N LATEX CYSTATIN

K041878 · Dade Behring, Inc. · NDY · Aug 16, 2004 · Clinical Chemistry

Device Facts

• Record ID: K041878
• Device Name: N LATEX CYSTATIN
• Applicant: Dade Behring, Inc.
• Product Code: NDY · Clinical Chemistry
• Decision Date: Aug 16, 2004
• Decision: SESE
• Submission Type: Traditional
• Regulation: 21 CFR 862.1225
• Device Class: Class 2

Intended Use

N Latex Cystatin C is an in vitro diagnostics kit containing reagents for the quantitative determination of cystatin C in human serum and heparinized plasma by means of particle-enhanced immunonephelometry using BN™ Systems. Cystatin C measurements are used in the diagnosis and treatment of renal diseases. This product is for prescription use only.

Device Story

N Latex Cystatin C is an in vitro diagnostic reagent kit used for quantitative measurement of cystatin C in human serum and heparinized plasma. The device utilizes particle-enhanced immunonephelometry on BN™ Systems. Polystyrene particles coated with anti-human cystatin C antibodies aggregate when exposed to patient samples containing cystatin C. These aggregates scatter light; the intensity of scattered light is proportional to the cystatin C concentration. Results are determined by comparing sample light scatter against a standard of known concentration. The assay is performed in clinical laboratory settings by trained personnel. Clinicians use the resulting cystatin C measurements to aid in the diagnosis and management of renal disease.

Clinical Evidence

No clinical data provided; substantial equivalence is based on bench testing and comparison to the predicate device.

Technological Characteristics

Reagents consist of polystyrene particles coated with specific antibodies to human cystatin C. Principle of operation is particle-enhanced immunonephelometry. The device is designed for use with BN™ Systems. It is an in vitro diagnostic kit for quantitative analysis.

Indications for Use

Indicated for the quantitative determination of cystatin C in human serum and heparinized plasma to aid in the diagnosis and treatment of renal diseases.

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 (k003503)

Submission Summary (Full Text)

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AUG 1 6 2004

# 510(k) Summary for N Latex Cystatin C

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.

Image /page/0/Picture/4 description: The image shows the text "The assigned 510(k) number is:" followed by the number K041878 written in handwriting. The number is written in black ink and is underlined. The text and number are likely part of a document or form related to a 510(k) submission.

## Manufacturer's Name, Address, Telephone, and Contact Person, Date of 1.

Manufacturer:

Preparation:

Dade Behring Marburg GmbH Emil-von-Behring Str. 76 Marburg/Germany

Contact Information:

Dade Behring Inc. Glasgow Site P.O. Box 6101 Newark, Delaware 19714 Attn: Kathleen Dray-Lyons Tel: [phone]

Preparation date:

July 9, 2004

#### Device Name/ Classification: 2.

Device Name: Device Description: Classification: Regulation Number: Panel: Product Code:

N Latex Cystatin C Creatinine test system Class II 21 CFR 862.1225 Clinical Chemistry NDY

#### Identification of the Legally Marketed Device: 3.

N Latex Cystatin C - K003503

#### Device Description: 4.

Polystyrene particles coated with specific antibodies to human cystatin C are aggregated when mixed with samples containing human cystatin C. These aggregates scatter a beam of light passed through the sample. The intensity of the scattered light is proportional to the concentration of the relevant protein in the sample. The result is evaluated by comparison with a standard of known concentration.

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#### Device Intended Use: 5.

N Latex Cystatin C is an in vitro diagnostics kit containing reagents for the quantitative N Latex Oyotatin O io an in W.P allag recum and heparinized plasma by means of particleenhanced immunonephelometry using BN™ Systems. Cystatin C measurements are used in the diagnosis and treatment of renal diseases.

#### Medical device to which equivalence is claimed and comparison information: 6.

The modified N Latex Cystatin C assay is substantially equivalent in intended use to the currently marketed N Latex Cystatin C assay (K003503).

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DEPARTMENT OF HEALTH & HUMAN SERVICES

Image /page/2/Picture/1 description: The image shows the logo for the Department of Health & Human Services - USA. The logo consists of a circular seal with the text "DEPARTMENT OF HEALTH & HUMAN SERVICES - USA" arranged around the perimeter. Inside the circle is a stylized symbol resembling three overlapping human profiles or abstract shapes, possibly representing the department's focus on people and services. The logo is black and white.

AUG 1 6 2004

000 and Drug Administration 2098 Gaither Road Rockville MD 20850

Ms. Kathleen A. Dray-Lyons Regulatory Affairs and Compliance Manager Dade Behring, Inc. Glasgow Site PO Box 6101 Newark, DE 19714

k041878 Re: Trade/Device Name: N Latex Cystatin C Regulation Number: 21 CFR 862.1225 Regulation Name: Creatinine test system Regulatory Class: Class II Product Code: NDY Dated: July 9, 2004 Received: July 15, 2004

Dear Ms. Dray-Lyons:

We have reviewed your Section 510(k) premarket notification of intent to market the device we nave reviewed your becamed the device is substantially equivalent (for the indications for use stated in the enclosure) to legally marketed predicate devices marketed in interstate 101 use stated in the encreativent date of the Medical Device Amendments, or to conninered prof to they 2017-11-11 in accordance with the provisions of the Federal Food, Drug, de vices that have been require approval of a premarket approval application (PMA). and Cosmetter For (110) that be device, subject to the general controls provisions of the Act. The r ou may, mercrere, mains of the Act include requirements for annual registration, listing of general controls provisions 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 it may be subject to Sach adde 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 r lease of actived had i brinnation that your device complies with other requirements of the Act that I Dri has intact and regulations administered by other Federal agencies. You must or any I ederal statutes and securities, 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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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,

Seain 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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# Indications Statement

Device Name: N Latex Cystatin C

# Indications for Use:

N Latex Cystatin C is an in vitro diagnostics kit containing reagents for the quantitative determination of cystatin C in human serum and heparinized plasma by means of particle-enhanced immunonephelometry using BN™ Systems. Cystatin C measurements are used in the diagnosis and treatment of renal diseases.

Prescription Use
(Per 21 CFR 801.109)

✓

Over-The-Counter-Use (Optional Format 1-2-96)

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

Concurrence of CDRH, Office of Device Evaluation (ODE)

Carol Benson
Division Sign-Off

Office of in Vitro Dlag

510(k) K041878

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