(428 days)
The EUROIMMUN Anti-Desmoglein 1 ELISA (IgG) test kit is intended for the qualitative or semi-quantitative determination of IgG class autoantibodies against desmoglein 1 in human serum and plasma. It is used as an aid in the diagnosis of pemphigus .foliaceus (PF), in conjunction with other laboratory and clinical findings.
The EUROIMMUN Anti-Desmoglein 3 ELISA (IgG) test kit is intended for the qualitative or semi-quantitative determination of IqG class autoantibodies against desmoqiein 3 in human serum and plasma. It is used as an aid in the diagnosis of pemphigus vulgaris (PV), in conjunction with other laboratory and clinical findings.
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The provided document is a 510(k) premarket notification letter from the FDA for an in vitro diagnostic (IVD) device, the EUROIMMUN Anti-Desmoglein 1 ELISA (IgG) and EUROIMMUN Anti-Desmoglein 3 ELISA (IgG) test kits. While it indicates substantial equivalence to a predicate device and lists the indications for use, it does not contain the detailed information required to describe the acceptance criteria and the study that proves the device meets those criteria.
The FDA letter is a regulatory document confirming clearance, not a technical study report. It states that the device is "substantially equivalent" to legally marketed predicate devices, which means its performance is considered comparable to already approved tests. To provide the requested information, one would typically need access to the actual 510(k) submission, specifically the sections detailing the analytical and clinical performance studies.
Therefore, for almost all points requested, the answer is "Information not provided in the given text."
However, based on the nature of the device (IVD for antibody detection), we can infer some general aspects and what kind of study would typically be conducted, even if the specifics aren't here.
Here's a breakdown of what can and cannot be answered:
1. A table of acceptance criteria and the reported device performance
- Information not provided in the given text. This would typically include metrics like sensitivity, specificity, positive predictive value (PPV), negative predictive value (NPV), often with confidence intervals, compared against pre-defined thresholds.
2. Sample size used for the test set and the data provenance (e.g. country of origin of the data, retrospective or prospective)
- Information not provided in the given text. For an IVD, the test set would typically involve a cohort of patients with and without the target condition (Pemphigus foliaceus or Pemphigus vulgaris) to evaluate diagnostic accuracy.
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)
- Information not provided in the given text. For IVDs, the "ground truth" (or reference method) is often established by a combination of clinical diagnosis, other established laboratory tests, and sometimes biopsy/histopathology interpreted by specialists (e.g., dermatologists, pathologists). The number and qualifications of these experts would be detailed in the study report.
4. Adjudication method (e.g. 2+1, 3+1, none) for the test set
- Information not provided in the given text. Adjudication methods are more common in imaging studies or clinical trials where expert consensus is needed. For an IVD, the "ground truth" is typically established by definitive diagnostic methods rather than subjective reader consensus on the test results themselves.
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
- N/A – This is not applicable to an IVD ELISA test kit. MRMC studies and AI assistance are relevant for image-based diagnostic systems where human interpretation is a key component. This device is an immunoassay, which generates quantitative or semi-quantitative antibody levels, and does not involve "human readers" in the same sense as an imaging study.
6. If a standalone (i.e. algorithm only without human-in-the-loop performance) was done
- Yes, this is a standalone device. An ELISA test kit is designed to provide a result (qualitative or semi-quantitative) based on a laboratory procedure, without direct human-in-the-loop interpretation impacting the primary test result. The "algorithm" here is the assay's biochemical reaction and detection method, and the cutoff values defining positive/negative results. Its performance is assessed independently.
7. The type of ground truth used (expert consensus, pathology, outcomes data, etc)
- Information not provided in the given text. For an anti-desmoglein antibody test, the ground truth for positive cases would typically be a definitive clinical diagnosis of Pemphigus foliaceus (PF) or Pemphigus vulgaris (PV) confirmed by established diagnostic criteria, which often includes histological findings from biopsy (pathology) and direct/indirect immunofluorescence, in addition to clinical presentation. Negative cases would be from healthy controls or patients with other dermatological conditions.
8. The sample size for the training set
- Information not provided in the given text. For IVDs, the concept of a distinct "training set" and "test set" as typically used in machine learning might not be explicitly separated in the same way. There would be samples used during assay development, optimization, and initial analytical validation (which could loosely be considered "training"), and then a separate clinical validation set (the "test set"). The document does not specify either.
9. How the ground truth for the training set was established
- Information not provided in the given text. Similar to point 7, the ground truth for any samples used during development would also be established by definitive diagnostic criteria for the respective conditions.
In summary, the provided FDA clearance letter indicates the device's intended use and regulatory status but does not contain the detailed performance data or study design specifics. These details would be found in the manufacturer's 510(k) submission, specifically the sections dedicated to analytical and clinical performance studies.
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DEPARTMENT OF HEALTH & HUMAN SERVICES
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Food & Drug Administration 10903 New Hampshire Avenue Building 66 Silver Spring. MD 20993
EUROIMMUN US INC. c/o Ms. Kathryn Kohl Managing Director 429 Rockaway Valley Road Unit 1200 Boonton Township, NJ 07005
SEP 0 2 2010
Re: K091969
Trade/Device Name: EUROIMMUN Anti- Desmoglein 1 ELISA (IgG) EUROIMMUN Anti- Desmoglein 3 ELISA (IgG) Regulation Number: 21 CFR§866.5660 Regulation Name: Multiple autoantibodies Immunological Test System Regulatory Class: Class II Product Code: NBO Dated: August 2, 2010 Received: August 9, 2010
Dear Ms. Kohl:
We have reviewed your Section 510(k) premarket notification of intent to market the device referenced above and 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) that do not require approval of a premarket approval application (PMA). 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 class II (Special Controls), it may be subject to such additional controls. Existing major regulations affecting your device can be found in Title 21, Code of Federal Regulations (CFR), Parts 800 to 895. In addition, FDA may publish further announcements concerning your device in the Federal Register.
Please be advised that FDA's issuance of a substantial equivalence determination does not mean that FDA has made a determination that your device complies with other requirements of the Act
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Page 2 - Ms. Kathryn Kohl
or any Federal statutes and regulations administered by other Federal agencies. You must comply with all the Act's requirements, including, but not limited to: registration and listing (21 CFR Part 807); labeling (21 CFR Parts 801 and 809); medical device reporting (reporting of medical device-related adverse events) (21 CFR 803); and good manufacturing practice requirements as set forth in the quality systems (QS) regulation (21 CFR Part 820). This letter will allow you to begin marketing your device as described in your Section 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 Parts 801 and 809), please contact the Office of In Vitro Diagnostic Device Evaluation and Safety at (301) 796-5450. Also, please note the regulation entitled, "Misbranding by reference to premarket notification" (21 CFR Part 807.97). For questions regarding the reporting of adverse events under the MDR regulation (21 CFR Part 803), please go to http://www.fda.gov/MedicalDevices/Safety/ReportaProblem/default.htm for the CDRH's Office of Surveillance and Biometrics/Division of Postmarket Surveillance.
You may obtain other general information on your responsibilities under the Act from the Division of Small Manufacturers, International and Consumer Assistance at its toll-free number (800) 638-2041 or (301) 796-7100 or at its Internet address http://www.fda.gov/cdrh/industry/support/index.html.
Sincerely yours,
ia m chan
Maria M. Chan, Ph.D. Director Division of Immunology and Hematology Devices Office of In Vitro Diagnostic Device Evaluation and Safety Center for Devices and Radiological Health
Enclosure
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EUROIMMUN US INC.
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ATTACHMENT 2
SEP 0 2 2010
INDICATIONS FOR USE STATEMENT
510(k) Number (if known): K091969
Anti-Desmoglein 1 ELISA (IgG) Device Name: Anti-Desmoglein 3 ELISA (IgG)
Indications For Use:
The EUROIMMUN Anti-Desmoglein 1 ELISA (IgG) test kit is intended for the qualitative or semi-quantitative determination of IgG class autoantibodies against desmoglein 1 in human serum and plasma. It is used as an aid in the diagnosis of pemphigus .foliaceus (PF), in conjunction with other laboratory and clinical findings.
The EUROIMMUN Anti-Desmoglein 3 ELISA (IgG) test kit is intended for the qualitative or semi-quantitative determination of IqG class autoantibodies against desmoqiein 3 in human serum and plasma. It is used as an aid in the diagnosis of pemphigus vulgaris (PV), in conjunction with other laboratory and clinical findings.
Prescription Use × (Part 21 CFR 801 Subpart D) AND/OR
Over-The-Counter Use (21 CFR 801 Subpart C)
(PLEASE DO NOT WRITE BELOW THIS LINE - CONTINUE ON ANOTHER PAGE IF NEEDED)
Concurrence of CDRH, Office of Device Evaluation (OIVD)
Bena Philip
Division Sign-Off
Office of In Vitro Diagnostic Device Evaluation and S
510K K091969
§ 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).