(60 days)
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.
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.
Here's an analysis of the provided text, focusing on the acceptance criteria and the study details:
1. Table of Acceptance Criteria and Reported Device Performance
| Acceptance Criteria Category | Acceptance Criteria (Implicit) | Reported Device Performance (MDI RF Test) |
|---|---|---|
| Relative Sensitivity | High | 95.2% |
| Relative Specificity | High | 100% |
| Precision (Inter-assay %CV) | Low | 1.9-5.15 |
| Precision (Intra-assay %CV) | Low | 1.44-3.62 |
| Stability | Sufficient for product shelf-life | One year at 2-8°C (predicted from stress, real-time monitored for 10 weeks) |
| Substantial Equivalence | To predicate assays | Claimed based on sensitivity, specificity, and precision |
Note on Acceptance Criteria: The document does not explicitly state numerical acceptance criteria for sensitivity, specificity, or precision. These are inferred from the context of a 510(k) submission, where performance metrics are presented to demonstrate substantial equivalence to predicate devices. The values presented are the reported performance of the device, which is implicitly deemed acceptable by the FDA's clearance.
2. Sample Size Used for the Test Set and Data Provenance
The provided text does not specify the sample size used for the test set or the data provenance (e.g., country of origin, retrospective or prospective). It only mentions "patient results obtained using the MDI RF Test."
3. Number of Experts Used to Establish the Ground Truth for the Test Set and Qualifications of Those Experts
The document does not provide any information on the number of experts used or their qualifications for establishing ground truth.
4. Adjudication Method for the Test Set
The document does not specify any adjudication method for the test set.
5. If a Multi-Reader Multi-Case (MRMC) Comparative Effectiveness Study Was Done
No. The document describes a diagnostic device (an immunoassay kit) for detecting antibodies, not an imaging or interpretive AI system that would typically involve human readers. Therefore, an MRMC comparative effectiveness study is not applicable here, and no information on human reader improvement with/without AI assistance is provided.
6. If a Standalone Study (Algorithm Only Without Human-in-the-Loop Performance) Was Done
Yes, implicitly. The MDI RF Test is described as a "manual procedure" and an "in vitro diagnostic device." The reported sensitivity, specificity, and precision figures represent the standalone performance of the assay itself, without a "human-in-the-loop" in the sense of interpreting results from an AI system. The "human" in this context would be laboratory personnel performing the manual steps and reading the results, which is inherent to an IVD.
7. The Type of Ground Truth Used
The document does not explicitly state the type of ground truth used. However, given that the test is "intended as an aid in the diagnosis of rheumatoid arthritis" and detects "IgM antibodies against human IgG (RF)," the ground truth for establishing sensitivity and specificity would likely be based on:
- Clinical Diagnosis of Rheumatoid Arthritis: Established by a physician using a combination of clinical symptoms, physical examination, and other diagnostic tests (e.g., ACR criteria for RA).
- Reference Methods: Comparison against established, perhaps more labor-intensive or expensive, methods for detecting RF or diagnosing RA.
8. The Sample Size for the Training Set
The provided text does not specify the sample size for a training set. This is consistent with a traditional IVD device development rather than a machine learning/AI model, where "training set" is a more common term. The development of reagents and assay parameters would involve extensive experimentation, but not typically a "training set" in the computational sense.
9. How the Ground Truth for the Training Set Was Established
Since there is no mention of a "training set" in the context of an AI/ML model, there is no information on how ground truth for such a set was established. For a traditional IVD, the development and optimization of the assay would involve using known positive and negative controls, and samples from patients with confirmed diagnoses (or lack thereof), but these are part of the overall assay validation rather than a distinct "training set."
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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.
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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
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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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(PLEASE DO NOT WRITE BELOW THIS LINE-CONTINUE ON ANOTHER PAGE IF NEEDED)
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)
§ 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).