N LATEX RF KIT

K071247 · Dade Behring, Inc. · DHR · Aug 8, 2007 · Immunology

Device Facts

• Record ID: K071247
• Device Name: N LATEX RF KIT
• Applicant: Dade Behring, Inc.
• Product Code: DHR · Immunology
• Decision Date: Aug 8, 2007
• Decision: SESE
• Submission Type: Traditional
• Regulation: 21 CFR 866.5775
• Device Class: Class 2

Intended Use

Quantitative determination of rheumatoid factors (RF) in human serum, lithium heparin and EDTA plasma on the BN™ II and BN ProSpec® Systems as an aid in the diagnosis of rheumatoid arthritis.

Device Story

N Latex RF Kit uses polystyrene particles coated with human immunoglobulin and sheep anti-human IgG. When mixed with patient serum, lithium heparin, or EDTA plasma samples containing RF, particles aggregate. Aggregation scatters light; intensity of scattered light is proportional to RF concentration. Used on BN™ II and BN ProSpec® Systems in clinical laboratory settings. Results are compared against known standards to quantify RF levels. Healthcare providers use these quantitative results as an aid in diagnosing rheumatoid arthritis.

Clinical Evidence

Bench testing only. Precision evaluated per CLSI EP5-A2 (repeatability/within-lab CVs 2.2-8.1%). Linearity confirmed across 10-640 IU/mL (r=1.00). Interference testing per CLSI EP7-A2 showed 89.7-100.7% recovery for bilirubin and hemoglobin. Method comparison (n=90) against predicate showed r=0.9757. Matrix comparison (n=111 for lithium heparin, n=33 for EDTA) showed high correlation (r≥0.992). No clinical sensitivity/specificity studies were performed.

Technological Characteristics

Particle-enhanced nephelometry. Reagents: polystyrene particles coated with human-γ-globulin/anti-human-γ-globulin immunocomplexes; polyethylene glycol/detergent supplement. Energy source: light scattering measurement. Analyzers: BN II and BN ProSpec systems. Standardized against N Rheumatology Standard SL and 1st British Standard 64/0023. Complies with CLSI EP5-A2 and EP7-A2 guidelines.

Indications for Use

Indicated for the quantitative determination of rheumatoid factors (RF) in human serum, lithium heparin, and EDTA plasma to aid in the diagnosis of rheumatoid arthritis.

Regulatory Classification

Identification

A rheumatoid factor immunological test system is a device that consists of the reagents used to measure by immunochemical techniques the rheumatoid factor (antibodies to immunoglobulins) in serum, other body fluids, and tissues. Measurement of rheumatoid factor may aid in the diagnosis of rheumatoid arthritis.

Predicate Devices

• N Latex RF (K942328)

Submission Summary (Full Text)

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## 510(k) Summary for N Latex RF Kit

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: K071247

- Manufacturer's Name, Address, Telephone, and Contact Person, Date 1. of Preparation:
Fax: [phone]

| Manufacturer: | Dade Behring Marburg GmbH<br>Emil-von-Behring Str. 76<br>35041 Marburg, Germany |
|----------------------|----------------------------------------------------------------------------------------------------------|
| Contact Information: | Dade Behring Inc.<br>P.O. Box 6101<br>Newark, Delaware 19714-610<br>Attn: Helen Lee<br>Tel: [phone] |

July 3, 2007 Preparation date:

- N Latex RF Kit 2. Device Name: Common Name: RF reagent Class II Classification: Product Code: DHR Immunology (82) Panel:
#### Identification of the Legally Marketed Device: 3.

N Latex RF – K942328

#### 4. Device Descriptions:

N Latex RF Kit

Polystyrene particles coated with an immunocomplex consisting of human immunoqlobulin and antihuman IgG from sheep are aggregated when mixed with samples containing RF. These aggregates scatter a beam of light passed through the sample. The intensity of the scattered light is proportional to the concentration of the respective protein in the sample. The result is evaluated by comparison with a standard of known concentration.

## CONFIDENTIAL

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#### 5. Device Intended Uses:

N Latex RF Kit

Quantitative determination of rheumatoid factors (RF) in human serum. lithium heparin and EDTA plasma on the BN™ II and BN ProSpec® Systems as an aid in the diagnosis of rheumatoid arthritis.

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

The N Latex RF Kit is substantially equivalent to the currently marketed N Latex RF device (K942328). The N Latex RF Kit, like the currently marketed N Latex RF assay, is an in vitro diagnostic test for the quantitative determination of rheumatoid factors (RF) in human serum by means of particle-enhanced immunonephelometry using the BN™ Systems as an aid in the diagnosis of Rheumatoid Arthritis.

#### 7. Device Performance Characteristics:

The N Latex RF Kit was compared to the current N Latex RF assay on the BN™ II System by evaluating serum samples with concentrations ranging from 15.8 to 589.8 IU/mL. Additionally, 43 of these same serum samples, with results ranging from 15.8 to 98.4 IU/mL, were evaluated by Passing-Bablok regression to demonstrate correlation at levels closer to the clinical cutoff. Regression analysis of these results vielded the following results:

| | n | Slope | Intercept | Correlation<br>Coefficient |
|--------------------|----|-------|-----------|----------------------------|
| N Latex RF Kit | 90 | 1.098 | -12.94 | 0.98 |
| Results ≤100 IU/mL | 43 | 0.992 | -6.81 | 0.87 |

#### 8. Conclusion:

Based upon the results of performance studies the N Latex RF Kit is substantially equivalent to the predicate device, N Latex RF.

## CONFIDENTIAL

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Image /page/2/Picture/1 description: The image shows a circular logo. The logo contains the symbol of the Department of Health & Human Services (HHS) in the center. The text "DEPARTMENT OF HEALTH & HUMAN SERVICES USA" is arranged around the symbol in a circular fashion.

Food and Drug Administration 2098 Gaither Road Rockville MD 20850

AUG - 8 2007

Dade Behring, Inc. c/o Ms Helen Lee Manager, Regulatory Affairs and Compliance Glasgow Site P.O. Box 6101 Newark, DE 19714-6101

Re: k071247

Trade/Device Name: N Latex RF Kit Regulation Number: 21 CFR 866.5775 Regulation Name: Rheumatoid factor immunological test system Regulatory Class: Class II Product Code: DHR Dated: July 03, 2007 Received: July 05, 2007

Dear Ms. Lee:

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 the Code of Federal Regulations, Title 21, Parts 800 to 898. 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 Part 801); good manufacturing practice requirements as set forth in the quality systems (QS) regulation (21 CFR Part 820). This letter will allow you to begin marketing your device as described in your Section 510(k) premarket notification. The

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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" (21 CFR Part 807.97). For questions regarding postmarket surveillance, please contact CDRH's Office of Surveillance and Biometric's (OSB's) Division of Postmarket Surveillance at 240-276-3474. For questions regarding the reporting of device adverse events (Medical Device Reporting (MDR)), please contact the Division of Surveillance Systems at 240-276-3464. 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,

Peter R. Rocker/

Robert L. Becker, Jr., M.D., Ph.D. Director Division of Immunology and Hematology Devices Office of In Vitro Diagnostic Device Evaluation and Safety Center for Devices and Radiological Health

Enclosure

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Dade Behring In N Latex RF Kit 510(k) Notification

## Indications Statement

# K071247

Device Name:

N Latex RF Kit

Indications for Use:

Quantitative determination of rheumatoid factors (RF) in human serum, heparinized and EDTA plasma on the BN™ II and BN ProSpec® Systems as an aid in the diagnosis of rheumatoid arthritis.

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) Page 1 of 1

Maria M Chan
Division Sign-Off

Office of In Vitro Diagnostic Device Evaluation and Safety

K071247