510(k) · Cleared
ClearedMesacup Models BP180 and BP230 Elisa Kits
Data to Oct 25, 2026 (FDA decisions) Oct 12, 2026 (recalls) Sep 30, 2026 (MAUDE) refreshed weekly
Mbl International Corporation · OEG Autoantibodies, Skin (Bullous Pemphigoid 180 And Bullous Pemphigoid 230
Cleared on Aug 25, 2008 as substantially equivalent to K902237 (Medica Corp., 1990) and 2 other predicates after a 406-day review. Its family tree reaches back 1 generation to 1989.
- Decided
- Aug 25, 2008
- Review
- 406 days
- Class
- Class II
- Product code
- OEG
- Recalls
- None
- Predicates
- 3
Its longest line of descent runs back 1 generation to K891098 (1989). 3 ancestors in all. No later device cites it as a predicate yet.
- Root · 1 generation backK891098 Anti-Skin Antibody Test (Monkey Esophagus Sections)Immco Diagnostics, Inc. · 1989
- This deviceK071961 Mesacup Models BP180 and BP230 Elisa KitsMbl International Corporation · 2008
View FIG. 1 as a table
Line of descent and top descendants
| Generation | Number | Device | Applicant | Decided | Recalls |
|---|---|---|---|---|---|
| −1 | K891098 | Anti-Skin Antibody Test (Monkey Esophagus Sections) | Immco Diagnostics, Inc. | 1989 | — |
| 0 (this device) | K071961 | Mesacup Models BP180 and BP230 Elisa Kits | Mbl International Corporation | 2008 | — |
Other ancestors by year cleared
| Year cleared | Devices | With a Class I recall |
|---|---|---|
| 1989 | 1 | 0 |
| 1990 | 1 | 0 |
Sources: FDA 510(k) database (decision fields), the FDA summary (predicates and indications), FDA recall and enforcement reports, and MAUDE; processed by 510(k) Report. Verify on FDA.gov · Methodology and accuracy.
Planning a device in OEG? A 510(k) Report weighs predicate choices, recall history and review times for a new device like this one.
- Candidate predicates for a device like this, rankedin the report
- Recall history across each candidate’s familyin the report
What was it cleared against? (3)
Devices the submitter claimed this one is substantially equivalent to (*), and reference devices cited for a specific test or feature (†), as written in the FDA summary.
| Type | Number | Device | Decided |
|---|---|---|---|
| * | K902237 | Medica Iif Anti-Skin Antibody Test KitSummary page 1…UP BP180 ELISA Kit and MESACUP BP230 ELISA Kit Classification Name/Product Codes: DBL Common/Usual Name: Antibody Test Kit 2. Equivalent legally marketed devices: K902237 Medica (Scimedix) If Anti-Skin Antibody Test Kit Medica Corp.; K891098 Anti-Skin Antibody Test(Monkey Esophagus Sections Immco… | 1990 |
| * | K891098 | Anti-Skin Antibody Test (Monkey Esophagus Sections)Summary page 1…uct Codes: DBL Common/Usual Name: Antibody Test Kit 2. Equivalent legally marketed devices: K902237 Medica (Scimedix) If Anti-Skin Antibody Test Kit Medica Corp.; K891098 Anti-Skin Antibody Test(Monkey Esophagus Sections Immco Diagnostics, Inc; K891099 Anti-Skin Antibody Test(Monkey/Guin Pig Esop… | 1989 |
| * | K891099 | Anti-Skin Antibody Test (Monkey/Guin Pig Esoph Sec)Summary page 1…d devices: K902237 Medica (Scimedix) If Anti-Skin Antibody Test Kit Medica Corp.; K891098 Anti-Skin Antibody Test(Monkey Esophagus Sections Immco Diagnostics, Inc; K891099 Anti-Skin Antibody Test(Monkey/Guin Pig Esoph Sec Immco Diagnostics, Inc. 3. Indications for Use (intended use): The MESACUP… | 1989 |
What descends from it?
No later submission names this one as a predicate yet.
Has anything in its family been recalled? (0 Class I)
No FDA recall names this device.
No ancestor or descendant has a Class I recall.
What does this lineage say?
- None of the 3 ancestors has a recall.
How does its category compare?
All OEG devicesOEG Autoantibodies, Skin (Bullous Pemphigoid 180 And Bullous Pemphigoid 230: FDA decisions, review times, recalls and adverse event reports over 20 years. 2008, this device’s year, is highlighted.
FDA decisions per year · OEG
1in 2020
2026 to Oct 25, outlined.
Median 510(k) review, days · OEG
Too few OEG 510(k)s in any year since 2007 to give a median.
Recalls per year · OEG
No recall names OEG since 2007.
Adverse event reports per year · OEG
No MAUDE report names OEG since 2007.
View these four charts as a table
| Year | Decisions | Median 510(k) review, days | Recalls (Class I) | MAUDE reports |
|---|---|---|---|---|
| 2007 | 0 | — | 0 | 0 |
| 2008 | 1 | — | 0 | 0 |
| 2009 | 1 | — | 0 | 0 |
| 2010 | 0 | — | 0 | 0 |
| 2011 | 0 | — | 0 | 0 |
| 2012 | 0 | — | 0 | 0 |
| 2013 | 0 | — | 0 | 0 |
| 2014 | 0 | — | 0 | 0 |
| 2015 | 0 | — | 0 | 0 |
| 2016 | 0 | — | 0 | 0 |
| 2017 | 0 | — | 0 | 0 |
| 2018 | 0 | — | 0 | 0 |
| 2019 | 0 | — | 0 | 0 |
| 2020 | 1 | — | 0 | 0 |
| 2021 | 0 | — | 0 | 0 |
| 2022 | 0 | — | 0 | 0 |
| 2023 | 0 | — | 0 | 0 |
| 2024 | 0 | — | 0 | 0 |
| 2025 | 0 | — | 0 | 0 |
| 2026 | 0 | — | 0 | — |
What is it indicated for?
The MESACUP BP180 or BP230 TEST is a semi-quantitative enzyme-linked immunosorbent assay (ELISA) for the detection of anti BPI80 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..
Indications for use as stated in the FDA summary.
https://510kreport.com/device/K071961 · printed Nov 6, 2026
Cite this page
510(k) Report. “K071961: Mesacup Models BP180 and BP230 Elisa Kits.” Lineage record from FDA 510(k) data and the FDA summary. Updated Nov 3, 2026. Accessed Nov 6, 2026. https://510kreport.com/device/K071961
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Record history
- FDA decision record loaded May 2, 2026
- Summary read Oct 13, 2026 (extraction version 9eaa42aa01ed)
- Lineage and recalls computed Nov 3, 2026
- Page last updated Nov 3, 2026