510(k) · Cleared
ClearedAptiva CTD Essential Reagent
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 Sep 29, 2023 as substantially equivalent to K152013 (Inova Diagnostics, Inc., 2016) and 9 other predicates after a 711-day review. Its family tree reaches back 4 generations to 2000.
- Decided
- Sep 29, 2023
- Review
- 711 days
- Class
- Class II
- Product code
- LLL
- Recalls
- None
- Predicates
- 10
Its longest line of descent runs back 4 generations to K000312 (2000). 27 ancestors in all, the oldest K922832 (1992). No later device cites it as a predicate yet.
- Root · 4 generations backK000312 Varelisa SM AntibodiesPharmacia & Upjohn Co. · 2000
- 3 generations backK042629 Varelisa SM Antibodies, Model 18296Sweden Diagnostics (Germany) GmbH · 2004
- 2 generations backK053653 Fidis Connective 10, Model MX006Biomedical Diagnostics (Bmd) SA · 2006
- 1 generation backK151429 QUANTA Flash Jo-1, QUANTA Flash Jo-1 Calibrators, and QUANTA Flash…Inova Diagnostics, Inc. · 2016
- This deviceK213403 Aptiva CTD Essential ReagentInova Diagnostics, Inc. · 2023
View FIG. 1 as a table
Line of descent and top descendants
| Generation | Number | Device | Applicant | Decided | Recalls |
|---|---|---|---|---|---|
| −4 | K000312 | Varelisa SM Antibodies | Pharmacia & Upjohn Co. | 2000 | — |
| −3 | K042629 | Varelisa SM Antibodies, Model 18296 | Sweden Diagnostics (Germany) GmbH | 2004 | — |
| −2 | K053653 | Fidis Connective 10, Model MX006 | Biomedical Diagnostics (Bmd) SA | 2006 | — |
| −1 | K151429 | QUANTA Flash Jo-1, QUANTA Flash Jo-1 Calibrators, and QUANTA Flash Jo-1… | Inova Diagnostics, Inc. | 2016 | — |
| 0 (this device) | K213403 | Aptiva CTD Essential Reagent | Inova Diagnostics, Inc. | 2023 | — |
Other ancestors by year cleared
| Year cleared | Devices | With a Class I recall |
|---|---|---|
| 1992 | 4 | 0 |
| 1994 | 5 | 0 |
| 1995 | 1 | 0 |
| 1996 | 1 | 0 |
| 1997 | 1 | 0 |
| 1998 | 1 | 0 |
| 1999 | 2 | 0 |
| 2007 | 1 | 0 |
| 2013 | 1 | 0 |
| 2014 | 1 | 0 |
| 2015 | 3 | 0 |
| 2016 | 2 | 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
What was it cleared against? (10)
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 |
|---|---|---|---|
| * | K152013 | QUANTA Flash dsDNA, QUANTA Flash dsDNA Calibrators and QUANTA Flash dsDNA ControlsSummary page 7…7 === 510(k) Summary Aptiva CTD Essential Reagent Page 3 of 53 Predicate device QUANTA Flash® dsDNA IgG, 510(k) number: K152013. Date declared: April 11, 2016. QUANTA Flash® RNP, 510(k) number: K123593. Date declared: April 17, 2013. Orgentec Sm ELISA, 510(… | 2016 |
| * | K123593 | Quanta Flash SM, Quanta Flash RNP, Quanta Flash SM Calibrators, Quanta Flash RNP…Summary page 7…Page 3 of 53 Predicate device QUANTA Flash® dsDNA IgG, 510(k) number: K152013. Date declared: April 11, 2016. QUANTA Flash® RNP, 510(k) number: K123593. Date declared: April 17, 2013. Orgentec Sm ELISA, 510(k) number: K954830. Date declared: May 8, 1996. QUANTA Flash® Ro52, 510(k)… | 2013 |
| * | K954830 | Orgentec Anti-SM (Smith) Pin Immuno AssaySummary page 7…A IgG, 510(k) number: K152013. Date declared: April 11, 2016. QUANTA Flash® RNP, 510(k) number: K123593. Date declared: April 17, 2013. Orgentec Sm ELISA, 510(k) number: K954830. Date declared: May 8, 1996. QUANTA Flash® Ro52, 510(k) number: K141655. Date declared: March 5, 2015. QUANTA Flash® Ro60, 510(k)… | 1996 |
| * | K141655 | Quanta Flash RO52, Quanta Flash RO52 Calibrators, and Quanta Flash RO52 ControlsSummary page 7…sh® RNP, 510(k) number: K123593. Date declared: April 17, 2013. Orgentec Sm ELISA, 510(k) number: K954830. Date declared: May 8, 1996. QUANTA Flash® Ro52, 510(k) number: K141655. Date declared: March 5, 2015. QUANTA Flash® Ro60, 510(k) number: K141328. Date declared: February 12, 2015. QUANTA Flash® SS-B,… | 2015 |
| * | K141328 | Quanta Flash RO60, Quanta Flash RO60 Calibrators, Quanta Flash RO60 ControlsSummary page 7…m ELISA, 510(k) number: K954830. Date declared: May 8, 1996. QUANTA Flash® Ro52, 510(k) number: K141655. Date declared: March 5, 2015. QUANTA Flash® Ro60, 510(k) number: K141328. Date declared: February 12, 2015. QUANTA Flash® SS-B, 510(k) number: K141210. Date declared: January 29, 2015. QUANTA Flash® Scl… | 2015 |
| * | K141210 | Quanta Flash SS-B, Quanta Flash SS-B Calibrators, and Quanta Flash SS-B ControlsSummary page 7…2, 510(k) number: K141655. Date declared: March 5, 2015. QUANTA Flash® Ro60, 510(k) number: K141328. Date declared: February 12, 2015. QUANTA Flash® SS-B, 510(k) number: K141210. Date declared: January 29, 2015. QUANTA Flash® Scl-70, 510(k) number: K152635. Date declared: June 1, 2016. QUANTA Flash® Jo-1,… | 2015 |
| * | K152635 | QUANTA Flash Scl-70, QUANTA Flash Scl-70 Calibrators, QUANTA Flash Scl-70 ControlsSummary page 7…0(k) number: K141328. Date declared: February 12, 2015. QUANTA Flash® SS-B, 510(k) number: K141210. Date declared: January 29, 2015. QUANTA Flash® Scl-70, 510(k) number: K152635. Date declared: June 1, 2016. QUANTA Flash® Jo-1, 510(k) number: K151429. Date declared: February 12, 2016. QUANTA Flash® Centrom… | 2016 |
| * | K151429 | QUANTA Flash Jo-1, QUANTA Flash Jo-1 Calibrators, and QUANTA Flash Jo-1 CiontrolsSummary page 7…B, 510(k) number: K141210. Date declared: January 29, 2015. QUANTA Flash® Scl-70, 510(k) number: K152635. Date declared: June 1, 2016. QUANTA Flash® Jo-1, 510(k) number: K151429. Date declared: February 12, 2016. QUANTA Flash® Centromere, 510(k) number: K123880. Date declared: February 7, 2014. QUANTA Lite… | 2016 |
| * | K123880 | Quanta Flash CentromereSummary page 7…0(k) number: K152635. Date declared: June 1, 2016. QUANTA Flash® Jo-1, 510(k) number: K151429. Date declared: February 12, 2016. QUANTA Flash® Centromere, 510(k) number: K123880. Date declared: February 7, 2014. QUANTA Lite® Ribo-P, 510(k) number: K981237. Date declared: June 5, 1998. Device description T… | 2014 |
| * | K981237 | Quanta Lite Ribosome P ElisaSummary page 7…number: K151429. Date declared: February 12, 2016. QUANTA Flash® Centromere, 510(k) number: K123880. Date declared: February 7, 2014. QUANTA Lite® Ribo-P, 510(k) number: K981237. Date declared: June 5, 1998. Device description The Aptiva CTD Essential reagent utilizes particle based multi-analyte technolo… | 1998 |
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.
What does this lineage say?
- The line of descent spans 23 years and passes through 4 companies; a new generation was cleared every 7.6 years on median.
- None of the 27 ancestors has a 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. 2023, 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?
The Aptiva CTD Essential Reagent consists of 10 multiplexed immunoassays utilizing particle-based multi-analyte technology for the quantitative determination of IgG autoantibodies against dsDNA, and semi-quantitative determination of IgG autoantibodies against RNP, Sm, Ro52, Ro60, SS-B, Scl-70, Jo-1, centromere, and Ribo-P in human serum: • The presence of dsDNA antibodies, in conjunction with clinical findings and other laboratory tests, is an aid in…
Read the full statement (330 words)
The Aptiva CTD Essential Reagent consists of 10 multiplexed immunoassays utilizing particle-based multi-analyte technology for the quantitative determination of IgG autoantibodies against dsDNA, and semi-quantitative determination of IgG autoantibodies against RNP, Sm, Ro52, Ro60, SS-B, Scl-70, Jo-1, centromere, and Ribo-P in human serum:
• The presence of dsDNA antibodies, in conjunction with clinical findings and other laboratory tests, is an aid in the diagnosis of systemic lupus erythematosus.
• The presence of RNP antibodies, in conjunction with clinical findings and other laboratory tests, is an aid in the diagnosis of mixed connective tissue disease and systemic lupus erythematosus.
• The presence of Sm antibodies, in conjunction with clinical findings and other laboratory tests, is an aid in the diagnosis of systemic lupus erythematosus.
• The presence of Ro52 antibodies, in conjunction with clinical findings and other laboratory tests, is an aid in the diagnosis of systemic lupus erythematosus, Sjögren’s syndrome, systemic sclerosis, and idiopathic inflammatory myositis.
• The presence of Ro60 antibodies, in conjunction with clinical findings and other laboratory tests, is an aid in the diagnosis of systemic lupus erythematosus and Sjögren’s syndrome.
• The presence of SS-B antibodies, in conjunction with clinical findings and other laboratory tests, is an aid in the diagnosis of systemic lupus erythematosus and Sjögren’s syndrome.
• The presence of Scl-70 antibodies, in conjunction with clinical findings and other laboratory tests, is an aid in the diagnosis of systemic sclerosis.
• The presence of Jo-1 antibodies, in conjunction with clinical findings and other laboratory tests, is an aid in the diagnosis of idiopathic inflammatory myositis.
• The presence of centromere antibodies, in conjunction with clinical findings and other laboratory tests, is an aid in the diagnosis of systemic sclerosis.
• The presence of Ribo-P antibodies, in conjunction with clinical findings and other laboratory tests, is an aid in the diagnosis of systemic lupus erythematosus.
The individual assays included in the Aptiva CTD Essential Reagent are intended for use with the Inova Diagnostics Aptiva System.
Indications for use as stated in the FDA summary.
https://510kreport.com/device/K213403 · printed Nov 6, 2026
Cite this page
510(k) Report. “K213403: Aptiva CTD Essential Reagent.” Lineage record from FDA 510(k) data and the FDA summary. Updated Nov 3, 2026. Accessed Nov 6, 2026. https://510kreport.com/device/K213403
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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