(60 days)
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No
The description explicitly states the device is a "manual procedure" and an "Enzyme Immunoassay (EIA) Kit," which are traditional laboratory techniques. There is no mention of AI, ML, or any computational analysis beyond standard assay calculations.
No.
Explanation: The device is an in vitro diagnostic (IVD) test for detecting IgM antibodies, intended as an aid in diagnosis and explicitly states "FOR IN VITRO DIAGNOSTIC USE ONLY." It does not directly treat or prevent disease.
Yes
The document explicitly states in the "Intended Use / Indications for Use" section that the test is "intended as an aid in the diagnosis of rheumatoid arthritis" and is "FOR IN VITRO DIAGNOSTIC USE ONLY."
No
The device description clearly states it is a "semi quantitative Enzyme Immunoassay (EIA) Kit" and lists physical components like a micro plate, reagents, buffers, and solutions, indicating it is a hardware-based in vitro diagnostic device, not software only.
Yes, this device is an IVD (In Vitro Diagnostic).
The "Intended Use / Indications for Use" section explicitly states: "FOR IN VITRO DIAGNOSTIC USE ONLY." This is the key indicator that the device is intended for use outside of the body to examine specimens from the human body for diagnostic purposes.
Furthermore, the description of the device and its intended use aligns perfectly with the definition of an IVD:
- Analyzes human serum: It detects antibodies in human serum.
- Aids in diagnosis: It is intended as an aid in the diagnosis of rheumatoid arthritis.
- Uses laboratory procedures: It is a semi-quantitative Enzyme Immunoassay (EIA) Kit, which is a laboratory-based test.
N/A
Intended Use / Indications for Use
The MDI RF Test reagents (P/N: RFKi-G) are intended for the semi-quantitative determination of IgM antibodies to IgG in human serum. The principal diagnostic value of this test is detection of autoantibodies, which are used as an aid in patients with rheumatoid diseases.
The MDI RF Test is a semi quantitative Enzyme Immunoassay (EIA) Kit for the detection of IgM antibodies against human IgG (RF) in human serum. The test is intended as an aid in the diagnosis of rheumatoid arthritis. FOR IN VITRO DIAGNOSTIC USE ONLY.
Product codes
DHR
Device Description
The Micro Detect, Inc. RF reagent ( MDI RF Test) is intended to be used as a manual procedure. The reagents are supplied as a micro plate coated with specific antigens and Controls, Wash Buffer, Sample Diluent, Conjugate, Substrate, and Stop Solution.
The Micro plate ELISA formats is a commonly used format for the detection of many entities of clinical interest, including autoimmune diseases.
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
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
Relative Sensitivity: 95.2% Relative Specificity: 100 %
Precision (%CV); 1.9-5.15(Inter) and 1.44-3.62(Intra)
Stability: One year at 2-8°C. The stability of the MDI RF Test Kit for the detection of IgM antibodies to IgG was found to be one year at 2-8℃. This was predicted from studies done under stress condition (47.59C), Real time stability has only been monitored for ten weeks at 2-8°C.
Key Metrics
Relative Sensitivity: 95.2%
Relative Specificity: 100 %
Precision (%CV); 1.9-5.15(Inter) and 1.44-3.62(Intra)
Predicate Device(s)
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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
JAN 1 1 2000
SUMMARY OF 510 (k) SAFETY AND EFFECTIVENESS INFORMATION
This summary of 510 (k) safety and effectiveness information is being submitted in accordance with the requirement of SMDA 1990 and 21 CFR 807.92.
MDI RF Test reagents (P/N: RFKi-G) are intended for the semi-quantitative determination of IgM antibodies to IgG in human serum. The principal diagnostic value of this test is detection of autoantibodies, which are used as an aid in patients with rheumatoid diseases.
The Micro Detect, Inc. RF reagent ( MDI RF Test) is intended to be used as a manual procedure. The reagents are supplied as a micro plate coated with specific antigens and Controls, Wash Buffer, Sample Diluent, Conjugate, Substrate, and Stop Solution.
The patient results obtained using the MDI RF Test is substantially equivalent to those obtained by using predicate assays:
Relative Sensitivity: 95.2% Relative Specificity: 100 %
Precision (%CV); 1.9-5.15(Inter) and 1.44-3.62(Intra)
Stability: One year at 2-8°C. The stability of the MDI RF Test Kit for the detection of IgM antibodies to IgG was found to be one year at 2-8℃. This was predicted from studies done under stress condition (47.59C), Real time stability has only been monitored for ten weeks at 2-8°C.
The Micro plate ELISA formats is a commonly used format for the detection of many entities of clinical interest, including autoimmune diseases.
The MDI RF Test system is shown to be safe and effective and provide results, which are substantially equivalent to those, obtained by predicate products.
1
DEPARTMENT OF HEALTH & HUMAN SERVICES
Image /page/1/Picture/1 description: The image is a black and white logo for the U.S. Department of Health & Human Services. The logo features a stylized eagle or bird-like figure with three curved lines forming its body and wings. The text "DEPARTMENT OF HEALTH & HUMAN SERVICES - USA" is arranged in a circular fashion around the bird figure.
Public Health Service
JAN 1 1 2000
Food and Drug Administration 2098 Gaither Road Rockville MD 20850
Mehdi Alem, Ph.D. President Micro Detect, Inc. 2852 Walnut Avenue Suite H-1 Tustin, California 92780
Re: K993843
Trade Name: MDI RF Test Regulatory Class: II Product Code: DHR Dated: December 17, 1999 Received: December 21, 1999
Dear Dr. Alem:
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 QS 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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Page 2
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.
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 (301) 443-6597, or at its internet address "http://www.fda.gov/cdrh/dsma/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
3
K 922723/A1
of of of of Page
510(k) Number (if known): K993843
Device Name: MDI RF Test
Indications For Use:
The MDI RF Test is a semi quantitative Enzyme Immunoassay (EIA) Kit for the test is The MDI KF Test is a sem qualintative 22 (RF) in human serum. The test is
detection of IgM antibodies against human IgG (RF) in human in VITRO detection of Igivi antionnies aganist framatoid arthritis. FOR IN VITRO
intended as an aid in the diagnosis of rheumatoid arthritis. FOR IN VITRO DIAGNOSTIC USE ONLY.
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Concurrence of CDRH, Office of Device Evaluation (ODE)
| Peter E. Makini | |
|---|---|
| (Division Sign-Off) | |
| Division of Clinical Laboratory Devices | |
| 510(k) Number | K993843 |
Prescription Use V (Per 21 CFR 801,109)
OR
Over-The-Counter Use__________________________________________________________________________________________________________________________________________________________
(Optional Format 1-2 -96)