N LATEX CDT

K060677 · Dade Behring, Inc. · NAO · Aug 25, 2006 · Clinical Chemistry

Device Facts

• Record ID: K060677
• Device Name: N LATEX CDT
• Applicant: Dade Behring, Inc.
• Product Code: NAO · Clinical Chemistry
• Decision Date: Aug 25, 2006
• Decision: SESE
• Submission Type: Traditional
• Regulation: 21 CFR 862.1360
• Device Class: Class 1

Intended Use

In vitro diagnostic for the quantitative determination of carbohydrate-deficient transferrin (CDT) in human serum by means of particle-enhanced immunonephelometry using the BN™ II and BN ProSpec® System. The N Latex CDT assay must be run concurrently with the N Antisera to Human Transferrin assay so that the result can be expressed as a relative ratio, i.e., %CDT of the total transferrin. The calculation of %CDT can be used as a tool to identify possible chronic heavy alcohol consumption.

Device Story

N Latex CDT Kit is an in vitro diagnostic assay for human serum; used on BN II and BN ProSpec systems. Operates via competitive immunonephelometry; CDT in sample competes with CDT-coated polystyrene particles for anti-CDT monoclonal antibody-coated particles. Sample CDT inhibits bead aggregation; resulting turbidity reduction measured as scattered light. Requires concurrent N Antisera to Human Transferrin assay; onboard software calculates %CDT ratio (mg/mL CDT / mg/mL total transferrin). Used in clinical laboratories; results assist clinicians in identifying potential chronic heavy alcohol consumption.

Clinical Evidence

Bench testing only. Precision evaluated (n=40) with total CVs 3.0-8.9%. Linearity/recovery (94-121%) and analytical sensitivity (0.003 g/L) met specifications. Interference testing showed no significant impact from bilirubin, hemoglobin, triglycerides, HAMA, ethanol, or paraprotein. Method comparison (n=116) against predicate yielded y = 0.720x + 0.75, r = 0.99. Reference range established using 561 adult subjects.

Technological Characteristics

Particle-enhanced immunonephelometry; reagents include CDT-coated polystyrene particles and monoclonal antibodies against human CDT. System requires BN II or BN ProSpec analyzers. Quantitative measurement based on light scattering.

Indications for Use

Indicated for the quantitative determination of carbohydrate-deficient transferrin (CDT) in human serum to identify possible chronic heavy alcohol consumption.

Regulatory Classification

Identification

A gamma-glutamyl transpeptidase and isoenzymes test system is a device intended to measure the activity of the enzyme gamma-glutamyl transpeptidase (GGTP) in plasma and serum. Gamma-glutamyl transpeptidase and isoenzymes measurements are used in the diagnosis and treatment of liver diseases such as alcoholic cirrhosis and primary and secondary liver tumors.

Predicate Devices

• Axis-Shield %CDT Assay (K992502)

Submission Summary (Full Text)

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# 510(k) Summary for N Latex CDT

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.

The assigned 510(k) number is: k060677

**AUG** 25 2006

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

Distributor:

Dade Behring Marburg GmbH Emil-von-Behring Str. 76 D-35001 Marburg, Germany

Contact Information:

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

Preparation date:

2. Device Name

Classification:

Panel: Product Code:

Class I 21 CFR 862.1360 Clinical Chemistry (75) NAO

August 15, 2006

N Latex CDT Kit

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

Axis-Shield %CDT Assay - K992502

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#### 4. Device Description:

The CDT in the sample competes with CDT-coated polystyrene particles for the bond to specific monoclonal antibodies against human CDT, which are likewise bound to polystyrene particles. In the presence of CDT in the sample, there is no or little aggregation of the polystyrene particles. In the absence of CDT in the sample, the polystyrene particles aggregate. The higher the CDT content in the assay, the lower the scattered light signal. The evaluation is performed by comparison with a standard of known concentration.

#### 5. Device Intended Use:

In vitro diagnostic for the quantitative determination of carbohydrate-deficient transferrin (CDT) in human serum by means of particle-enhanced immunonephelometry using the BN™ II and BN ProSpec® System. The N Latex CDT assay must be run concurrently with the N Antisera to Human Transferrin assay so that the result can be expressed as a relative ratio, i.e., %CDT of the total transferrin. The calculation of %CDT can be used as a tool to identify possible chronic heavy alcohol consumption.

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

The N Latex CDT test kit is substantially equivalent to the Axis-Shield %CDT assay (K992502). The N Latex CDT assay, like the Axis-Shield %CDT assay, is an in vitro reagent system for the quantitative measurement of carbohydrate-deficient transferrin in human serum.

#### 7. Device Performance Characteristics:

The N Latex CDT assay (y) was compared to a commercially available immunoassay (x) by evaluating 116 serum samples with %CDT concentrations ranging from 0.77 to 21.3 %CDT. Regression analysis of the results yielded the following equation:

y = 0.720x + 0.75 %CDT, correlation coefficient 0.99

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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 features a stylized eagle with three tail feathers, representing the department's commitment to health, human services, and well-being. The text "DEPARTMENT OF HEALTH & HUMAN SERVICES - USA" is arranged in a circular pattern around the eagle symbol.

Food and Drug Administration 2098 Gaither Road Rockville MD 20850

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

, ,

AUG 25 2006

k060677 Re:

> Trade/Device Name: N Latex CDT Kit Regulation Number: 21 CFR 862.1360 Regulation Name: Gamma-glutamyl transpeptidase and isoenzymes test system Regulatory Class: Class I Product Code: NAO Dated: July12, 2006 Received: July 13, 2006

Dear Ms. Dray-Lyons:

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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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/industry/support/index.html.

Sincerely yours,

Alberto G

Alberto Gutierrez, Ph.D. 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

### N Latex CDT Kit Device Name:

## Indications for Use:

In vitro diagnostic for the quantitative determination of carbohydratedeficient transferrin (CDT) in human serum by means of particle-enhanced immunonephelometry using the BN™ II and BN ProSpec® System. The N Latex CDT assay must be run concurrently with the N Antisera to Human Transferrin assay so that the result can be expressed as a relative ratio, i.e., %CDT of the total transferrin. The calculation of %CDT can be used as a tool to identify possible chronic heavy alcohol consumption.

Prescription Use × (Per 21 CFR 801 Subpart D) Over-The-Counter-Use_ (21 CFR 801)

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

Concurrence of CDRH, Office of In Vitro Diagnostic Devices (OIVD)

Carol Benson

Livision Sign-Off

Office of In Vitro Diagnostic Device Evaluation and Safety

K060677

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