510(k) · Cleared
ClearedQuanta Flash ENA7
Data to Oct 25, 2026 (FDA decisions) Oct 12, 2026 (recalls) Sep 30, 2026 (MAUDE) refreshed weekly
Inova Diagnostics, Inc. · LLL Extractable Antinuclear Antibody, Antigen And Control
Cleared on May 7, 2013 after a 225-day review. FDA’s file for it is a 510(k) statement, which names no predicate.
- Decided
- May 7, 2013
- Review
- 225 days
- Class
- Class II
- Product code
- LLL
- Recalls
- None
- Predicates
- 0
FDA’s file for it is a 510(k) statement, which names no predicate.
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 LLL? A 510(k) Report weighs predicate choices, recall history and review times for a new device like this one.
Top candidate predicates for a new LLL device
- #1 K253817 IDS SS-A/Ro; IDS SS-A/Ro 60 kDa; IDS SS-B/Lascore 12.2 · 2 generations · no Class I recall
- #2 Held for the reportin the report
- #3 Held for the reportin 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?
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.
How does its category compare?
All LLL devicesLLL Extractable Antinuclear Antibody, Antigen And Control: FDA decisions, review times, recalls and adverse event reports over 20 years. 2013, this device’s year, is highlighted.
FDA decisions per year · LLL
2in 2025
2026 to Oct 25, outlined.
Median 510(k) review, days · LLL
265in 2015
Receipt to decision; years with fewer than 3 clearances left blank.
Recalls per year · LLL
1in 2012
Class I (0 since 2007) Class II/III not classified
Adverse event reports per year · LLL
1in 2011
MAUDE reports naming product code LLL, 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 | 1 | — | 1 | 0 |
| 2009 | 0 | — | 0 | 0 |
| 2010 | 1 | — | 0 | 0 |
| 2011 | 1 | — | 1 | 1 |
| 2012 | 0 | — | 1 | 0 |
| 2013 | 2 | — | 0 | 0 |
| 2014 | 0 | — | 0 | 0 |
| 2015 | 3 | 265 | 0 | 0 |
| 2016 | 2 | — | 0 | 0 |
| 2017 | 0 | — | 0 | 0 |
| 2018 | 1 | — | 0 | 0 |
| 2019 | 1 | — | 0 | 0 |
| 2020 | 0 | — | 0 | 0 |
| 2021 | 0 | — | 0 | 0 |
| 2022 | 0 | — | 0 | 0 |
| 2023 | 1 | — | 0 | 0 |
| 2024 | 0 | — | 0 | 0 |
| 2025 | 2 | — | 0 | 0 |
| 2026 | 2 | — | 0 | — |
What is it indicated for?
QUANTA Flash ENA7 is a chemiluminescent immunoassay for the qualitative screening of IgG autoantibodies to Sm, RNP, Ro6O (SS-A), RoS2/TRIM2i, SS-B3 (La), Scl-70 (topoisomerase 1) and Jo-i in human serum. The presence of these autoantilbodies is used as an aid in the diagnosis of systemic lupus erythematosus (SLE), systemic sclerosis (SSc), pofymyositis (PM), dlermatomyositis (DM), siogren's syndrome (SjS) and mixed connective tissue disease (MaTD) in…
Read the full statement (165 words)
QUANTA Flash ENA7 is a chemiluminescent immunoassay for the qualitative screening of IgG autoantibodies to Sm, RNP, Ro6O (SS-A), RoS2/TRIM2i, SS-B3 (La), Scl-70 (topoisomerase 1) and Jo-i in human serum. The presence of these autoantilbodies is used as an aid in the diagnosis of systemic lupus erythematosus (SLE), systemic sclerosis (SSc), pofymyositis (PM), dlermatomyositis (DM), siogren's syndrome (SjS) and mixed connective tissue disease (MaTD) in conjunction with clinical findings and other laboratory tests.
QUANTA Flash. ENA7 Calibrators are intended for use with the QUANTA Flash ENA7 Reagents for the determination of IgO autoantibodies to Sm, RNP, Ro6O (SS-A), Ro52/TRIM21, S5-B3 (La), Scl-70 (topoisomerase 1)and Jo-i in human serum. Each calibrator establishes a point of reference for the working curve that is used to calculate the unit values.
QUANTA Flash ENA7 Controls are intended for use with the QUANTA Flash ENA7 Reagents for quality control in the determination of lgG autoantibodies to Sm, RNP, Ro6O (55-A), Ro52/TRIM21, 55-83 (La), Scl-70 (topoisomerase 1)and Jo-i in human serum.
Indications for use as stated in the FDA 510(k) statement.
https://510kreport.com/device/K122923 · printed Nov 6, 2026
Cite this page
510(k) Report. “K122923: Quanta Flash ENA7.” Lineage record from FDA 510(k) data and the FDA summary. Updated Nov 3, 2026. Accessed Nov 6, 2026. https://510kreport.com/device/K122923
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Record history
- FDA decision record loaded May 2, 2026
- Summary read Oct 13, 2026 (extraction version 9eaa42aa01ed)
- Page last updated Nov 3, 2026