The SYNCHRON® Systems Rheumatoid Factor (RF) Reagent, in conjunction with Beckman SYNCHRON Systems is intended for the quantitative determination of rheumatoid factor concentration in human serum or plasma.

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.

Device Description

The SYNCHRON Systems Rheumatoid Factor (RF) Reagent is designed for optimal performance on Beckman's SYNCHRON® Systems. It is intended for use in the quantitative determination of human rheumatoid factor by rate nephelometry.

AI/ML Overview

Here's an analysis of the provided text regarding the SYNCHRON® Systems Rheumatoid Factor (RF) Reagent, focusing on acceptance criteria and supporting study details:

1. Table of Acceptance Criteria and Reported Device Performance

The document does not explicitly state formal "acceptance criteria" for the SYNCHRON® Systems RF Reagent in terms of a pre-defined threshold for performance metrics. Instead, it presents performance data (method comparison, imprecision) and makes a statement of "substantial equivalence" to a predicate device. The performance data implicitly serves as the basis for this claim of equivalence.

Acceptance Criterion (Implicit)	Reported Device Performance (SYNCHRON RF Reagent)
Method Comparison (vs. Predicate IMMAGE RF Reagent)
Slope close to 1.0	0.982
Intercept close to 0	-3.43
Correlation coefficient (r) close to 1.0	0.953
Imprecision (Within-Run)
Level 1 %CV	5.6% (Mean: 68.3 IU/mL)
Level 2 %CV	2.3% (Mean: 220.7 IU/mL)
Level 3 %CV	2.2% (Mean: 582.2 IU/mL)
Imprecision (Total)
Level 1 %CV	11.5% (Mean: 68.3 IU/mL)
Level 2 %CV	2.9% (Mean: 220.7 IU/mL)
Level 3 %CV	2.8% (Mean: 582.2 IU/mL)
Analytical Range	20 to 800 IU/mL
Shelf-life	24 months (at 2-8°C)

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

Method Comparison Test Set Sample Size: Not explicitly stated. The table shows a single slope, intercept, and 'r' value derived from a comparison, but the number of individual samples tested for this comparison is not provided.
Imprecision Test Set Sample Size: For each of the three levels (Level 1, Level 2, Level 3), N=80 individual measurements were performed for both "Within-Run Imprecision" and "Total Imprecision."
Data Provenance: Not explicitly stated. The document does not specify the country of origin for the samples or if the data was retrospective or prospective. Given the context of a 510(k) submission for a diagnostic device, it's highly probable these were prospective experimental studies conducted in a laboratory setting.

3. Number of Experts Used to Establish Ground Truth for the Test Set and Their Qualifications

This information is not applicable and not provided in the document. The SYNCHRON® Systems RF Reagent is an in vitro diagnostic device for quantitative determination of rheumatoid factor in human serum or plasma. Its performance is assessed through analytical studies (method comparison, imprecision) against a predicate device or expected analytical characteristics, not by expert interpretation of images or clinical diagnoses. Therefore, there is no "ground truth" established by experts in the context of clinical interpretation, like a radiologist, for this type of device.

4. Adjudication Method for the Test Set

This information is not applicable and not provided. As explained above, the device's performance is evaluated analytically, not through a process requiring expert adjudication in the traditional sense (e.g., for diagnostic discrepancies).

5. Multi-Reader Multi-Case (MRMC) Comparative Effectiveness Study

Was it done? No.
Effect size of how much human readers improve with AI vs. without AI assistance? This is not applicable. The device is a laboratory reagent system for quantitative measurement, not an AI-assisted diagnostic tool that aids human readers (like radiologists or ophthalmologists) in interpreting medical images or clinical cases.

6. Standalone Performance Study

Was it done? Yes. The "Summary of Performance Data" explicitly presents the standalone performance of the SYNCHRON® Systems RF Reagent through:
- Method Comparison Study: Comparing its results directly against the predicate IMMAGE™ Immunochemistry System RF Reagent.
- Imprecision experiments: Reporting its inherent within-run and total imprecision at different analyte levels.
  The data presented are for the algorithm (reagent system) itself, independent of human interpretation.

7. Type of Ground Truth Used

The "ground truth" in this context refers to the reference standard against which the new device's performance is measured. For the method comparison study, the predicate device (IMMAGE™ Immunochemistry System RF Reagent) served as the reference or comparator. For the imprecision studies, the "ground truth" is the true concentration of RF in the control samples, as determined by precise laboratory methods and used to calculate the mean and variability.

8. Sample Size for the Training Set

This information is not applicable and not provided. This device is a chemical reagent system, not a machine learning or AI model that requires a "training set" in the computational sense. The development of such a system involves chemical formulation, optimization, and extensive analytical validation but not computational training data.

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 machine learning for this type of device. The development and validation of the SYNCHRON® Systems RF Reagent would involve established analytical chemistry principles and quality control processes to ensure the accuracy and reliability of the reagent's performance.

Summary

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K971788

Summary of Safety & Effectiveness SYNCHRON® Systems Rheumatoid Factor (RF) Reagent

V - 3 1997

Submitted By: 1.0

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:

13 May 1997

3.0 Device Name(s):

3.1 Proprietary Names

SYNCHRON® Systems Rheumatoid Factor (RF) Reagent SYNCHRON CX® Systems RF Calibrator

3.2 Classification Names

Rheumatoid factor immunological test system(21 CFR 866.5775) Calibrator (21 CFR 862.1150)

4.0 Predicate Device(s):

IMMAGE™ Immunochemistry System Rheumatoid Factor (RF) Reagent Test System K963048

5.0 Description:

6.0 Intended Use:

The SYNCHRON CX® Systems RF Calibrator, a six level calibrator set, in conjunction with SYNCHRON® Systems RF Reagent, is intended for use on SYNCHRON CX Systems for the calibration of Rheumatoid Factor.

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Beckman Instruments, Inc., Section 510(k) Notification SYNCHRON® Systems Rheumatoid Factor (RF) 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
SYNCHRONSystems RFReagent	Latex particles coatedwith human IgG
SYNCHRONSystems RFReagent	Shelf-life of 24 months(stored at 2-8°C)	Same as IMMAGE System RF Reagent
SYNCHRONSystems RFReagent	Initial analytic range of20 to 800 IU/mL
DIFFERENCES
SYNCHRONSystems RFReagent	Calibrator	The SYNCHRON uses a six level systemcalibration while the IMMAGE uses a singlecal point update
SYNCHRONSystems RFReagent	Methodology	The SYNCHRON Systems RF utilizes aturbidimetric method while the IMMAGESystem RF utilizes a nephelometric method.

8.0 Summary of Performance Data:

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 relate results obtained from the SYNCHRON RF Reagent to the IMMAGE System RF Reagent.

Method Comparison Study Results SYNCHRON RF Reagent vs. IMMAGE RF Reagent

Analyte	Slope	Intercept	r	Predicate
RF	0.982	-3.43	0.953	IMMAGE RF

Estimated SYNCHRON RF Reagent Imprecision

Sample	Mean (IU/mL)	S.D. (IU/mL)	%C.V.	N
Within-Run Imprecision
Level 1	68.3	3.79	5.6	80
Level 2	220.7	5.07	2.3	80
Level 3	582.2	12.9	2.2	80
Total Imprecision
Level 1	68.3	7.84	11.5	80
Level 2	220.7	6.46	2.9	80
Level 3	582.2	16.4	2.8	80

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/2/Picture/1 description: The image shows the logo for the U.S. Department of Health & Human Services. The logo consists of a circular seal with the words "DEPARTMENT OF HEALTH & HUMAN SERVICES - USA" around the perimeter. Inside the circle is an emblem featuring a stylized caduceus, a symbol often associated with medicine and healthcare. The caduceus is depicted with a staff entwined by a serpent and topped with wings.

Food and Drug Administration 2098 Gaither Road Rockville MD 20850

JUN - 3 1997

Ms. Annette Hellie Regulatory Specialist, Product Submissions Beckman Instruments, Inc ..................................................................................................................................................... 200 S. Kraemer Boulevard, W-337 Brea. California 92822-8000

Re: K971788

Trade Name: SYNCHRON® Systems Rheumatoid Factor (RF) Reagent Regulatory Class: II Product Code: DHR Dated: May 13, 1997 Received: May 14. 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 vour premarket notification submission does not affect any obligation vou 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 Putman

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

510(k) Number (if known):

Device Name: SYNCHRON® Systems Rheumatoid Factor (RF) Reagent

Indications for Use: - - - - -

The SYNCHRON® Systems Rheumatoid Factor (RF) Reagent , in conjunction with Beckman SYNCHRON Systems is intended for the quantitative determination of rheumatoid factor concentration in human serum or plasma.

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)

Retur E. Maluss

(Division Sign-Off) Division of Clinical Laboratory Devices 510(k) Number .

Prescription Use ﺑﻠﻨﺪﯼ (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).