510(k) · Cleared
ClearedAce -GT Reagent; Ace Lipase Ragent; Ace T4 Reagent
Data to Oct 25, 2026 (FDA decisions) Oct 12, 2026 (recalls) Sep 30, 2026 (MAUDE) refreshed weekly
Alfa Wassermann · KLI Enzyme Immunoassay, Non-Radiolabeled, Total Thyroxine
Cleared on Aug 14, 2013 as substantially equivalent to K930104 (Schiapparelli Biosystems, Inc., 1993) and 5 other predicates after a 78-day review. Its family tree reaches back 3 generations to 1995.
- Decided
- Aug 14, 2013
- Review
- 78 days
- Class
- Class II
- Product code
- KLI
- Recalls
- None
- Predicates
- 6
Its longest line of descent runs back 3 generations to K951586 (1995). 14 ancestors in all, the oldest K930104 (1993). No later device cites it as a predicate yet.
- Root · 3 generations backK951586 T-Uptake Eia TestDiagnostic Reagents, Inc. · 1995
- 2 generations backK981375 Ace T Uptake Reagent TU CalibratorsSchiapparelli Biosystems, Inc. · 1998
- 1 generation backK113437 Ace Hemoglobin Alc (Hbalc) Reagent, Ace Cedia T Uptake Reagent, Ace…Alfa Wassermann Diagnostic Technologies, Inc. · 2012
- This deviceK131515 Ace -GT Reagent; Ace Lipase Ragent; Ace T4 ReagentAlfa Wassermann · 2013
View FIG. 1 as a table
Line of descent and top descendants
| Generation | Number | Device | Applicant | Decided | Recalls |
|---|---|---|---|---|---|
| −3 | K951586 | T-Uptake Eia Test | Diagnostic Reagents, Inc. | 1995 | — |
| −2 | 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 | — |
| 0 (this device) | K131515 | Ace -GT Reagent; Ace Lipase Ragent; Ace T4 Reagent | Alfa Wassermann | 2013 | — |
Other ancestors by year cleared
| Year cleared | Devices | With a Class I recall |
|---|---|---|
| 1993 | 2 | 0 |
| 1994 | 1 | 0 |
| 1995 | 1 | 0 |
| 1998 | 1 | 0 |
| 2000 | 1 | 0 |
| 2005 | 1 | 0 |
| 2007 | 1 | 0 |
| 2012 | 3 | 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? (6)
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 |
|---|---|---|---|
| * | K930104 | Ace Clinical Chemistry SystemSummary page 1…Code KLI Predicate Manufacturer for reagent system predicates: Devices: Alfa Wassermann ACE Clinical Chemistry System and ACE Reagents (K930104, K981377, K1 13253, K1 13382, K1 13438, KI 13437) Device In the ACE y-GT Reagent assay, y-GT in serum or heparin plasm… | 1993 |
| * | K981377 | Ace T4 Reagent T4 CalibratorsSummary page 1…Predicate Manufacturer for reagent system predicates: Devices: Alfa Wassermann ACE Clinical Chemistry System and ACE Reagents (K930104, K981377, K1 13253, K1 13382, K1 13438, KI 13437) Device In the ACE y-GT Reagent assay, y-GT in serum or heparin plasma catalyz… | 1998 |
| * | K113253 | Ace Axcel Clinical Chemistry System,Ace Albumin Reagent,Ace Total Protein Reagent,Ace…Summary page 1…te Manufacturer for reagent system predicates: Devices: Alfa Wassermann ACE Clinical Chemistry System and ACE Reagents (K930104, K981377, K1 13253, K1 13382, K1 13438, KI 13437) Device In the ACE y-GT Reagent assay, y-GT in serum or heparin plasma catalyzes the tra… | 2012 |
| * | K113382 | Ace Alt ReagentSummary page 1…Manufacturer for reagent system predicates: Devices: Alfa Wassermann ACE Clinical Chemistry System and ACE Reagents (K930104, K981377, K1 13253, K1 13382, K1 13438, KI 13437) Device In the ACE y-GT Reagent assay, y-GT in serum or heparin plasma catalyzes the transfer Desc… | 2012 |
| * | K113438 | Ace Direct Totaliron-Binding Capacity (Tibc) Reagent, Ace Serum Iron Reagent, Ace Lipase…Summary page 1…er for reagent system predicates: Devices: Alfa Wassermann ACE Clinical Chemistry System and ACE Reagents (K930104, K981377, K1 13253, K1 13382, K1 13438, KI 13437) Device In the ACE y-GT Reagent assay, y-GT in serum or heparin plasma catalyzes the transfer Descriptions:… | 2012 |
| * | K113437 | Ace Hemoglobin Alc (Hbalc) Reagent, Ace Cedia T Uptake Reagent, Ace T4 Reagent, Ace…Summary page 10…ormance POL - Precision for ACE and ACE Allert, Clinical Chemistry Systems Data: (Note: Refer to previously cleared submissions k1 13382, k1 13438 and kI 113437 for ACE Axcel Precision - POL data) POL… | 2012 |
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?
- The line of descent spans 18 years and passes through 4 companies; a new generation was cleared every 3.1 years on median.
- 2 of the 14 ancestors have a recall of any class.
- 6 other devices also cite its predicate K930104.
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. 2013, this device’s year, is highlighted.
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?
The ACE y-GT Reagent is intended for the quantitative determination of gamma-glutamyltransferase activity in serum and lithium heparin plasma using the ACE, ACE Alera, and ACE Axcel Clinical Chemistry Systems. Gamma-glutamyltransferase measurements are used in the diagnosis and treatment of liver diseases such as alcoholic cirrhosis and primary and secondary liver tumors. This test is intended for use in clinical laboratories and physician office…
Read the full statement (206 words)
The ACE y-GT Reagent is intended for the quantitative determination of gamma-glutamyltransferase activity in serum and lithium heparin plasma using the ACE, ACE Alera, and ACE Axcel Clinical Chemistry Systems. Gamma-glutamyltransferase measurements are used in the diagnosis and treatment of liver diseases such as alcoholic cirrhosis and primary and secondary liver tumors. This test is intended for use in clinical laboratories and physician office laboratories. For in vitro diagnostic use only.
The ACE Lipase Reagent is intended for the quantitative determination of lipase activity in serum and lithium heparin plasma using the ACE, ACE Alera, and ACE Axcel Clinical Chemistry Systems. Lipase measurements are used in diagnosis and treatment of diseases of the pancreas such as acute pancreatitis and obstruction of the pancreatic duct. This test is intended for use in clinical laboratories and physician office laboratories. For in vitro diagnostic use only.
The ACE T4 Reagent is intended for the quantitative determination of total thyroxine (T4) in serum and lithium heparin plasma using the ACE, ACE Alera, and ACE Axcel Clinical Chemistry Systems. Total thyroxine measurements are used in the diagnosis and treatment of thyroid diseases. This test is intended for use in clinical laboratories and physician office laboratories. For in vitro diagnostic use only.
Indications for use as stated in the FDA summary.
https://510kreport.com/device/K131515 · printed Nov 6, 2026
Cite this page
510(k) Report. “K131515: Ace -GT Reagent; Ace Lipase Ragent; Ace T4 Reagent.” Lineage record from FDA 510(k) data and the FDA summary. Updated Nov 3, 2026. Accessed Nov 6, 2026. https://510kreport.com/device/K131515
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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