510(k) · Cleared
ClearedQuanta Flash RO60, Quanta Flash RO60 Calibrators, Quanta Flash RO60 Controls
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 Feb 12, 2015 as substantially equivalent to K962719 (Hycor Biomedical, Inc., 1997) after a 267-day review. Its family tree reaches back 1 generation to 1997. 3 later devices descend from it.
- Decided
- Feb 12, 2015
- Review
- 267 days
- Class
- Class II
- Product code
- LLL
- Recalls
- None
- Predicates
- 1
Its longest line of descent runs back 1 generation to K962719 (1997). 3 later devices descend from it, 3 citing it directly.
- Root · 1 generation backK962719 Hycor HY.Tec/Manual SS-a Auto-AntibodyHycor Biomedical, Inc. · 1997
- This deviceK141328 Quanta Flash RO60, Quanta Flash RO60 Calibrators, Quanta Flash RO60…Inova Diagnostics, Inc. · 2015
- Descendant · cites it directly · 0 of its ownK253817 IDS SS-A/Ro; IDS SS-A/Ro 60 kDa; IDS SS-B/LaImmunodiagnostics Systems Limited · 2026
- Descendant · cites it directly · 0 of its ownK213403 Aptiva CTD Essential ReagentInova Diagnostics, Inc. · 2023
- Descendant · cites it directly · 0 of its ownK210902 EliA Ro52, EliA Ro60Phadia AB · 2022
Most influential descendants
Showing 3 of 3 · See allView FIG. 1 as a table
Line of descent and top descendants
| Generation | Number | Device | Applicant | Decided | Recalls |
|---|---|---|---|---|---|
| −1 | K962719 | Hycor HY.Tec/Manual SS-a Auto-Antibody | Hycor Biomedical, Inc. | 1997 | — |
| 0 (this device) | K141328 | Quanta Flash RO60, Quanta Flash RO60 Calibrators, Quanta Flash RO60 Controls | Inova Diagnostics, Inc. | 2015 | — |
| +1 | K253817 | IDS SS-A/Ro; IDS SS-A/Ro 60 kDa; IDS SS-B/La | Immunodiagnostics Systems Limited | 2026 | — |
| +1 | K213403 | Aptiva CTD Essential Reagent | Inova Diagnostics, Inc. | 2023 | — |
| +1 | K210902 | EliA Ro52, EliA Ro60 | Phadia AB | 2022 | — |
Descendants by year cleared
| Year cleared | Devices | With a Class I recall |
|---|---|---|
| 2022 | 1 | 0 |
| 2023 | 1 | 0 |
| 2026 | 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 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? (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 |
|---|---|---|---|
| * | K962719 | Hycor HY.Tec/Manual SS-a Auto-AntibodySummary page 6…n Number 862.1660 Device Class 1 (reserved) Predicate device: Hycor AUTOSTAT™ II Anti-SS-A Ro ELISA, 510(k) number: K962719 Device description The QUANTA Flash Ro60 assay is designed to run on the BIO-FLASH® instrument. This platform is a fully automa… | 1997 |
What descends from it? (3)
3 later devices cite it directly; ranked here by how many devices descend from each in turn.
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, K253817 (Immunodiagnostics Systems Limited, 2026) has gone furthest, with 0 descendants of its own.
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. 2015, 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 Ro60 is a chemiluminescent immunoassay for the semi-quantitative determination of IgG anti-Ro60 autoantibodies in human serum. The presence of anti-Ro60 autoantibodies, in conjunction with clinical findings and other laboratory tests, is an aid in the diagnosis of Systemic Lupus Erythematosus and Sjögren’s Syndrome. QUANTA Flash Ro60 Calibrators are intended for use with the QUANTA Flash Ro60 Reagents for the determination of IgG anti-Ro60…
Read the full statement (114 words)
QUANTA Flash Ro60 is a chemiluminescent immunoassay for the semi-quantitative determination of IgG anti-Ro60 autoantibodies in human serum. The presence of anti-Ro60 autoantibodies, in conjunction with clinical findings and other laboratory tests, is an aid in the diagnosis of Systemic Lupus Erythematosus and Sjögren’s Syndrome.
QUANTA Flash Ro60 Calibrators are intended for use with the QUANTA Flash Ro60 Reagents for the determination of IgG anti-Ro60 autoantibodies in human serum. Each calibrator establishes a point of reference for the working curve that is used to calculate unit values.
QUANTA Flash Ro60 Controls are intended for use with the QUANTA Flash Ro60 reagents for quality control in the determination of IgG anti-Ro60 autoantibodies in human serum.
Indications for use as stated in the FDA summary.
https://510kreport.com/device/K141328 · printed Nov 6, 2026
Cite this page
510(k) Report. “K141328: Quanta Flash RO60, Quanta Flash RO60 Calibrators, Quanta Flash RO60 Controls.” Lineage record from FDA 510(k) data and the FDA summary. Updated Nov 3, 2026. Accessed Nov 6, 2026. https://510kreport.com/device/K141328
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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