510(k) Report

510(k) · Cleared

Cleared

Irma Trupoint Creatinine Control Kit

K050983510(k) TraditionalCleared May 16, 200527-day reviewClass I21 CFR 862.1660

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

International Technidyne Corporation · JJX Single (Specified) Analyte Controls (Assayed And Unassayed)

Cleared on May 16, 2005 as substantially equivalent to K943754 (Bionostics, Inc., 1994) and 1 other predicate after a 27-day review. Its family tree reaches back 1 generation to 1994.

Decided
May 16, 2005
Review
27 days
Class
Class I
Product code
JJX
Recalls
None
Predicates
2

Its longest line of descent runs back 1 generation to K943754 (1994). 2 ancestors in all. No later device cites it as a predicate yet.

Other ancestors, by year cleared 2003: 1 other ancestorK943754 · Blood Gads, Electrolyte, Glucose, Latate and Bun Quality Control Product · Bionostics, Inc. · 19941990199520002005
Other ancestors, by generation 1 generation back: 1 other ancestor K943754 · Blood Gads, Electrolyte, Glucose, Latate and Bun Quality Control Product · Bionostics, Inc. · 19940
  1. Root · 1 generation backK943754 Blood Gads, Electrolyte, Glucose, Latate and Bun Quality Control…Bionostics, Inc. · 1994
  2. This deviceK050983 Irma Trupoint Creatinine Control KitInternational Technidyne Corporation · 2005
View FIG. 1 as a table

Line of descent and top descendants

GenerationNumberDeviceApplicantDecidedRecalls
−1K943754Blood Gads, Electrolyte, Glucose, Latate and Bun Quality Control ProductBionostics, Inc.1994—
0 (this device)K050983Irma Trupoint Creatinine Control KitInternational Technidyne Corporation2005—

Other ancestors by year cleared

Year clearedDevicesWith a Class I recall
200310
FIG. 1 — Lineage of K050983, 1994–2005Source: 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 JJX? 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? (2)

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
*K943754Blood Gads, Electrolyte, Glucose, Latate and Bun Quality Control Product
Summary page 1
…anel: Chemistry Product Code: 75JJX Predicate Device Substantial equivalence is claimed to the currently marketed Bionostics Inc. RNA 823 Controls (K943754) and Medical Analysis Systems' Moni-Trol H Controls (K030942). Description of Device The Creatinine Control Kit includes creatin…
Bionostics, Inc.1994—
*K030942Mas Chemtrak H & Dade Moni-Trol H Liquid Assayed Chemistry Control
Summary page 1
…dicate Device Substantial equivalence is claimed to the currently marketed Bionostics Inc. RNA 823 Controls (K943754) and Medical Analysis Systems' Moni-Trol H Controls (K030942). Description of Device The Creatinine Control Kit includes creatinine control materials at two levels for monitoring the IRMA a…
Medical Analysis Systems, Inc.2003—

Also cleared against K943754: 1 other device →

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?

  • None of the 2 ancestors has a recall.
  • 1 other device also cites its predicate K943754.

How does its category compare?

All JJX devices

JJX Single (Specified) Analyte Controls (Assayed And Unassayed): FDA decisions, review times, recalls and adverse event reports over 20 years.

FDA decisions per year · JJX

2in 2017

2007: 62008: 82009: 172010: 242011: 192012: 152013: 192014: 222015: 112016: 62017: 2
2007high 24 (2010) · low 0 (2018)2026

2026 to Oct 25, outlined.

Median 510(k) review, days · JJX

31in 2016

2007: 53 days median2008: 52 days median2009: 80 days median2010: 80 days median2011: 62 days median2012: 40 days median2013: 37 days median2014: 30 days median2015: 65 days median2016: 31 days median
2007high 80 (2009) · low 30 (2014)2026

Receipt to decision; years with fewer than 3 clearances left blank.

Recalls per year · JJX

1in 2021

2007: 32008: 32010: 32011: 22014: 12015: 12016: 22018: 22021: 1
2007high 3 (2007) · low 0 (2009)2026

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

Adverse event reports per year · JJX

22in 2025

2007: 22009: 12010: 62011: 622012: 322013: 512014: 482015: 672016: 372017: 192018: 352019: 822020: 772021: 432022: 242023: 222024: 302025: 22
2007high 82 (2019) · low 0 (2008)2025

MAUDE reports naming product code JJX, 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
200765332
200885230
2009178001
2010248036
20111962262
20121540032
20131937051
20142230148
20151165167
2016631237
20172—019
20180—235
20190—082
20200—077
20210—143
20220—024
20230—022
20240—030
20250—022
20260—0—

What is it indicated for?

The IRMA TRUpoint TM Creatinine Control Kit is for use on the IRMA TRUpoint TM Blood Analysis System to perform Quality Control assays for Creatinine on the IRMA TRUpoint TM Blood Analysis System.

Indications for use as stated in the FDA summary.

Also cleared against K943754

1 other device cites the same predicate.

  • K151978EDAN i15 Blood Gas and Chemistry Analysis System, EDAN i15 Calibrant Fluid Pack, EDAN i15 Blood Gas and…Edan Instruments, Inc. · 2016

Recent decisions in JJX

The JJX category page

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  • K162514Multichem A1cTechnopath Manufacturing · 2016
  • K161874Audit MicroControls Linearity DROP LQ Blood GlucoseAalto Scientific, Ltd. · 2016
  • K161522LIAISON EBV IgM Serum Control SetDiaSorin, Inc. · 2016

https://510kreport.com/device/K050983 · printed Nov 6, 2026

Cite this page

510(k) Report. “K050983: Irma Trupoint Creatinine Control Kit.” Lineage record from FDA 510(k) data and the FDA summary. Updated Nov 3, 2026. Accessed Nov 6, 2026. https://510kreport.com/device/K050983

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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