The Array® Systems Rheumatoid Factor (RFME) reagent, when used in conjunction with the Beckman Array System and Beckman Calibrator 5 Plus, is intended for quantitative determination of human rheumatoid factor by rate nephelometry.

Device Description

The Array Systems Rheumatoid Factor (RFupe) Reagent is designed for optimal performance on Beckman's Array® Systems. It is intended for use in the quantitative determination of human rheumatoid factor concentrations in human serum samples.

AI/ML Overview

Here's an analysis of the provided text to extract the acceptance criteria and study details:

1. Table of Acceptance Criteria and Reported Device Performance

The provided text does not explicitly state acceptance criteria in a pass/fail format. Instead, it presents performance data (method comparison, stability, imprecision) and states that this data "supports a finding of substantial equivalence" to the predicate device. For the purpose of this response, I infer the implicit acceptance criteria from the context of demonstrating substantial equivalence, meaning the performance of the new device is comparable to the predicate.

Acceptance Criteria (Inferred)	Reported Device Performance
Method Comparison: Array RFMPE Reagent results should be comparable to IMMAGE System RF Reagent results.	Details of the method comparison study are missing due to OCR errors. However, the text states: "Equivalence is demonstrated through method comparison... experiments that results obtained from the Array RFMPE Reagent to the IMMAGE System RF Reagent." This implies the results were favorably comparable.
Stability: Reagent should maintain performance over its stated shelf-life (24 months at 2-8°C).	Details of the stability study are missing due to OCR errors. The text mentions "Stability Study Results" and lists "SHELF-LIFE OF 24 MONTHS (STORED AT 2-8°C)" under similarities to the predicate. This implies the stability study confirmed the 24-month shelf-life.
Imprecision (Repeatability & Reproducibility): The device should demonstrate acceptable levels of imprecision.	Within-Run Imprecision:- Level 1 (30.2 IU/mL): S.D. 1.07 IU/mL, %C.V. 3.56- Level 2 (313 IU/mL): S.D. 8.71 IU/mL, %C.V. 2.78- Level 3 (564 IU/mL): S.D. 15.2 IU/mL, %C.V. 2.69Total Imprecision:- Level 1 (30.2 IU/mL): S.D. 1.56 IU/mL, %C.V. 5.16- Level 2 (313 IU/mL): S.D. 10.4 IU/mL, %C.V. 3.32- Level 3 (564 IU/mL): S.D. 17.9 IU/mL, %C.V. 3.17

2. Sample Size Used for the Test Set and Data Provenance

Test Set Sample Size:
- For Imprecision, the sample size (N) for each level (within-run and total) was 160.
- The sample size for the Method Comparison and Stability studies is not explicitly stated in the provided text due to OCR errors in the table.
Data Provenance: The document does not specify the country of origin of the data or whether the study was retrospective or prospective.

3. Number of Experts Used to Establish Ground Truth and Qualifications of Experts

This information is not applicable to this type of device (an in-vitro diagnostic reagent for quantitative determination using nephelometry). The "ground truth" for such devices is typically established through reference methods and calibrated standards, not expert consensus on interpretations.

4. Adjudication Method for the Test Set

This information is not applicable for this type of device. Adjudication methods (like 2+1) are common in studies involving human interpretation (e.g., imaging devices) where experts might disagree.

5. If a Multi-Reader Multi-Case (MRMC) Comparative Effectiveness Study Was Done

No, an MRMC comparative effectiveness study was not done. This type of study assesses how human readers' performance (e.g., diagnostic accuracy) changes with or without AI assistance. The device in question is a reagent for an automated laboratory system, not an AI-assisted interpretation tool for human readers.

6. If a Standalone (i.e., Algorithm Only Without Human-in-the-Loop Performance) Was Done

Yes, the performance data presented (method comparison, stability, imprecision) represents the standalone performance of the Array® Systems Rheumatoid Factor (RFMPE) Reagent when used with the Beckman Array System. The device itself is an automated assay, so its performance is inherently "standalone" in this context; there is no human interpretation step being assisted or evaluated.

7. The Type of Ground Truth Used

The ground truth for this type of quantitative diagnostic assay would typically be established through:

Reference materials/calibrators: The device uses "Beckman Calibrator 5 Plus," which would be crucial for establishing the quantitative accuracy.
Comparison to a predicate device: The method comparison study directly compares the new device's results to the IMMAGE™ Immunochemistry System Rheumatoid Factor (RF) Reagent (K963048), which itself would have been validated against established reference methods. While not explicitly stated as the ground truth, the predicate serves as the comparative standard against which equivalence is demonstrated.

8. The Sample Size for the Training Set

This information is not applicable to this device. This device is a chemical reagent kit with an associated automated analyzer, not a machine learning or AI algorithm that requires a training set in the typical sense. The "training" for such a system would involve optimizing the reagent formulation and instrument parameters, but not through a labeled data training set as understood in AI development.

9. How the Ground Truth for the Training Set Was Established

This information is not applicable as there is no "training set" in the context of an AI/ML algorithm development. The development and optimization of the reagent and system would rely on physicochemical principles, established analytical chemistry methods, and performance testing against known concentrations of rheumatoid factor, often using certified reference materials.

Summary

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BECKMAN

JUN 27 1997

Summary of Safety & Effectiveness Array® Systems Rheumatoid Factor (RFupe) Reagent

K971602

1.0 Submitted By:

Annette Hellie Sr. Regulatory Specialist, Product Submissions Beckman Instruments, Inc. 200 S. Kraemer Blvd., W-337 Brea, California 92822-8000 Telephone: (714) 993-8767 FAX: (714) 961-4457

2.0 Date Submitted:

30 April 1997

3.0 Device Name(s):

3.1 Proprietary Names

Array® Systems Rheumatoid Factor (RFMPE) Reagent

3.2 Classification Names

Rheumatoid factor immunological test system(21 CFR 866.5775)

4.0 Predicate Device(s):

IMMAGE™ Immunochemistry System Rheumatoid Factor (RF) Reagent K963048

5.0 Description:

6.0 Intended Use:

The Array® Systems Rheumatoid Factor (RF upe) reagent, when used in conjunction with the Beckman Array System and Beckman Calibrator 5 Plus, is intended for quantitative determination of human rheumatoid factor by rate nephelometry.

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Beckman Instruments, Inc., Section 510(k) Notification Array® Systems Rheumatoid Factor (RFMPE) Reagent Summary of Safety & Effectiveness

7.0 Comparison to Predicate(s):

The following table shows similarities and differences between the predicates identified in Section 4.0 of this summary.

Reagent	Aspect/Characteristic	Comments
	SIMILARITIES
	Intended use
	Nephelometric principle
Array SystemsRFMPE Reagent	Latex coated particles	Same as IMMAGE System RFReagent
	Shelf-life of 24 months(stored at 2-8°C)
	Calibrator(Beckman Calibrator 5 Plus)
	DIFFERENCES
Array SystemsRFMPE Reagent	Angle of measurement	The Array System measures ata 70° angle while the IMMAGESystem measures at a 90°angle
Array SystemsRFMPE Reagent	Initial analytic range	The initial analytic range forArray is 20 to 600 IU/mL whilethe IMMAGE System is 20 to800.
Array SystemsRFMPE Reagent	Reaction temperature	The Array Systems measure at26.7°C while the IMMAGESystem measures at 37°C

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Beckman Instruments, Inc., Section 510(k) Notification Array® Systems Rheumatoid Factor (RFMPE) Reagent Summary of Safety & Effectiveness

Summary of Performance Data: 8.0

The data in the Premarket Notification on safety and effectiveness supports a finding of substantial equivalence to chemistry test systems already in commercial distribution. Equivalence is demonstrated through method companson, stability, and imprecision experiments that results obtained from the Array RFMPE Reagent to the IMMAGE System RF Reagent.

Method Comparison Study Results Array RFMPE Reagent vs. IMMAGE RF Reagent

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Stability Study Results

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Estimated Array RFMPE Reagent Imprecision

Sample	Mean (IU/mL)	S.D. (IU/mL)	%C.V.	N
Within-Run Imprecision
Level 1	30.2	1.07	3.56	160
Level 2	313	8.71	2.78	160
Level 3	564	15.2	2.69	160
Total Imprecision
Level 1	30.2	1.56	5.16	160
Level 2	313	10.4	3.32	160
Level 3	564	17.9	3.17	160

This summary of safety and effectiveness is being submitted in accordance with the requirements of the Safe Medical Device Act of 1990 and the implementing regulation 21 CFR 807.92.

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Image /page/3/Picture/1 description: The image shows the logo for the U.S. Department of Health & Human Services. The logo features a stylized eagle with three overlapping profiles facing right. The text "DEPARTMENT OF HEALTH & HUMAN SERVICES • USA" is arranged in a circular fashion around the eagle.

Food and Drug Administration 2098 Gaither Road Rockville MD 20850

Annette Hellie Sr. Regulatory Specialist, Product Submissions Beckman Instruments, Inc. 200 S. Kraemer Blvd., W-337 Brea, CA 92822-8000

JUN 2 7 1997

Re: K971602 Trade Name: Array® Systems Rheumatoid Factor(RFME) Reagent Regulatorv Class: II Product Code: DHR Dated: April 30, 1997 Received: May 01, 1997

Dear Ms. Hellie:

We have reviewed your Section 510(k) notification of intent to market the device referenced above and we have determined the device is substantially equivalent (for the indications for use stated in the enclosure) to 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). 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 (Premarket Approval), 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 895. A substantially equivalent determination assumes compliance with the Good Manufacturing Practice for Medical Devices: General (GMP) regulation (21 CFR Part 820) and that, through periodic GMP inspections, the Food and Drug Administration (FDA) will verify such assumptions. Failure to comply with the GMP regulation may result in regulatory action. In addition, FDA may publish further announcements concerning your device in the Federal Register.

Please note: this response to your premarket notification submission does not affect any obligation you might have under sections 531 through 542 of the Act for devices under the Electronic Product Radiation Control provisions, or other Federal Laws or Regulations.

Under the Clinical Laboratory Improvement Amendments of 1988 (CLIA-88), this device may require a CLIA complexity categorization. To determine if it does, you should contact the Centers for Disease Control and Prevention (CDC) at (770)488-7655.

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Page 2

This letter will allow you to begin marketing your device as described in your 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 advice for your device on our labeling regulation (21 CFR Part 801 and additionally 809.10 for in vitro diagnostic devices), please contact the Office of Compliance at (301) 594-4588. Additionally, for questions on the promotion and advertising of your device, please contact the Office of Compliance at (301) 594-4639. Also, please note the regulation entitled, "Misbranding by reference to premarket notification" (21 CFR 807.97). Other general information on your responsibilities under the Act may be obtained from the Division of Small Manufacturers Assistance at its toll free number (800) 638-2041 or at (301) 443-6597 or at its internet address "http://www.fda.gov/cdrh/dsmamain.html"

Sincerely yours,

Steven Sutman

Steven I. Gutman, M.D., M.B.A. Director Division of Clinical Laboratory Devices Office of Device Evaluation Center for Devices and Radiological Health

Enclosure

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page _ of _

510(k) Number (if known):

Device Name: Array® Systems Rheumatoid Factor (RFMPE) Reagent

Indications for Use:

Rheumatoid factor immunological test system(21 CFR 866.5775)

(a) Identification. A rheumatoid factor immunological test system is a device that consists of the reagents used to measure bv 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).

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

Concurrence of CDRH, Office of Device Evaluation (ODE)

Petie E. Mahon

aboratory Devices

Prescription Use & (per 21 CFR 801.109)

Over-the-Counter Use Optional Format 1-2-96

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).