510(k) · Cleared
ClearedQuanta Flash (TM) DGP Screen
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 Oct 20, 2011 after a 153-day review. FDA’s file for it is a 510(k) statement, which names no predicate.
- Decided
- Oct 20, 2011
- Review
- 153 days
- Class
- Class II
- Product code
- MST
- Recalls
- None
- Predicates
- 0
FDA’s file for it is a 510(k) statement, which names no predicate.
Sources: FDA 510(k) database (decision fields), the FDA 510(k) statement (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?
FDA’s file for it is a 510(k) statement, which names no predicate.
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.
How does its category compare?
All MST devicesMST Antibodies, Gliadin: FDA decisions, review times, recalls and adverse event reports over 20 years. 2011, 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 TM DGP Screen is a chemiluminescent immunoassay (CIA) for the semi-quantitative detection of IqG and IgA anti-dleamidlated gliadin peptidle (DGP) antibodies in human serum on the RIO-FLASHS instrument, it is an aid in the diagnosis of celiac disease and dermatitis herpetiformis in conjunction with clinical findings and other laboratory tests. The QUANTA Flash Tm DGP Screen Calibrators are intended for use with the QUANTA Flash " DGP…
Read the full statement (137 words)
The QUANTA Flash TM DGP Screen is a chemiluminescent immunoassay (CIA) for the semi-quantitative detection of IqG and IgA anti-dleamidlated gliadin peptidle (DGP) antibodies in human serum on the RIO-FLASHS instrument, it is an aid in the diagnosis of celiac disease and dermatitis herpetiformis in conjunction with clinical findings and other laboratory tests.
The QUANTA Flash Tm DGP Screen Calibrators are intended for use with the QUANTA Flash " DGP Screen chemiluminescent immunoassay (CIA) on the BIO-FLASH® instrument. Each calibrator establishes a point of reference for the working curve that is used to determine Chemiluminescent Unit (CU) values in the measurement of IgG and igA anti-DGP antibodies in serum.
The QUANTA FlashTm DGP Screen Controls are intended for quality control purposes of the QUANTA Flash Tm DOP Screen chemiluminescent immunoassay (CIA) kit run on a RIO-FLASH®, instrument.
Indications for use as stated in the FDA 510(k) statement.
https://510kreport.com/device/K111414 · printed Nov 5, 2026
Cite this page
510(k) Report. “K111414: Quanta Flash (TM) DGP Screen.” Lineage record from FDA 510(k) data and the FDA summary. Updated Nov 3, 2026. Accessed Nov 5, 2026. https://510kreport.com/device/K111414
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Record history
- FDA decision record loaded May 2, 2026
- Summary read Oct 13, 2026 (extraction version 9eaa42aa01ed)
- Page last updated Nov 3, 2026