(406 days)
The MESACUP BP180 or BP230 TEST is a semi-quantitative enzyme-linked immunosorbent assay (ELISA) for the detection of anti BP180 or BP230 antibodies in human serum. The MESACUP TESTS are intended for in vitro diagnostic use as an aid in the diagnosis of bullous pemphigoid in conjunction with other laboratory and clinical findings. Patients with Bullous Pemphigoid are known to have either BP180 or BP230 or both types of antibodies in serum. It is recommended that each patient be tested for BP180 and BP230 antibodies.
BP means Bullous pemphigoid. Bullous pemphigoid (BP) is a chronic blistering of the skin. It ranges from mildly itchy welts to severe blisters and infection, and may affect a small area of the body or be widespread. The vast majority of those affected are elderly, but it has been seen at all ages. It is an autoimmune disorder, meaning it is caused when the body's immune system malfunctions. The immune system is meant to defend the body against bacteria, viruses, and disease, but instead produces against healthy tissue, cells and organs. Some patients with BP have other autoimmune diseases such diabetes and rheumatoid arthritis. Various other factors have been reported to play a role in triggering BP. These include drugs (furosemide, penicillin's), mechanical trauma, and physical traumas (burns from radiation, sun or heat). The BP180 Elisa kit is designed to detect the BP180 protein. The related BP230 Elisa kit is designed to detect the autoantigen BP230, also known as bullous pemphigoid antigen.
This appears to be a 510(k) summary for an ELISA kit, which is a laboratory diagnostic device, not an AI/ML powered device. As such, many of the requested categories (like MRMC studies, number of experts for ground truth, sample size for training set, etc.) are not applicable in the context of this traditional in-vitro diagnostic device submission.
Based on the provided text, here's what can be extracted:
Acceptance Criteria and Device Performance for MESACUP BP180 ELISA Kit and MESACUP BP230 ELISA Kit
The provided 510(k) summary (K071961) focuses on establishing "substantial equivalence" to predicate devices, rather than defining specific quantitative performance acceptance criteria in the way a novel AI/ML device might. The core "acceptance criteria" here is that the device is "comparably safe and effective" and has "similar indications" to the predicate devices.
1. Table of Acceptance Criteria and Reported Device Performance
| Characteristic | Acceptance Criteria (Implicit from Substantial Equivalence) | Reported Device Performance |
|---|---|---|
| Safety | Comparably safe to predicate devices | Results of clinical and nonclinical testing indicate safety comparable to predicates. |
| Effectiveness | Comparably effective to predicate devices | Results of clinical and nonclinical testing indicate effectiveness comparable to predicates. |
| Indications for Use | Similar indications as predicate devices | "The MESACUP BP180 or BP230 TEST is a semiquantitative enzyme-linked immunosorbent assay (ELISA) for the detection of anti BP180 or BP230 antibodies in human serum. The MESACUP TESTS are intended for in vitro diagnostic use as an aid in the diagnosis of bullous pemphigoid in conjunction with other laboratory and clinical findings." This is deemed similar to the predicates' indications for detecting anti-skin antibodies in human serum for diagnosis of skin diseases, specifically bullous pemphigoid. |
| Technology | Capable of detecting target antibodies as effectively as predicate devices (using a different technology) | Uses ELISA technology to detect Anti BP180 Antibodies and Anti BP230 Antibodies. The performance is considered "comparably effective" to predicate devices using Indirect Immunofluorescence. |
| Test Fluid | Works with human serum | Confirmed to work with human serum. |
| IVD Status | Intended for In Vitro Diagnostic Use | Confirmed as an In Vitro Diagnostic (IVD) device. |
2. Sample Size Used for the Test Set and Data Provenance
The document states "The results of clinical and nonclinical testing indicates that the new device is as safe and effective as the predicate devices and methods." However, specific sample sizes for clinical or nonclinical test sets are not provided in this 510(k) summary. The summary does not mention country of origin or whether the data was retrospective or prospective.
3. Number of Experts Used to Establish the Ground Truth for the Test Set and Qualifications of Those Experts
This information is not provided in the 510(k) summary. For an ELISA kit, ground truth typically comes from a reference method or clinical diagnosis, but details about expert involvement are not included here.
4. Adjudication Method for the Test Set
This information is not provided in the 510(k) summary.
5. If a Multi-Reader Multi-Case (MRMC) Comparative Effectiveness Study Was Done, and Effect Size
No, an MRMC comparative effectiveness study was not applicable and not done for this type of in-vitro diagnostic device (ELISA kit). MRMC studies are typically performed for imaging or other diagnostic devices where human readers interpret results. This is a laboratory test where the result is quantitative or semi-quantitative, not interpreted by human readers in the same way.
6. If a Standalone (i.e., algorithm only without human-in-the-loop performance) Study Was Done
This is an ELISA kit, not an algorithm. Therefore, the concept of a "standalone" algorithm performance study is not applicable. The device itself is the "standalone" diagnostic tool.
7. The Type of Ground Truth Used
The 510(k) summary does not explicitly state the type of ground truth used. However, for a diagnostic test like this, the ground truth for clinical studies would typically be established based on:
- Clinical Diagnosis: Established by a physician based on the patient's symptoms, physical examination, and other laboratory/histopathological findings consistent with bullous pemphigoid.
- Reference Methods: Comparison to established "gold standard" or highly accepted diagnostic methods for detecting BP180 or BP230 antibodies (e.g., Western blot, immunofluorescence, or other validated assays).
8. The Sample Size for the Training Set
The concept of a "training set" in the context of machine learning or AI is not applicable here. This is a traditional ELISA diagnostic kit, not an algorithm that learns from data.
9. How the Ground Truth for the Training Set Was Established
As there is no "training set" in the AI/ML sense, this question is not applicable.
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510(k) Summary, K071961 MBL INTERNATIONAL CORPORATION 4 Constitution Way Woburn, Ma 01801 Phone: 800.200.5459 or 781.939.6964 AUG 2 5 2008 Fax: 781.939.6963 Contact: Chris Adamcik, Associate IVD Products Manager Prepared August 19, 2008
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- Identification of the Device: Proprietary-Trade Name: MESACUP BP180 ELISA Kit and MESACUP BP230 ELISA Kit Classification Name/Product Codes: DBL Common/Usual Name: Antibody Test Kit
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- Indications for Use (intended use): The MESACUP BP180 or BP230 TEST is a semiquantitative enzyme-linked immunosorbent assay (ELISA) for the detection of anti BP180 or BP230 antibodies in human serum. The MESACUP TESTS are intended for in vitro diagnostic use as an aid in the diagnosis of bullous pemphigoid in conjunction with other laboratory and clinical findings. Patients with Bullous Pemphigoid are known to have either BP180 or BP230 or both types of antibodies in serum. It is recommended that each patient be tested for BP180 and BP230 antibodies.
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- Description of the Device: BP means Bullous pemphigoid. Bullous pemphigoid (BP) is a chronic blistering of the skin. It ranges from mildly itchy welts to severe blisters and infection, and may affect a small area of the body or be widespread. The vast majority of those affected are elderly, but it has been seen at all ages. It is an autoimmune disorder, meaning it is caused when the body's immune system malfunctions. The immune system is meant to defend the body against bacteria, viruses, and disease, but instead produces against healthy tissue, cells and organs. Some patients with BP have other autoimmune diseases such diabetes and rheumatoid arthritis. Various other factors have been reported to play a role in triggering BP. These include drugs (furosemide, penicillin's), mechanical trauma, and physical traumas (burns from radiation, sun or heat). The BP180 Elisa kit is designed to detect the BP180 protein. The related BP230 Elisa kit is designed to detect the autoantigen BP230, also known as bullous pemphigoid antigen.
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- Safety and Effectiveness, comparison to predicate device. The results of clinical and nonclinical testing indicates that the new device is as safe and effective as the predicate devices and methods.
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6. Substantial Equivalence Chart
| Characteristic | K891098 Anti-SkinAntibody Test (MonkeyEsophagus Sections)Immco Diagnostics, Inc;K891099 Anti-SkinAntibodyTest(Monkey/Guin PigEsoph Sec ImmcoDiagnostics, Inc. | K902237 Medica(Scimedix) IIF Anti-SkinAntibody Test KitMedica Corp.; (NowScimedix) | MESACUP BP180ELISA Kit andMESACUP BP230ELISA Kit |
|---|---|---|---|
| Indications | An indirectimmunofluorescenceantibody test for thedetection andquantitation of anti-skin(anti-intercellular and anti-basement membrane)antibodies in human serum. | The in vitro detection ofskin antibodies by theindirectimmunofluorescenttechnique has beenestablished as an aid in thediagnosis of skin andsystemic diseases.Monkey esophagus is usedfor the detection of bothbasement membraneantibodies and intercellularsubstance antibodies. Thedetection of the basementmembrane antibody hasbeen associated with thepresence of a variety ofbullous pemphigoidautoimmune disorders ofthe skin. | The MESACUP BP180and MESACUP BP230 isintended for in vitrodiagnostic use as an aid inthe diagnosis of bullouspemphigoid. |
| Technology | Indirect immunofluorescence | Indirectimmunofluorescence | ELISA |
| Detect what? | Anti-intercellular antibodiesand anti-basementmembrane antibodies. | Anti-intercellular antibodiesand anti-basementmembrane antibodies. | Anti BP180 AntibodiesAnd Anti BP230Antibodies |
| Disease | Pemphigus Vulgaris;Pemphigus FoliaceusPemphigoid/EBA | Multiple anti-immunediseases, systemicrheumatoid disease | Bullous Pemphigoid |
| Test fluid | Serum | Serum | Serum |
| IVD | IVD | IVD | IVD |
7. Conclusion
After analyzing clinical and non-clinical testing data, it is the conclusion of MBL INTERNATIONAL CORPORATION that the MESACUP BP180 ELISA Kits and MESACUP BP230 ELISA Kits are comparably safe and effective as the predicate devices, and have similar indications thus rendering them substantially equivalent to the predicate devices.
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DEPARTMENT OF HEALTH & HUMAN SERVICES
Image /page/2/Picture/1 description: The image shows the logo for the U.S. Department of Health and Human Services. The logo consists of a stylized eagle with three stripes forming its body and wing. The eagle is enclosed in a circle with the text "DEPARTMENT OF HEALTH & HUMAN SERVICES USA" around the perimeter.
Public Health Service
Food and Drug Administration 2098 Gaither Road Rockville MD 20850
MBL International Corporation C/O Daniel Kamm Kamm & Associates PO Box 7007 Deerfield, Illinois 60015
AUG 2 5 2008
Re: K071961
Trade/Device Name: Models BP180 and BP230 Elisa Kits Regulation Number: 21 CFR 866.5660 Regulation Name: Multiple Autoantibodies Immunological Test System Regulatory Class: Class II Product Code: OEG Dated: July 8, 2007 Received: July 24, 2007
Dear Mr. Kamm:
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 either class II (Special Controls) or class III (PMA), 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 Pegister.
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 af the Act 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); and good manufacturing practice requirements as set forth in the quality systems (QS) regulation (21 CFR Part 820). This letter
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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 Part 801), please contact the Office of In Vitro Diagnostic Device Evaluation and Safety at (240) 276-0450. Also, please note the regulation entitled, "Misbranding by reference to premarket notification" (21CFR Part 807.97). For questions regarding postmarket surveillance, please contact CDRH's Office of Surveillance and Biometric's (OSB's) Division of Postmarket Surveillance at (240) 276-3474. For questions regarding the reporting of device adverse events (Medical Device Reporting (MDR)), please contact the Division of Surveillance Systems at (240) 276-3464. 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 (240) 276-3150 or at its Internet address http://www.fda.gov/cdrh/industry/support/index.html.
Sincerely yours.
Josephine Bautista
Maria Chan, Ph.D.
cting Director Division of Immunology and Hematology Office of In Vitro Diagnostic Device Evaluation and Safety Center for Devices and Radiological Health
Enclosure
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Indications for Use
510(k) Number (if known):K071961
Device Name: _________________________________________________________________________________________________________________________________________________________________
Indications For Use:
The MESACUP BP180 or BP230 TEST is a semi-quantitative enzyme-linked immunosorbent assay (ELISA) for the detection of anti BP180 or BP230 antibodies in human serum. The MESACUP TESTS are intended for in vitto diagnostic use as an aid in the diagnosis of bullous pemphigoid in conjunction with other laboratory and clinical findings. Patients with Bullous Pemphigoid are known to have either BP180 or BP230 or both types of antibodies in serum. It is recommended that each patient be tested for BP180 and BP230 antibodies..
Prescription Use X (Part 21 CFR 801 Subpart D) AND/OR
Over-The-Counter Use (21 CFR 807 Subpart C)
(PLEASE DO NOT WRITE BELOW THIS LINE-CONTINUE ON ANOTHER PAGE IF NEEDED)
Concurrence of CDRH, Office of In Vitro Diagnostic Devices (OIVD)
Douglas Bautista
Division Sign-Off
Device
510(k) 071941
Page 1 of 1
§ 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).