510(k) · Cleared
ClearedTDX/Tdxflx & Tdxflx Theophylline Monoclonal II
Data to Oct 25, 2026 (FDA decisions) Oct 12, 2026 (recalls) Sep 30, 2026 (MAUDE) refreshed weekly
Abbott Laboratories · LGS Fluorescence Polarization Immunoassay, Theophylline
Cleared on Aug 9, 1993 after a 98-day review. FDA has not posted a summary or statement for it, so its predicates are not known. 2 later devices descend from it.
- Decided
- Aug 9, 1993
- Review
- 98 days
- Class
- Class II
- Product code
- LGS
- Recalls
- None
- Predicates
- 0
2 later devices descend from it, 2 citing it directly.
- This deviceK932127 TDX/Tdxflx & Tdxflx Theophylline Monoclonal IIAbbott Laboratories · 1993
- Descendant · cites it directly · 0 of its ownK972495 Accumeter Theophylline TestChemtrak, Inc. · 1997
- Descendant · cites it directly · 0 of its ownK962294 Immage Immunochemistry SystemBeckman Instruments, Inc. · 1996 · Recalled
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 |
|---|---|---|---|---|---|
| 0 (this device) | K932127 | TDX/Tdxflx & Tdxflx Theophylline Monoclonal II | Abbott Laboratories | 1993 | — |
| +1 | K972495 | Accumeter Theophylline Test | Chemtrak, Inc. | 1997 | — |
| +1 | K962294 | Immage Immunochemistry System | Beckman Instruments, Inc. | 1996 | 2 |
Descendants by year cleared
| Year cleared | Devices | With a Class I recall |
|---|---|---|
| 1996 | 1 | 0 |
| 1997 | 1 | 0 |
Sources: FDA 510(k) database (decision fields), FDA recall and enforcement reports, and MAUDE; processed by 510(k) Report. Verify on FDA.gov · Methodology and accuracy.
Planning a device in LGS? 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 has not posted a summary or statement for it, so its predicates are not known.
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?
- Of its descendants, K972495 (Chemtrak, Inc., 1997) has gone furthest, with 0 descendants of its own.
How does its category compare?
All LGS devicesLGS Fluorescence Polarization Immunoassay, Theophylline: FDA decisions, review times, recalls and adverse event reports over 20 years.
FDA decisions per year · LGS
1in 2007
2026 to Oct 25, outlined.
Median 510(k) review, days · LGS
Too few LGS 510(k)s in any year since 2007 to give a median.
Recalls per year · LGS
No recall names LGS since 2007.
Adverse event reports per year · LGS
2in 2010
MAUDE reports naming product code LGS, 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 | 1 | — | 0 | 0 |
| 2008 | 0 | — | 0 | 1 |
| 2009 | 0 | — | 0 | 0 |
| 2010 | 0 | — | 0 | 2 |
| 2011 | 0 | — | 0 | 0 |
| 2012 | 0 | — | 0 | 0 |
| 2013 | 0 | — | 0 | 0 |
| 2014 | 0 | — | 0 | 0 |
| 2015 | 0 | — | 0 | 0 |
| 2016 | 0 | — | 0 | 0 |
| 2017 | 0 | — | 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 | — |
https://510kreport.com/device/K932127 · printed Nov 6, 2026
Cite this page
510(k) Report. “K932127: TDX/Tdxflx & Tdxflx Theophylline Monoclonal II.” Lineage record from FDA 510(k) data and the FDA summary. Updated Nov 3, 2026. Accessed Nov 6, 2026. https://510kreport.com/device/K932127
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Record history
- FDA decision record loaded May 2, 2026
- Lineage and recalls computed Nov 3, 2026
- Page last updated Nov 3, 2026