510(k) · Cleared
Recalled · Class II · 2022Abx Pentra Creatinine 120 CP; Abx Pentra Multical; Abx Pentra N Control; Abx Pentra P Control; Abx Pentra Urine Control
Data to Oct 25, 2026 (FDA decisions) Oct 12, 2026 (recalls) Sep 30, 2026 (MAUDE) refreshed weekly
Horiba Abx Sas · CGX Alkaline Picrate, Colorimetry, Creatinine
Cleared on Apr 30, 2012 as substantially equivalent to K934361 (Olympus Corp., 1993) and 2 other predicates after a 431-day review. Its family tree reaches back 4 generations to 1994. 1 later device descends from it. It has been recalled 3 times.
- Decided
- Apr 30, 2012
- Review
- 431 days
- Class
- Class II
- Product code
- CGX
- Recalls
- 3
- Predicates
- 3
Its longest line of descent runs back 4 generations to K933930 (1994). 21 ancestors in all, the oldest K801297 (1980). 1 later device descends from it, 1 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 deviceK110530 Abx Pentra Creatinine 120 CP; Abx Pentra Multical; Abx Pentra N…Horiba Abx Sas · 2012
- Descendant · cites it directly · 0 of its ownK191396 Yumizen C1200 Calcium AS, Yumizen C1200 Creatinine JaffeHoriba Abx Sas · 2019
Most influential descendants
Showing 1 of 1 · See all- K191396Yumizen C1200 Calcium AS, Yumizen C1200 Creatinine JaffeHoriba Abx Sas · 2019 · 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) | K110530 | Abx Pentra Creatinine 120 CP; Abx Pentra Multical; Abx Pentra N Control; Abx… | Horiba Abx Sas | 2012 | — |
| +1 | K191396 | Yumizen C1200 Calcium AS, Yumizen C1200 Creatinine Jaffe | Horiba Abx Sas | 2019 | — |
Other ancestors by year cleared
| Year cleared | Devices | With a Class I recall |
|---|---|---|
| 1980 | 1 | 0 |
| 1988 | 1 | 0 |
| 1990 | 1 | 0 |
| 1991 | 3 | 0 |
| 1992 | 1 | 0 |
| 1993 | 2 | 0 |
| 1994 | 1 | 0 |
| 1996 | 1 | 0 |
| 1997 | 2 | 0 |
| 1999 | 1 | 0 |
| 2002 | 1 | 0 |
| 2003 | 1 | 0 |
| 2007 | 1 | 0 |
Descendants by year cleared
| Year cleared | Devices | With a Class I recall |
|---|---|---|
| 2019 | 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 CGX? 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 CGX device
- #1 K242685 Atellica® CH Creatinine_3 (Crea3)score 12.1 · 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? (3)
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 |
|---|---|---|---|
| * | K934361 | Olympus Creatinine ReagentSummary page 2…Substantially equivalent Submission device Predicate device ABX PENTRA Creatinine 120 CP K934361 ABX PENTRA Multical K052007 ABX PENTRA N Control… | 1993 |
| * | K052007 | Abx Pentra 400 Clinical Chemistry Analyzer (Option: I.S.E. Module)Summary page 1…: Creatinine Test System Product Code: COX: alkaline picrate, colorimetry, creatinine CALIBRATORS: Trade/Proprietary Name: ABX PENTRA Multical (K052007) Common or Usual Name: Multical Device Class Class 11 Classification Name: §862.1150 : Calib… | 2005 |
| * | K070249 | Abx Pentra 400, Calcium CP, Creatinine CP, Phosphorus CP, Amylase CP, Urine Control L/HSummary page 2…ontrol material (assayed) Product Code: JJY; Multi-Analyte Controls, All Kinds (assayed) Trade/Proprietary Name: ABX PENTRA Urine Control L/lA (K070249) Common or Usual Name: Urine control Device Class Class I Classification Name: §862.1660 : Q… | 2007 |
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 |
|---|---|---|---|
| K191396 | Yumizen C1200 Calcium AS, Yumizen C1200 Creatinine Jaffe | 2019 | 0 |
Has anything in its family been recalled? (0 Class I)
Recalls of this device
| Date | Class | Recall | Root cause | Reason |
|---|---|---|---|---|
| May 25, 2022 | Class II | Z-1586-2022 | Environmental control | Facility Temperature excursions (from June 2021-August 2021) prior to delivery; exposure to higher temperatures may have impacted product effectiveness. All lots received between 06/01/21-9/30/21. |
| Jan 20, 2014 | Class II | Z-1146-2014 | Under Investigation by firm | HORIBA Medical is informing all ABX PENTRA MultiCal, N Control, and P Control customers running the Creatinine Rate Blank Method assay on the ABX PENTRA 400 and PC200 that the Target Values for Creatinine Rate Blank Method have been… |
| Dec 18, 2013 | Class III | Z-0924-2014 | Pending | HORIBA Medical is informing all ABX PENTRA Urine Control L/H customers running the Creatinine assay on ABX PENTRA Chemistry Analyzers that the Target Range for Creatinine has been updated. The ABX PENTRA Urine Control L/H lot specific… |
No ancestor or descendant has a Class I recall.
What does this lineage say?
- The line of descent spans 18 years and passes through 4 companies; a new generation was cleared every 5.6 years on median.
- 5 of the 21 ancestors have a recall of any class.
- Of its descendants, K191396 (Horiba Abx Sas, 2019) has gone furthest, with 0 descendants of its own.
- 1 other device also cites its predicate K934361.
How does its category compare?
All CGX devicesCGX Alkaline Picrate, Colorimetry, Creatinine: FDA decisions, review times, recalls and adverse event reports over 20 years. 2012, this device’s year, is highlighted.
FDA decisions per year · CGX
1in 2025
2026 to Oct 25, outlined.
Median 510(k) review, days · CGX
25in 2007
Receipt to decision; years with fewer than 3 clearances left blank.
Recalls per year · CGX
2in 2016
Class I (0 since 2007) Class II/III not classified
Adverse event reports per year · CGX
34in 2025
MAUDE reports naming product code CGX, 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 | 4 | 25 | 0 | 15 |
| 2008 | 0 | — | 1 | 27 |
| 2009 | 1 | — | 2 | 5 |
| 2010 | 0 | — | 2 | 5 |
| 2011 | 0 | — | 1 | 32 |
| 2012 | 1 | — | 2 | 13 |
| 2013 | 1 | — | 0 | 24 |
| 2014 | 2 | — | 0 | 13 |
| 2015 | 0 | — | 0 | 13 |
| 2016 | 1 | — | 2 | 3 |
| 2017 | 0 | — | 0 | 21 |
| 2018 | 0 | — | 0 | 14 |
| 2019 | 0 | — | 0 | 25 |
| 2020 | 0 | — | 0 | 19 |
| 2021 | 0 | — | 0 | 13 |
| 2022 | 1 | — | 0 | 23 |
| 2023 | 0 | — | 0 | 19 |
| 2024 | 2 | — | 0 | 32 |
| 2025 | 1 | — | 0 | 34 |
| 2026 | 1 | — | 1 | — |
What is it indicated for?
ABX PENTRA Creatinine 120 CP reagent, with associated calibrator and controls, is a diagnostic reagent for quantitative in vitro determination of Creatinine in human serum, plasma and urine based on a kinetic method using alkaline picrate (Jaffd 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. The ABX PENTRA Multical is…
Read the full statement (136 words)
ABX PENTRA Creatinine 120 CP reagent, with associated calibrator and controls, is a diagnostic reagent for quantitative in vitro determination of Creatinine in human serum, plasma and urine based on a kinetic method using alkaline picrate (Jaffd 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.
The ABX PENTRA Multical is a calibrator for use in the calibration of quantitative Horiba Medical methods on Horiba Medical clinical chemistry analyzers.
The ABX PENTRLA 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.
The ABX PENTRA Urine Control L11I is for use in quality control by monitoring accuracy and precision.
Indications for use as stated in the FDA summary.
https://510kreport.com/device/K110530 · printed Nov 6, 2026
Cite this page
510(k) Report. “K110530: Abx Pentra Creatinine 120 CP; Abx Pentra Multical; Abx Pentra N Control; Abx Pentra P Control; Abx Pentra Urine Control.” Lineage record from FDA 510(k) data and the FDA summary. Updated Nov 3, 2026. Accessed Nov 6, 2026. https://510kreport.com/device/K110530
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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