510(k) · Cleared
Recalled · Class II · 2016Abx Pentra 400: Lipoproteins
Data to Oct 25, 2026 (FDA decisions) Oct 12, 2026 (recalls) Sep 30, 2026 (MAUDE) refreshed weekly
Horiba Abx · JIT Calibrator, Secondary
Cleared on Aug 24, 2006 as substantially equivalent to K941573 (Roche Diagnostic Systems, Inc., 1994) and 4 other predicates after a 148-day review. Its family tree reaches back 4 generations to 1994. 3 later devices descend from it. It has been recalled 2 times.
- Decided
- Aug 24, 2006
- Review
- 148 days
- Class
- Class II
- Product code
- JIT
- Recalls
- 2
- Predicates
- 6
Its longest line of descent runs back 4 generations to K933930 (1994). 17 ancestors in all, the oldest K801297 (1980). 3 later devices descend from it, 3 citing it directly.
- Root · 4 generations backK933930 Puritan-Bennett Companion 550 Liquid Oxygen Portable UnitPuritan Bennett Corp. · 1994
- 3 generations backK993220 Puritan-Bennett Helios Portable Liquid Oxygen SystemPuritan Bennett Corp. · 1999
- 2 generations backK041122 Precision Liquid Oxygen SystemPrecision Medical, Inc. · 2004 · Recalled
- 1 generation backK052007 Abx Pentra 400 Clinical Chemistry Analyzer (Option: I.S.E. Module)Horiba Abx · 2005 · Recalled
- This deviceK060854 Abx Pentra 400: LipoproteinsHoriba Abx · 2006
- Descendant · cites it directly · 0 of its ownK103747 Elitech Clincal Systems Cholesterol HDL SL 2G, HDL 2G Calibrator…Elitechgroup Seppim S.A.S. · 2011
- Descendant · cites it directly · 0 of its ownK102993 Elitech Clinical Systems Triglycerides SL, Elitech Clinical Systems…Seppim S.A.S. · 2011
- Descendant · cites it directly · 0 of its ownK062737 Cardiac Markers on Abx Pentra 400 Clinical Chemistry AnalyzerHoriba Abx · 2007
Most influential descendants
Showing 3 of 3 · See all- K103747Elitech Clincal Systems Cholesterol HDL SL 2G, HDL 2G Calibrator, LDL SL 2G, LDL 2G…Elitechgroup Seppim S.A.S. · 2011 · cites it directly0descendants
- K102993Elitech Clinical Systems Triglycerides SL, Elitech Clinical Systems Cholesterol SLSeppim S.A.S. · 2011 · cites it directly0descendants
- K062737Cardiac Markers on Abx Pentra 400 Clinical Chemistry AnalyzerHoriba Abx · 2007 · cites it directly0descendants
View FIG. 1 as a table
Line of descent and top descendants
| Generation | Number | Device | Applicant | Decided | Recalls |
|---|---|---|---|---|---|
| −4 | K933930 | Puritan-Bennett Companion 550 Liquid Oxygen Portable Unit | Puritan Bennett Corp. | 1994 | — |
| −3 | K993220 | Puritan-Bennett Helios Portable Liquid Oxygen System | Puritan Bennett Corp. | 1999 | — |
| −2 | K041122 | Precision Liquid Oxygen System | Precision Medical, Inc. | 2004 | 1 |
| −1 | K052007 | Abx Pentra 400 Clinical Chemistry Analyzer (Option: I.S.E. Module) | Horiba Abx | 2005 | 6 |
| 0 (this device) | K060854 | Abx Pentra 400: Lipoproteins | Horiba Abx | 2006 | — |
| +1 | K103747 | Elitech Clincal Systems Cholesterol HDL SL 2G, HDL 2G Calibrator, LDL SL 2G… | Elitechgroup Seppim S.A.S. | 2011 | — |
| +1 | K102993 | Elitech Clinical Systems Triglycerides SL, Elitech Clinical Systems… | Seppim S.A.S. | 2011 | — |
| +1 | K062737 | Cardiac Markers on Abx Pentra 400 Clinical Chemistry Analyzer | Horiba Abx | 2007 | — |
Other ancestors by year cleared
| Year cleared | Devices | With a Class I recall |
|---|---|---|
| 1980 | 1 | 0 |
| 1989 | 1 | 0 |
| 1991 | 3 | 0 |
| 1992 | 1 | 0 |
| 1993 | 1 | 0 |
| 1994 | 1 | 0 |
| 1996 | 1 | 0 |
| 1997 | 1 | 0 |
| 1999 | 1 | 0 |
| 2002 | 1 | 0 |
| 2003 | 1 | 0 |
Descendants by year cleared
| Year cleared | Devices | With a Class I recall |
|---|---|---|
| 2007 | 1 | 0 |
| 2011 | 2 | 0 |
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 JIT? 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
What was it cleared against? (6)
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; numbers the summary cites that cannot be its predicate are marked – and kept off the family tree.
| Type | Number | Device | Decided |
|---|---|---|---|
| * | K941573 | Roche ReagentSummary page 3…Substantially equivalent Submission device Predicate device ABX PENTRA Cholesterol CP K941573 ABX PENTRA HDL Direct CP K021316 ABX PENTRA LDL Direct CP K971573… | 1994 |
| * | K021316 | Ultra N-Geneous HDL Cholesterol Reagent 1/REAGENT2; Ultra N-Geneous HDL Cholestreol…Summary page 3…bmission device Predicate device ABX PENTRA Cholesterol CP K941573 ABX PENTRA HDL Direct CP K021316 ABX PENTRA LDL Direct CP K971573 ABX PENTRA Triglycerides CP K893973… | 2002 |
| * | K971573 | N-Geneous LDL Cholesterol Reagent, N-Geneous LDL Cholesterol Calibrator, Genzyme LDL…Summary page 3…PENTRA Cholesterol CP K941573 ABX PENTRA HDL Direct CP K021316 ABX PENTRA LDL Direct CP K971573 ABX PENTRA Triglycerides CP K893973 ABX PENTRA HDL Cal K021316… | 1997 |
| * | K893973 | Roche Reagent for TriglyceridesSummary page 3…PENTRA HDL Direct CP K021316 ABX PENTRA LDL Direct CP K971573 ABX PENTRA Triglycerides CP K893973 ABX PENTRA HDL Cal K021316 ABX PENTRA LDL Cal K91573 ABX PENT… | 1989 |
| Kept off the family tree | K091573 | ABX PENTRA LDL Cal Not matched in our reading of the summary (scans can blur digits), so it is kept off the family tree | |
| * | K052007 | Abx Pentra 400 Clinical Chemistry Analyzer (Option: I.S.E. Module)Summary page 1…Date Prepared: 10 July 2006 Device Names: The following reagents, controls & calibrators are for use in conjunction with the ABX PENTRA 400, cleared to market under K052007. REAGENTS: Trade/Proprietary Name: ABX PENTRA Cholesterol CP Common or Usual Name: Cholesterol Device Class… | 2005 |
What descends from it? (3)
3 later devices cite it directly; ranked here by how many devices descend from each in turn.
Has anything in its family been recalled? (0 Class I)
Recalls of this device
| Date | Class | Recall | Root cause | Reason |
|---|---|---|---|---|
| Jan 11, 2016 | Class II | Z-0742-2016 | Under Investigation by firm | N-Acetylcysteine (NAC) present in the blood of patients treated for paracetamol overdose can interfere with the Trinder reaction that uses hydrogen peroxide catalytic on aminoantipyrine and phenol, and can produce falsely low results with… |
| Jan 11, 2016 | Class II | Z-0738-2016 | Under Investigation by firm | N-Acetylcysteine (NAC) present in the blood of patients treated for paracetamol overdose can interfere with the Trinder reaction that uses hydrogen peroxide catalytic on aminoantipyrine and phenol, and can produce falsely low results with… |
No ancestor or descendant has a Class I recall.
What does this lineage say?
- The line of descent spans 12 years and passes through 3 companies; a new generation was cleared every 5.0 years on median.
- 3 of the 17 ancestors have a recall of any class.
- Of its descendants, K103747 (Elitechgroup Seppim S.A.S., 2011) has gone furthest, with 0 descendants of its own.
How does its category compare?
All JIT devicesJIT Calibrator, Secondary: FDA decisions, review times, recalls and adverse event reports over 20 years.
FDA decisions per year · JIT
7in 2017
2026 to Oct 25, outlined.
Median 510(k) review, days · JIT
28in 2017
Receipt to decision; years with fewer than 3 clearances left blank.
Recalls per year · JIT
1in 2023
Class I (0 since 2007) Class II/III not classified
Adverse event reports per year · JIT
7in 2025
MAUDE reports naming product code JIT, not matched to any one device; reports are not rates.
View these four charts as a table
| Year | Decisions | Median 510(k) review, days | Recalls (Class I) | MAUDE reports |
|---|---|---|---|---|
| 2007 | 5 | 78 | 1 | 0 |
| 2008 | 6 | 46 | 0 | 0 |
| 2009 | 2 | — | 2 | 0 |
| 2010 | 6 | 65 | 0 | 3 |
| 2011 | 7 | 48 | 3 | 2 |
| 2012 | 2 | — | 3 | 10 |
| 2013 | 5 | 140 | 0 | 43 |
| 2014 | 10 | 33 | 2 | 9 |
| 2015 | 4 | 30 | 1 | 6 |
| 2016 | 4 | 33 | 0 | 3 |
| 2017 | 7 | 28 | 0 | 7 |
| 2018 | 0 | — | 5 | 8 |
| 2019 | 0 | — | 0 | 215 |
| 2020 | 0 | — | 2 | 12 |
| 2021 | 0 | — | 0 | 3 |
| 2022 | 0 | — | 0 | 4 |
| 2023 | 0 | — | 1 | 6 |
| 2024 | 0 | — | 0 | 17 |
| 2025 | 0 | — | 0 | 7 |
| 2026 | 0 | — | 1 | — |
What is it indicated for?
ABX PENTRA Cholesterol CP reagent with associated calibrators and controls are for quantitative in vitro diagnostic determination of cholesterol in human serum and plasma based on an enzymatic photometric test (Trinder's reaction). ABX PENTRA HDL Direct CP reagent with associated calibrators and controls are for quantitative in vitro diagnostic determination of High Density Lipoprotein Cholesterol (HDL-C) in human serum and plasma based on an enzymatic…
Read the full statement (244 words)
ABX PENTRA Cholesterol CP reagent with associated calibrators and controls are for quantitative in vitro diagnostic determination of cholesterol in human serum and plasma based on an enzymatic photometric test (Trinder's reaction).
ABX PENTRA HDL Direct CP reagent with associated calibrators and controls are for quantitative in vitro diagnostic determination of High Density Lipoprotein Cholesterol (HDL-C) in human serum and plasma based on an enzymatic assay with accelerator selective detergent methodology.
ABX PENTRA LDL Direct CP reagent with associated calibrators and controls are for quantitative in vitro diagnostic determination of Low Density Lipoprotein Cholesterol (LDL-C) in human serum and plasma based on an enzymatic colorimetric assay.
Cholesterol measurements are used in the diagnosis and treatment of disorders involving excess cholesterol in the blood and lipid and lipoprotein metabolism disorders.
ABX PENTRA Triglycerides CP reagent with associated calibrators and controls are for quantitative in vitro diagnostic determination of triglycerides in human serum and plasma based on an enzymatic calorimetric assay.
Measurements obtained by this device are used in the diagnosis and treatment of patients with diabetes mellitus, nephrosis, liver obstruction, other diseases involving lipid metabolism, or various endocrine disorders.
The ABX PENTRA HDL Cal is a calibrator for use in the calibration of quantitative Horiba ABX PENTRA HDL Direct CP method on Horiba ABX clinical chemistry analyzers.
The ABX PENTRA LDL Cal is a calibrator for use in the calibration of quantitative Horiba ABX PENTRA LDL Direct CP method on Horiba ABX clinical chemistry analyzers.
Indications for use as stated in the FDA summary.
https://510kreport.com/device/K060854 · printed Nov 6, 2026
Cite this page
510(k) Report. “K060854: Abx Pentra 400: Lipoproteins.” Lineage record from FDA 510(k) data and the FDA summary. Updated Nov 3, 2026. Accessed Nov 6, 2026. https://510kreport.com/device/K060854
Report an extraction error
Are you the manufacturer?
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