510(k) · Cleared
ClearedAbx Pentra Amylase CP; Multical; N Control; P Control; Clean-Chem CP; Clean-Chem 99 CP
Data to Oct 25, 2026 (FDA decisions) Oct 12, 2026 (recalls) Sep 30, 2026 (MAUDE) refreshed weekly
Horiba Abx · JFJ Catalytic Methods, Amylase
Cleared on Oct 2, 2006 as substantially equivalent to K801295 (Roche Analytical Instruments, Inc., 1980) and 1 other predicate after a 63-day review. Its family tree reaches back 4 generations to 1994.
- Decided
- Oct 2, 2006
- Review
- 63 days
- Class
- Class II
- Product code
- JFJ
- Recalls
- None
- Predicates
- 2
Its longest line of descent runs back 4 generations to K933930 (1994). 14 ancestors in all, the oldest K801297 (1980). No later device cites it as a predicate yet.
- 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 deviceK062180 Abx Pentra Amylase CP; Multical; N Control; P Control; Clean-Chem…Horiba Abx · 2006
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) | K062180 | Abx Pentra Amylase CP; Multical; N Control; P Control; Clean-Chem CP… | Horiba Abx | 2006 | — |
Other ancestors by year cleared
| Year cleared | Devices | With a Class I recall |
|---|---|---|
| 1980 | 2 | 0 |
| 1991 | 3 | 0 |
| 1992 | 1 | 0 |
| 1993 | 1 | 0 |
| 1996 | 1 | 0 |
| 1999 | 1 | 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 JFJ? 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 JFJ device
- #1 K210633 Amylase2score 3.7 · 2 generations · no Class I recall
What was it cleared against? (2)
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 |
|---|---|---|---|
| * | K801295 | Cobas Reagent for a-AmylaseSummary page 2…Substantially equivalent Submission device Predicate device ABX PENTRA Amnylase CP K801295 ABX PENTRA Multical K052007 ABX PENTRA N Control K052… | 1980 |
| * | K052007 | Abx Pentra 400 Clinical Chemistry Analyzer (Option: I.S.E. Module)Summary page 1…Date Prepared: 27"' 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 Amtylase CP Common or Usual Name: Amylase Device Class… | 2005 |
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 12 years and passes through 3 companies; a new generation was cleared every 5.0 years on median.
- 3 of the 14 ancestors have a recall of any class.
How does its category compare?
All JFJ devicesJFJ Catalytic Methods, Amylase: FDA decisions, review times, recalls and adverse event reports over 20 years.
FDA decisions per year · JFJ
1in 2022
2026 to Oct 25, outlined.
Median 510(k) review, days · JFJ
Too few JFJ 510(k)s in any year since 2007 to give a median.
Recalls per year · JFJ
1in 2007
Class I (0 since 2007) Class II/III not classified
Adverse event reports per year · JFJ
1in 2025
MAUDE reports naming product code JFJ, 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 | 0 |
| 2008 | 1 | — | 0 | 0 |
| 2009 | 1 | — | 0 | 0 |
| 2010 | 0 | — | 0 | 1 |
| 2011 | 0 | — | 0 | 2 |
| 2012 | 1 | — | 0 | 1 |
| 2013 | 1 | — | 0 | 0 |
| 2014 | 0 | — | 0 | 0 |
| 2015 | 0 | — | 0 | 0 |
| 2016 | 0 | — | 0 | 0 |
| 2017 | 0 | — | 0 | 0 |
| 2018 | 0 | — | 0 | 2 |
| 2019 | 2 | — | 0 | 0 |
| 2020 | 0 | — | 0 | 1 |
| 2021 | 0 | — | 0 | 0 |
| 2022 | 1 | — | 0 | 1 |
| 2023 | 0 | — | 0 | 0 |
| 2024 | 0 | — | 0 | 1 |
| 2025 | 0 | — | 0 | 1 |
| 2026 | 0 | — | 0 | — |
What is it indicated for?
Amylase reagent, with associated calibrators and controls, are intended for use on ABX PENTRA 400 Clinical Chemistry Analyzer to measure amylase analyte. ABX PENTRA Amylase CP reagent with associated calibrators and controls are for quantitative in vitro diagnostic determination of the activity of the enzyme amylase in human serum and plasma based on an enzymatic photometric assay. Amylase measurements are used primarily for the diagnosis and treatment…
Read the full statement (128 words)
Amylase reagent, with associated calibrators and controls, are intended for use on ABX PENTRA 400 Clinical Chemistry Analyzer to measure amylase analyte.
ABX PENTRA Amylase CP reagent with associated calibrators and controls are for quantitative in vitro diagnostic determination of the activity of the enzyme amylase in human serum and plasma based on an enzymatic photometric assay.
Amylase measurements are used primarily for the diagnosis and treatment of pancreatitis (inflammation of the pancreas).
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 read by OCR from a scanned FDA summary, so letters may be misread. Check the PDF before quoting it.
https://510kreport.com/device/K062180 · printed Nov 6, 2026
Cite this page
510(k) Report. “K062180: Abx Pentra Amylase CP; Multical; N Control; P Control; Clean-Chem CP; Clean-Chem 99 CP.” Lineage record from FDA 510(k) data and the FDA summary. Updated Nov 3, 2026. Accessed Nov 6, 2026. https://510kreport.com/device/K062180
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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