510(k) · Cleared
Recalled · Class II · 2017Abx Pentra 400 Clinical Chemistry Analyzer (Option: I.S.E. Module)
Data to Oct 25, 2026 (FDA decisions) Oct 12, 2026 (recalls) Sep 30, 2026 (MAUDE) refreshed weekly
Horiba Abx · CFR Hexokinase, Glucose
Cleared on Dec 16, 2005 as substantially equivalent to K920402 (Roche Diagnostic Systems, Inc., 1992) and 4 other predicates after a 144-day review. Its family tree reaches back 3 generations to 1994. 15 later devices descend from it. It has been recalled 6 times.
- Decided
- Dec 16, 2005
- Review
- 144 days
- Class
- Class II
- Product code
- CFR
- Recalls
- 6
- Predicates
- 5
Its longest line of descent runs back 3 generations to K933930 (1994). 12 ancestors in all, the oldest K801297 (1980). 15 later devices descend from it, 9 citing it directly.
- Root · 3 generations backK933930 Puritan-Bennett Companion 550 Liquid Oxygen Portable UnitPuritan Bennett Corp. · 1994
- 2 generations backK993220 Puritan-Bennett Helios Portable Liquid Oxygen SystemPuritan Bennett Corp. · 1999
- 1 generation backK041122 Precision Liquid Oxygen SystemPrecision Medical, Inc. · 2004 · Recalled
- This deviceK052007 Abx Pentra 400 Clinical Chemistry Analyzer (Option: I.S.E. Module)Horiba Abx · 2005
- Descendant · cites it directly · 3 of its ownK060854 Abx Pentra 400: LipoproteinsHoriba Abx · 2006 · Recalled
- Descendant · cites it directly · 2 of its ownK123171 Abx Pentra Calcium as CP, Abx Pentra Urine Control L/H, Abx Pentra…Horiba Abx Sas · 2013
- Descendant · cites it directly · 1 of its ownK110530 Abx Pentra Creatinine 120 CP; Abx Pentra Multical; Abx Pentra N…Horiba Abx Sas · 2012 · Recalled
- Descendant · cites it directly · 1 of its ownK110137 Abx Pentra Enzymatic Creatinine CP, Abx Pentra Multical, Abx Pentra…Horiba Abx Sas · 2011 · Recalled
- Descendant · 2 generations on · 0 of its ownK193649 Yumizen C1200 Creatinine PAPHoriba Abx Sas · 2021
Showing 5 of 15 descendants. See all descendants
Descendants cleared per year
Most influential descendants
Showing 5 of 15 · See all- K060854Abx Pentra 400: LipoproteinsHoriba Abx · 2006 · cites it directly3descendants
- K123171Abx Pentra Calcium as CP, Abx Pentra Urine Control L/H, Abx Pentra Multical, Abx Pentra…Horiba Abx Sas · 2013 · cites it directly2descendants
- K110530Abx Pentra Creatinine 120 CP; Abx Pentra Multical; Abx Pentra N Control; Abx Pentra P…Horiba Abx Sas · 2012 · cites it directly1descendant
- K110137Abx Pentra Enzymatic Creatinine CP, Abx Pentra Multical, Abx Pentra N Control, Abx…Horiba Abx Sas · 2011 · cites it directly1descendant
- K193649Yumizen C1200 Creatinine PAPHoriba Abx Sas · 2021 · 2 generations on0descendants
View FIG. 1 as a table
Line of descent and top descendants
| Generation | Number | Device | Applicant | Decided | Recalls |
|---|---|---|---|---|---|
| −3 | K933930 | Puritan-Bennett Companion 550 Liquid Oxygen Portable Unit | Puritan Bennett Corp. | 1994 | — |
| −2 | K993220 | Puritan-Bennett Helios Portable Liquid Oxygen System | Puritan Bennett Corp. | 1999 | — |
| −1 | K041122 | Precision Liquid Oxygen System | Precision Medical, Inc. | 2004 | 1 |
| 0 (this device) | K052007 | Abx Pentra 400 Clinical Chemistry Analyzer (Option: I.S.E. Module) | Horiba Abx | 2005 | — |
| +1 | K060854 | Abx Pentra 400: Lipoproteins | Horiba Abx | 2006 | 2 |
| +1 | K123171 | Abx Pentra Calcium as CP, Abx Pentra Urine Control L/H, Abx Pentra Multical… | Horiba Abx Sas | 2013 | — |
| +1 | K110530 | Abx Pentra Creatinine 120 CP; Abx Pentra Multical; Abx Pentra N Control; Abx… | Horiba Abx Sas | 2012 | 3 |
| +1 | K110137 | Abx Pentra Enzymatic Creatinine CP, Abx Pentra Multical, Abx Pentra N Control… | Horiba Abx Sas | 2011 | 2 |
| +2 | K193649 | Yumizen C1200 Creatinine PAP | Horiba Abx Sas | 2021 | — |
Other ancestors by year cleared
| Year cleared | Devices | With a Class I recall |
|---|---|---|
| 1980 | 1 | 0 |
| 1991 | 3 | 0 |
| 1992 | 1 | 0 |
| 1993 | 1 | 0 |
| 1996 | 1 | 0 |
| 1999 | 1 | 0 |
| 2003 | 1 | 0 |
Descendants by year cleared
| Year cleared | Devices | With a Class I recall |
|---|---|---|
| 2006 | 2 | 0 |
| 2007 | 2 | 0 |
| 2010 | 1 | 0 |
| 2011 | 5 | 0 |
| 2012 | 1 | 0 |
| 2013 | 1 | 0 |
| 2015 | 1 | 0 |
| 2019 | 1 | 0 |
| 2021 | 1 | 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 CFR? A 510(k) Report weighs predicate choices, recall history and review times for a new device like this one.
Top candidate predicates for a new CFR device
- #1 K253490 Glucose HK Gen.3; ONLINE DAT Methadone II…score 11.4 · 3 generations · no Class I recall
- #2 Held for the reportin the report
- #3 Held for the reportin the report
What was it cleared against? (5)
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.
| Type | Number | Device | Decided |
|---|---|---|---|
| * | K920402 | Roche Cobas Mira PlusSummary page 3…vice developed by HoribaABX. It has been demonstrated that the ABX PENTRA 400 can be considered substantially equivalent to the predicate device Roche Cobas Mira Plus (K920402). HORIBA ABX, FRANCE Section 6-3 The… | 1992 |
| * | K963627 | (Modified Version) Integra Ion Selective Electrode (Ise) ModuleSummary page 4…, FRANCE Section 6-3 The optional ISE module has been similarly demonstrated as being substantially equivalent to K963627; the Roche Ion Selective Electrode. Whilst the ABX PENTRA Glucose HK CP, and ABX PENTRA Glucose PAP CP have been demonstrated sub… | 1996 |
| * | K801297 | Cobas Reagent for Glucose RapidSummary page 4…lent to K963627; the Roche Ion Selective Electrode. Whilst the ABX PENTRA Glucose HK CP, and ABX PENTRA Glucose PAP CP have been demonstrated substantially equivalent to K801297; the Cobas Reagent for Glucose Rapid (K801297). ABX PENTRA Multical, ABX PENTRA N Control and ABX PENTRA P Control… | 1980 |
| * | K033501 | Modification to Calibrator for Automatic Systems (Cfas)Summary page 4…apid (K801297). ABX PENTRA Multical, ABX PENTRA N Control and ABX PENTRA P Control have been respectively demonstrated as being substantially equivalent to K033501, Roche Calibrator for Automated Systems and K0411227, Roche Precinorm U and Roche Precipath U. Description: The ABX PENTRA 400… | 2003 |
| * | K041122 | Precision Liquid Oxygen SystemSummary page 4…ntrol and ABX PENTRA P Control have been respectively demonstrated as being substantially equivalent to K033501, Roche Calibrator for Automated Systems and K0411227, Roche Precinorm U and Roche Precipath U. Description: The ABX PENTRA 400 is a benchtop clinical chemistry analyzer using two… | 2004 |
What descends from it? (15)
See all 159 later devices cite it directly; ranked here by how many devices descend from each in turn.
| Number | Device | Decided | Descendants |
|---|---|---|---|
| K060854 | Abx Pentra 400: Lipoproteins | 2006 | 3 |
| K123171 | Abx Pentra Calcium as CP, Abx Pentra Urine Control L/H, Abx Pentra Multical, Abx Pentra… | 2013 | 2 |
| K110530 | Abx Pentra Creatinine 120 CP; Abx Pentra Multical; Abx Pentra N Control; Abx Pentra P… | 2012 | 1 |
| K110137 | Abx Pentra Enzymatic Creatinine CP, Abx Pentra Multical, Abx Pentra N Control, Abx… | 2011 | 1 |
| K103788 | Pentra C200, Ise Module and Abx Pentra Glucose HK CP Reagent | 2011 | 0 |
| K102647 | Elitech Clinical Systems Selectra Prom/Elical 2/Elitrol I and Elitrol II/Ast/Got 4+1… | 2011 | 0 |
| K100525 | Elitech Clinical Systems Glucose Pap SL Elitech Clinical Systems Elical 2, Elitech… | 2010 | 0 |
| K072115 | Abx Pentra Creatinine 120 CP, Total Protein 100 CP, Multical, N and P Controls, and… | 2007 | 0 |
| K062180 | Abx Pentra Amylase CP; Multical; N Control; P Control; Clean-Chem CP; Clean-Chem 99 CP | 2006 | 0 |
Has anything in its family been recalled? (0 Class I)
Recalls of this device
| Date | Class | Recall | Root cause | Reason |
|---|---|---|---|---|
| Nov 21, 2017 | Class II | Z-0494-2018 | Process control | The ABX PENTRA Reagent Containers do not always sit properly into the reagent rack. In low reagent level scenarios, this could lead to insufficient reagent volume being pipetted and could lead to incorrect results being reported without… |
| Nov 21, 2017 | Class II | Z-0493-2018 | Process control | The ABX PENTRA Reagent Containers do not always sit properly into the reagent rack. In low reagent level scenarios, this could lead to insufficient reagent volume being pipetted and could lead to incorrect results being reported without… |
| Jan 11, 2016 | Class II | Z-0740-2016 | 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… |
| Nov 13, 2014 | Class II | Z-0902-2015 | Package design/selection | HORIBA Medical is recalling the ABX PENTRA 400 Reagent Container because they do not always sit properly into the reagent rack. In low reagent level scenarios, this could lead to insufficient reagent volume being pipetted and could lead… |
| Nov 21, 2013 | Class II | Z-0904-2014 | Under Investigation by firm | Horiba Medical is recalling the ABX PENTRA N Control because it has been updated to include a revised Target Value assignment for Potassium. |
| Mar 20, 2013 | Class II | Z-1141-2013 | Software design | HORIBA Medical is informing all ABX PENTRA 400 Analyzer with I.S.E. Module customers that there are no Linearity Limit Flags for the I.S.E. assays currently programmed into the ABX PENTRA 400 Analyzer software. All other assays run on… |
The 5 latest of 6 recalls; the web page lists all.
No ancestor or descendant has a Class I recall.
What does this lineage say?
- The line of descent spans 11 years and passes through 3 companies; a new generation was cleared every 5.0 years on median.
- 2 of the 12 ancestors have a recall of any class.
- Of its descendants, K060854 (Horiba Abx, 2006) has gone furthest, with 3 descendants of its own.
- 1 other device also cites its predicate K920402.
How does its category compare?
All CFR devicesCFR Hexokinase, Glucose: FDA decisions, review times, recalls and adverse event reports over 20 years.
FDA decisions per year · CFR
1in 2025
2026 to Oct 25, outlined.
Median 510(k) review, days · CFR
115in 2012
Receipt to decision; years with fewer than 3 clearances left blank.
Recalls per year · CFR
1in 2016
Class I (0 since 2007) Class II/III not classified
Adverse event reports per year · CFR
16in 2025
MAUDE reports naming product code CFR, 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 | 1 | — | 0 | 1 |
| 2008 | 5 | 182 | 7 | 2 |
| 2009 | 3 | 101 | 1 | 7 |
| 2010 | 0 | — | 0 | 11 |
| 2011 | 3 | 316 | 0 | 43 |
| 2012 | 4 | 115 | 1 | 49 |
| 2013 | 1 | — | 0 | 36 |
| 2014 | 1 | — | 1 | 2 |
| 2015 | 0 | — | 0 | 3 |
| 2016 | 2 | — | 1 | 1 |
| 2017 | 1 | — | 0 | 13 |
| 2018 | 0 | — | 0 | 8 |
| 2019 | 1 | — | 0 | 10 |
| 2020 | 0 | — | 0 | 4 |
| 2021 | 0 | — | 0 | 5 |
| 2022 | 1 | — | 0 | 3 |
| 2023 | 0 | — | 0 | 29 |
| 2024 | 0 | — | 0 | 15 |
| 2025 | 1 | — | 0 | 16 |
| 2026 | 1 | — | 0 | — |
What is it indicated for?
The ABX PENTRA 400 is a discrete photometric benchtop chemistry analyzer for clinical use. The device is intended to duplicate manual analytical procedures by performing various steps such as pipetting, mixing, heating and measuring color intensity. The device is intended for use in conjunction with certain materials to measure a variety of analytes. ABX PENTRA Glucose HK CP, Glucose PAP CP reagents with associated calibrators and controls are for…
Read the full statement (245 words)
The ABX PENTRA 400 is a discrete photometric benchtop chemistry analyzer for clinical use.
The device is intended to duplicate manual analytical procedures by performing various steps such as pipetting, mixing, heating and measuring color intensity.
The device is intended for use in conjunction with certain materials to measure a variety of analytes.
ABX PENTRA Glucose HK CP, Glucose PAP CP reagents with associated calibrators and controls are for quantitative in vitro diagnostic determination of glucose in serum and plasma using glucose hexokinase and glucose oxidase methods by colorimetry.
Glucose measurements are used in the diagnosis and treatment of carbohydrate metabolism disorders including diabetes mellitus, neonatal hypoglycemia, idiopathic hypoglycemia, and of pancreatic islet cell carcinoma.
The option of an I.S.E. (Ion Selective Electrode) module is intended for the quantitative determination of Sodium, Chloride, and Potassium by potentiometry using ion selective electrode with associated reference solution, calibrators and controls. Measurement of Sodium, Chloride, and Potassium are used in diagnosis and treatment diseases involving electrolyte imbalance.
The ABX PENTRA Multical is a calibrator for use in the calibration of quantitative Horiba ABX methods on Horiba ABX clinical chemistry analyzers as specified in the enclosed annex.
The ABX PENTRA N Control is for use in quality control by monitoring accuracy and precision for the quantitative methods as specified in the enclosed annex.
The ABX PENTRA P Control is for use in quality control by monitoring accuracy and precision for the quantitative methods as specified in the enclosed annex.
Indications for use as stated in the FDA summary.
https://510kreport.com/device/K052007 · printed Nov 3, 2026
Cite this page
510(k) Report. “K052007: Abx Pentra 400 Clinical Chemistry Analyzer (Option: I.S.E. Module).” Lineage record from FDA 510(k) data and the FDA summary. Updated Nov 3, 2026. Accessed Nov 3, 2026. https://510kreport.com/device/K052007
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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