510(k) · Cleared
ClearedQuanta Lite M2 EP (MIT3) Elisa
Data to Oct 25, 2026 (FDA decisions) Oct 12, 2026 (recalls) Sep 30, 2026 (MAUDE) refreshed weekly
Inova Diagnostics, Inc. · DBM Antimitochondrial Antibody, Indirect Immunofluorescent, Antigen, Control
Cleared on Oct 27, 2005 after a 69-day review. FDA’s file for it is a 510(k) statement, which names no predicate. 5 later devices descend from it.
- Decided
- Oct 27, 2005
- Review
- 69 days
- Class
- Class II
- Product code
- DBM
- Recalls
- None
- Predicates
- 0
5 later devices descend from it, 4 citing it directly.
- This deviceK052262 Quanta Lite M2 EP (MIT3) ElisaInova Diagnostics, Inc. · 2005
- Descendant · cites it directly · 1 of its ownK141375 Elia M2; Immunoassay, Positive Control 100, Positive Control 250Phadia US, Inc. · 2015
- Descendant · 2 generations on · 0 of its ownK181556 EliA M2 ImmunoassayPhadia AB · 2018
- Descendant · cites it directly · 0 of its ownK163525 QUANTA Flash M2 (MIT3), QUANTA Flash M2 (MIT3) Calibrators, QUANTA…Inova Diagnostics, Inc. · 2017
- Descendant · cites it directly · 0 of its ownK113439 Euroimmun Euroline Profile Autoimmune Liver Disease 8AG (Igg)Euroimmun US · 2013
- Descendant · cites it directly · 0 of its ownK092736 Euroimmun Anti-M2-3E Elisa (Igg)Euroimmun Us, Inc. · 2010
Most influential descendants
Showing 5 of 5 · See all- K141375Elia M2; Immunoassay, Positive Control 100, Positive Control 250Phadia US, Inc. · 2015 · cites it directly1descendant
- K181556EliA M2 ImmunoassayPhadia AB · 2018 · 2 generations on0descendants
- K163525QUANTA Flash M2 (MIT3), QUANTA Flash M2 (MIT3) Calibrators, QUANTA Flash M2 (MIT3)…Inova Diagnostics, Inc. · 2017 · cites it directly0descendants
- K113439Euroimmun Euroline Profile Autoimmune Liver Disease 8AG (Igg)Euroimmun US · 2013 · cites it directly0descendants
- K092736Euroimmun Anti-M2-3E Elisa (Igg)Euroimmun Us, Inc. · 2010 · cites it directly0descendants
View FIG. 1 as a table
Line of descent and top descendants
| Generation | Number | Device | Applicant | Decided | Recalls |
|---|---|---|---|---|---|
| 0 (this device) | K052262 | Quanta Lite M2 EP (MIT3) Elisa | Inova Diagnostics, Inc. | 2005 | — |
| +1 | K141375 | Elia M2; Immunoassay, Positive Control 100, Positive Control 250 | Phadia US, Inc. | 2015 | — |
| +2 | K181556 | EliA M2 Immunoassay | Phadia AB | 2018 | — |
| +1 | K163525 | QUANTA Flash M2 (MIT3), QUANTA Flash M2 (MIT3) Calibrators, QUANTA Flash M2… | Inova Diagnostics, Inc. | 2017 | — |
| +1 | K113439 | Euroimmun Euroline Profile Autoimmune Liver Disease 8AG (Igg) | Euroimmun US | 2013 | — |
| +1 | K092736 | Euroimmun Anti-M2-3E Elisa (Igg) | Euroimmun Us, Inc. | 2010 | — |
Descendants by year cleared
| Year cleared | Devices | With a Class I recall |
|---|---|---|
| 2010 | 1 | 0 |
| 2013 | 1 | 0 |
| 2015 | 1 | 0 |
| 2017 | 1 | 0 |
| 2018 | 1 | 0 |
Sources: FDA 510(k) database (decision fields), the FDA 510(k) statement (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?
FDA’s file for it is a 510(k) statement, which names no predicate.
What descends from it? (5)
4 later devices cite it directly; ranked here by how many devices descend from each in turn.
| Number | Device | Decided | Descendants |
|---|---|---|---|
| K141375 | Elia M2; Immunoassay, Positive Control 100, Positive Control 250 | 2015 | 1 |
| K163525 | QUANTA Flash M2 (MIT3), QUANTA Flash M2 (MIT3) Calibrators, QUANTA Flash M2 (MIT3)… | 2017 | 0 |
| K113439 | Euroimmun Euroline Profile Autoimmune Liver Disease 8AG (Igg) | 2013 | 0 |
| K092736 | Euroimmun Anti-M2-3E Elisa (Igg) | 2010 | 0 |
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?
- Of its descendants, K141375 (Phadia US, Inc., 2015) has gone furthest, with 1 descendant of its own.
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 QUANTA LiteTM M2 EP (MIT3) ELISA is an enzyme-linked immunosorbent assay (ELISA) for the semi-quantitative detection of mitochondrial antibodies in human serum. The presence of mitochondrial antibodies can be used in conjunction with clinical findings and other laboratory tests to aid in the diagnosis of primary biliary cirrhosis.
Indications for use as stated in the FDA 510(k) statement.
https://510kreport.com/device/K052262 · printed Nov 6, 2026
Cite this page
510(k) Report. “K052262: Quanta Lite M2 EP (MIT3) Elisa.” Lineage record from FDA 510(k) data and the FDA summary. Updated Nov 3, 2026. Accessed Nov 6, 2026. https://510kreport.com/device/K052262
Report an extraction error
Are you the manufacturer?
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