510(k) · Cleared

Cleared

Elia M2; Immunoassay, Positive Control 100, Positive Control 250

K141375510(k) TraditionalCleared Feb 13, 2015262-day reviewClass II21 CFR 866.5090

Data to Oct 25, 2026 (FDA decisions) Oct 12, 2026 (recalls) Sep 30, 2026 (MAUDE) refreshed weekly, last Nov 3, 2026

Phadia US, Inc. · DBM Antimitochondrial Antibody, Indirect Immunofluorescent, Antigen, Control

Cleared on Feb 13, 2015 as substantially equivalent to K052262 (Inova Diagnostics, Inc., 2005) after a 262-day review. Its family tree reaches back 1 generation to 2005. 1 later device descends from it.

Decided: Feb 13, 2015
Review: 262 days
Class: Class II
Product code: DBM
Recalls: None
Predicates: 1

Its longest line of descent runs back 1 generation to K052262 (2005). 1 later device descends from it, 1 citing it directly.

By dateBy generation

Root · 1 generation backK052262 Quanta Lite M2 EP (MIT3) ElisaInova Diagnostics, Inc. · 2005
This deviceK141375 Elia M2; Immunoassay, Positive Control 100, Positive Control 250Phadia US, Inc. · 2015
Descendant · cites it directly · 0 of its ownK181556 EliA M2 ImmunoassayPhadia AB · 2018

Most influential descendants

Showing 1 of 1 · See all

K181556EliA M2 ImmunoassayPhadia AB · 2018 · cites it directly0descendants

View FIG. 1 as a table

Line of descent and top descendants

Generation	Number	Device	Applicant	Decided	Recalls
−1	K052262	Quanta Lite M2 EP (MIT3) Elisa	Inova Diagnostics, Inc.	2005	—
0 (this device)	K141375	Elia M2; Immunoassay, Positive Control 100, Positive Control 250	Phadia US, Inc.	2015	—
+1	K181556	EliA M2 Immunoassay	Phadia AB	2018	—

Descendants by year cleared

Year cleared	Devices	With a Class I recall
2018	1	0

FIG. 1 — Lineage of K141375, 2005–2018Source: FDA 510(k) summaries, read by 510(k) Report · How lineage is built

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

Get a 510(k) 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	Applicant	Decided	Recalls
*	K052262	Quanta Lite M2 EP (MIT3) Elisa Summary page 5 …A.7-2 Substantial Equivalence to Quanta Lite M2 EP (MIT3), INOVA K052262 Intended Use Statements of the New Devices 1) EliA M2 is intended for the in vitro semi-quantitative measurement of IgG antibo…	Inova Diagnostics, Inc.	2005	—

Also cleared against K052262: 3 other devices →

What descends from it? (1)

1 later device cites it directly; ranked here by how many devices descend from each in turn.

Number	Device	Applicant	Decided	Descendants
K181556	EliA M2 Immunoassay	Phadia AB	2018	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?

Its one ancestor has no recall.
Of its descendants, K181556 (Phadia AB, 2018) has gone furthest, with 0 descendants of its own.
3 other devices also cite its predicate K052262.

How does its category compare?

All DBM devices

DBM Antimitochondrial Antibody, Indirect Immunofluorescent, Antigen, Control: FDA decisions, review times, recalls and adverse event reports over 20 years. 2015, this device’s year, is highlighted.

FDA decisions per year · DBM

1in 2018

2007high 2 (2017) · low 0 (2007)2026

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

2007high 1 (2008) · low 0 (2007)2026

Class I (0 since 2007) Class II/III not classified

Adverse event reports per year · DBM

1in 2018

2007high 1 (2018) · low 0 (2007)2025

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?

EliA M2 is intended for the in vitro semi-quantitative measurement of IgG antibodies directed to M2 in human serum and plasma (heparin, EDTA) to aid in the clinical diagnosis of primary biliary cirrhosis in conjunction with other laboratory and clinical findings. EliA M2 uses the EliA IgG method on the instrument Phadia 100. EliA M2 is intended for the in vitro semi-quantitative measurement of IgG antibodies directed to M2 in human serum and plasma…

Read the full statement (164 words)

EliA M2 Positive Control 100 is intended for laboratory use in monitoring the performance of in vitro measurement of M2 antibodies with Phadia 100 using the EliA IgG method.

EliA M2 Positive Control 250 is intended for laboratory use in monitoring the performance of in vitro measurement of M2 antibodies with Phadia 250 using the EliA IgG method.

Indications for use as stated in the FDA summary.

https://510kreport.com/device/K141375 · printed Nov 6, 2026

Cite this page

510(k) Report. “K141375: Elia M2; Immunoassay, Positive Control 100, Positive Control 250.” Lineage record from FDA 510(k) data and the FDA summary. Updated Nov 3, 2026. Accessed Nov 6, 2026. https://510kreport.com/device/K141375

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