(57 days)
Not Found
No
The summary describes a reagent for quantitative determination of rheumatoid factor using rate nephelometry, a standard laboratory technique. There is no mention of AI, ML, image processing, or any data-driven algorithms beyond standard statistical analysis for performance metrics.
No
This device is a reagent intended for the quantitative determination of human rheumatoid factor, which is a diagnostic tool, not a therapeutic intervention.
Yes
The device is described as a reagent for the quantitative determination of human rheumatoid factor, which is used to aid in the diagnosis and monitoring of rheumatoid arthritis. This falls under the definition of a diagnostic device as it provides information for disease detection or assessment.
No
The device description clearly states it is a reagent intended for use with a specific hardware system (Beckman Array Systems) for quantitative determination of rheumatoid factor, indicating it is a physical component, not software only.
Yes, this device is an IVD (In Vitro Diagnostic).
Here's why:
- Intended Use: The intended use explicitly states "intended for quantitative determination of human rheumatoid factor by rate nephelometry." This describes a test performed on a sample taken from the human body (serum) to provide information about a medical condition (rheumatoid factor levels).
- Device Description: The description reinforces this by stating it's for "quantitative determination of human rheumatoid factor concentrations in human serum samples."
- Sample Type: The device uses human serum samples, which are biological specimens taken from the body.
- Measurement: It performs a quantitative determination of a substance (rheumatoid factor) in the sample.
- Context: The context of measuring rheumatoid factor is for diagnostic purposes related to rheumatoid arthritis.
These characteristics align directly with the definition of an In Vitro Diagnostic device, which is used to examine specimens derived from the human body to provide information for diagnostic, monitoring, or compatibility purposes.
N/A
Intended Use / Indications for Use
The Array® Systems Rheumatoid Factor (RFMPE) 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.
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 (comma separated list FDA assigned to the subject device)
DHR
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.
Mentions image processing
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Mentions AI, DNN, or ML
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Input Imaging Modality
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Anatomical Site
human serum samples, other body fluids, and tissues.
Indicated Patient Age Range
Not Found
Intended User / Care Setting
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Description of the training set, sample size, data source, and annotation protocol
Not Found
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 results obtained from the Array RFMPE Reagent to the IMMAGE System RF Reagent.
Method Comparison Study Results Array RFMPE Reagent vs. IMMAGE RF Reagent
Summary data is presented in a table without specific values provided in text.
Stability Study Results
Summary data is presented in a table without specific values provided in text.
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 |
Key Metrics (Sensitivity, Specificity, PPV, NPV, etc.)
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Predicate Device(s): If the device was cleared using the 510(k) pathway, identify the Predicate Device(s) K/DEN number used to claim substantial equivalence and list them here in a comma separated list exactly as they appear in the text. List the primary predicate first in the list.
Reference Device(s): Identify the Reference Device(s) K/DEN number and list them here in a comma separated list exactly as they appear in the text.
Not Found
Predetermined Change Control Plan (PCCP) - All Relevant Information for the subject device only (e.g. presence / absence, what scope was granted / cleared under the PCCP, any restrictions, etc).
Not Found
§ 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
BECKMAN
JUN 27 1997
Summary of Safety & Effectiveness Array® Systems Rheumatoid Factor (RFupe) Reagent
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:
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.
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.
1
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 Systems | ||
| RFMPE Reagent | Latex coated particles | Same as IMMAGE System RF |
| Reagent | ||
| Shelf-life of 24 months | ||
| (stored at 2-8°C) | ||
| Calibrator | ||
| (Beckman Calibrator 5 Plus) | ||
| DIFFERENCES | ||
| Array Systems | ||
| RFMPE Reagent | Angle of measurement | The Array System measures at |
| a 70° angle while the IMMAGE | ||
| System measures at a 90° | ||
| angle | ||
| Array Systems | ||
| RFMPE Reagent | Initial analytic range | The initial analytic range for |
| Array is 20 to 600 IU/mL while | ||
| the IMMAGE System is 20 to |
- |
| Array Systems
RFMPE Reagent | Reaction temperature | The Array Systems measure at
26.7°C while the IMMAGE
System measures at 37°C |
2
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.
3
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.
4
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
5
page _ of _
510(k) Number (if known):
510(k) Number (if known):
Device Name: Array® Systems Rheumatoid Factor (RFMPE) Reagent
Indications for Use:
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.
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)
OR
Over-the-Counter Use Optional Format 1-2-96