510(k) Report

510(k) · Cleared

Cleared

Ace Direct Totaliron-Binding Capacity (Tibc) Reagent, Ace Serum Iron Reagent, Ace Lipase Reagent

K113438510(k) TraditionalCleared Jun 1, 2012193-day reviewClass I21 CFR 862.1415

Data to Oct 25, 2026 (FDA decisions) Oct 12, 2026 (recalls) Sep 30, 2026 (MAUDE) refreshed weekly, last Nov 3, 2026

Alfa Wassermann Diagnostic Technologies, Inc. · JMO Ferrozine (Colorimetric) Iron Binding Capacity

Cleared on Jun 1, 2012 as substantially equivalent to K931786 (Schiapparelli Biosystems, Inc., 1993) and 2 other predicates after a 193-day review. Its family tree reaches back 1 generation to 1993. 1 later device descends from it.

Decided
Jun 1, 2012
Review
193 days
Class
Class I
Product code
JMO
Recalls
None
Predicates
3

Its longest line of descent runs back 1 generation to K931786 (1993). 3 ancestors in all. 1 later device descends from it, 1 citing it directly.

Other ancestors, by year clearedDescendants, by year cleared 2000: 1 other ancestor1995: 1 other ancestor2013: 1 descendant clearedK931786 · Ace Clinical Chemistry System · Schiapparelli Biosystems, Inc. · 19931990200020102020
Other ancestors, by generationDescendants, by generation 1 generation back: 2 other ancestors 1 generation forward: 1 descendant K931786 · Ace Clinical Chemistry System · Schiapparelli Biosystems, Inc. · 19930
  1. Root · 1 generation backK931786 Ace Clinical Chemistry SystemSchiapparelli Biosystems, Inc. · 1993
  2. This deviceK113438 Ace Direct Totaliron-Binding Capacity (Tibc) Reagent, Ace Serum Iron…Alfa Wassermann Diagnostic Technologies, Inc. · 2012
  3. Descendant · cites it directly · 0 of its ownK131515 Ace -GT Reagent; Ace Lipase Ragent; Ace T4 ReagentAlfa Wassermann · 2013

Most influential descendants

Showing 1 of 1 · See all
  • K131515Ace -GT Reagent; Ace Lipase Ragent; Ace T4 ReagentAlfa Wassermann · 2013 · cites it directly0descendants
View FIG. 1 as a table

Line of descent and top descendants

GenerationNumberDeviceApplicantDecidedRecalls
−1K931786Ace Clinical Chemistry SystemSchiapparelli Biosystems, Inc.1993—
0 (this device)K113438Ace Direct Totaliron-Binding Capacity (Tibc) Reagent, Ace Serum Iron Reagent…Alfa Wassermann Diagnostic Technologies, Inc.2012—
+1K131515Ace -GT Reagent; Ace Lipase Ragent; Ace T4 ReagentAlfa Wassermann2013—

Other ancestors by year cleared

Year clearedDevicesWith a Class I recall
199510
200010

Descendants by year cleared

Year clearedDevicesWith a Class I recall
201310
FIG. 1 — Lineage of K113438, 1993–2013Source: FDA 510(k) summaries, read by 510(k) Report · How lineage is built

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Notable FDA decisions, review times and new Class I recalls. See an issue.

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 JMO? 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
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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.

TypeNumberDeviceApplicantDecidedRecalls
*K931786Ace Clinical Chemistry System
Summary page 2
…Product Code CHI Predicate Manufacturer for analyzer/reagent system predicate: Devices: Alfa Wassermann ACE Clinical Chemistry System (K93 1786) ___________ACE Reagents (K00078 1, K94491 1) Device The ACE Axcel Clinical Chemistry System…
Schiapparelli Biosystems, Inc.1993—
*K000781Direct Tibc Kit
Summary page 2
…urer for analyzer/reagent system predicate: Devices: Alfa Wassermann ACE Clinical Chemistry System (K93 1786) ___________ACE Reagents (K00078 1, K94491 1) Device The ACE Axcel Clinical Chemistry System consists of two major Descriptions: co…
Reference Diagnostics, Inc.2000—
*K944911Ace Iron Reagent
Summary page 2
…nalyzer/reagent system predicate: Devices: Alfa Wassermann ACE Clinical Chemistry System (K93 1786) ___________ACE Reagents (K00078 1, K94491 1) Device The ACE Axcel Clinical Chemistry System consists of two major Descriptions: components,…
Schiapparelli Biosystems, Inc.1995—

Also cleared against K931786: 21 other devices →

What descends from it? (1)

1 later device cites it directly; ranked here by how many devices descend from each in turn.

NumberDeviceApplicantDecidedDescendants
K131515Ace -GT Reagent; Ace Lipase Ragent; Ace T4 ReagentAlfa Wassermann20130

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?

  • None of the 3 ancestors has a recall.
  • Of its descendants, K131515 (Alfa Wassermann, 2013) has gone furthest, with 0 descendants of its own.
  • 21 other devices also cite its predicate K931786.

How does its category compare?

All JMO devices

JMO Ferrozine (Colorimetric) Iron Binding Capacity: FDA decisions, review times, recalls and adverse event reports over 20 years. 2012, this device’s year, is highlighted.

FDA decisions per year · JMO

1in 2012

2012: 1
2007high 1 (2012) · low 0 (2007)2026

2026 to Oct 25, outlined.

Median 510(k) review, days · JMO

Too few JMO 510(k)s in any year since 2007 to give a median.

Recalls per year · JMO

1in 2012

2008: 12009: 12012: 1
2007high 1 (2008) · low 0 (2007)2026

Class I (0 since 2007) Class II/III not classified

Adverse event reports per year · JMO

No MAUDE report names JMO since 2007.

View these four charts as a table
YearDecisionsMedian 510(k) review, daysRecalls (Class I)MAUDE reports
20070—00
20080—10
20090—10
20100—00
20110—00
20121—10
20130—00
20140—00
20150—00
20160—00
20170—00
20180—00
20190—00
20200—00
20210—00
20220—00
20230—00
20240—00
20250—00
20260—0—

What is it indicated for?

The ACE TIBC Reagent is intended for the quantitative determination of total iron-binding capacity in serum using the ACE Axcel 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 or physician office laboratories. For in vitro diagnostic use only. The ACE Serum Iron Reagent is intended for the quantitative determination of iron…

Read the full statement (205 words)

The ACE TIBC Reagent is intended for the quantitative determination of total iron-binding capacity in serum using the ACE Axcel 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 or physician office laboratories. For in vitro diagnostic use only.

The ACE Serum Iron Reagent is intended for the quantitative determination of iron concentration in serum using the ACE Axcel Clinical Chemistry System. Iron (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 skin), and chronic renal disease. This test is intended for use in clinical laboratories or physician office laboratories. For in vitro diagnostic use only.

The ACE Lipase Reagent is intended for the quantitative determination of lipase activity in serum using the ACE Axcel Clinical Chemistry System. 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 or physician office laboratories. For in vitro diagnostic use only.

Indications for use as stated in the FDA summary.

Also cleared against K931786

21 other devices cite the same predicate.

  • K131975Ace Direct Total Iron-Binding Capacity (Tibc) Reagent, Ace Total Iron Reagent, Ace LDH-L ReagentAlfa Wassermann Diagnostic Technologies, Inc. · 2013
  • K131351Ace Alkaline Phosphatase Reagent, Amylase Reagent, Alt Reagent, Ast ReagentAlfa Wassermann Diagnostic Technologies, LLC · 20131 recall
  • K123953Ace Carbon Dioxide Reagent, Ace Direct Biliubin Reagent, Ace Total Bilirubin Reagent, Ace Magnesium ReagentAlfa Wassermann Diagnostic Technologies, Inc. · 2013
  • K113437Ace Hemoglobin Alc (Hbalc) Reagent, Ace Cedia T Uptake Reagent, Ace T4 Reagent, Ace Ferritin ReagentAlfa Wassermann Diagnostic Technologies, Inc. · 2012
  • K113382Ace Alt ReagentAlfa Wassermann · 20121 recall
  • K113374Ace Albumin Reagent Ace Total Protein Reagent Ace Calcium-Arsenazo Reagent Ace Phosphorus U.V. ReagentAlfa Wassermann Diagnostic Technologies, Inc. · 2012

More from Alfa Wassermann Diagnostic…

21 FDA decisions under this applicant name. See the company

  • K131975Ace Direct Total Iron-Binding Capacity (Tibc) Reagent, Ace Total Iron Reagent, Ace LDH-L ReagentAlfa Wassermann Diagnostic Technologies, Inc. · 2013
  • K123953Ace Carbon Dioxide Reagent, Ace Direct Biliubin Reagent, Ace Total Bilirubin Reagent, Ace Magnesium ReagentAlfa Wassermann Diagnostic Technologies, Inc. · 2013
  • K123018Ace Alera Clinical Chemistry System, Ace Glucose Reagent, Ace Ion Selective Electrode (Ise) ModuleAlfa Wassermann Diagnostic Technologies, Inc. · 2013
  • K122757Ace Cholesterol Reagent, Ace HDL-C Reagent, Ace LDL-C Reagent, Ace Triglycerides ReagentAlfa Wassermann Diagnostic Technologies, Inc. · 2012
  • K113389Ace CK Reagent,Ace Bun/Urea Reagent,Ace Uric Acid Reagent,Ace Creatinine ReagentAlfa Wassermann Diagnostic Technologies, Inc. · 2012

Recent decisions in JMO

The JMO category page

  • K061464Vitros Chemistry Products Tibc Kit, Model 886 7541; Calibrator Kit 4, Model 120 4668Ortho-Clinical Diagnostics, Inc. · 2006
  • K052867Vitros Chemistry Products Dtibc ReagentOrtho-Clinical Diagnostics, Inc. · 20051 recall
  • K041793Olympus Unsaturated Iron Binding Capcity Reagent, OSR6124/0SR6524Olympus America, Inc. · 20042 recalls
  • K013102Wiener Lab. Fer-Color Transferrina, Model Aux. Reagents for 25 Samples Cat. 1492002Wiener Laboratories Saic · 2001
  • K012340Bayer Advia System; Unsaturated Iron Binding Capacity (Uibc)Bayer Corp. · 2001

https://510kreport.com/device/K113438 · printed Nov 6, 2026

Cite this page

510(k) Report. “K113438: Ace Direct Totaliron-Binding Capacity (Tibc) Reagent, Ace Serum Iron Reagent, Ace Lipase Reagent.” Lineage record from FDA 510(k) data and the FDA summary. Updated Nov 3, 2026. Accessed Nov 6, 2026. https://510kreport.com/device/K113438

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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