510(k) · Cleared
ClearedAce T Uptake Reagent TU Calibrators
Data to Oct 25, 2026 (FDA decisions) Oct 12, 2026 (recalls) Sep 30, 2026 (MAUDE) refreshed weekly
Schiapparelli Biosystems, Inc. · KHQ Radioassay, Triiodothyronine Uptake
Cleared on Jun 10, 1998 as substantially equivalent to K951586 (Diagnostic Reagents, Inc., 1995) after a 55-day review. Its family tree reaches back 1 generation to 1995. 2 later devices descend from it.
- Decided
- Jun 10, 1998
- Review
- 55 days
- Class
- Class II
- Product code
- KHQ
- Recalls
- None
- Predicates
- 1
Its longest line of descent runs back 1 generation to K951586 (1995). 2 later devices descend from it, 1 citing it directly.
- Root · 1 generation backK951586 T-Uptake Eia TestDiagnostic Reagents, Inc. · 1995
- This deviceK981375 Ace T Uptake Reagent TU 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 · 2 generations on · 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 | K951586 | T-Uptake Eia Test | Diagnostic Reagents, Inc. | 1995 | — |
| 0 (this device) | K981375 | Ace T Uptake Reagent TU 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 | — |
| +2 | 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 KHQ? 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 |
|---|---|---|---|
| * | K951586 | T-Uptake Eia TestSummary page 1…gent Common Name: Enzyme immunoassay for T Uptake Classification Name: T Uptake test Predicate Device: Diagnostic Reagents, Inc. (DRI) - T Uptake Reagent [510(k) Number K951586] Device Description The ACE T Uptake Regent contains two reagents, and Antibody/Substrate reagent and an Enzyme Conjugate reage… | 1995 |
What descends from it? (2)
1 later device cites it directly; ranked here by how many devices descend from each in turn.
| Number | Device | Decided | Descendants |
|---|---|---|---|
| K113437 | Ace Hemoglobin Alc (Hbalc) Reagent, Ace Cedia T Uptake Reagent, Ace T4 Reagent, Ace… | 2012 | 1 |
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 KHQ devicesKHQ Radioassay, Triiodothyronine Uptake: FDA decisions, review times, recalls and adverse event reports over 20 years.
FDA decisions per year · KHQ
FDA has decided no KHQ device since 2007.
Median 510(k) review, days · KHQ
Too few KHQ 510(k)s in any year since 2007 to give a median.
Recalls per year · KHQ
No recall names KHQ since 2007.
Adverse event reports per year · KHQ
1in 2021
MAUDE reports naming product code KHQ, 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 | 0 | — | 0 | 0 |
| 2010 | 0 | — | 0 | 0 |
| 2011 | 0 | — | 0 | 1 |
| 2012 | 0 | — | 0 | 0 |
| 2013 | 0 | — | 0 | 0 |
| 2014 | 0 | — | 0 | 0 |
| 2015 | 0 | — | 0 | 0 |
| 2016 | 0 | — | 0 | 0 |
| 2017 | 0 | — | 0 | 1 |
| 2018 | 0 | — | 0 | 1 |
| 2019 | 0 | — | 0 | 0 |
| 2020 | 0 | — | 0 | 0 |
| 2021 | 0 | — | 0 | 1 |
| 2022 | 0 | — | 0 | 0 |
| 2023 | 0 | — | 0 | 0 |
| 2024 | 0 | — | 0 | 0 |
| 2025 | 0 | — | 0 | 0 |
| 2026 | 0 | — | 0 | — |
What is it indicated for?
ACE® T Uptake Reagent is used in the diagnosis and treatment of thyroid disorders. It is intended for the quantitative determination of unsaturated binding sites on the thyroid-binding proteins 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/K981375 · printed Nov 4, 2026
Cite this page
510(k) Report. “K981375: Ace T Uptake Reagent TU Calibrators.” Lineage record from FDA 510(k) data and the FDA summary. Updated Nov 3, 2026. Accessed Nov 4, 2026. https://510kreport.com/device/K981375
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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