510(k) · Cleared
Recalled · Class III · 2012Abx Pentra Creatinine 120 CP, Total Protein 100 CP, Multical, N and P Controls, and Urine Control L/H
Data to Oct 25, 2026 (FDA decisions) Oct 12, 2026 (recalls) Sep 30, 2026 (MAUDE) refreshed weekly
Horiba Abx · CGX Alkaline Picrate, Colorimetry, Creatinine
Cleared on Nov 30, 2007 as substantially equivalent to K973869 (Trace America, Inc., 1998) and 3 other predicates after a 121-day review. Its family tree reaches back 4 generations to 1994. It has been recalled once.
- Decided
- Nov 30, 2007
- Review
- 121 days
- Class
- Class II
- Product code
- CGX
- Recalls
- 1
- Predicates
- 4
Its longest line of descent runs back 4 generations to K933930 (1994). 21 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 deviceK072115 Abx Pentra Creatinine 120 CP, Total Protein 100 CP, Multical, N and…Horiba Abx · 2007
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) | K072115 | Abx Pentra Creatinine 120 CP, Total Protein 100 CP, Multical, N and P… | Horiba Abx | 2007 | — |
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 | 1 | 0 |
| 1994 | 1 | 0 |
| 1996 | 1 | 0 |
| 1997 | 2 | 0 |
| 1998 | 1 | 0 |
| 1999 | 1 | 0 |
| 2002 | 1 | 0 |
| 2003 | 1 | 0 |
| 2007 | 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? (4)
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 |
|---|---|---|---|
| * | K973869 | Trace Reagent Line for the Cobas MiraSummary page 2…Substantially equivalent Submission device Predicate device ABX PENTRA Creatinine 120 CP K973869 (serum/plasma samples) K941837 (urine samples) ABX PENTRA Total Protein 1… | 1998 |
| * | K941837 | Roche Reagent for CreatinineSummary page 2…Predicate device ABX PENTRA Creatinine 120 CP K973869 (serum/plasma samples) K941837 (urine samples) ABX PENTRA Total Protein 100 CP K973869 ABX PENTRA Multical… | 1994 |
| * | K052007 | Abx Pentra 400 Clinical Chemistry Analyzer (Option: I.S.E. Module)Summary page 1…Date Prepared: 2 6th July 2007 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 Creatinine 120 CP Common or Usual Name: Creatinine Device Class… | 2005 |
| * | K070249 | Abx Pentra 400, Calcium CP, Creatinine CP, Phosphorus CP, Amylase CP, Urine Control L/HSummary page 2…control material (assayed) Product Code: JJY; Multi-Analyte Controls, All Kinds (assayed) Trade/Proprietary Name: ABX PENTRA Urine Control L/H (K070249) Common or Usual Name: Urine control Device Class Class I Classification Name: §862.1660 : Q… | 2007 |
What descends from it?
No later submission names this one as a predicate yet.
Has anything in its family been recalled? (0 Class I)
Recalls of this device
| Date | Class | Recall | Root cause | Reason |
|---|---|---|---|---|
| Sep 14, 2012 | Class III | Z-0289-2013 | Nonconforming Material/Component | This recall was initiated because some customers were experiencing an alarm during Creatinine calibration "REAG RANGE HIGH". This alarm caused the calibration to fail and prevented the user from using the Creatinine assay. |
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 5.0 years on median.
- 4 of the 21 ancestors have a recall of any class.
How does its category compare?
All CGX devicesCGX Alkaline Picrate, Colorimetry, Creatinine: FDA decisions, review times, recalls and adverse event reports over 20 years. 2007, 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?
Creatinine and Total Protein 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 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 (Jaffé method). Creatinine…
Read the full statement (224 words)
Creatinine and Total Protein 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 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 (Jaffé 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 Total Protein 100 CP reagent, with associated calibrator and controls, is a diagnostic reagent for quantitative in-vitro determination of Total Proteins in serum and plasma by colorimetry.
Measurements obtained by this device are used in the diagnosis and treatment of a variety of diseases involving the liver, kidney, or bone marrow as well as other metabolic or nutritional disorders.
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.
The ABX PENTRA Urine Control L/H is for use in quality control by monitoring accuracy and precision.
Indications for use as stated in the FDA summary.
https://510kreport.com/device/K072115 · printed Nov 6, 2026
Cite this page
510(k) Report. “K072115: Abx Pentra Creatinine 120 CP, Total Protein 100 CP, Multical, N and P Controls, and Urine Control L/H.” Lineage record from FDA 510(k) data and the FDA summary. Updated Nov 3, 2026. Accessed Nov 6, 2026. https://510kreport.com/device/K072115
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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