510(k) · Cleared
ClearedAptiva Celiac Disease IgG Reagent
Data to Oct 25, 2026 (FDA decisions) Oct 12, 2026 (recalls) Sep 30, 2026 (MAUDE) refreshed weekly
Inova Diagnostics, Inc. · MVM Autoantibodies, Endomysial (Tissue Transglutaminase)
Cleared on Aug 26, 2021 as substantially equivalent to K113863 (Inova Diagnostics, Inc., 2012) and 1 other predicate after a 574-day review. Its family tree reaches back 2 generations to 2005.
- Decided
- Aug 26, 2021
- Review
- 574 days
- Class
- Class II
- Product code
- MVM
- Recalls
- None
- Predicates
- 2
Its longest line of descent runs back 2 generations to K052143 (2005). 4 ancestors in all. No later device cites it as a predicate yet.
View FIG. 1 as a table
Line of descent and top descendants
| Generation | Number | Device | Applicant | Decided | Recalls |
|---|---|---|---|---|---|
| −2 | K052143 | Quanta Lite Gliadin Iga II | Inova Diagnostics, Inc. | 2005 | — |
| −1 | K113863 | Quanta Flash DGP Iga, Quanta Flash DGP Igg, Quanta Flash DGP Iga Calibrators… | Inova Diagnostics, Inc. | 2012 | — |
| 0 (this device) | K200230 | Aptiva Celiac Disease IgG Reagent | Inova Diagnostics, Inc. | 2021 | — |
Other ancestors by year cleared
| Year cleared | Devices | With a Class I recall |
|---|---|---|
| 2005 | 1 | 0 |
| 2011 | 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 MVM? 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 MVM device
- #1 K193604 Aptiva Celiac Disease IgA Reagentscore 1.8 · 2 generations · 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 |
|---|---|---|---|
| * | K113863 | Quanta Flash DGP Iga, Quanta Flash DGP Igg, Quanta Flash DGP Iga Calibrators, Quanta…Summary page 6…tTG IgG: MVM Regulation Number 866.5750, 866.5660 Device Class 2 Predicate device QUANTA Flash® DGP IgG, 510(k) number: k113863. Date declared: October 23, 2012. QUANTA Flash® h-tTG IgG, 510(k) number: k101644. Date declared: March 23, 2011. Device descrip… | 2012 |
| * | K101644 | Quanta Flash H-TTG IggSummary page 6…Class 2 Predicate device QUANTA Flash® DGP IgG, 510(k) number: k113863. Date declared: October 23, 2012. QUANTA Flash® h-tTG IgG, 510(k) number: k101644. Date declared: March 23, 2011. Device description The Aptiva Celiac Disease IgG reagent utilizes particle based multi-analyte… | 2011 |
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 16 years and passes through 1 company; a new generation was cleared every 8.9 years on median.
- None of the 4 ancestors has a recall.
- 1 other device also cites its predicate K113863.
How does its category compare?
All MVM devicesMVM Autoantibodies, Endomysial (Tissue Transglutaminase): FDA decisions, review times, recalls and adverse event reports over 20 years. 2021, this device’s year, is highlighted.
FDA decisions per year · MVM
2in 2021
2026 to Oct 25, outlined.
Median 510(k) review, days · MVM
275in 2011
Receipt to decision; years with fewer than 3 clearances left blank.
Recalls per year · MVM
No recall names MVM since 2007.
Adverse event reports per year · MVM
1in 2024
MAUDE reports naming product code MVM, 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 | 2 | — | 0 | 0 |
| 2008 | 3 | 98 | 0 | 0 |
| 2009 | 0 | — | 0 | 0 |
| 2010 | 2 | — | 0 | 0 |
| 2011 | 3 | 275 | 0 | 0 |
| 2012 | 0 | — | 0 | 0 |
| 2013 | 2 | — | 0 | 0 |
| 2014 | 1 | — | 0 | 0 |
| 2015 | 0 | — | 0 | 0 |
| 2016 | 0 | — | 0 | 0 |
| 2017 | 0 | — | 0 | 1 |
| 2018 | 0 | — | 0 | 0 |
| 2019 | 2 | — | 0 | 0 |
| 2020 | 0 | — | 0 | 0 |
| 2021 | 2 | — | 0 | 0 |
| 2022 | 0 | — | 0 | 0 |
| 2023 | 0 | — | 0 | 0 |
| 2024 | 0 | — | 0 | 1 |
| 2025 | 0 | — | 0 | 0 |
| 2026 | 0 | — | 0 | — |
What is it indicated for?
The Aptiva Celiac Disease IgG Reagent is an immunoassay utilizing particle-based multi-analyte technology for the semi-quantitative determination of anti-tissue transglutaminase IgG autoantibodies and anti-deamidated gliadin peptide IgG autoantibodies in human serum. The presence of these antibodies, in conjunction with clinical findings and other laboratory tests, is an aid in the diagnosis of celiac disease and dermatitis herpetiformis, particularly in patients with selective IgA deficiency.
The Aptiva Celiac Disease IgG Reagent is intended for use with the Inova Diagnostics Aptiva System.
Indications for use read by OCR from a scanned FDA summary, so letters may be misread. Check the PDF before quoting it.
https://510kreport.com/device/K200230 · printed Nov 3, 2026
Cite this page
510(k) Report. “K200230: Aptiva Celiac Disease IgG Reagent.” Lineage record from FDA 510(k) data and the FDA summary. Updated Nov 3, 2026. Accessed Nov 3, 2026. https://510kreport.com/device/K200230
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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