(20 days)
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No
The document describes a reagent and system for quantitative determination of rheumatoid factor using rate nephelometry, a standard laboratory technique. There is no mention of AI, ML, or any related concepts in the intended use, device description, or performance studies.
No
This device is an in vitro diagnostic (IVD) reagent used for quantitative determination of rheumatoid factor, aiding in diagnosis rather than directly treating or preventing a disease.
Yes
The device is described as an "immunological test system" that measures rheumatoid factor, and the "Measurement of rheumatoid factor may aid in the diagnosis of rheumatoid arthritis," clearly indicating its use in aiding diagnosis.
No
The device is a reagent intended for use with a specific hardware system (Beckman SYNCHRON Systems) for a quantitative determination. It is not a standalone software product.
Yes, this device is an IVD (In Vitro Diagnostic).
Here's why:
- Intended Use: The intended use explicitly states it's for the "quantitative determination of rheumatoid factor concentration in human serum or plasma." This involves testing biological samples in vitro (outside the body).
- Device Description: The description confirms it's a "reagent" used for "quantitative determination of human rheumatoid factor by rate nephelometry." Reagents used to analyze biological samples are characteristic of IVDs.
- Regulatory Context: The document mentions a "Premarket Notification" and "substantial equivalence to chemistry test systems already in commercial distribution." This regulatory language is specific to medical devices, and in this context, specifically to IVDs. The predicate device listed (IMMAGE™ Immunochemistry System Rheumatoid Factor (RF) Reagent Test System) is also an IVD.
- Definition Provided: The document even includes a definition of a "rheumatoid factor immunological test system" which clearly describes a device that uses reagents to measure rheumatoid factor in biological samples, aligning with the definition of an IVD.
N/A
Intended Use / 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.
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.
Product codes
DHR
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 meumatoid factor by rate nephelometry.
Mentions image processing
Not Found
Mentions AI, DNN, or ML
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Input Imaging Modality
Not Found
Anatomical Site
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Indicated Patient Age Range
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Intended User / Care Setting
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Description of the training set, sample size, data source, and annotation protocol
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Description of the test set, sample size, data source, and annotation protocol
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Summary of Performance Studies (study type, sample size, AUC, MRMC, standalone performance, key results)
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:
Analyte: RF, Slope: 0.982, Intercept: -3.43, r: 0.953, Predicate: IMMAGE RF
Estimated SYNCHRON RF Reagent Imprecision:
Within-Run Imprecision:
Level 1: Mean (IU/mL) 68.3, S.D. (IU/mL) 3.79, %C.V. 5.6, N 80
Level 2: Mean (IU/mL) 220.7, S.D. (IU/mL) 5.07, %C.V. 2.3, N 80
Level 3: Mean (IU/mL) 582.2, S.D. (IU/mL) 12.9, %C.V. 2.2, N 80
Total Imprecision:
Level 1: Mean (IU/mL) 68.3, S.D. (IU/mL) 7.84, %C.V. 11.5, N 80
Level 2: Mean (IU/mL) 220.7, S.D. (IU/mL) 6.46, %C.V. 2.9, N 80
Level 3: Mean (IU/mL) 582.2, S.D. (IU/mL) 16.4, %C.V. 2.8, N 80
Key Metrics (Sensitivity, Specificity, PPV, NPV, etc.)
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Predicate Device(s)
Reference Device(s)
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Predetermined Change Control Plan (PCCP) - All Relevant Information
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§ 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).
0
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:
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 meumatoid factor by rate nephelometry.
6.0 Intended 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.
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.
1
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 | ||
| SYNCHRON | ||
| Systems RF | ||
| Reagent | Latex particles coated | |
| with human IgG | ||
| SYNCHRON | ||
| Systems RF | ||
| Reagent | Shelf-life of 24 months | |
| (stored at 2-8°C) | Same as IMMAGE System RF Reagent | |
| SYNCHRON | ||
| Systems RF | ||
| Reagent | Initial analytic range of | |
| 20 to 800 IU/mL | ||
| DIFFERENCES | ||
| SYNCHRON | ||
| Systems RF | ||
| Reagent | Calibrator | The SYNCHRON uses a six level system |
| calibration while the IMMAGE uses a single | ||
| cal point update | ||
| SYNCHRON | ||
| Systems RF | ||
| Reagent | Methodology | The SYNCHRON Systems RF utilizes a |
| turbidimetric method while the IMMAGE | ||
| System 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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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
4
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)
OR
Over-the-Counter Use Optional Format 1-2-96