510(k) · Cleared
Recalled · Class II · 2021General Chemistries on Abx Pentra 400 Clinical Chemistry Analyzer
Data to Oct 25, 2026 (FDA decisions) Oct 12, 2026 (recalls) Sep 30, 2026 (MAUDE) refreshed weekly
Horiba Abx · CJE Nitrophenylphosphate, Alkaline Phosphatase Or Isoenzymes
Cleared on Jul 21, 2006 as substantially equivalent to K801242 (Roche Analytical Instruments, Inc., 1980) and 9 other predicates after a 176-day review. Its family tree reaches back 4 generations to 1984. 1 later device descends from it. It has been recalled 2 times.
- Decided
- Jul 21, 2006
- Review
- 176 days
- Class
- Class II
- Product code
- CJE
- Recalls
- 2
- Predicates
- 10
Its longest line of descent runs back 4 generations to K842280 (1984). 16 ancestors in all, the oldest K801242 (1980). 1 later device descends from it, 1 citing it directly.
- Root · 4 generations backK842280 TDX DigitoxinAbbott Laboratories · 1984
- 3 generations backK972250 Roche Cobas Integra Reagent Cassettes & Ancillary ReagentsRoche Diagnostic Systems, Inc. · 1997 · Recalled
- 2 generations backK980996 Cobas Integra Carbon Dioxide (CO2-S), Cobas Integra Glucose HK…Roche Diagnostic Systems, Inc. · 1998
- 1 generation backK031879 Cobas Integra Carbon Dioxide AssayRoche Diagnostics Corp. · 2003
- This deviceK060205 General Chemistries on Abx Pentra 400 Clinical Chemistry AnalyzerHoriba Abx · 2006
- Descendant · cites it directly · 0 of its ownK100263 Elitech Clinical Systems Phosphorus, Uric Acid Mono SL and Urea UV…Seppim S.A.S. · 2011
Most influential descendants
Showing 1 of 1 · See all- K100263Elitech Clinical Systems Phosphorus, Uric Acid Mono SL and Urea UV SL ReagentsSeppim S.A.S. · 2011 · cites it directly0descendants
View FIG. 1 as a table
Line of descent and top descendants
| Generation | Number | Device | Applicant | Decided | Recalls |
|---|---|---|---|---|---|
| −4 | K842280 | TDX Digitoxin | Abbott Laboratories | 1984 | — |
| −3 | K972250 | Roche Cobas Integra Reagent Cassettes & Ancillary Reagents | Roche Diagnostic Systems, Inc. | 1997 | 1 |
| −2 | K980996 | Cobas Integra Carbon Dioxide (CO2-S), Cobas Integra Glucose HK Liquid (Glulf) | Roche Diagnostic Systems, Inc. | 1998 | — |
| −1 | K031879 | Cobas Integra Carbon Dioxide Assay | Roche Diagnostics Corp. | 2003 | — |
| 0 (this device) | K060205 | General Chemistries on Abx Pentra 400 Clinical Chemistry Analyzer | Horiba Abx | 2006 | — |
| +1 | K100263 | Elitech Clinical Systems Phosphorus, Uric Acid Mono SL and Urea UV SL Reagents | Seppim S.A.S. | 2011 | — |
Other ancestors by year cleared
| Year cleared | Devices | With a Class I recall |
|---|---|---|
| 1980 | 1 | 0 |
| 1987 | 1 | 0 |
| 1988 | 2 | 0 |
| 1989 | 1 | 0 |
| 1990 | 1 | 0 |
| 1991 | 1 | 0 |
| 1992 | 1 | 0 |
| 1994 | 1 | 0 |
| 1995 | 2 | 0 |
| 1996 | 1 | 0 |
Descendants by year cleared
| Year cleared | Devices | With a Class I recall |
|---|---|---|
| 2011 | 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 CJE? 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 CJE device
- #1 K251074 Tru Liver Health Test Panelscore 10.8 · 2 generations · no Class I recall
- #2 Held for the reportin the report
- #3 Held for the reportin the report
What was it cleared against? (10)
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 |
|---|---|---|---|
| * | K801242 | Cobas Reagent for Alkaline PhosphataseSummary page 3…Substantially equivalent Submission device predicate device ABX PENTRA ALP CP K801242 ABX PENTRA Calcium CP K883453 ABX PENTRA C02 RTU K031879… | 1980 |
| * | K883453 | Roche Reagent for CalciumSummary page 3…Submission device predicate device ABX PENTRA ALP CP K801242 ABX PENTRA Calcium CP K883453 ABX PENTRA C02 RTU K031879 ABX PENTRA Creatinine CP K941837… | 1988 |
| * | K031879 | Cobas Integra Carbon Dioxide AssaySummary page 3…PENTRA ALP CP K801242 ABX PENTRA Calcium CP K883453 ABX PENTRA C02 RTU K031879 ABX PENTRA Creatinine CP K941837 ABX PENTRA Iron CP K864819… | 2003 |
| * | K941837 | Roche Reagent for CreatinineSummary page 3…PENTRA Calcium CP K883453 ABX PENTRA C02 RTU K031879 ABX PENTRA Creatinine CP K941837 ABX PENTRA Iron CP K864819 ABX PENTRA Magnesium RTU K901758… | 1994 |
| * | K864819 | Raichem (TM)Serum Iron and Tibc ReagentsSummary page 3…PENTRA C02 RTU K031879 ABX PENTRA Creatinine CP K941837 ABX PENTRA Iron CP K864819 ABX PENTRA Magnesium RTU K901758 ABX PENTRA Phosphorus CP K883962… | 1987 |
| * | K901758 | Roche Reagent for MagnesiumSummary page 3…PENTRA Creatinine CP K941837 ABX PENTRA Iron CP K864819 ABX PENTRA Magnesium RTU K901758 ABX PENTRA Phosphorus CP K883962 ABX PENTRA Urea CP K954000… | 1990 |
| * | K883962 | Roche Reagent for Inorganic PhosphorusSummary page 3…PENTRA Iron CP K864819 ABX PENTRA Magnesium RTU K901758 ABX PENTRA Phosphorus CP K883962 ABX PENTRA Urea CP K954000 ABX PENTRA Uric Acid CP K922762… | 1988 |
| * | K954000 | Roche Reagent for BunSummary page 3…PENTRA Magnesium RTU K901758 ABX PENTRA Phosphorus CP K883962 ABX PENTRA Urea CP K954000 ABX PENTRA Uric Acid CP K922762 ABX PENTRA C02 Cal K031879… | 1995 |
| * | K922762 | Roche Reagent for Uric Acid--ModificationSummary page 3…PENTRA Phosphorus CP K883962 ABX PENTRA Urea CP K954000 ABX PENTRA Uric Acid CP K922762 ABX PENTRA C02 Cal K031879 ABX PENTRA C02 Control K891475… | 1992 |
| * | K891475 | Lyphochek (R) Immunoassay Contr Serum (Human) 1,2,3Summary page 3…TRA Uric Acid CP K922762 ABX PENTRA C02 Cal K031879 ABX PENTRA C02 Control K891475 HORIBA ABX, FRANCE Section 5-3 Des… | 1989 |
What descends from it? (1)
1 later device cites it directly; ranked here by how many devices descend from each in turn.
| Number | Device | Decided | Descendants |
|---|---|---|---|
| K100263 | Elitech Clinical Systems Phosphorus, Uric Acid Mono SL and Urea UV SL Reagents | 2011 | 0 |
Has anything in its family been recalled? (0 Class I)
Recalls of this device
| Date | Class | Recall | Root cause | Reason |
|---|---|---|---|---|
| Oct 22, 2021 | Class II | Z-1140-2022 | Process control | Product was shipped from a Medline warehouse to a customer at room temperature instead of refrigerated (ice). If affected product is used, the results from this impacted Calcium reagent will not be provided due to probable Quality Control… |
| Aug 11, 2014 | Class II | Z-2692-2014 | Other | Horiba Medical is recalling the ABX PENTRA Magnesium RTU Reagent because the on-board stability claims has been updated. Horiba has updated the ABX PENTRA Magnesium RTU package inserts by removing the 7-day on-board stability claim and… |
No ancestor or descendant has a Class I recall.
What does this lineage say?
- The line of descent spans 22 years and passes through 4 companies; a new generation was cleared every 5.1 years on median.
- 2 of the 16 ancestors have a recall of any class.
- Of its descendants, K100263 (Seppim S.A.S., 2011) has gone furthest, with 0 descendants of its own.
How does its category compare?
All CJE devicesCJE Nitrophenylphosphate, Alkaline Phosphatase Or Isoenzymes: FDA decisions, review times, recalls and adverse event reports over 20 years.
FDA decisions per year · CJE
1in 2025
2026 to Oct 25, outlined.
Median 510(k) review, days · CJE
Too few CJE 510(k)s in any year since 2007 to give a median.
Recalls per year · CJE
1in 2013
Class I (0 since 2007) Class II/III not classified
Adverse event reports per year · CJE
10in 2025
MAUDE reports naming product code CJE, 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 | 0 | — | 0 | 0 |
| 2008 | 1 | — | 8 | 0 |
| 2009 | 0 | — | 0 | 0 |
| 2010 | 0 | — | 0 | 3 |
| 2011 | 2 | — | 1 | 24 |
| 2012 | 1 | — | 0 | 0 |
| 2013 | 2 | — | 1 | 0 |
| 2014 | 0 | — | 0 | 0 |
| 2015 | 0 | — | 0 | 0 |
| 2016 | 0 | — | 0 | 0 |
| 2017 | 2 | — | 0 | 0 |
| 2018 | 1 | — | 0 | 0 |
| 2019 | 1 | — | 0 | 1 |
| 2020 | 0 | — | 0 | 1 |
| 2021 | 0 | — | 0 | 1 |
| 2022 | 0 | — | 0 | 6 |
| 2023 | 1 | — | 0 | 11 |
| 2024 | 1 | — | 0 | 11 |
| 2025 | 1 | — | 0 | 10 |
| 2026 | 0 | — | 0 | — |
What is it indicated for?
General Chemistries reagents, with associated calibrators and controls, are intended for use on ABX PENTRA 400 Clinical Chemistry Analyzer to measure a variety of analytes. ABX PENTRA ALP CP reagent with associated calibrators and controls are for quantitative in vitro diagnostic determination of alkaline phosphatase in human serum and plasma based on a kinetic photometric test using p-Nitrophenylphosphate. Measurements of alkaline phosphatase or its…
Read the full statement (629 words)
General Chemistries reagents, with associated calibrators and controls, are intended for use on ABX PENTRA 400 Clinical Chemistry Analyzer to measure a variety of analytes.
ABX PENTRA ALP CP reagent with associated calibrators and controls are for quantitative in vitro diagnostic determination of alkaline phosphatase in human serum and plasma based on a kinetic photometric test using p-Nitrophenylphosphate. Measurements of alkaline phosphatase or its isoenzymes are used in the diagnosis and treatment of liver, bone, parathyroid, and intestinal diseases.
ABX PENTRA Calcium CP reagent with associated calibrators and controls are for quantitative in vitro diagnostic determination of calcium in human serum and plasma based on a photometric test using orthocresolphtalein complexone. Calcium measurements are used in the diagnosis and treatment of parathyroid disease, a variety of bone diseases, chronic renal disease and tetany (intermittent muscular contractions or spasms).
ABX PENTRA C02 RTU reagent with associated calibrators and controls are for quantitative in vitro diagnostic determination of carbon dioxide in human serum and plasma based on an enzymatic test using phosphoenolpyruvate (PEP), phosphorenolpyruvate carboxylase (PEPC) and an analog of NADH. Bicarbonate/carbon measurements are used in the diagnosis and treatment of numerous potentially serious disorders associated with changes in body acid-base balance.
ABX PENTRA Creatinine CP reagent with associated calibrators and controls are for quantitative in vitro diagnostic determination of creatinine in human serum and plasma based on a kinetic method using alkaline picrate (Jaff6 method). Creatinine measurements are used in the diagnosis and treatment of renal diseases, in monitoring renal dialysis, and as a calculation basis for measuring other urine analytes.
ABX PENTRA Iron OIP reagent with associated calibrators and controls are for quantitative in vitro diagnostic determination of iron (non-heme) in human serum and plasma based on a photometric test (Ferene method). Iron (non-heme) measurements are used in the diagnosis and treatment of diseases such as iron deficiency anemia and hemochromatosis.
ABX PENTRA Magnesium RTU reagent with associated calibrators and controls are for quantitative in vitro diagnostic determination of magnesium in human serum and plasma based on a photometric test using xylidyl blue. Magnesium measurements are used in the diagnosis and treatment of hypomagnesemnia (abnormally low plasma levels of magnesium) and hypermagnesemnia (abnormally high plasma levels of magnesium).
ABX PENTRA Phosphorus OP reagent with associated calibrators and controls are for quantitative in vitro diagnostic determination of phosphorus in human serum and plasma based on a UV method using phosphomolybdate. Measurement of phosphorus (inorganic) are used in the diagnosis and treatment of various disorders, including parathyroid gland and kidney diseases, and vitamin D imbalance.
ABX PENTRA Urea CR reagent with associated calibrators and controls are for quantitative in vitro diagnostic determination of urea / urea nitrogen (an end-product of nitrogen metabolism) in human serum and plasma based on an enzymatic UV test using urease and glutamate dehydrogenase. Measurements obtained by this device are used in the diagnosis and treatment of certain renal and metabolic diseases.
ABX PENTRA Uric Acid CR reagent with associated calibrators and controls are for quantitative in vitro diagnostic determination of uric acid in human serum and plasma based on the enzymatic determination of uric acid using a chromogenic system in the presence of peroxidase and uricase (Trinder method). Measurements obtained by this device are used in the diagnosis and treatment of numerous renal and metabolic disorders, including renal failure, gout, leukemia, psoriasis, starvation or other wasting conditions, and of patients receiving cytotoxic drugs.
The ABX PENTRA, CO2 Cal is a calibrator for use in the calibration of quantitative Horiba ABX PENTRA CO2 RTU method on Horiba ABX clinical chemistry analyzers as specified on the vial.
The ABX PENTRA CO 2 Control is for use in quality control by monitoring accuracy and precision for the quantitative ABX PENTRA CO2 RTU method as specified in the enclosed annex.
Indications for use as stated in the FDA summary.
https://510kreport.com/device/K060205 · printed Nov 6, 2026
Cite this page
510(k) Report. “K060205: General Chemistries on Abx Pentra 400 Clinical Chemistry Analyzer.” Lineage record from FDA 510(k) data and the FDA summary. Updated Nov 3, 2026. Accessed Nov 6, 2026. https://510kreport.com/device/K060205
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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