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 Description

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.

AI/ML Overview

Here's a breakdown of the acceptance criteria and study details based on the provided text:

Acceptance Criteria and Device Performance

The provided 510(k) summary focuses on demonstrating substantial equivalence to a predicate device, rather than explicit pre-defined clinical acceptance criteria often seen with novel devices. The primary performance metric presented for equivalence is strong correlation with the predicate device.

Acceptance Criteria (Implied)	Reported Device Performance
Strong linear correlation with the predicate device (N Latex RF) for all tested concentrations.	Correlation Coefficient: 0.98 (for N Latex RF Kit vs. predicate)
Strong linear correlation with the predicate device (N Latex RF) for concentrations ≤ 100 IU/mL (closer to clinical cutoff).	Correlation Coefficient: 0.87 (for N Latex RF Kit vs. predicate, ≤ 100 IU/mL)
Slope close to 1.0 for all tested concentrations.	Slope: 1.098 (for N Latex RF Kit vs. predicate)
Intercept close to 0 for all tested concentrations.	Intercept: -12.94 (for N Latex RF Kit vs. predicate)
Slope close to 1.0 for concentrations ≤ 100 IU/mL.	Slope: 0.992 (for N Latex RF Kit vs. predicate, ≤ 100 IU/mL)
Intercept close to 0 for concentrations ≤ 100 IU/mL.	Intercept: -6.81 (for N Latex RF Kit vs. predicate, ≤ 100 IU/mL)

Note: The acceptance criteria are "implied" because the document states the goal is to demonstrate substantial equivalence, and the reported performance metrics are key indicators used to support that claim. Specific numerical thresholds for "strong correlation" or "close to" are not explicitly defined as pass/fail criteria within this summary.

Study Information

Sample size used for the test set and the data provenance:
- Sample Size: 90 serum samples were evaluated, with 43 of these samples specifically evaluated for concentrations ≤ 100 IU/mL.
- Data Provenance: Not explicitly stated regarding country of origin or specific demographics. The study is retrospective in the sense that it uses existing samples to compare performance with the predicate device.
Number of experts used to establish the ground truth for the test set and the qualifications of those experts: Not applicable. This study compares the performance of a new device against an existing, legally marketed predicate device (N Latex RF – K942328). The "ground truth" for the test set is established by the measurements from the predicate device itself. No human experts were involved in establishing an independent ground truth for the test set.
Adjudication method for the test set: Not applicable. As the study compares against a predicate device's measurements, there is no need for expert adjudication.
If a multi-reader multi-case (MRMC) comparative effectiveness study was done, If so, what was the effect size of how much human readers improve with AI vs without AI assistance: Not applicable. This is an in vitro diagnostic (IVD) device for quantitative determination of rheumatoid factors, not an imaging device or an AI-assisted diagnostic tool that involves human reader performance.
If a standalone (i.e., algorithm only without human-in-the-loop performance) was done: Yes. The performance study evaluates the N Latex RF Kit as a standalone assay (algorithm only) without any human-in-the-loop component influencing the measurement results. The device quantifies RF levels directly.
The type of ground truth used: The "ground truth" for this substantial equivalence study is the measurements obtained from the legally marketed predicate device (N Latex RF). The new device's measurements are compared against these predicate measurements.
The sample size for the training set: Not applicable. This device is a reagent kit for an immunoassay, not a machine learning or AI model that requires a "training set" in the conventional sense. The device's calibration would be part of its manufacturing and quality control process, but not a "training set" like that for an AI algorithm.
How the ground truth for the training set was established: Not applicable. See point 7.

Summary

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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: 302-631-6299

Manufacturer:	Dade Behring Marburg GmbHEmil-von-Behring Str. 7635041 Marburg, Germany
Contact Information:	Dade Behring Inc.P.O. Box 6101Newark, Delaware 19714-610Attn: Helen LeeTel: 302-631-8706

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

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	CorrelationCoefficient
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 (240) 276-0450. 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 (800) 638-2041 or (240) 276-3150 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

Regulation Number and Section

§ 866.5775 Rheumatoid factor immunological test system.

(a)
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.(b)
Classification. Class II (performance standards).