510(k) · Cleared
ClearedQUANTA Flash Scl-70, QUANTA Flash Scl-70 Calibrators, QUANTA Flash Scl-70 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 Jun 1, 2016 as substantially equivalent to K924898 (Inova Diagnostics, Inc., 1992) after a 260-day review. Its family tree reaches back 1 generation to 1992. 1 later device descends from it.
- Decided
- Jun 1, 2016
- Review
- 260 days
- Class
- Class II
- Product code
- LLL
- Recalls
- None
- Predicates
- 1
Its longest line of descent runs back 1 generation to K924898 (1992). 1 later device descends from it, 1 citing it directly.
- Root · 1 generation backK924898 Quanta Lite (TM) SCL-70 ElisaInova Diagnostics, Inc. · 1992
- This deviceK152635 QUANTA Flash Scl-70, QUANTA Flash Scl-70 Calibrators, 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 | K924898 | Quanta Lite (TM) SCL-70 Elisa | Inova Diagnostics, Inc. | 1992 | — |
| 0 (this device) | K152635 | QUANTA Flash Scl-70, QUANTA Flash Scl-70 Calibrators, QUANTA Flash Scl-70… | 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 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 |
|---|---|---|---|
| * | K924898 | Quanta Lite (TM) SCL-70 ElisaSummary page 7…Page 4 of 19 Predicate device: QUANTA Lite® Scl-70 ELISA, 510(k) number: K924898 Device description The QUANTA Flash Scl-70 assay is designed to run on the BIO-FLASH® instrument. This platform is a fully auto… | 1992 |
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?
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. 2016, 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 Scl-70 is a chemiluminescent immunoassay for the semi-quantitative determination of IgG anti-Scl-70 autoantibodies in human serum. The presence of anti-Scl-70 autoantibodies, in conjunction with clinical findings and other laboratory tests, aids in the diagnosis of systemic sclerosis. QUANTA Flash Scl-70 Calibrators are intended for use with the QUANTA Flash Scl-70 chemiluminescent immunoassay for the determination of IgG anti-Scl-70…
Read the full statement (110 words)
QUANTA Flash Scl-70 is a chemiluminescent immunoassay for the semi-quantitative determination of IgG anti-Scl-70 autoantibodies in human serum. The presence of anti-Scl-70 autoantibodies, in conjunction with clinical findings and other laboratory tests, aids in the diagnosis of systemic sclerosis.
QUANTA Flash Scl-70 Calibrators are intended for use with the QUANTA Flash Scl-70 chemiluminescent immunoassay for the determination of IgG anti-Scl-70 autoantibodies in human serum. Each calibrator establishes a point of reference for the working curve that is used to calculate unit values.
QUANTA Flash Scl-70 Controls are intended for use with the QUANTA Flash Scl-70 chemiluminescent immunoassay for quality control in the determination of IgG anti-Scl-70 autoantibodies in human serum.
Indications for use as stated in the FDA summary.
https://510kreport.com/device/K152635 · printed Nov 6, 2026
Cite this page
510(k) Report. “K152635: QUANTA Flash Scl-70, QUANTA Flash Scl-70 Calibrators, QUANTA Flash Scl-70 Controls.” Lineage record from FDA 510(k) data and the FDA summary. Updated Nov 3, 2026. Accessed Nov 6, 2026. https://510kreport.com/device/K152635
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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