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.

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.

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

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.
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.

AI/ML Overview

The provided text describes a 510(k) pre-market notification for a medical device called the "MeDiCa Indirect Immunofluorescence (IIF) Anti-Endomysial Antibody (AEmA) Test Kit." The purpose of this submission is to demonstrate substantial equivalence to a predicate device, the "Scimedx Anti-Endomysial IgA (EMA) Test System."

Here's an analysis of the acceptance criteria and the study as described in the document:

1. A table of acceptance criteria and the reported device performance

The document does not explicitly state numerical acceptance criteria in the typical sense (e.g., "sensitivity must be >90%"). Instead, the acceptance criteria are implicitly defined by demonstrating the MeDiCa device "matches" or is "substantially equivalent" to the predicate Scimedx test kit in terms of key performance characteristics.

Acceptance Criteria (Implicit)	Reported Device Performance (MeDiCa IIF AEmA Test Kit)
Specificity	Matches Scimedx test kit.
Sensitivity	Matches Scimedx test kit.
Reproducibility	Matches Scimedx test kit. The sequential sectioning from a single block of substrate also "contributes to better reproducibility and comparability of test results."
Reactivity	Matches Scimedx test kit.
Intended Use	Similar to Scimedx test kit. (Qualitative and semiquantitative detection of IgA class endomysial autoantibodies in human serum as an aid in diagnosis of Celiac Disease and related disorders).
Methodology	Similar to Scimedx test kit (indirect immunofluorescence method).
Test Kit Composition	Similar to Scimedx test kit.
Type of Substrate	Similar to Scimedx test kit (monkey esophagus distal substrate sections).
Volume of Conjugate/Controls	Demonstrated to be sufficient, despite being 50-65% less than Scimedx. No issues with cross-contamination reported.
Presentation of Substrate	Different from Scimedx (sequential cutting from one block vs. four different blocks). This difference is presented as an advantage for MeDiCa, leading to "ease in interpretation of fluorescent patterns."

2. Sample size used for the test set and the data provenance (e.g. country of origin of the data, retrospective or prospective)

The document does not provide specific details on the sample size used for the performance evaluation, nor does it mention the data provenance (country of origin, retrospective/prospective). It only states that "Results of performance evaluation show that MeDiCa IIF Anti-Endomysial Antibody Test Kit matches Scimedx test kit."

3. Number of experts used to establish the ground truth for the test set and the qualifications of those experts (e.g. radiologist with 10 years of experience)

The document does not provide information on the number of experts used or their qualifications for establishing ground truth for the test set. Given the nature of the device (an in vitro diagnostic test kit), ground truth would likely be established through clinical diagnosis, possibly confirmed by other diagnostic methods or pathology, rather than expert interpretation of images. However, the details of this process are not included.

4. Adjudication method (e.g. 2+1, 3+1, none) 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, If so, what was the effect size of how much human readers improve with AI vs without AI assistance

This section is not applicable as the device is an in vitro diagnostic test kit for the detection of antibodies, not an AI-powered image analysis tool requiring human readers. Therefore, an MRMC comparative effectiveness study involving human readers with and without AI assistance was not conducted or described.

6. If a standalone (i.e. algorithm only without human-in-the-loop performance) was done

This concept is not fully applicable to this device in the same way it would be for an AI algorithm. The device itself is a laboratory test kit that produces a result (qualitative or semi-quantitative detection of antibodies) which is then interpreted by a laboratory professional. The document describes the kit's performance ("matches Scimedx test kit" on specificity, sensitivity, etc.), which represents its standalone analytical performance. However, there isn't an "algorithm" in the typical AI sense. The "interpretation of fluorescent patterns" mentioned in the MeDiCa kit's advantages implies a human in the loop for reading the final result.

7. The type of ground truth used (expert consensus, pathology, outcomes data, etc.)

The document does not explicitly state the type of ground truth used. For a diagnostic test for Celiac Disease and Dermatitis Herpetiformis, ground truth would typically be established by a definitive clinical diagnosis, often involving biopsy (pathology) for Celiac Disease, and/or other established diagnostic criteria and patient outcomes.

8. The sample size for the training set

The document describes a 510(k) submission for a traditional in vitro diagnostic test kit, not an AI/machine learning device. Therefore, the concept of a "training set" for an algorithm is not applicable in the context of this submission. The performance evaluation was likely conducted on a test set of patient samples to demonstrate equivalence to the predicate device.

9. How the ground truth for the training set was established

As explained in point 8, the concept of a "training set" is not applicable to this device.

Summary

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NOV - I 1999

K993034

Pre-market Notification [510 (k)] Summary

Summary prepared on:	Sept. 8, 1999
Submitted by:	MeDiCa
Address:	336 Encinitas Blvd., Suite 200Encinitas, 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)

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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)

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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)

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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

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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:

(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
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Prescription Use(Per 21 CFR 801.109)	Over the Counter Use
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	MeDiCa Inc.AEmA-510(k)
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Regulation Number and Section

§ 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).