(75 days)
The MDI SS-A Test is a semi- quantitative Enzyme Immunoassay (EIA) Kit for the detection of auto- antibodies against human SS-A in human serum. The test is intended as an aid in the diagnosis of rheumatic diseases. FOR IN VITRO DIAGNOSTIC USE ONLY.
The Micro Detect, Inc. SS-A reagent ( MDI SS-A 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 acceptance criteria and study for the MDI SS-A Test, addressing your specific questions:
Acceptance Criteria and Device Performance Study for MDI SS-A Test
1. Table of Acceptance Criteria and Reported Device Performance
| Acceptance Criteria | Reported Device Performance |
|---|---|
| Relative Sensitivity | 100% |
| Relative Specificity | 97.2% |
| Precision (Inter-Assay) | 3.23 - 6.42 |
| Precision (Intra-Assay) | 1.73 - 5.52 |
| Stability (Shelf Life) | One year at 2-8°C |
Note: The document does not explicitly state pre-defined acceptance thresholds for sensitivity, specificity, and precision. Instead, it reports the achieved performance values, implying these met the internal or regulatory expectations for substantial equivalence.
2. Sample Size Used for the Test Set and Data Provenance
The provided document does not specify the sample size used for the test set or the data provenance (e.g., country of origin, retrospective or prospective nature).
3. Number of Experts Used to Establish Ground Truth for the Test Set and Qualifications
The provided document does not specify the number of experts used to establish the ground truth for the test set or their qualifications.
4. Adjudication Method for the Test Set
The provided document does not specify any adjudication method used for the test set.
5. Multi-Reader Multi-Case (MRMC) Comparative Effectiveness Study
An MRMC comparative effectiveness study was not performed or reported in this document. The device is a diagnostic reagent, and the study focuses on its analytical performance (sensitivity, specificity, precision) rather than human reader improvement with AI assistance.
6. Standalone (Algorithm Only) Performance
The device is a manual procedure using a microplate ELISA format (a reagent kit). It is not an algorithm or AI-powered device. Therefore, a standalone (algorithm only) performance study is not applicable and was not performed. The reported performance metrics (sensitivity, specificity, precision) inherently reflect the standalone performance of the reagent kit when used as intended.
7. Type of Ground Truth Used
The document states that "The patient results obtained using the MDI SS-A Test is substantially equivalent to those obtained by using predicate assays." This implies that the ground truth for determining sensitivity and specificity was established by comparing the MDI SS-A Test results with results from legally marketed predicate devices. The exact nature of how those predicate devices established their ground truth (e.g., expert consensus, pathology, clinical diagnosis, or outcomes data) is not detailed for this particular study, but it relies on the established accuracy of the predicate tests.
8. Sample Size for the Training Set
The provided document does not specify a training set sample size. Given that this is a diagnostic reagent and not an AI/machine learning model, the concept of a "training set" in the context of model development is not directly applicable. The "training" in such a context would typically involve optimizing the assay's reagents and conditions, which is part of the product development process, not usually reported as a "training set" in regulatory submissions.
9. How Ground Truth for the Training Set Was Established
As noted above, the concept of a "training set" for an AI/ML model is not applicable here. The assay development process would involve optimizing parameters against known positive and negative samples, often characterized by predicate method results or clinically diagnosed patient samples. However, the document does not provide details on how the ground truth for these developmental samples (if considered a "training set") was established.
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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.
MD1 SS-A Test reagents (P/N: SAKi-G) are intended for the semi-quantitative determination of IgG antibodies to SS-A 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. SS-A reagent ( MDI SS-A 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 SS-A Test is substantially equivalent to those obtained by using predicate assays:
Relative Sensitivity: 100% Relative Specificity: 97.2 %
Precision: 3.23-6.42(Inter) and 1.73-5.52(Intra)
Stability: One year at 2-8°C. The stability of the MDI SS-A Test Kit for the detection of IgG antibodies to SS-A was found to be one year at 2-8°C. 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 SS-A 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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JAN 1 0 2000
Mehdi Alem, Ph.D. President Micro Detect, Inc. 2852 Walnut Avenue Suite H-1 Tustin, California 92780
Re: K993636 Trade Name: MDI SS-A 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 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 (OS) 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): K993636
Device Name: MDI SS-A Test
Indications For Use:
The MDI SS-A Test is a semi- quantitative Enzyme Immunoassay (EIA) Kit for the detection of auto- antibodies against human SS-A in human serum. The test is intended as an aid in the diagnosis of rheumatic 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)
Ritu E Mafim
(Division Side - City) Division of Clinical Laboratory Fravic is 510(k) Number ------
ﮨﮯ Prescription Use (Per 21 CFR 801,109)
OR
Image /page/3/Picture/11 description: The image shows the text "Over-The-Counter Use" at the top, followed by "(Optional Format 1-2-96)". There is also some text that is not clear, but it seems to be a code or reference number. The text "FDA/GDPH/ODE/DHC" is written vertically on the right side of the image.
§ 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).