510(k) · Cleared
ClearedCardiac Markers 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 · CGS Nad Reduction/Nadh Oxidation, Cpk Or Isoenzymes
Cleared on Jun 12, 2007 as substantially equivalent to K834502 (Roche Diagnostic Systems, Inc., 1984) and 4 other predicates after a 272-day review. Its family tree reaches back 5 generations to 1994.
- Decided
- Jun 12, 2007
- Review
- 272 days
- Class
- Class II
- Product code
- CGS
- Recalls
- None
- Predicates
- 5
Its longest line of descent runs back 5 generations to K933930 (1994). 23 ancestors in all, the oldest K801297 (1980). No later device cites it as a predicate yet.
- Root · 5 generations backK933930 Puritan-Bennett Companion 550 Liquid Oxygen Portable UnitPuritan Bennett Corp. · 1994
- 4 generations backK993220 Puritan-Bennett Helios Portable Liquid Oxygen SystemPuritan Bennett Corp. · 1999
- 3 generations backK041122 Precision Liquid Oxygen SystemPrecision Medical, Inc. · 2004 · Recalled
- 2 generations backK052007 Abx Pentra 400 Clinical Chemistry Analyzer (Option: I.S.E. Module)Horiba Abx · 2005 · Recalled
- 1 generation backK060854 Abx Pentra 400: LipoproteinsHoriba Abx · 2006 · Recalled
- This deviceK062737 Cardiac Markers on Abx Pentra 400 Clinical Chemistry AnalyzerHoriba Abx · 2007
View FIG. 1 as a table
Line of descent and top descendants
| Generation | Number | Device | Applicant | Decided | Recalls |
|---|---|---|---|---|---|
| −5 | K933930 | Puritan-Bennett Companion 550 Liquid Oxygen Portable Unit | Puritan Bennett Corp. | 1994 | — |
| −4 | K993220 | Puritan-Bennett Helios Portable Liquid Oxygen System | Puritan Bennett Corp. | 1999 | — |
| −3 | K041122 | Precision Liquid Oxygen System | Precision Medical, Inc. | 2004 | 1 |
| −2 | K052007 | Abx Pentra 400 Clinical Chemistry Analyzer (Option: I.S.E. Module) | Horiba Abx | 2005 | 6 |
| −1 | K060854 | Abx Pentra 400: Lipoproteins | Horiba Abx | 2006 | 2 |
| 0 (this device) | 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 |
| 1984 | 1 | 0 |
| 1989 | 1 | 0 |
| 1991 | 3 | 0 |
| 1992 | 1 | 0 |
| 1993 | 1 | 0 |
| 1994 | 1 | 0 |
| 1995 | 1 | 0 |
| 1996 | 2 | 0 |
| 1997 | 1 | 0 |
| 1999 | 1 | 0 |
| 2000 | 1 | 0 |
| 2002 | 2 | 0 |
| 2003 | 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 CGS? 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 CGS device
- #1 K191296 Pointe Scientific Creatinine Kinase (CK)…score -0.2 · 1 generation · no Class I recall
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 |
|---|---|---|---|
| * | K834502 | CK-Nac ReagentSummary page 3…Substantially equivalent Submission device Predicate device ABX PENTRA CK NAC CP K834502 ABX PENTRA Myoglobin CP K021229 ABX PENTRA Myoglobin Cal K021229… | 1984 |
| * | K021229 | Myoglobin and Myoglobin Calibrators on the Access Immunoassay Systems, Model 973243…Summary page 3…bmission device Predicate device ABX PENTRA CK NAC CP K834502 ABX PENTRA Myoglobin CP K021229 ABX PENTRA Myoglobin Cal K021229 ABX PENTRA Multical K060854… | 2002 |
| * | K060854 | Abx Pentra 400: LipoproteinsSummary page 2…Class II Classification Name: §862.1150 : Calibrator Product Code: JIT; Calibrator, Secondary Trade/Proprietary Name: ABX PENTRA Multical (K060854) Common or Usual Name: Multical Device Class Class II Classification Name: §862.1150 : Calibrator Product C… | 2006 |
| * | K954074 | Aalto Scientific Liquid Cardiac ControlSummary page 3…TRA Myoglobin Cal K021229 ABX PENTRA Multical K060854 ABX PENTRA CK Control K954074 ABX PENTRA Immuno II Control K961828 L/H ABX PENTRA N Control K0… | 1995 |
| * | K961828 | Liquichek Cardiac Markers Control (Cat. NO. 685,686,687,688)Summary page 3…TRA Multical K060854 ABX PENTRA CK Control K954074 ABX PENTRA Immuno II Control K961828 L/H ABX PENTRA N Control K060854 ABX PENTRA P Control K0… | 1996 |
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?
- The line of descent spans 13 years and passes through 3 companies; a new generation was cleared every 1.2 years on median.
- 5 of the 23 ancestors have a recall of any class.
- 3 other devices also cite its predicate K834502.
How does its category compare?
All CGS devicesCGS Nad Reduction/Nadh Oxidation, Cpk Or Isoenzymes: FDA decisions, review times, recalls and adverse event reports over 20 years. 2007, this device’s year, is highlighted.
FDA decisions per year · CGS
1in 2020
2026 to Oct 25, outlined.
Median 510(k) review, days · CGS
Too few CGS 510(k)s in any year since 2007 to give a median.
Recalls per year · CGS
1in 2025
Class I (0 since 2007) Class II/III not classified
Adverse event reports per year · CGS
2in 2025
MAUDE reports naming product code CGS, 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 | — | 1 | 64 |
| 2008 | 2 | — | 0 | 0 |
| 2009 | 1 | — | 0 | 0 |
| 2010 | 0 | — | 0 | 1 |
| 2011 | 1 | — | 0 | 3 |
| 2012 | 0 | — | 0 | 0 |
| 2013 | 1 | — | 0 | 0 |
| 2014 | 0 | — | 0 | 0 |
| 2015 | 0 | — | 0 | 0 |
| 2016 | 1 | — | 0 | 0 |
| 2017 | 0 | — | 0 | 2 |
| 2018 | 0 | — | 0 | 1,434 |
| 2019 | 1 | — | 0 | 4 |
| 2020 | 1 | — | 0 | 0 |
| 2021 | 0 | — | 0 | 0 |
| 2022 | 0 | — | 0 | 1 |
| 2023 | 0 | — | 0 | 0 |
| 2024 | 0 | — | 0 | 1 |
| 2025 | 0 | — | 1 | 2 |
| 2026 | 0 | — | 0 | — |
What is it indicated for?
Cardiac Markers reagents, with associated calibrators and controls, are intended for use on ABX PENTRA 400 Clinical Chemistry Analyzer to measure cardiac marker analytes. ABX PENTRA CK-NAC CP reagent with associated calibrators and controls are for quantitative in vitro diagnostic determination of the total creatine kinase in human serum and plasma based on an optimized UV test. Measurements of creatine phosphokinase and its isoenzymes are used in the…
Read the full statement (261 words)
Cardiac Markers reagents, with associated calibrators and controls, are intended for use on ABX PENTRA 400 Clinical Chemistry Analyzer to measure cardiac marker analytes.
ABX PENTRA CK-NAC CP reagent with associated calibrators and controls are for quantitative in vitro diagnostic determination of the total creatine kinase in human serum and plasma based on an optimized UV test.
Measurements of creatine phosphokinase and its isoenzymes are used in the diagnosis and treatment of myocardial infarction and muscle diseases such as progressive, Duchenne-type muscular dystrophy.
The ABX PENTRA CK Control is for use in quality control by monitoring accuracy and precision for the quantitative ABX PENTRA CK-MB RTU and ABX PENTRA CK-NAC methods.
ABX PENTRA Myoglobin CP reagent with associated calibrators and controls are for quantitative in vitro diagnostic determination of myoglobin (an oxygen storage protein found in muscle) in human serum and plasma based on a latex-enhanced immunoturbidimetric assay.
Measurements of myoglobin aids in the rapid diagnosis of heart or renal disease.
The ABX PENTRA Myoglobin Cal is a calibrator for use in the calibration of quantitative Horiba ABX PENTRA Myoglobin CP method on Horiba ABX clinical chemistry analyzers.
The ABX PENTRA Immuno II Control L/H is for use in quality control by monitoring accuracy and precision.
The ABX PENTRA Multical is a calibrator for use in the calibration of quantitative Horiba ABX methods on Horiba ABX clinical chemistry analyzers.
The ABX PENTRA N Control is for use in quality control by monitoring accuracy and precision.
The ABX PENTRA P Control is for use in quality control by monitoring accuracy and precision.
Indications for use as stated in the FDA summary.
https://510kreport.com/device/K062737 · printed Nov 5, 2026
Cite this page
510(k) Report. “K062737: Cardiac Markers on Abx Pentra 400 Clinical Chemistry Analyzer.” Lineage record from FDA 510(k) data and the FDA summary. Updated Nov 3, 2026. Accessed Nov 5, 2026. https://510kreport.com/device/K062737
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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