510(k) · Cleared
ClearedQuanta Flash DGP Iga, Quanta Flash DGP Igg, Quanta Flash DGP Iga Calibrators, Quanta Flash DGP Igg Calibrators
Data to Oct 25, 2026 (FDA decisions) Oct 12, 2026 (recalls) Sep 30, 2026 (MAUDE) refreshed weekly
Inova Diagnostics, Inc. · MST Antibodies, Gliadin
Cleared on Sep 20, 2012 as substantially equivalent to K052143 (Inova Diagnostics, Inc., 2005) and 1 other predicate after a 265-day review. Its family tree reaches back 1 generation to 2005. 2 later devices descend from it.
- Decided
- Sep 20, 2012
- Review
- 265 days
- Class
- Class II
- Product code
- MST
- Recalls
- None
- Predicates
- 2
Its longest line of descent runs back 1 generation to K052143 (2005). 2 ancestors in all. 2 later devices descend from it, 2 citing it directly.
- Root · 1 generation backK052143 Quanta Lite Gliadin Iga IIInova Diagnostics, Inc. · 2005
- This deviceK113863 Quanta Flash DGP Iga, Quanta Flash DGP Igg, Quanta Flash DGP Iga…Inova Diagnostics, Inc. · 2012
- Descendant · cites it directly · 0 of its ownK200230 Aptiva Celiac Disease IgG ReagentInova Diagnostics, Inc. · 2021
- Descendant · cites it directly · 0 of its ownK193604 Aptiva Celiac Disease IgA ReagentInova Diagnostics, Inc. · 2021
Most influential descendants
Showing 2 of 2 · See allView FIG. 1 as a table
Line of descent and top descendants
| Generation | Number | Device | Applicant | Decided | Recalls |
|---|---|---|---|---|---|
| −1 | K052143 | Quanta Lite Gliadin Iga II | Inova Diagnostics, Inc. | 2005 | — |
| 0 (this device) | K113863 | Quanta Flash DGP Iga, Quanta Flash DGP Igg, Quanta Flash DGP Iga Calibrators… | Inova Diagnostics, Inc. | 2012 | — |
| +1 | K200230 | Aptiva Celiac Disease IgG Reagent | Inova Diagnostics, Inc. | 2021 | — |
| +1 | K193604 | Aptiva Celiac Disease IgA Reagent | Inova Diagnostics, Inc. | 2021 | — |
Other ancestors by year cleared
| Year cleared | Devices | With a Class I recall |
|---|---|---|
| 2005 | 1 | 0 |
Descendants by year cleared
| Year cleared | Devices | With a Class I recall |
|---|---|---|
| 2021 | 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 MST? A 510(k) Report weighs predicate choices, recall history and review times for a new device like this one.
- Candidate predicates for a device like this, rankedin the report
- Recall history across each candidate’s familyin the report
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 |
|---|---|---|---|
| * | K052143 | Quanta Lite Gliadin Iga IISummary page 2…ulation Medical Specialty Clinical Chemistry Product Code JIX Regulation Number 862.1660 Device Class 1 Predicate device(s): QUANTA Lite™ Gliadin IgA I, 510(k) number: K052143 QUANTA Lite™ Gliadin IgG I, 510(k) number: K052142 Device description: Synthetic deamidated gliadin peptide is coated onto the… | 2005 |
| * | K052142 | Quanta Lite Gliadin Igg IISummary page 2…ct Code JIX Regulation Number 862.1660 Device Class 1 Predicate device(s): QUANTA Lite™ Gliadin IgA I, 510(k) number: K052143 QUANTA Lite™ Gliadin IgG I, 510(k) number: K052142 Device description: Synthetic deamidated gliadin peptide is coated onto the surface of paramagnetic beads (microparticles), whi… | 2005 |
What descends from it? (2)
2 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?
How does its category compare?
All MST devicesMST Antibodies, Gliadin: FDA decisions, review times, recalls and adverse event reports over 20 years. 2012, this device’s year, is highlighted.
FDA decisions per year · MST
1in 2017
2026 to Oct 25, outlined.
Median 510(k) review, days · MST
Too few MST 510(k)s in any year since 2007 to give a median.
Recalls per year · MST
1in 2008
Class I (0 since 2007) Class II/III not classified
Adverse event reports per year · MST
No MAUDE report names MST since 2007.
View these four charts as a table
| Year | Decisions | Median 510(k) review, days | Recalls (Class I) | MAUDE reports |
|---|---|---|---|---|
| 2007 | 2 | — | 0 | 0 |
| 2008 | 1 | — | 1 | 0 |
| 2009 | 2 | — | 0 | 0 |
| 2010 | 2 | — | 0 | 0 |
| 2011 | 1 | — | 0 | 0 |
| 2012 | 2 | — | 0 | 0 |
| 2013 | 1 | — | 0 | 0 |
| 2014 | 0 | — | 0 | 0 |
| 2015 | 0 | — | 0 | 0 |
| 2016 | 0 | — | 0 | 0 |
| 2017 | 1 | — | 0 | 0 |
| 2018 | 0 | — | 0 | 0 |
| 2019 | 0 | — | 0 | 0 |
| 2020 | 0 | — | 0 | 0 |
| 2021 | 0 | — | 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 DGP IgA Controls are intended for quality control purposes of the QUANTA Flash DGP IgA chemiluminescent immunoassay (CIA) kit run on the BIO FLASH® Instrument that is used for the measurement of IgA anti-deamidated gliadin peptide (DGP) antibodies in human serum. The QUANTA Flash DGP IgG Controls are intended for quality control purposes of the QUANTA Flash DGP IgG chemiluminescent immunoassay (CIA) kit run on the BIO FLASH ® Instrument…
Read the full statement (299 words)
The QUANTA Flash DGP IgA Controls are intended for quality control purposes of the QUANTA Flash DGP IgA chemiluminescent immunoassay (CIA) kit run on the BIO FLASH® Instrument that is used for the measurement of IgA anti-deamidated gliadin peptide (DGP) antibodies in human serum.
The QUANTA Flash DGP IgG Controls are intended for quality control purposes of the QUANTA Flash DGP IgG chemiluminescent immunoassay (CIA) kit run on the BIO FLASH ® Instrument that is used for the measurement of IgG anti-deamidated gliadin peptide (DGP) antibodies in human serum.
The QUANTA Flash™ DGP IgA is a chemiluminescent immunoassay for the semi-quantitative determination of IgA antibodies to synthetic, deamidated gliadin peptides in human serum. The presence of IgA deamidated gliadin peptide antibodies can be used in conjunction with clinical findings and other laboratory tests to aid in the diagnosis of celiac disease and dermatitis herpetiformis.
The QUANTA Flash™ DGP IgG is a chemiluminescent immunoassay for the semi-quantitative detection of IgG antibodies to synthetic, deamidated gliadin peptides in human serum. The presence of IgG deamidated gliadin peptide antibodies can be used in conjunction with clinical findings and other laboratory tests to aid in the diagnosis of celiac disease in both IgA sufficient and IgA deficient subjects, as well as dermatitis herpetiformis.
The QUANTA Flash™ DGP IgA Calibrators are intended for use with the QUANTA Flash™ DGP IgA chemiluminescent immunoassay to establish paints of reference for the working curve that is used to determine Chemiluminescent Unit (CU) values in the measurement of IgA anti-DGP antibodies in serum.
The QUANTA Flash™ DGP IgG Calibrators are intended for use with the QUANTA Flash™ DGP IgG chemiluminescent immunoassay to establish points of reference for the working curve that is used to determine Chemiluminescent Unit (CU) values in the measurement of IgG anti-DGP antibodies in serum.
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/K113863 · printed Nov 6, 2026
Cite this page
510(k) Report. “K113863: Quanta Flash DGP Iga, Quanta Flash DGP Igg, Quanta Flash DGP Iga Calibrators, Quanta Flash DGP Igg Calibrators.” Lineage record from FDA 510(k) data and the FDA summary. Updated Nov 3, 2026. Accessed Nov 6, 2026. https://510kreport.com/device/K113863
Report an extraction error
Are you the manufacturer?
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