(53 days)
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No
The description focuses on the methodology (indirect immunofluorescence) and kit components, with no mention of AI or ML.
No
The device is described as a test kit used for diagnosis, not for treating a condition.
Yes
The device is described as an "aid in the diagnosis of Celiac Disease and other related disorders," which directly indicates a diagnostic purpose.
No
The device description clearly outlines a physical test kit with components like substrate slides, conjugate, and controls, indicating it is a hardware-based diagnostic test, not software-only.
Yes, this device is an IVD (In Vitro Diagnostic).
Here's why:
- Intended Use: The intended use explicitly states it is "used for the qualitative and semi- quantitative detection of IgA class endomysial autoantibodies (AEmA) in human serum as an aid in the diagnosis of Celiac Disease and other related disorders". This involves testing a sample taken from the human body (serum) to provide information for diagnostic purposes.
- Device Description: The description reinforces the intended use and details the methodology (indirect immunofluorescence) and the sample type (human serum).
- Methodology: Indirect immunofluorescence is a common technique used in IVD tests to detect antibodies in biological samples.
- Sample Type: The test is performed on human serum, which is a biological sample.
All of these factors align with the definition of an In Vitro Diagnostic device, which is a medical device intended for use in vitro for the examination of specimens derived from the human body solely or principally for the purpose of providing information concerning a physiological or pathological state, or a congenital abnormality, or to determine the compatibility of human tissues or organs, or to monitor therapeutic measures.
N/A
Intended Use / Indications for Use
MeDiCa Indirect Immunofluorescence (IIF) Anti- Endomysial Antibody Test Kit is used for the qualitative and semi- quantitative detection of IgA class endomysial autoantibodies (AEmA) in human serum as an aid in the diagnosis of Celiac Disease and other related disorders such as Dermatitis Herpetiformis.
Product codes (comma separated list FDA assigned to the subject device)
MVM
Device Description
MeDiCa Indirect Immunofluorescence (IIF) Anti- Endomysial Antibody Test Kit is used for the qualitative and semiquantitative detection of IgA class endomysial autoantibodies (AEmA) in human serum as an aid in the diagnosis of Celiac Disease and other related disorders such as Dermatitis Herpetiformis.
MeDiCa and Scimedx test kits differ in the following features:
a) volume of conjugate and controls provided by MeDiCa is about 50-65% less than Scimedx test kit. During evaluation, it was demonstrated that the amount of conjuqate and controls provided by MeDiCa are sufficient. The kit was designed with this volume of reagents, in order for the end user not to overfill the wells of the slides with controls and/ or reagents. Applying enough reagents prevents cross contamination of adjacent wells.
b) presentation of substrate on slide wells. Both MeDiCa and Scimedx provide the same type of substrate. The only difference is that MeDiCa monkey esophaqus distal substrate sections are cut sequentially from one and the same block. They are deposited individually one after another and oriented the same way in all wells of each slide. The sections for Scimedx are cut from four different blocks at the same time, resulting in different orientation of sections from well to well. The advantage of sequential sectioning from a single block is the ease in interpretation of fluorescent patterns. This also contributes to better reproducibility and comparability of test results.
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
Not Found
Indicated Patient Age Range
Not Found
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 (study type, sample size, AUC, MRMC, standalone performance, key results)
Results of performance evaluation show that MeDiCa IIF Anti-Endomysial Antibody Test Kit matches Scimedx test kit, the predicate device on:
a) specificity
b) sensitivity
c) reproducibility
d) reactivity
Key Metrics (Sensitivity, Specificity, PPV, NPV, etc.)
Not Found
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.
Scimedx Anti- Endomysial IgA (EMA) Test System
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.
Not Found
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
§ 866.5660 Multiple autoantibodies immunological test system.
(a)
Identification. A multiple autoantibodies immunological test system is a device that consists of the reagents used to measure by immunochemical techniques the autoantibodies (antibodies produced against the body's own tissues) in serum and other body fluids. Measurement of multiple autoantibodies aids in the diagnosis of autoimmune disorders (disease produced when the body's own tissues are injured by autoantibodies).(b)
Classification. Class II (performance standards).
0
NOV - I 1999
K993034
Pre-market Notification [510 (k)] Summary
| Summary prepared on: | Sept. 8, 1999 |
|---|---|
| Submitted by: | MeDiCa |
| Address: | 336 Encinitas Blvd., Suite 200 |
| Encinitas, California 92024 | |
| Telephone: | (760) 634- 5440 |
| Fax: | (760) 634- 5442 |
| Registration number: | 2021875 |
| Contact person: | Rhodora Chapoco |
| Contact Title: | Lab Manager |
| Device Name: | Indirect Immunofluorescence Anti- |
| Endomysial Antibody Test Kit | |
| Common Name: | Indirect Immunofluorescence Anti- |
| Endomysial Antibody Test Kit | |
| Trade Name: | MeDiCa Indirect Immunofluorescence |
| (IIF) Anti- Endomysial Antibody (AEmA) | |
| Test Kit | |
| _Product Code: | MVM |
| CFR Section: | 866.5660 |
| Device Class: | II |
| Classification Panel: | Immunology/ Microbiology |
| Predicate Device: | Scimedx Anti- Endomysial IgA (EMA) |
| Test System |
MeDiCa Inc. AEmA-510(k)
1
Pre-market Notification [510 (k)] Summary (continuation)
MeDiCa Indirect Immunofluorescence Description of Device: (IIF) Anti- Endomysial Antibody Test Kit is used for the qualitative and semiquantitative detection of IgA class endomysial autoantibodies (AEmA) in human serum as an aid in the diagnosis of Celiac Disease and other related disorders such as Dermatitis Herpetiformis.
In general, MeDiCa and Scimedx Anti- Endomysial Antibody Test Kits have the following similarities:
- a) intended use
- b) methodology- indirect immunofluorescence method
- c) test kit composition
- d) type of substrate
Results of performance evaluation show that MeDiCa IIF Anti-Endomysial Antibody Test Kit matches Scimedx test kit, the predicate device on:
- a) specificity
- b) sensitivity
- c) reproducibility
- d) reactivity
MeDiCa and Scimedx test kits differ in the following features:
a) volume of conjugate and controls provided by MeDiCa is . about 50-65% less than Scimedx test kit. During evaluation, it was demonstrated that the amount of conjuqate and controls provided by MeDiCa are sufficient. The kit was designed with this volume of reagents, in order for the end user not to overfill the wells of the slides with controls and/ or reagents. Applying enough reagents prevents cross contamination of adjacent wells.
MeDiCa Inc. AEmA-510(k)
2
Pre-market Notification [510 (k)] Summary (continuation)
b) presentation of substrate on slide wells. Both MeDiCa and Scimedx provide the same type of substrate. The only difference is that MeDiCa monkey esophaqus distal substrate sections are cut sequentially from one and the same block. They are deposited individually one after another and oriented the same way in all wells of each slide. The sections for Scimedx are cut from four different blocks at the same time, resulting in different orientation of sections from well to well. The advantage of sequential sectioning from a single block is the ease in interpretation of fluorescent patterns. This also contributes to better reproducibility and comparability of test results.
In summary, MeDiCa IIF Anti- Endomysial Antibody Test Kit, described and summarized in this 510 (k) notification submission, in our opinion, is substantially equivalent to the predicate device, Scimedx Anti-Endomysial (IgA) Test System.
MeDiCa Inc. AEmA-510(k)
3
Image /page/3/Picture/1 description: The image is a black and white emblem for the U.S. Department of Health & Human Services. The emblem features a stylized design of three human profiles facing right, stacked on top of each other. The profiles are abstract and created with thick, curved lines. The emblem is encircled by the text "DEPARTMENT OF HEALTH & HUMAN SERVICES - USA" in a circular arrangement.
NOV - 1 1999
Food and Drug Administration 2098 Gaither Road Rockville MD 20850
Ms. Rhodora Chapoco Lab Manager MeDiCa Medical Diagnostics, California 336 Encinitas Boulevard Suite 200 Encinitas, California 92024
Re: K993034
Trade Name: Indirect Immunofluorescence Anti-Endomysial Antibody Test Kit Regulatory Class: II Product Code: MVM Dated: September 8, 1999 Received: September 9, 1999
Dear Ms. Chapoco:
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/cdrlv/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
5
Indication for Use Statement
510(k) Number (if known): -not-known- K 99 30 34
Device Name:
MeDiCa Indirect Immunofluorescence (IIF) Anti- Endomysial Antibody (AEmA) Test Kit
Indications For Use:
MeDiCa Indirect Immunofluorescence (IIF) Anti- Endomysial Antibody Test Kit is used for the qualitative and semi- quantitative detection of IgA class endomysial autoantibodies (AEmA) in human serum as an aid in the diagnosis of Celiac Disease and other related disorders such as Dermatitis Herpetiformis.
(PLEASE DO NOT WRITE BELOW THIS LINE- CONTINUE ON ANOTHER PAGE IF NEEDED)
Concurrence of CDRH, Office of Device Evaluation (ODE)
| (Division Sign-Off) | |
|---|---|
| 5. | Laboratory Devices |
| K993034 | |
|---|---|
| -- | --------- |
| Prescription Use
| (Per 21 CFR 801.109) | Over the Counter Use |
|---|---|
| ------------------------------------------ | ---------------------- |
| | MeDiCa Inc.
AEmA-510(k) |
| -- | ---------------------------- |
|---|