510(k) Report

510(k) · Cleared

Cleared

Ace Iron Reagent

K944911510(k) TraditionalCleared Feb 10, 1995128-day reviewClass I21 CFR 862.1410

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

Schiapparelli Biosystems, Inc. · JIY Photometric Method, Iron (Non-Heme)

Cleared on Feb 10, 1995 after a 128-day review. FDA has not posted a summary or statement for it, so its predicates are not known. 3 later devices descend from it.

Decided
Feb 10, 1995
Review
128 days
Class
Class I
Product code
JIY
Recalls
None
Predicates
0

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

Descendants, by year cleared 2013: 2 descendants cleared2012: 1 descendant cleared1995200020052010201520202025
  1. This deviceK944911 Ace Iron ReagentSchiapparelli Biosystems, Inc. · 1995
  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 · cites it directly · 0 of its ownK131975 Ace Direct Total Iron-Binding Capacity (Tibc) Reagent, Ace Total…Alfa Wassermann Diagnostic Technologies, Inc. · 2013
  4. Descendant · 2 generations on · 0 of its ownK131515 Ace -GT Reagent; Ace Lipase Ragent; Ace T4 ReagentAlfa Wassermann · 2013

Most influential descendants

Showing 3 of 3 · See all
  • K113438Ace Direct Totaliron-Binding Capacity (Tibc) Reagent, Ace Serum Iron Reagent, Ace Lipase…Alfa Wassermann Diagnostic Technologies, Inc. · 2012 · cites it directly1descendant
  • K131975Ace Direct Total Iron-Binding Capacity (Tibc) Reagent, Ace Total Iron Reagent, Ace LDH-L…Alfa Wassermann Diagnostic Technologies, Inc. · 2013 · cites it directly0descendants
  • 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)K944911Ace Iron ReagentSchiapparelli Biosystems, Inc.1995—
+1K113438Ace Direct Totaliron-Binding Capacity (Tibc) Reagent, Ace Serum Iron Reagent…Alfa Wassermann Diagnostic Technologies, Inc.2012—
+1K131975Ace Direct Total Iron-Binding Capacity (Tibc) Reagent, Ace Total Iron Reagent…Alfa Wassermann Diagnostic Technologies, Inc.2013—
+2K131515Ace -GT Reagent; Ace Lipase Ragent; Ace T4 ReagentAlfa Wassermann2013—

Descendants by year cleared

Year clearedDevicesWith a Class I recall
201210
201320
FIG. 1 — Lineage of K944911, 1995–2013Source: 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 JIY? 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 has not posted a summary or statement for it, so its predicates are not known.

What descends from it? (3)

2 later devices cite 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
K131975Ace Direct Total Iron-Binding Capacity (Tibc) Reagent, Ace Total Iron Reagent, Ace LDH-L…Alfa Wassermann Diagnostic Technologies, Inc.20130

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 JIY devices

JIY Photometric Method, Iron (Non-Heme): FDA decisions, review times, recalls and adverse event reports over 20 years.

FDA decisions per year · JIY

FDA has decided no JIY device since 2007.

Median 510(k) review, days · JIY

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

Recalls per year · JIY

1in 2025

2008: 12009: 82012: 12013: 12016: 32023: 22025: 1
2007high 8 (2009) · low 0 (2007)2026

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

Adverse event reports per year · JIY

7in 2025

2012: 152013: 22016: 22017: 12020: 32021: 22022: 32023: 62024: 82025: 7
2007high 15 (2012) · low 0 (2007)2025

MAUDE reports naming product code JIY, not matched to any one device; reports are not rates.

View these four charts as a table
YearDecisionsMedian 510(k) review, daysRecalls (Class I)MAUDE reports
20070—00
20080—10
20090—80
20100—00
20110—00
20120—115
20130—12
20140—00
20150—00
20160—32
20170—01
20180—00
20190—00
20200—03
20210—02
20220—03
20230—26
20240—08
20250—17
20260—0—

More from Schiapparelli Biosystems, Inc.

24 FDA decisions under this applicant name. See the company

  • K991733Ace LDL-C Reagent, LDL-C Calibrator, LDL-C ControlsSchiapparelli Biosystems, Inc. · 1999
  • K981375Ace T Uptake Reagent TU CalibratorsSchiapparelli Biosystems, Inc. · 1998
  • K981377Ace T4 Reagent T4 CalibratorsSchiapparelli Biosystems, Inc. · 1998
  • K973583Ace Theophylline Reagent, Theo CalibratorsSchiapparelli Biosystems, Inc. · 1997
  • K973581Ace Valproic Acid Reagent, Aed CalibratorsSchiapparelli Biosystems, Inc. · 1997

Recent decisions in JIY

The JIY category page

  • K061793Dimension Vista Iron Flex Reagent Cartridge and CalibratorDade Behring, Inc. · 20061 recall
  • K060264Dimension Iron Flex Reagent Cartridge (Iron-DF85)Dade Behring, Inc. · 20062 recalls
  • K051115Sentinel Iron LiquidSentinel Ch. Srl · 2005
  • K033983Vitalab Iron ReagentClinical Data, Inc. · 2004
  • K030528Atac Iron Reagent, Atac Tibc Column Kit and Iron Calibrator (500 UG/DL)Clinical Data · 2003

https://510kreport.com/device/K944911 · printed Nov 6, 2026

Cite this page

510(k) Report. “K944911: Ace Iron Reagent.” Lineage record from FDA 510(k) data and the FDA summary. Updated Nov 3, 2026. Accessed Nov 6, 2026. https://510kreport.com/device/K944911

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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