(406 days)
Not Found
No
The device description and intended use describe a standard ELISA assay for detecting antibodies, with no mention of AI or ML technologies.
No
The device is an in vitro diagnostic (IVD) test intended to aid in the diagnosis of bullous pemphigoid by detecting specific antibodies, it does not directly treat or prevent a disease.
Yes
Explanation: The "Intended Use / Indications for Use" section explicitly states that the device is "intended for in vitro diagnostic use as an aid in the diagnosis of bullous pemphigoid."
No
The device is an enzyme-linked immunosorbent assay (ELISA) kit, which is a laboratory test involving physical reagents and procedures, not solely software.
Yes, this device is an IVD (In Vitro Diagnostic).
Here's why:
- Intended Use/Indications for Use: The description explicitly states the device is "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 a clear statement of its diagnostic purpose and its use outside of a living organism (in vitro).
- Device Description: The description details how the device works to detect specific antibodies (anti BP180 or BP230) in human serum, which are markers associated with bullous pemphigoid. This aligns with the function of an IVD, which analyzes biological samples to provide diagnostic information.
- Sample Type: The device analyzes "human serum," which is a biological sample commonly used in IVD testing.
The information provided strongly indicates that this device is designed and intended for use in a laboratory setting to diagnose a medical condition by analyzing a biological sample, which is the definition of an In Vitro Diagnostic device.
N/A
Intended Use / Indications for 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.
Product codes (comma separated list FDA assigned to the subject device)
DBL, OEG
Device Description
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.
Mentions image processing
Not Found
Mentions AI, DNN, or ML
Not Found
Input Imaging Modality
Not Found
Anatomical Site
Not Found
Indicated Patient Age Range
Not Found
Intended User / Care Setting
Not Found
Description of the training set, sample size, data source, and annotation protocol
Not Found
Description of the test set, sample size, data source, and annotation protocol
Not Found
Summary of Performance Studies (study type, sample size, AUC, MRMC, standalone performance, key results)
The results of clinical and nonclinical testing indicates that the new device is as safe and effective as the predicate devices and methods.
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.
X902237 Medica (Scimedix) IIf Anti-Skin Antibody Test Kit, K891098 Anti-Skin Antibody Test(Monkey Esophagus Sections Immco Diagnostics, Inc, K891099 Anti-Skin Antibody Test(Monkey/Guin Pig Esoph Sec Immco Diagnostics. Inc.
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
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
-
- 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
-
- 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.
-
- 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.
-
- 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.
1
6. Substantial Equivalence Chart
| Characteristic | K891098 Anti-Skin
Antibody Test (Monkey
Esophagus Sections)
Immco Diagnostics, Inc;
K891099 Anti-Skin
Antibody
Test(Monkey/Guin Pig
Esoph Sec Immco
Diagnostics, Inc. | K902237 Medica
(Scimedix) IIF Anti-Skin
Antibody Test Kit
Medica Corp.; (Now
Scimedix) | MESACUP BP180
ELISA Kit and
MESACUP BP230
ELISA Kit |
|----------------|-----------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------|------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------|----------------------------------------------------------------------------------------------------------------------------------------------|
| Indications | An indirect
immunofluorescence
antibody test for the
detection and
quantitation of anti-skin
(anti-intercellular and anti-
basement membrane)
antibodies in human serum. | The in vitro detection of
skin antibodies by the
indirect
immunofluorescent
technique has been
established as an aid in the
diagnosis of skin and
systemic diseases.
Monkey esophagus is used
for the detection of both
basement membrane
antibodies and intercellular
substance antibodies. The
detection of the basement
membrane antibody has
been associated with the
presence of a variety of
bullous pemphigoid
autoimmune disorders of
the skin. | The MESACUP BP180
and MESACUP BP230 is
intended for in vitro
diagnostic use as an aid in
the diagnosis of bullous
pemphigoid. |
| Technology | Indirect immunofluorescence | Indirect
immunofluorescence | ELISA |
| Detect what? | Anti-intercellular antibodies
and anti-basement
membrane antibodies. | Anti-intercellular antibodies
and anti-basement
membrane antibodies. | Anti BP180 Antibodies
And Anti BP230
Antibodies |
| Disease | Pemphigus Vulgaris;
Pemphigus Foliaceus
Pemphigoid/EBA | Multiple anti-immune
diseases, systemic
rheumatoid 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.
2
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
3
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
4
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