510(k) · Cleared
ClearedAce Direct Total Iron-Binding Capacity (Tibc) Reagent, Ace Total Iron Reagent, Ace LDH-L Reagent
Data to Oct 25, 2026 (FDA decisions) Oct 12, 2026 (recalls) Sep 30, 2026 (MAUDE) refreshed weekly
Alfa Wassermann Diagnostic Technologies, Inc. · CFJ Nad Reduction/Nadh Oxidation, Lactate Dehydrogenase
Cleared on Oct 2, 2013 as substantially equivalent to K930104 (Schiapparelli Biosystems, Inc., 1993) and 2 other predicates after a 96-day review. Its family tree reaches back 1 generation to 1993.
- Decided
- Oct 2, 2013
- Review
- 96 days
- Class
- Class II
- Product code
- CFJ
- Recalls
- None
- Predicates
- 3
Its longest line of descent runs back 1 generation to K930104 (1993). 3 ancestors in all. No later device cites it as a predicate yet.
- Root · 1 generation backK930104 Ace Clinical Chemistry SystemSchiapparelli Biosystems, Inc. · 1993 · Recalled
- This deviceK131975 Ace Direct Total Iron-Binding Capacity (Tibc) Reagent, Ace Total…Alfa Wassermann Diagnostic Technologies, Inc. · 2013
View FIG. 1 as a table
Line of descent and top descendants
| Generation | Number | Device | Applicant | Decided | Recalls |
|---|---|---|---|---|---|
| −1 | K930104 | Ace Clinical Chemistry System | Schiapparelli Biosystems, Inc. | 1993 | 1 |
| 0 (this device) | K131975 | Ace Direct Total Iron-Binding Capacity (Tibc) Reagent, Ace Total Iron Reagent… | Alfa Wassermann Diagnostic Technologies, Inc. | 2013 | — |
Other ancestors by year cleared
| Year cleared | Devices | With a Class I recall |
|---|---|---|
| 1993 | 1 | 0 |
| 1995 | 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 CFJ? 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? (3)
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 2…Page 1 of 15 Predicate Manufacturer for reagent system predicates: Devices: Alfa Wassermann ACE Clinical Chemistry System and ACE Reagents (K930 104, K94491 1, K931786) Device In the ACE Direct Total Iron-Binding Capacity (TIBC) Reagent assay, Direct T… | 1993 |
| * | K944911 | Ace Iron ReagentSummary page 2…=== Predicate Manufacturer for reagent system predicates: Devices: Alfa Wassermann ACE Clinical Chemistry System and ACE Reagents (K930 104, K94491 1, K931786) Device In the ACE Direct Total Iron-Binding Capacity (TIBC) Reagent assay, Direct TI BC Descriptions: Color… | 1995 |
| * | K931786 | Ace Clinical Chemistry SystemSummary page 2…ate Manufacturer for reagent system predicates: Devices: Alfa Wassermann ACE Clinical Chemistry System and ACE Reagents (K930 104, K94491 1, K931786) Device In the ACE Direct Total Iron-Binding Capacity (TIBC) Reagent assay, Direct TI BC Descriptions: Color Reagent,… | 1993 |
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?
- 1 of the 3 ancestors has a recall of any class.
- 6 other devices also cite its predicate K930104.
How does its category compare?
All CFJ devicesCFJ Nad Reduction/Nadh Oxidation, Lactate Dehydrogenase: FDA decisions, review times, recalls and adverse event reports over 20 years. 2013, this device’s year, is highlighted.
FDA decisions per year · CFJ
1in 2013
2026 to Oct 25, outlined.
Median 510(k) review, days · CFJ
Too few CFJ 510(k)s in any year since 2007 to give a median.
Recalls per year · CFJ
1in 2018
Class I (0 since 2007) Class II/III not classified
Adverse event reports per year · CFJ
12in 2025
MAUDE reports naming product code CFJ, 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 | — | 0 | 4 |
| 2011 | 0 | — | 0 | 3 |
| 2012 | 0 | — | 0 | 1 |
| 2013 | 1 | — | 1 | 0 |
| 2014 | 0 | — | 0 | 0 |
| 2015 | 0 | — | 0 | 0 |
| 2016 | 0 | — | 0 | 4 |
| 2017 | 0 | — | 0 | 15 |
| 2018 | 0 | — | 1 | 10 |
| 2019 | 0 | — | 0 | 18 |
| 2020 | 0 | — | 0 | 10 |
| 2021 | 0 | — | 0 | 10 |
| 2022 | 0 | — | 0 | 8 |
| 2023 | 0 | — | 0 | 3 |
| 2024 | 0 | — | 0 | 10 |
| 2025 | 0 | — | 0 | 12 |
| 2026 | 0 | — | 0 | — |
What is it indicated for?
The ACE Direct Total Iron-Binding Capacity (TIBC) Reagent is intended for the quantitative determination of total iron-binding capacity in serum using the ACE Alera Clinical Chemistry System. Iron-binding capacity measurements are used in the diagnosis and treatment of anemia. This test is intended for use in clinical laboratories and physician office laboratories. For in vitro diagnostic use only. The ACE Total Iron Reagent is intended for the…
Read the full statement (224 words)
The ACE Direct Total Iron-Binding Capacity (TIBC) Reagent is intended for the quantitative determination of total iron-binding capacity in serum using the ACE Alera Clinical Chemistry System. Iron-binding capacity measurements are used in the diagnosis and treatment of anemia. This test is intended for use in clinical laboratories and physician office laboratories. For in vitro diagnostic use only.
The ACE Total Iron Reagent is intended for the quantitative determination of iron in serum using the ACE Alera Clinical Chemistry System. Ion (non-heme) measurements are used in the diagnosis and treatment of diseases such as iron deficiency anemia, hemochromatosis (a disease associated with widespread deposit in the tissues of two iron-containing pigments, hemosiderin and hemofuscin, and characterized by pigmentation of the sin), and chronic renal disease. This test is intended for use in clinical laboratories and physician office laboratories. For in vitro diagnostic use only.
The ACE LDH-L Reagent is intended for the quantitative determination of lactate dehydrogenase activity in serum using the ACE Alera Clinical Chemistry System. Lactate dehydrogenase measurements are used in the diagnosis and treatment of liver diseases such as acute viral hepatitis, cirrhosis, and metastatic carcinoma of the liver, cardiac diseases such as myocardial infarction and tumors of the lung or kidneys. 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/K131975 · printed Nov 4, 2026
Cite this page
510(k) Report. “K131975: Ace Direct Total Iron-Binding Capacity (Tibc) Reagent, Ace Total Iron Reagent, Ace LDH-L Reagent.” Lineage record from FDA 510(k) data and the FDA summary. Updated Nov 3, 2026. Accessed Nov 4, 2026. https://510kreport.com/device/K131975
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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