510(k) · Cleared
ClearedQuanta Flash SM, Quanta Flash RNP, Quanta Flash SM Calibrators, Quanta Flash RNP Calibrators, Quanta Flash SM Controls,
Data to Oct 25, 2026 (FDA decisions) Oct 12, 2026 (recalls) Sep 30, 2026 (MAUDE) refreshed weekly
Inova Diagnostics, Inc. · LKP Anti-Sm Antibody, Antigen And Control
Cleared on Apr 17, 2013 as substantially equivalent to K922831 (Inova Diagnostics, Inc., 1992) and 1 other predicate after a 147-day review. Its family tree reaches back 1 generation to 1992. 1 later device descends from it.
- Decided
- Apr 17, 2013
- Review
- 147 days
- Class
- Class II
- Product code
- LKP
- Recalls
- None
- Predicates
- 2
Its longest line of descent runs back 1 generation to K922831 (1992). 2 ancestors in all. 1 later device descends from it, 1 citing it directly.
- Root · 1 generation backK922831 Quanta Lite SM ElisaInova Diagnostics, Inc. · 1992
- This deviceK123593 Quanta Flash SM, Quanta Flash RNP, Quanta Flash SM Calibrators…Inova Diagnostics, Inc. · 2013
- 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 | K922831 | Quanta Lite SM Elisa | Inova Diagnostics, Inc. | 1992 | — |
| 0 (this device) | K123593 | Quanta Flash SM, Quanta Flash RNP, Quanta Flash SM Calibrators, Quanta Flash… | Inova Diagnostics, Inc. | 2013 | — |
| +1 | K213403 | Aptiva CTD Essential Reagent | Inova Diagnostics, Inc. | 2023 | — |
Other ancestors by year cleared
| Year cleared | Devices | With a Class I recall |
|---|---|---|
| 1992 | 1 | 0 |
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 LKP? 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 LKP device
- #1 K202067 EliA SmDP-Sscore 1.7 · 1 generation · no Class I recall
What was it cleared against? (2)
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 |
|---|---|---|---|
| * | K922831 | Quanta Lite SM ElisaSummary page 2…ulation Number* 862.1660 Device Class 1 Predicate device (for Device 1): QUANTA Lite'" Sm ELISA, 510(k) number: K(922831 Device (2) name (assay kit): Proprietary name: QUANTA Flash® RNP Common nam… | 1992 |
| * | K922833 | Quanta Lite RNP ElisaSummary page 3…on Number 862.1660 Device Class 1 Predicate device (for Device2): QUANTA Lite TmRNP ELISA, 510(k) number: K(922833 Device (1) and (2) description:0 The QUANTA Flash Sm and RNP assays are designed to run on the BIO-FLASH instrument. This plat… | 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 LKP devicesLKP Anti-Sm 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 · LKP
1in 2021
2026 to Oct 25, outlined.
Median 510(k) review, days · LKP
Too few LKP 510(k)s in any year since 2007 to give a median.
Recalls per year · LKP
1in 2015
Class I (0 since 2007) Class II/III not classified
Adverse event reports per year · LKP
No MAUDE report names LKP 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 | — | 0 | 0 |
| 2009 | 0 | — | 0 | 0 |
| 2010 | 0 | — | 0 | 0 |
| 2011 | 0 | — | 0 | 0 |
| 2012 | 0 | — | 0 | 0 |
| 2013 | 1 | — | 0 | 0 |
| 2014 | 1 | — | 0 | 0 |
| 2015 | 0 | — | 1 | 0 |
| 2016 | 0 | — | 0 | 0 |
| 2017 | 0 | — | 0 | 0 |
| 2018 | 1 | — | 0 | 0 |
| 2019 | 0 | — | 0 | 0 |
| 2020 | 0 | — | 0 | 0 |
| 2021 | 1 | — | 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?
The QUANTA Flash Sm is a chemiluminescent immunoassay for the semi-quantitative determination of lgG anti-Sm antibodies in human serum. The presence of anti-Sm antibodies, in conjunction with clinical findings and other laboratory tests, can aid in the diagnosis of Systemic Lupus Erythematosus (SLE). QUANTA Flash Sm Calibrators are intended for use with the QUANTA Flash Sm chemiluminescent immunoassay for the determination of lgG anti-Sm antibodies in…
Read the full statement (235 words)
The QUANTA Flash Sm is a chemiluminescent immunoassay for the semi-quantitative determination of lgG anti-Sm antibodies in human serum. The presence of anti-Sm antibodies, in conjunction with clinical findings and other laboratory tests, can aid in the diagnosis of Systemic Lupus Erythematosus (SLE).
QUANTA Flash Sm Calibrators are intended for use with the QUANTA Flash Sm chemiluminescent immunoassay for the determination of lgG anti-Sm antibodies in human serum. Each calibrator establishes a point of reference for the working curve that is used to calculate unit values.
QUANTA Flash Sm Controls are intended for use with the QUANTA Flash Sm chemiluminescent immunoassay for quality control in the determination of lgG anti-Sm antibodies in human serum.
The QUANTA Flash RNP is a chemiluminescent immunoassay for the semi-quantitative determination of IgG anti-ribonucleoprotein (RNP) antibodies in human serum. The presence of anti-RNP antibodies, in conjunction with clinical findings and other laboratory tests, can aid in the diagnosis of Systemic Lupus Erythematosus (SLE) and Mixed Connective Tissue Disease (MCTD).
QUANTA Flash RNP Calibrators are intended for use with the QUANTA Flash RNP chemiluminescent immunoassay for the determination of IgG anti-RNP antibodies in human serum. Each calibrator establishes a point of reference for the working curve that is used to calculate unit values.
QUANTA Flash RNP Controls are intended for use with the QUANTA Flash RNP chemiluminescent immunoassay for quality control in the determination of lgG anti-RNP antibodies in human serum.
Indications for use as stated in the FDA summary.
https://510kreport.com/device/K123593 · printed Nov 6, 2026
Cite this page
510(k) Report. “K123593: Quanta Flash SM, Quanta Flash RNP, Quanta Flash SM Calibrators, Quanta Flash RNP Calibrators, Quanta Flash SM Controls,.” Lineage record from FDA 510(k) data and the FDA summary. Updated Nov 3, 2026. Accessed Nov 6, 2026. https://510kreport.com/device/K123593
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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