510(k) · Cleared

Cleared

Mesacup-2 Test Cenp-B

K040200510(k) TraditionalCleared Mar 4, 200435-day reviewClass II21 CFR 866.5100

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

Rhigene, Inc. · LJM Antinuclear Antibody (Enzyme-Labeled), Antigen, Controls

Cleared on Mar 4, 2004 as substantially equivalent to K926562 (Inova Diagnostics, Inc., 1993) after a 35-day review. Its family tree reaches back 1 generation to 1993. 1 later device descends from it.

Decided: Mar 4, 2004
Review: 35 days
Class: Class II
Product code: LJM
Recalls: None
Predicates: 1

Its longest line of descent runs back 1 generation to K926562 (1993). 1 later device descends from it, 1 citing it directly.

By dateBy generation

Root · 1 generation backK926562 Quanta Lite (TM) JO-1 Elisa KitInova Diagnostics, Inc. · 1993
This deviceK040200 Mesacup-2 Test Cenp-BRhigene, Inc. · 2004
Descendant · cites it directly · 0 of its ownK060431 Anti Rna Polymerase Iii Elisa Kit, Model 7805Mbl International Corporation · 2006

Most influential descendants

Showing 1 of 1 · See all

K060431Anti Rna Polymerase Iii Elisa Kit, Model 7805Mbl International Corporation · 2006 · cites it directly0descendants

View FIG. 1 as a table

Line of descent and top descendants

Generation	Number	Device	Applicant	Decided	Recalls
−1	K926562	Quanta Lite (TM) JO-1 Elisa Kit	Inova Diagnostics, Inc.	1993	—
0 (this device)	K040200	Mesacup-2 Test Cenp-B	Rhigene, Inc.	2004	—
+1	K060431	Anti Rna Polymerase Iii Elisa Kit, Model 7805	Mbl International Corporation	2006	—

Descendants by year cleared

Year cleared	Devices	With a Class I recall
2006	1	0

FIG. 1 — Lineage of K040200, 1993–2006Source: 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 LJM? 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

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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
*	K926562	Quanta Lite (TM) JO-1 Elisa Kit Summary page 1 …ESACUP-2 Test CENP-B is compared to a legally marketed predicate device and a substantial equivalence claim made. The predicate device is Quanta Lite Centromere ELISA (K9265 62) currently manufactured and marketed by Inova Diagnostics, Inc., 10180 Scripps Ranch Boulevard, San Diego, CA 92131. The M…	Inova Diagnostics, Inc.	1993	—

Also cleared against K926562: 2 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
K060431	Anti Rna Polymerase Iii Elisa Kit, Model 7805	Mbl International Corporation	2006	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, K060431 (Mbl International Corporation, 2006) has gone furthest, with 0 descendants of its own.
2 other devices also cite its predicate K926562.

How does its category compare?

All LJM devices

LJM Antinuclear Antibody (Enzyme-Labeled), Antigen, Controls: FDA decisions, review times, recalls and adverse event reports over 20 years.

FDA decisions per year · LJM

1in 2018

2007high 3 (2014) · low 0 (2007)2026

2026 to Oct 25, outlined.

Median 510(k) review, days · LJM

265in 2014

2007high 265 (2014)2026

Receipt to decision; years with fewer than 3 clearances left blank.

Recalls per year · LJM

2in 2008

2007high 2 (2008) · low 0 (2007)2026

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

Adverse event reports per year · LJM

No MAUDE report names LJM 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	0	—	2	0
2009	1	—	0	0
2010	0	—	0	0
2011	0	—	0	0
2012	0	—	0	0
2013	1	—	0	0
2014	3	265	0	0
2015	0	—	0	0
2016	1	—	0	0
2017	0	—	0	0
2018	1	—	0	0
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 CENP-B is a semi-quantitative enzymc-linkcd immunosorbcnt assay (ELISA) for the detection of anti-CENP-B antibodies in human serum. The MESACUP-2 Test CENP-B is intended for in vitro diagnostic use as an aid ill the diagnosis of CREST syndrome and related connective tissue diseases.

The MESACUP-2 Test CENP-B is intended to be used by clinical (hospital and reference) laboratories.

Indications for use as stated in the FDA summary.

https://510kreport.com/device/K040200 · printed Nov 6, 2026

Cite this page

510(k) Report. “K040200: Mesacup-2 Test Cenp-B.” Lineage record from FDA 510(k) data and the FDA summary. Updated Nov 3, 2026. Accessed Nov 6, 2026. https://510kreport.com/device/K040200

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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