510(k) · Cleared
ClearedQuanta Flash Centromere
Data to Oct 25, 2026 (FDA decisions) Oct 12, 2026 (recalls) Sep 30, 2026 (MAUDE) refreshed weekly
Inova Diagnostics, Inc. · LJM Antinuclear Antibody (Enzyme-Labeled), Antigen, Controls
Cleared on Feb 7, 2014 after a 417-day review. FDA’s file for it is a 510(k) statement, which names no predicate. 1 later device descends from it.
- Decided
- Feb 7, 2014
- Review
- 417 days
- Class
- Class II
- Product code
- LJM
- Recalls
- None
- Predicates
- 0
1 later device descends from it, 1 citing it directly.
- This deviceK123880 Quanta Flash CentromereInova Diagnostics, Inc. · 2014
- Descendant · cites it directly · 0 of its ownK213403 Aptiva CTD Essential ReagentInova Diagnostics, Inc. · 2023
Most influential descendants
Showing 1 of 1 · See all- K213403Aptiva CTD Essential ReagentInova Diagnostics, Inc. · 2023 · cites it directly0descendants
View FIG. 1 as a table
Line of descent and top descendants
| Generation | Number | Device | Applicant | Decided | Recalls |
|---|---|---|---|---|---|
| 0 (this device) | K123880 | Quanta Flash Centromere | Inova Diagnostics, Inc. | 2014 | — |
| +1 | K213403 | Aptiva CTD Essential Reagent | Inova Diagnostics, Inc. | 2023 | — |
Descendants by year cleared
| Year cleared | Devices | With a Class I recall |
|---|---|---|
| 2023 | 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 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
What was it cleared against?
FDA’s file for it is a 510(k) statement, which names no predicate.
What descends from it? (1)
1 later device cites it directly; ranked here by how many devices descend from each in turn.
| Number | Device | Decided | Descendants |
|---|---|---|---|
| K213403 | Aptiva CTD Essential Reagent | 2023 | 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, K213403 (Inova Diagnostics, Inc., 2023) has gone furthest, with 0 descendants of its own.
How does its category compare?
All LJM devicesLJM Antinuclear Antibody (Enzyme-Labeled), Antigen, Controls: FDA decisions, review times, recalls and adverse event reports over 20 years. 2014, this device’s year, is highlighted.
FDA decisions per year · LJM
1in 2018
2026 to Oct 25, outlined.
Median 510(k) review, days · LJM
265in 2014
Receipt to decision; years with fewer than 3 clearances left blank.
Recalls per year · LJM
2in 2008
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?
QUANTA Flash Centromere is a chemiluminescent immunoassay for the semi-quantitative determination of lgG anti-centromere protein B autoantibodies in human serum. 'Me presence of anti-centromere protein B autoantibodies is used as an aid in the diagnosis Systemic Sclerosis, in conjunction with clinical finding and other laboratory tests. QUANTA Flash Centromnere Calibrators are intended for use with the QUANTA Flash Centroniere Reagents for the…
Read the full statement (118 words)
QUANTA Flash Centromere is a chemiluminescent immunoassay for the semi-quantitative determination of lgG anti-centromere protein B autoantibodies in human serum. 'Me presence of anti-centromere protein B autoantibodies is used as an aid in the diagnosis Systemic Sclerosis, in conjunction with clinical finding and other laboratory tests.
QUANTA Flash Centromnere Calibrators are intended for use with the QUANTA Flash Centroniere Reagents for the determination of lgG axti-Centromere autoantibodies in human serumn. Each calibrator establishes a point of reference for the working curve that is used to calculate the unit values.
QUANTA Flash Centromere Controls are intended for use with the QUANTA Flash Centromere Reagents for quality control in the determination of lgG anti-centromere protein B autoantibodies in human serum.
Indications for use as stated in the FDA 510(k) statement.
https://510kreport.com/device/K123880 · printed Nov 6, 2026
Cite this page
510(k) Report. “K123880: Quanta Flash Centromere.” Lineage record from FDA 510(k) data and the FDA summary. Updated Nov 3, 2026. Accessed Nov 6, 2026. https://510kreport.com/device/K123880
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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