510(k) · Cleared
ClearedQUANTA Flash dsDNA, QUANTA Flash dsDNA Calibrators and QUANTA Flash dsDNA Controls
Data to Oct 25, 2026 (FDA decisions) Oct 12, 2026 (recalls) Sep 30, 2026 (MAUDE) refreshed weekly
Inova Diagnostics, Inc. · LSW Anti-Dna Antibody, Antigen And Control
Cleared on Apr 11, 2016 as substantially equivalent to K993727 (The Binding Site, Ltd., 1999) after a 265-day review. Its family tree reaches back 1 generation to 1999. 1 later device descends from it.
- Decided
- Apr 11, 2016
- Review
- 265 days
- Class
- Class II
- Product code
- LSW
- Recalls
- None
- Predicates
- 1
Its longest line of descent runs back 1 generation to K993727 (1999). 1 later device descends from it, 1 citing it directly.
- Root · 1 generation backK993727 Bindazyme Anti-Dsdna Eia KitThe Binding Site, Ltd. · 1999
- This deviceK152013 QUANTA Flash dsDNA, QUANTA Flash dsDNA Calibrators and QUANTA Flash…Inova Diagnostics, Inc. · 2016
- 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 |
|---|---|---|---|---|---|
| −1 | K993727 | Bindazyme Anti-Dsdna Eia Kit | The Binding Site, Ltd. | 1999 | — |
| 0 (this device) | K152013 | QUANTA Flash dsDNA, QUANTA Flash dsDNA Calibrators and QUANTA Flash dsDNA… | Inova Diagnostics, Inc. | 2016 | — |
| +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 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 LSW? 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? (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 | Decided |
|---|---|---|---|
| * | K993727 | Bindazyme Anti-Dsdna Eia KitSummary page 7…Page 4 of 21 Predicate device: QUANTA Lite® dsDNA SC ELISA, 510(k) number: K993727 Device description QUANTA Flash dsDNA is a chemiluminescent microparticle immunoassay for the quantitative determination of IgG… | 1999 |
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?
- Its one ancestor has no recall.
- Of its descendants, K213403 (Inova Diagnostics, Inc., 2023) has gone furthest, with 0 descendants of its own.
How does its category compare?
All LSW devicesLSW Anti-Dna Antibody, Antigen And Control: FDA decisions, review times, recalls and adverse event reports over 20 years. 2016, this device’s year, is highlighted.
FDA decisions per year · LSW
1in 2018
2026 to Oct 25, outlined.
Median 510(k) review, days · LSW
Too few LSW 510(k)s in any year since 2007 to give a median.
Recalls per year · LSW
No recall names LSW since 2007.
Adverse event reports per year · LSW
1in 2019
MAUDE reports naming product code LSW, 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 | 1 | — | 0 | 0 |
| 2008 | 1 | — | 0 | 0 |
| 2009 | 0 | — | 0 | 0 |
| 2010 | 0 | — | 0 | 0 |
| 2011 | 0 | — | 0 | 0 |
| 2012 | 0 | — | 0 | 0 |
| 2013 | 0 | — | 0 | 1 |
| 2014 | 0 | — | 0 | 0 |
| 2015 | 0 | — | 0 | 0 |
| 2016 | 1 | — | 0 | 0 |
| 2017 | 0 | — | 0 | 0 |
| 2018 | 1 | — | 0 | 0 |
| 2019 | 0 | — | 0 | 1 |
| 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 dsDNA is a chemiluminescent immunoassay for the quantitative determination of IgG anti-double stranded deoxyribonucleic acid (dsDNA) antibodies in human serum. The presence of anti-dsDNA antibodies, in conjunction with clinical findings and other laboratory tests, is an aid in the diagnosis of Systemic Lupus Erythematosus. QUANTA Flash dsDNA Calibrators are intended for use with the QUANTA Flash dsDNA chemiluminescent immunoassay for the…
Read the full statement (117 words)
QUANTA Flash dsDNA is a chemiluminescent immunoassay for the quantitative determination of IgG anti-double stranded deoxyribonucleic acid (dsDNA) antibodies in human serum. The presence of anti-dsDNA antibodies, in conjunction with clinical findings and other laboratory tests, is an aid in the diagnosis of Systemic Lupus Erythematosus.
QUANTA Flash dsDNA Calibrators are intended for use with the QUANTA Flash dsDNA chemiluminescent immunoassay for the determination of IgG anti-dsDNA antibodies in human serum. Each calibrator establishes a point of reference for the working curve that is used to calculate unit values.
QUANTA Flash dsDNA Controls are intended for use with the QUANTA Flash dsDNA chemiluminescent immunoassay for quality control in the determination of IgG anti-dsDNA antibodies in human serum.
Indications for use as stated in the FDA summary.
https://510kreport.com/device/K152013 · printed Nov 6, 2026
Cite this page
510(k) Report. “K152013: QUANTA Flash dsDNA, QUANTA Flash dsDNA Calibrators and QUANTA Flash dsDNA Controls.” Lineage record from FDA 510(k) data and the FDA summary. Updated Nov 3, 2026. Accessed Nov 6, 2026. https://510kreport.com/device/K152013
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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