510(k) · Cleared
ClearedQuanta Lite H-TTG Screen
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 Feb 12, 2008 as substantially equivalent to K011566 (Inova Diagnostics, Inc., 2001) and 1 other predicate after a 96-day review. Its family tree reaches back 1 generation to 2001.
- Decided
- Feb 12, 2008
- Review
- 96 days
- Class
- Class II
- Product code
- MVM
- Recalls
- None
- Predicates
- 2
Its longest line of descent runs back 1 generation to K011566 (2001). 2 ancestors in all. No later device cites it as a predicate yet.
- Root · 1 generation backK011566 Quanta Lite H-TTG (Human Tissue Transglutaminase) Iga ElisaInova Diagnostics, Inc. · 2001
- This deviceK073145 Quanta Lite H-TTG ScreenInova Diagnostics, Inc. · 2008
View FIG. 1 as a table
Line of descent and top descendants
| Generation | Number | Device | Applicant | Decided | Recalls |
|---|---|---|---|---|---|
| −1 | K011566 | Quanta Lite H-TTG (Human Tissue Transglutaminase) Iga Elisa | Inova Diagnostics, Inc. | 2001 | — |
| 0 (this device) | K073145 | Quanta Lite H-TTG Screen | Inova Diagnostics, Inc. | 2008 | — |
Other ancestors by year cleared
| Year cleared | Devices | With a Class I recall |
|---|---|---|
| 2001 | 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 K200230 Aptiva Celiac Disease IgG Reagentscore 2.2 · 2 generations · no Class I recall
- #2 Held for the reportin 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 |
|---|---|---|---|
| * | K011566 | Quanta Lite H-TTG (Human Tissue Transglutaminase) Iga ElisaSummary page 2…. J. Substantial Equivalence Information: 1. Predicate device name(s): QUANTA LiteTM h-tTG IgA QUANTA LiteTM h-tTG IgG 2. Predicate K number(s): k011566 (h-tTG IgA) k01 1570 (h-tTG IgG) 3. Comparison with predicate: Similarities… | 2001 |
| * | K011570 | Quanta Lite H-TTG (Human Tissue Transglutaminase) Igg ElisaSummary page 2…lence Information: 1. Predicate device name(s): QUANTA LiteTM h-tTG IgA QUANTA LiteTM h-tTG IgG 2. Predicate K number(s): k011566 (h-tTG IgA) k01 1570 (h-tTG IgG) 3. Comparison with predicate: Similarities QUANTA Lit… | 2001 |
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?
- None of the 2 ancestors has a recall.
- 2 other devices also cite its predicate K011566.
How does its category compare?
All MVM devicesMVM Autoantibodies, Endomysial (Tissue Transglutaminase): FDA decisions, review times, recalls and adverse event reports over 20 years. 2008, 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 QUANTA Lite T H h-tTG Screen is an enzyme-linked immunosorbent assay (ELISA) for the semi-quantitative detection of IgA and IgG antibodies to human tissue transglutaminase (h-tTG) in human serum. The presence of these antibodies can be used in conjunction with clinical findings and other laboratory tests to aid in the diagnosis of both IgA sufficient and IgA deficient celiac disease as well as dermatitis herpetiformis.
Indications for use as stated in the FDA summary.
https://510kreport.com/device/K073145 · printed Nov 6, 2026
Cite this page
510(k) Report. “K073145: Quanta Lite H-TTG Screen.” Lineage record from FDA 510(k) data and the FDA summary. Updated Nov 3, 2026. Accessed Nov 6, 2026. https://510kreport.com/device/K073145
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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