupled to polystyrene particles. In clinical laboratory setting, patient serum or plasma is mixed with immunoparticles; immune complexes form. Turbidimetric or nephelometric analyzers measure resulting signal. Concentration of cystatin C is calculated via interpolation on a standard curve established by the calibrator. Results assist clinicians in diagnosing and monitoring renal disease. System is intended for professional use only.

Clinical Evidence

Bench testing only. Performance characteristics including precision, accuracy, linearity, sensitivity, specificity, and interference testing were evaluated. Assay results compared across various commercially available turbidimeters and the IMMAGE Immunochemistry System. Performance demonstrated comparability to Dade Behring N Latex Cystatin C Test Kit and Roche Creatinine Plus assay.

Technological Characteristics

Immunoparticles: rabbit anti-cystatin C immunoglobulin fraction coupled to polystyrene particles. Measurement: turbidimetry or nephelometry. Energy source: clinical chemistry analyzer light source. Connectivity: standalone integration with compatible analyzers. Storage: 2-8°C. Calibrators/Controls: delipidated human serum enriched with recombinant human cystatin C (E. coli), preserved with 15 mmol/L sodium azide.

Indications for Use

Indicated for quantitative determination of cystatin C in human serum, heparinized plasma, and EDTA plasma to aid in diagnosis and treatment of renal diseases in professional clinical settings.

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

• N Latex Cystatin C Test Kit, Dade Behring, Inc. (K003503)
• Creatinine Plus, Roche Diagnostics Corp. (K953239)
• N Cystatin C Control, Dade Behring, Inc. (K003503)
• N Protein Standard UY, Dade Behring, Inc. (K003501)

Submission Summary (Full Text)

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SEP - 3 2004

# 510(k) SUMMARY OF SAFETY AND EFFECTIVENESS

This summary of 510(k) safety and effectiveness is being submitted in accordance with the requirements of 21 CFR 807.92(c).

Assigned 510(k) number

K04 627 ----------------------------------------------------------------------------------------------------------------------------------------------------------------------

#### Submitter's Information

Name: Address:

Phone: Fax Contact person: Date of preparation:

#### Device Name

Trade Name: Common/Usual name: Classification name:

Trade Name: Common/Usual name: Classification name:

DakoCytomation Denmark A/S Produktionsvej 42 DK-2600 Glostrup Denmark + 45 44 85 95 00 + 45 88 30 59 98 Dana Olsen, Requiatory Affairs June 10, 2004

Cystatin C Immunoparticles (code No. LX 002) Cystatin C Reagent Test, Cystatin C (21 CFR - 862.1225)

Cystatin C Control Set (code No. X 0973) Controls Single (Specified) Analyte Controls (Assayed and Unassayed) (21 CFR 862.1660)

Cystatin C Calibrator (code No. X 0974) Trade Name: Common/Usual name: Calibrator Classification name: Calibrator, Secondary (21 CFR 862.1150)

#### Predicate Devices

For Cystatin C Immunoparticles:

N Latex Cystatin C Test Kit, Dade Behring, Inc. (K003503) Creatinine Plus, Roche Diagnostics Corp. (K953239)

For Cystatin C Control Set: N Cystatin C Control, Dade Behring, Inc. (K003503)

For Cystatin C Calibrator: N Protein Standard UY, Dade Behring, Inc. (K003501)

Cystatin C Immunoparticles - Cystatin C Control Set - Cystatin C Calibrator DakoCytomation Denmark A/S

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### Device Description

Cystatin C Immunoparticles are purified immunoglobulin fraction of rabbit antiserum directed against cystatin C covalently coupled to uniform polystyrene particles. The Cystatin C Immunoparticles are provided as a suspension preserved with 15 mmol/L sodium azide and are supplied ready for use. Recombinant human cystatin C produced in E. coli was used as an immunogen for raising the antibody coupled to the polystyrene particles.

In the DakoCytomation Cystatin C Assay, human serum or plasma is mixed with the Cystatin C Immunoparticles. The resulting immune complexes are measured by turbidimetry or nephelometry. The generated signal is correlated with the concentration of cystatin C in the sample. By interpolation on a standard curve, the concentration of cystatin C in the sample is calculated.

Cystatin C Control Set is a bi-level control. The controls are liquid pools of delipidated human serum enriched with recombinant human cystatin C produced in E. coli and preserved with 15 mmol/L sodium azide. Each donor has been tested and found negative for hepatitis B virus surface antigen, antibodies to hepatitis C virus and human immunodeficiency virus 1 and 2. The Cystatin C Control Set is supplied ready for use.

The cystatin C value assignment has been carried out by turbidimetry using the DakoCytomation Cystatin C Calibrator, code No. X 0974, as reference.

Cystatin C Calibrator is a liquid pool of delipidated human serum enriched with recombinant human cystatin C produced in E. coli and preserved with 15 mmol/L sodium azide. Each donor has been tested and found negative for hepatitis B virus surface antigen, antibodies to hepatitis C virus and human immunodeficiency virus 1 and 2. The Cystatin C Calibrator is supplied ready for use.

The cystatin C value assignment has been carried out by turbidimetry using a precise transfer protocol ensuring traceability to a pure recombinant human cystatin C reference preparation, where the cystatin C concentration was established by dry mass determination.

## Intended Use

For In Vitro Diagnostic Use. For Professional Use Only.

Cystatin C Immunoparticles are intended for the quantitative determination of cystatin C in human serum, heparinized plasma and EDTA plasma by turbidimetry and nephelometry. Cystatin C measurements are used as an aid in the diagnosis and treatment of renal diseases

Cystatin C Control Set is an assayed bi-level control intended to monitor and evaluate the precision and accuracy of the quantitative immunological determination of human cystatin C by turbidimetry or nephelometry.

The Cystatin C Calibrator is intended for establishing calibration curves for the quantitative immunological determination of human cystatin C by turbidimetry or nephelometry.

Cystatin C Immunoparticles - Cystatin C Control Set - Cystatin C Calibrator DakoCytomation Denmark AJS

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### Substantial Equivalence Comparison

The DakoCytomation Cystatin C Immunoparticles are substantially equivalent to the Dade Behring, Inc., N Latex Cystatin C Test Kit (K003503) with respect to indications for use, device design, materials and operational principles. The basic differences between the new device and the Dade Behring predicate device is the instruments used for testing. The DakoCytomation device can be used on commercially available turbidimetry and nephelometry analyzers, while the Dade Behring, Inc. product is applicable only on the Dade Behring, Inc. Nephelometer Systems. The DakoCytomation Cystatin C Immunoparticles are also claimed substantially equivalent to the Roche Diagnostics Corp. Creatinine Plus (K953239) in the intended use and results obtained. The difference in technology does not introduce new issues of safety and effectiveness.

The DakoCytomation Cystatin C Control Set is substantially equivalent to the Dade Behring N Cystatin C Control (K003503), with regard to the technological characteristics and in terms of the intended use.

The DakoCytomation Cystatin C Calibrator is substantially equivalent to the Dade Behring N Protein Standard UY (K003501), with regard to the technological characteristics and in terms of the intended use.

## Performance Characteristics and Data

Performance characteristics and data presented in support of the Cystatin C Immunoparticles together with Cystatin C Control Set and Cystatin C Calibrator include precision, accuracy, linearity, sensitivity, specificity, security ranges, interferences and stability testing. Assay results obtained with various commercially available turbidimeters and IMMAGE® Immunochemistry System (nephelometer) were analyzed and found to be comparable.

A comparison of performance between the DakoCytomation Cystatin C Immunoparticles, Cystatin C Control Set and Cystatin C Calibrator with the Dade Behring, Inc. N Latex Cystatin C Test Kit (K003503) and N Protein Standard UY (K003501) demonstrated substantial equivalence. Additionally, a comparison of performance between the DakoCytomation Cystatin C Assay, and the Roche Diagnostics Corp. Creatinine Plus assay (K953239) demonstrated substantial equivalence.

## Substantial Equivalence

Based on the information provided in this premarket notification, DakoCytomation concludes that the new devices, Cystatin C Immunoparticles, Cystatin C Control Set and Cystatin C Calibrator, are safe, effective and substantially equivalent to the Dade Behring predicate devices N Latex Cystatin C Test Kit (K003503), N Cystatin C Control (K003503) and N Protein Standard UY (K003501) respectively, with regard to the indications for use, device design, materials and operational principles. Additionally, the Cystatin C Immunoparticles are substantially equivalent to Roche Diagnostics Corp. Creatinine Plus (K953239) with regard to the intended use.

Cystatin C Immunoparticles - Cystatin C Control Set - Cystatin C Calibrator DakoCytomation Denmark A/S

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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 stylized caduceus symbol, which features a staff with a snake entwined around it, overlaid on three human figures. The text "DEPARTMENT OF HEALTH & HUMAN SERVICES • USA" is arranged in a circular fashion around the symbol.

Food and Drug Administration 2098 Gaither Road Rockville MD 20850

SEP - 3 2004

Ms. Dana Olsen Regulatory Affairs DakoCytomation Denmark A/S Produktionsvej 42 DK-2600 Glostrup Denmark

k041627

Re:

Trade/Device Name: Cystatin C Immunoparticles Cystatin C Control Set Cystatin C Calibrator Regulation Number: 21 CFR 862.1225 Regulation Name: Creatinine Test system

Regulatory Class: Class II Product Code: NDY, JJX, JIT Dated: June 10, 2004 Received: June 16, 2004

Dear Ms. Olsen:

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,

Jean M. Cooper MS, DVM.
Jean M. Cooper MS DVM

Jean M. Cooper, MS. 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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510(k) Number K041627

## Indications for Use

Device Name: Cystatin C Immunoparticles

## Indications for Use:

For In Vitro Diagnostic Use. For Professional Use Only.

Cystatin C Immunoparticles are intended for the quantitative defermiof cystation of cystatin C in human serum, heparinized plasma and EDTA nation of of overbidimetry and nephelometry. Cystatin C measurements are used as an aid in the diagnosis and treatment of renal diseases.

Prescription Use (Part 21 CFR 801 Subpart D)

AND/OR

Over-The-Counter Use (21 CFR 807 Subpart C)

PLEASE DO NOT WRITE BELOW THIS LINE – CONTINUE ON ANOTHER PAGE IF NEEDED

Concurrence of CDRH, Office of Device Evaluation (ODE)

Carol C Benem

Division Sign-Off

Office of In Vitro Diagnostic Device Evaluation and Safety

510(k) K041627

Page 1 of 3

Cystatin C Immunoparticles - Cystatin C Control Set - Cystatin C Calibrator DakoCytomation Denmark A/S

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510(k) Number K04 1627

## Indications for Use

Device Name: Cystatin C Control Set

#### Indications for Use:

For In Vitro Diagnostic Use. For Professional Use Only.

Cystatin C Control Set is an assayed bi-level control intended to monitor and evaluate the precision and accuracy of the quantitative immunological determination of human cystatin C by turbidimetry or nephelometry.

Prescription Use (Part 21 CFR 801 Subpart D)

AND/OR

Over-The-Counter Use (21 CFR 807 Subpart C)

PLEASE DO NOT WRITE BELOW THIS LINE – CONTINUE ON ANOTHER PAGE IF NEEDED

Concurrence of CDRH, Office of Device Evaluation (ODE)

Carol C. Benson

Division Sign-Off

Office of In Vitro Diagnostic Device Evaluation and Safe

510(k) K041627

Page 2 of 3

Cystatin C Immunoparticles - Cystatin C Control Set - Cystatin C Calibrator DakoCytomation Denmark A/S

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K641627 510(k) Number

Indications for Use

Device Name: Cystatin C Calibrator

Indications for Use:

For In Vitro Diagnostic Use. For Professional Use Only.

Cystatin C Calibrator is intended for establishing calibration curves for the quantitative immunological determination of human cystatin C by turbidimetry or nephelometry.

Prescription Use (Part 21 CFR 801 Subpart D)

AND/OR

Over-The-Counter Use (21 CFR 807 Subpart C)

Please Do Not WRITE BELOW THIS LINE – CONTINUE ON ANOTHER PAGE IF NEEDED

Concurrence of CDRH, Office of Device Evaluation (ODE)

Carol C. Benson

inn Sien-Oft

Office of In Vitro Diagnostic Device Evaluation and Safe

510(k) K041627

Page 3 of 3

Cystatin C Immunoparticles - Cystatin C Control Set - Cystatin C Calibrator DakoCytomation Denmark A/S