510(k) · Cleared
ClearedAce T4 Reagent T4 Calibrators
Data to Oct 25, 2026 (FDA decisions) Oct 12, 2026 (recalls) Sep 30, 2026 (MAUDE) refreshed weekly
Schiapparelli Biosystems, Inc. · KLI Enzyme Immunoassay, Non-Radiolabeled, Total Thyroxine
Cleared on Jun 10, 1998 as substantially equivalent to K944703 (Diagnostic Reagents, Inc., 1994) after a 55-day review. Its family tree reaches back 1 generation to 1994. 2 later devices descend from it.
- Decided
- Jun 10, 1998
- Review
- 55 days
- Class
- Class II
- Product code
- KLI
- Recalls
- None
- Predicates
- 1
Its longest line of descent runs back 1 generation to K944703 (1994). 2 later devices descend from it, 2 citing it directly.
- Root · 1 generation backK944703 Thyroxine Enzyme ImmunoassayDiagnostic Reagents, Inc. · 1994
- This deviceK981377 Ace T4 Reagent T4 CalibratorsSchiapparelli Biosystems, Inc. · 1998
- Descendant · cites it directly · 1 of its ownK113437 Ace Hemoglobin Alc (Hbalc) Reagent, Ace Cedia T Uptake Reagent, Ace…Alfa Wassermann Diagnostic Technologies, Inc. · 2012
- Descendant · cites it directly · 0 of its ownK131515 Ace -GT Reagent; Ace Lipase Ragent; Ace T4 ReagentAlfa Wassermann · 2013
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 | K944703 | Thyroxine Enzyme Immunoassay | Diagnostic Reagents, Inc. | 1994 | — |
| 0 (this device) | K981377 | Ace T4 Reagent T4 Calibrators | Schiapparelli Biosystems, Inc. | 1998 | — |
| +1 | K113437 | Ace Hemoglobin Alc (Hbalc) Reagent, Ace Cedia T Uptake Reagent, Ace T4… | Alfa Wassermann Diagnostic Technologies, Inc. | 2012 | — |
| +1 | K131515 | Ace -GT Reagent; Ace Lipase Ragent; Ace T4 Reagent | Alfa Wassermann | 2013 | — |
Descendants by year cleared
| Year cleared | Devices | With a Class I recall |
|---|---|---|
| 2012 | 1 | 0 |
| 2013 | 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 KLI? 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? (1)
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 |
|---|---|---|---|
| * | K944703 | Thyroxine Enzyme ImmunoassaySummary page 1…on Name: Enzyme immunoassay for thyroxine Classification Name: Thyroxine test Predicate Device: Diagnostic Reagents, Inc. (DRI) - Thyroxine (T4) Reagent [510(k) Number K944703] Device Description The ACE® T4 Reagent contains two reagents, an Antibody/Substrate reagent and an Enzyme Conjugate reagent. T… | 1994 |
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?
- Its one ancestor has no recall.
- Of its descendants, K113437 (Alfa Wassermann Diagnostic Technologies, Inc., 2012) has gone furthest, with 1 descendant of its own.
How does its category compare?
All KLI devicesKLI Enzyme Immunoassay, Non-Radiolabeled, Total Thyroxine: FDA decisions, review times, recalls and adverse event reports over 20 years.
FDA decisions per year · KLI
1in 2016
2026 to Oct 25, outlined.
Median 510(k) review, days · KLI
Too few KLI 510(k)s in any year since 2007 to give a median.
Recalls per year · KLI
2in 2021
Class I (0 since 2007) Class II/III not classified
Adverse event reports per year · KLI
3in 2021
MAUDE reports naming product code KLI, 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 | 0 | — | 0 | 0 |
| 2008 | 0 | — | 0 | 0 |
| 2009 | 1 | — | 0 | 0 |
| 2010 | 0 | — | 1 | 3 |
| 2011 | 1 | — | 1 | 7 |
| 2012 | 0 | — | 0 | 2 |
| 2013 | 1 | — | 0 | 0 |
| 2014 | 0 | — | 0 | 5 |
| 2015 | 0 | — | 0 | 0 |
| 2016 | 1 | — | 0 | 0 |
| 2017 | 0 | — | 0 | 0 |
| 2018 | 0 | — | 0 | 3 |
| 2019 | 0 | — | 0 | 1 |
| 2020 | 0 | — | 0 | 0 |
| 2021 | 0 | — | 2 | 3 |
| 2022 | 0 | — | 0 | 0 |
| 2023 | 0 | — | 0 | 0 |
| 2024 | 0 | — | 0 | 0 |
| 2025 | 0 | — | 0 | 0 |
| 2026 | 0 | — | 1 | — |
What is it indicated for?
ACE® T4 Reagent is used in the diagnosis and treatment of thyroid disorders. It is intended for the quantitative determination of thyroxine in serum using the ACE clinical chemistry analyzer.
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/K981377 · printed Nov 4, 2026
Cite this page
510(k) Report. “K981377: Ace T4 Reagent T4 Calibrators.” Lineage record from FDA 510(k) data and the FDA summary. Updated Nov 3, 2026. Accessed Nov 4, 2026. https://510kreport.com/device/K981377
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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