510(k) Report

510(k) · Cleared

Cleared

Direct Tibc Kit

K000781510(k) TraditionalCleared May 2, 200053-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

Reference Diagnostics, Inc. · JMO Ferrozine (Colorimetric) Iron Binding Capacity

Cleared on May 2, 2000 after a 53-day review. FDA lists a 510(k) statement for it but has not posted the file, so its predicates are not known. 2 later devices descend from it.

Decided
May 2, 2000
Review
53 days
Class
Class I
Product code
JMO
Recalls
None
Predicates
0

2 later devices descend from it, 1 citing it directly.

Descendants, by year cleared 2012: 1 descendant cleared2013: 1 descendant cleared200020052010201520202025
  1. This deviceK000781 Direct Tibc KitReference Diagnostics, Inc. · 2000
  2. Descendant · cites it directly · 1 of its ownK113438 Ace Direct Totaliron-Binding Capacity (Tibc) Reagent, Ace Serum Iron…Alfa Wassermann Diagnostic Technologies, Inc. · 2012
  3. 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 all
  • K113438Ace Direct Totaliron-Binding Capacity (Tibc) Reagent, Ace Serum Iron Reagent, Ace Lipase…Alfa Wassermann Diagnostic Technologies, Inc. · 2012 · cites it directly1descendant
  • K131515Ace -GT Reagent; Ace Lipase Ragent; Ace T4 ReagentAlfa Wassermann · 2013 · 2 generations on0descendants
View FIG. 1 as a table

Line of descent and top descendants

GenerationNumberDeviceApplicantDecidedRecalls
0 (this device)K000781Direct Tibc KitReference Diagnostics, Inc.2000—
+1K113438Ace Direct Totaliron-Binding Capacity (Tibc) Reagent, Ace Serum Iron Reagent…Alfa Wassermann Diagnostic Technologies, Inc.2012—
+2K131515Ace -GT Reagent; Ace Lipase Ragent; Ace T4 ReagentAlfa Wassermann2013—

Descendants by year cleared

Year clearedDevicesWith a Class I recall
201210
201310
FIG. 1 — Lineage of K000781, 2000–2013Source: 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), 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?

FDA lists a 510(k) statement for it but has not posted the file, so its predicates are not known.

What descends from it? (2)

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

NumberDeviceApplicantDecidedDescendants
K113438Ace Direct Totaliron-Binding Capacity (Tibc) Reagent, Ace Serum Iron Reagent, Ace Lipase…Alfa Wassermann Diagnostic Technologies, Inc.20121

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?

  • Of its descendants, K113438 (Alfa Wassermann Diagnostic Technologies, Inc., 2012) has gone furthest, with 1 descendant of its own.

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.

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—

More from Reference Diagnostics, Inc.

17 FDA decisions under this applicant name. See the company

  • K053291Ferritin Calibrator Set, Catalog NO. 8203Reference Diagnostics, Inc. · 2006
  • K053211Rdi Hsferritin KitReference Diagnostics, Inc. · 2006
  • K052148Total Iron-Binding Capacity Calibrator Set. Direct Tibc Calibrator SetReference Diagnostics, Inc. · 2005
  • K030044Extended Range HS CRP Kit, Cat NO:9200Reference Diagnostics, Inc. · 2003
  • K030772Rdi Extended Range CRP Calibrator SetReference Diagnostics, Inc. · 2003

Recent decisions in JMO

The JMO category page

  • K113438Ace Direct Totaliron-Binding Capacity (Tibc) Reagent, Ace Serum Iron Reagent, Ace Lipase ReagentAlfa Wassermann Diagnostic Technologies, Inc. · 2012
  • 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

https://510kreport.com/device/K000781 · printed Nov 4, 2026

Cite this page

510(k) Report. “K000781: Direct Tibc Kit.” Lineage record from FDA 510(k) data and the FDA summary. Updated Nov 3, 2026. Accessed Nov 4, 2026. https://510kreport.com/device/K000781

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Record history
  • FDA decision record loaded May 2, 2026
  • Lineage and recalls computed Nov 3, 2026
  • Page last updated Nov 3, 2026