(75 days)
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No
The document describes a manual enzyme immunoassay kit and explicitly states "Not Found" for mentions of AI, DNN, or ML.
No
Explanation: The device is an in vitro diagnostic (IVD) test intended to aid in the diagnosis of rheumatic diseases by detecting autoantibodies in human serum. It is explicitly stated as "FOR IN VITRO DIAGNOSTIC USE ONLY," which means it is not a therapeutic device that treats or prevents a disease.
Yes
The "Intended Use / Indications for Use" section explicitly states that the test is "used as an aid in patients with rheumatoid diseases" and "as an aid in the diagnosis of rheumatic diseases," which are characteristics of a diagnostic device.
No
The device description explicitly states it is a manual procedure and lists physical reagents and components (micro plate, controls, buffers, conjugate, substrate, stop solution), indicating it is a hardware-based in vitro diagnostic test kit, not software only.
Yes, this device is an IVD (In Vitro Diagnostic).
Here's why:
- Intended Use/Indications for Use: The description explicitly states "FOR IN VITRO DIAGNOSTIC USE ONLY." It also describes the test's purpose as the "semi quantitative determination of IgG antibodies to Sm/RNP in human serum" and its use as "an aid in the diagnosis of rheumatic diseases." These are all hallmarks of an IVD.
- Device Description: The device is a kit containing reagents designed to be used with human serum, which is a biological sample taken from the body.
- Anatomical Site: The test is performed on "human serum," which is a sample taken from the human body.
The information provided clearly indicates that this device is intended to be used outside of the body (in vitro) to diagnose or aid in the diagnosis of a medical condition (rheumatic diseases) by analyzing a human sample (serum).
N/A
Intended Use / Indications for Use
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.
Product codes (comma separated list FDA assigned to the subject device)
LJM
Device Description
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.
Mentions image processing
Not Found
Mentions AI, DNN, or ML
Not Found
Input Imaging Modality
Not Found
Anatomical Site
Not Found
Indicated Patient Age Range
Not Found
Intended User / Care Setting
Not Found
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 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.
Key Metrics (Sensitivity, Specificity, PPV, NPV, etc.)
Relative Sensitivity: 96.2%
Relative Specificity: 97.9%
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 for the subject device only (e.g. presence / absence, what scope was granted / cleared under the PCCP, any restrictions, etc).
Not Found
§ 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).
0
:
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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Page 1 of 1
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.