(135 days)
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No
The summary describes a standard immunoassay for detecting antibodies, with no mention of AI or ML in the intended use, device description, or any other section.
No.
The device is an in vitro diagnostic (IVD) assay designed to detect specific antibodies as an aid in diagnosing rheumatoid arthritis, not to treat or mitigate a disease.
Yes
The device is described as an "aid in the diagnosis of rheumatoid arthritis (RA)" and is explicitly labeled "For in vitro diagnostic use only", indicating its role in diagnosis.
No
The device is an in vitro diagnostic assay kit, which is a physical product containing reagents and intended for use with a specific instrument. It is not a software-only device.
Yes, this device is an IVD (In Vitro Diagnostic).
Here's why:
- Explicit Statement: The document explicitly states "For in vitro diagnostic use only."
- Intended Use: The intended use is the "semi-quantitative determination of specific IgA rheumatoid factor (RF) antibodies in human serum." This involves testing a sample (serum) taken from the human body in vitro (outside the body) to provide information for diagnosis.
- Diagnostic Aid: The results are intended to be used "as an aid in the diagnosis of rheumatoid arthritis (RA)." This clearly indicates a diagnostic purpose.
The definition of an IVD is a medical device that is used to examine specimens, such as blood, tissue, or urine, taken from the human body to detect diseases, conditions, or infections. This device fits that definition perfectly.
N/A
Intended Use / Indications for Use
Enzyme linked immunosorbent assay method for the semi-quantitative determination of specific IgA rheumatoid factor (RF) antibodies in human serum.
Uses:
The results of the RF IgA assay can be used as an aid in the diagnosis of rheumatoid arthritis (RA) when supported by other laboratory and clinical investigations.
Levels of these autoantibodies are one indicator in a multi-factorial diagnostic regime.
The assay may be used on the Hycor Hy. Tec Automated EIA instrument.
For in vitro diagnostic use only.
Product codes
DHR
Device Description
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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
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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)
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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.
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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.
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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).
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Image /page/0/Picture/1 description: The image is a black and white circular logo for the Department of Health & Human Services USA. The logo features the department's emblem, which is a stylized caduceus with three snakes intertwined around a staff. The text "DEPARTMENT OF HEALTH & HUMAN SERVICES - USA" is arranged around the upper half of the circle, following its curvature.
MAR - 3 2000
Food and Drug Administration 2098 Gaither Road Rockville MD 20850
Ms. Danielle M. Knight Ouality Manager Cogent Diagnostics Limited Pentlands Science Park Bush Loan, Penicuik EH26 OPL Scotland, United Kingdom
Re: K993557
Trade Name: Autostat II Rheumatoid Factor IgA ELISA Regulatory Class: II Product Code: DHR Dated: February 7, 2000 Received: February 10, 2000
Dear Ms. Knight:
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 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). 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 Current Good Manufacturing Practice requirements, as set forth in the Quality System Regulation (QS) for Medical Devices: General regulation (21 CFR Part 820) and that, through periodic OS 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.
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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" (21CFR 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 (301) 443-6597 or at its internet address "http://www.fda.gov/cdrh/dsma/dsmamain.html".
Sincerely yours,
Steven Toutman
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
| Labels | Values |
|---|---|
| 510(k) Number (if known) | K993557 |
| Device Name | Autostat |
| Rheumatoid Factor IgA ELISA |
Indications For Use:
Enzyme linked immunosorbent assay method for the semi-quantitative determination of specific IgA rheumatoid factor (RF) antibodies in human serum.
Uses:
The results of the RF IgA assay can be used as an aid in the diagnosis of rheumatoid arthritis (RA) when supported by other laboratory and clinical investigations.
Levels of these autoantibodies are one indicator in a multi-factorial diagnostic regime.
The assay may be used on the Hycor Hy. Tec Automated EIA instrument.
For in vitro diagnostic use only.
(PLEASE DO NOT WRITE BELOW THIS LINE-CONTINUE ON ANOTHER PAGE IF NEEDED)
Concurrence of CDRH, Office of Device Evaluation (ODE)
(Division
of
Serial Number = K 493554
Prescription Use Y (Per 21 CFR 801.109) OR
Over-The-Counter Use
(Optional Format 1-2-96)