510(k) · Cleared
ClearedRhigene Mesacup-2 Anti-Mitochondria M2 Test, Model 10760
Data to Oct 25, 2026 (FDA decisions) Oct 12, 2026 (recalls) Sep 30, 2026 (MAUDE) refreshed weekly
Rhigene, Inc. · DBM Antimitochondrial Antibody, Indirect Immunofluorescent, Antigen, Control
Cleared on Sep 26, 2003 as substantially equivalent to K933180 (Inova Diagnostics, Inc., 1993) after a 155-day review. Its family tree reaches back 1 generation to 1993.
- Decided
- Sep 26, 2003
- Review
- 155 days
- Class
- Class II
- Product code
- DBM
- Recalls
- None
- Predicates
- 1
Its longest line of descent runs back 1 generation to K933180 (1993). No later device cites it as a predicate yet.
- Root · 1 generation backK933180 Quanta Lite Mitochondria M2 ElisaInova Diagnostics, Inc. · 1993
- This deviceK031308 Rhigene Mesacup-2 Anti-Mitochondria M2 Test, Model 10760Rhigene, Inc. · 2003
View FIG. 1 as a table
Line of descent and top descendants
| Generation | Number | Device | Applicant | Decided | Recalls |
|---|---|---|---|---|---|
| −1 | K933180 | Quanta Lite Mitochondria M2 Elisa | Inova Diagnostics, Inc. | 1993 | — |
| 0 (this device) | K031308 | Rhigene Mesacup-2 Anti-Mitochondria M2 Test, Model 10760 | Rhigene, Inc. | 2003 | — |
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 DBM? 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? (1)
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 |
|---|---|---|---|
| * | K933180 | Quanta Lite Mitochondria M2 Elisa Our reading of the summary gave K933150, FDA’s number for Noblepharma Dec 500 Straight Handpiece (Nobelpharma USA, Inc.). Corrected to the number one digit away whose FDA name carries the summary’s words for the device, “Quanta Lite Mitochondria M2 ELISA”. | 1993 |
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?
- Its one ancestor has no recall.
How does its category compare?
All DBM devicesDBM Antimitochondrial Antibody, Indirect Immunofluorescent, Antigen, Control: FDA decisions, review times, recalls and adverse event reports over 20 years.
FDA decisions per year · DBM
1in 2018
2026 to Oct 25, outlined.
Median 510(k) review, days · DBM
Too few DBM 510(k)s in any year since 2007 to give a median.
Recalls per year · DBM
1in 2008
Class I (0 since 2007) Class II/III not classified
Adverse event reports per year · DBM
1in 2018
MAUDE reports naming product code DBM, not matched to any one device; reports are not rates.
View these four charts as a table
| Year | Decisions | Median 510(k) review, days | Recalls (Class I) | MAUDE reports |
|---|---|---|---|---|
| 2007 | 0 | — | 0 | 0 |
| 2008 | 0 | — | 1 | 0 |
| 2009 | 0 | — | 0 | 0 |
| 2010 | 1 | — | 0 | 0 |
| 2011 | 0 | — | 0 | 0 |
| 2012 | 0 | — | 0 | 0 |
| 2013 | 0 | — | 0 | 0 |
| 2014 | 0 | — | 0 | 0 |
| 2015 | 1 | — | 0 | 0 |
| 2016 | 0 | — | 0 | 0 |
| 2017 | 2 | — | 0 | 0 |
| 2018 | 1 | — | 0 | 1 |
| 2019 | 0 | — | 0 | 0 |
| 2020 | 0 | — | 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-2 TEST Mitochondria M2 is semiquantitative enzyme-linked immunosorbent assay (ELISA)
for the detection of anti-Mitochondrial antibodies in human serum as an aid in the diagnosis of primary biliary
cirrhosis.
The MESACUP-2 TEST Mitochondria M2 is intended to be used by clinical (hospital and reference)
laboratories.
Indications for use as stated in the FDA summary.
https://510kreport.com/device/K031308 · printed Nov 6, 2026
Cite this page
510(k) Report. “K031308: Rhigene Mesacup-2 Anti-Mitochondria M2 Test, Model 10760.” Lineage record from FDA 510(k) data and the FDA summary. Updated Nov 3, 2026. Accessed Nov 6, 2026. https://510kreport.com/device/K031308
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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