(75 days)
The MDI Sm/RNP Test reagents (P/N: RNKi-G) are intended for the semi quantitative determination of IgG antibodies to Sm/RNP 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 Sm/RNP Test is a semi- quantitative Enzyme Immunoassay (EIA) Kit for the detection of auto- antibodies against human Sm/RNP in human serum. The test is intended as an aid in the diagnosis of theumatic diseases. FOR IN VITRO DIAGNOSTIC USE ONLY.
The Micro Detect, Inc. Sm/RNP reagent ( MDI Sm/RNP 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 regarding the MDI Sm/RNP Test, outlining the acceptance criteria and study details:
Acceptance Criteria and Device Performance
1. Table of Acceptance Criteria and Reported Device Performance
| Performance Metric | Acceptance Criteria (Implied) | Reported Device Performance |
|---|---|---|
| Relative Sensitivity | Not explicitly stated (implied to be comparable to predicate) | 96.2% |
| Relative Specificity | Not explicitly stated (implied to be comparable to predicate) | 97.9% |
| Precision (Inter-assay) | Not explicitly stated | 2.29-5.59 |
| Precision (Intra-assay) | Not explicitly stated | 2.07-7.01 |
| Stability | One year at 2-8°C | One year at 2-8°C (predicted from stress, real-time monitored) |
Note: The document states the device is "substantially equivalent to those obtained by using predicate assays," which implies the acceptance criteria for sensitivity and specificity were met by matching or exceeding the performance of the predicate device. The exact numerical criteria are not explicitly listed, but the reported values are presented as meeting these implicit criteria.
Study Details:
The provided document is a summary of 510(k) safety and effectiveness information, not a detailed study report. Therefore, many of the specific details requested about the study methodology are not present in the provided text.
2. Sample size used for the test set and the data provenance:
- Sample Size: Not specified in the provided text.
- Data Provenance: Not specified in the provided text (e.g., country of origin, retrospective or prospective).
3. Number of experts used to establish the ground truth for the test set and the qualifications of those experts:
- Number of Experts: Not specified.
- Qualifications of Experts: Not specified.
4. Adjudication method for the test set:
- Adjudication Method: Not specified.
5. If a multi-reader multi-case (MRMC) comparative effectiveness study was done, and if so, what was the effect size of how much human readers improve with AI vs without AI assistance:
- This device is an in-vitro diagnostic (IVD) lab test (Enzyme Immunoassay Kit), not an AI-assisted diagnostic tool for human readers. Therefore, an MRMC study with human readers and AI assistance is not applicable and not mentioned.
6. If a standalone (i.e., algorithm only without human-in-the-loop performance) was done:
- This device is a standalone test; it performs the semi-quantitative determination of IgG antibodies. Its performance (sensitivity, specificity, precision) is what's reported. Human intervention is limited to performing the manual procedure, not interpreting results in conjunction with an AI.
7. The type of ground truth used (expert consensus, pathology, outcomes data, etc.):
- The document implies ground truth was established by comparison to "predicate assays" and through clinical performance for "detection of autoantibodies, which are used as an aid in patients with rheumatoid diseases." This suggests the ground truth was likely established through a combination of:
- Clinically established diagnoses: Patients with confirmed rheumatoid diseases vs. healthy controls or other conditions.
- Comparison to a gold standard or well-established reference method for Sm/RNP antibody detection (the "predicate assays").
- Outcome data is not explicitly stated but is inherent in the "aid in patients with rheumatoid diseases" statement.
8. The sample size for the training set:
- Sample Size: Not specified. Information about training sets is typically relevant for machine learning algorithms, which is not the primary focus of this type of IVD kit (though internal assay development would involve optimizing reagents).
9. How the ground truth for the training set was established:
- Ground Truth Establishment: Not specified. Similar to point 8, this detail is less explicit for a chemical/biological assay kit than for an AI algorithm. Ground truth for optimizing such a kit would generally involve known positive and negative samples, often characterized by reference labs or with clinically confirmed diagnoses.
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SUMMARY OF 510 (k) SAFETY AND EFFECTIVENESS INFORMATION
This summary of 510 (k) salety and effectiveness information is being submitted in accordance with the requirement of SMDA 1990 and 21 CFR 807.92.
MDI Sm/RNP Test reagents (P/N: RNKi-G) are intended for the semi quantitative determination of IgG antibodies to Sm/RNP 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. Sm/RNP reagent ( MDI Sm/RNP 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 Sm/RNP Test is substantially equivalent to those obtained by using predicate assays:
| Relative Sensitivity: | 96.2% |
|---|---|
| Relative Specificity: | 97.9% |
Precision: 2.29-5.59(Inter) and 2.07-7.01(Intra)
Stability: One year at 2-8°C. The stability of the MDI Sm/RNP Test Kit for the detection of IgG antibodies to Sm/RNP was found to be one year at 2-8℃. This was predicted from studies done under stress condition (37℃). Real time stability is being monitored 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 Sm/RNP 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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Image /page/1/Picture/2 description: The image shows the seal of the U.S. Department of Health & Human Services. The seal features an abstract eagle design with three curved lines representing the eagle's head and wings. The text "DEPARTMENT OF HEALTH & HUMAN SERVICES - USA" is arranged in a circular pattern around the eagle. The seal is black and white.
JAN 1 0 2000
Mehdi Alem, Ph.D. President Micro Detect, Inc. 2852 Walnut Avenue Suite H-1 Tustin, California 92780
Re: K993635 Trade Name: MDI Sm/RNP Test Regulatory Class: II Product Code: LJM Dated: October 25, 1999 Received: October 27, 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 vour 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.
Food and Drug Administration 2098 Gaither Road Rockville MD 20850
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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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510(k) Number (if known): K993635
Device Name: MDI Sm/RNP Test
Indications For Use:
The MDI Sm/RNP Test is a semi- quantitative Enzyme Immunoassay (EIA) Kit for the detection of auto- antibodies against human Sm/RNP in human serum. The test is intended as an aid in the diagnosis of theumatic diseases. 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)
Peter E. Mrakovcic
(Division Sign-Off)
Division of Clinical Laboratory Devices K993635
510(k) Number.
Prescription Use V (Per 21 CFR 801,109)
OR
Over-The-Counter Use__________________________________________________________________________________________________________________________________________________________
(Optional Format 1-2 -96)
Image /page/3/Figure/13 description: The image shows a document with text in both English and Arabic. The English text includes a date, "2017-10," and a file path, "/VGS." The Arabic text appears to be part of a larger document, possibly related to the United Nations, given the repetition of the word "المتحدة" (United). The layout suggests a formal document with structured information.
§ 866.5100 Antinuclear antibody immunological test system.
(a)
Identification. An antinuclear antibody immunological test system is a device that consists of the reagents used to measure by immunochemical techniques the autoimmune antibodies in serum, other body fluids, and tissues that react with cellular nuclear constituents (molecules present in the nucleus of a cell, such as ribonucleic acid, deoxyribonucleic acid, or nuclear proteins). The measurements aid in the diagnosis of systemic lupus erythematosus (a multisystem autoimmune disease in which antibodies attack the victim's own tissues), hepatitis (a liver disease), rheumatoid arthritis, Sjögren's syndrome (arthritis with inflammation of the eye, eyelid, and salivary glands), and systemic sclerosis (chronic hardening and shrinking of many body tissues).(b)
Classification. Class II (performance standards).