510(k) Report

510(k) · Cleared

Cleared

Technicon RA Systems for Triglycerides Analysis in

K854152510(k) TraditionalCleared Nov 5, 198525-day reviewClass I21 CFR 862.1705

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

Technicon Instruments Corp. · CDT Lipase Hydrolysis/Glycerol Kinase Enzyme, Triglycerides

Cleared on Nov 5, 1985 after a 25-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
Nov 5, 1985
Review
25 days
Class
Class I
Product code
CDT
Recalls
None
Predicates
0

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

Descendants, by year cleared 2003: 1 descendant cleared2012: 1 descendant cleared2025: 1 descendant cleared1990200020102020
  1. This deviceK854152 Technicon RA Systems for Triglycerides Analysis inTechnicon Instruments Corp. · 1985
  2. Descendant · cites it directly · 2 of its ownK023639 Piccolo Triglycerides Test SystemAbaxis, Inc. · 2003
  3. Descendant · 2 generations on · 0 of its ownK251091 LipidsTruvian Health · 2025
  4. Descendant · 2 generations on · 0 of its ownK120664 Piccolo Trglycerides-Capillary Test SystemAbaxis, Inc. · 2012

Most influential descendants

Showing 3 of 3 · See all
  • K023639Piccolo Triglycerides Test SystemAbaxis, Inc. · 2003 · cites it directly2descendants
  • K251091LipidsTruvian Health · 2025 · 2 generations on0descendants
  • K120664Piccolo Trglycerides-Capillary Test SystemAbaxis, Inc. · 2012 · 2 generations on0descendants
View FIG. 1 as a table

Line of descent and top descendants

GenerationNumberDeviceApplicantDecidedRecalls
0 (this device)K854152Technicon RA Systems for Triglycerides Analysis inTechnicon Instruments Corp.1985—
+1K023639Piccolo Triglycerides Test SystemAbaxis, Inc.2003—
+2K251091LipidsTruvian Health2025—
+2K120664Piccolo Trglycerides-Capillary Test SystemAbaxis, Inc.2012—

Descendants by year cleared

Year clearedDevicesWith a Class I recall
200310
201210
202510
FIG. 1 — Lineage of K854152, 1985–2025Source: 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 CDT? 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)

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

NumberDeviceApplicantDecidedDescendants
K023639Piccolo Triglycerides Test SystemAbaxis, Inc.20032

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, K023639 (Abaxis, Inc., 2003) has gone furthest, with 2 descendants of its own.

How does its category compare?

All CDT devices

CDT Lipase Hydrolysis/Glycerol Kinase Enzyme, Triglycerides: FDA decisions, review times, recalls and adverse event reports over 20 years.

FDA decisions per year · CDT

1in 2015

2007: 12011: 12012: 12013: 22015: 1
2007high 2 (2013) · low 0 (2008)2026

2026 to Oct 25, outlined.

Median 510(k) review, days · CDT

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

Recalls per year · CDT

1in 2021

2009: 12014: 22016: 32018: 12021: 1
2007high 3 (2016) · low 0 (2007)2026

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

Adverse event reports per year · CDT

12in 2025

2010: 32011: 112012: 42013: 12015: 62016: 122017: 32018: 42019: 22020: 22022: 42023: 72024: 52025: 12
2007high 12 (2016) · low 0 (2007)2025

MAUDE reports naming product code CDT, 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
20071—00
20080—00
20090—10
20100—03
20111—011
20121—04
20132—01
20140—20
20151—06
20160—312
20170—03
20180—14
20190—02
20200—02
20210—10
20220—04
20230—07
20240—05
20250—012
20260—0—

More from Technicon Instruments Corp.

157 FDA decisions under this applicant name. See the company

  • K914888Technicon Chem 1(TM) Syst (GEN2 Syst)Technicon Instruments Corp. · 1991
  • K914511Technicon Axon (TM) System Methods Anyalye HDL CholTechnicon Instruments Corp. · 1991
  • K914025Technicon Axon (TM) Systems, Alt (P 5-P)/Ast (P 5-P)Technicon Instruments Corp. · 1991
  • K912616Technicon Immuno 1 TM System Additional AnalytesTechnicon Instruments Corp. · 1991
  • K912413Chem-Link Data Base ManagerTechnicon Instruments Corp. · 1991

Recent decisions in CDT

The CDT category page

  • K150819TriglyceridesRandox Laboratories Limited · 2015
  • K133067Advia Chemistry Triglycerides_2 (Trig_2) ReagentSiemens Healthcare Diagnostics, Inc. · 20133 recalls
  • K130332Vitros Chemistry Products Trig SlidesOrtho-Clinical Diagnostics, Inc. · 20132 recalls
  • K113830Vantera Clinical AnalyzerLiposcience · 2012
  • K102993Elitech Clinical Systems Triglycerides SL, Elitech Clinical Systems Cholesterol SLSeppim S.A.S. · 2011

https://510kreport.com/device/K854152 · printed Nov 5, 2026

Cite this page

510(k) Report. “K854152: Technicon RA Systems for Triglycerides Analysis in.” Lineage record from FDA 510(k) data and the FDA summary. Updated Nov 3, 2026. Accessed Nov 5, 2026. https://510kreport.com/device/K854152

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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