510(k) · Cleared
ClearedAbx Pentra Albumin CP, Abx Pentra Micro-Albumin CP, Abx Pentra Total Protein CP, Abx Pentra Multical
Data to Oct 25, 2026 (FDA decisions) Oct 12, 2026 (recalls) Sep 30, 2026 (MAUDE) refreshed weekly
Horiba Abx · CIX Bromcresol Green Dye-Binding, Albumin
Cleared on Jun 5, 2007 as substantially equivalent to K896235 (Roche Diagnostic Systems, Inc., 1990) and 2 other predicates after a 469-day review. Its family tree reaches back 1 generation to 1990. 1 later device descends from it.
- Decided
- Jun 5, 2007
- Review
- 469 days
- Class
- Class II
- Product code
- CIX
- Recalls
- None
- Predicates
- 3
Its longest line of descent runs back 1 generation to K896230 (1990). 3 ancestors in all. 1 later device descends from it, 1 citing it directly.
- Root · 1 generation backK896230 Cobas Ready Total Protein ReagentRoche Diagnostic Systems, Inc. · 1990
- This deviceK060434 Abx Pentra Albumin CP, Abx Pentra Micro-Albumin CP, Abx Pentra Total…Horiba Abx · 2007
- Descendant · cites it directly · 0 of its ownK191245 Yumizen C1200 ALP, Yumizen C1200 AlbuminHoriba Abx Sas · 2019
Most influential descendants
Showing 1 of 1 · See all- K191245Yumizen C1200 ALP, Yumizen C1200 AlbuminHoriba Abx Sas · 2019 · cites it directly0descendants
View FIG. 1 as a table
Line of descent and top descendants
| Generation | Number | Device | Applicant | Decided | Recalls |
|---|---|---|---|---|---|
| −1 | K896230 | Cobas Ready Total Protein Reagent | Roche Diagnostic Systems, Inc. | 1990 | — |
| 0 (this device) | K060434 | Abx Pentra Albumin CP, Abx Pentra Micro-Albumin CP, Abx Pentra Total Protein… | Horiba Abx | 2007 | — |
| +1 | K191245 | Yumizen C1200 ALP, Yumizen C1200 Albumin | Horiba Abx Sas | 2019 | — |
Other ancestors by year cleared
| Year cleared | Devices | With a Class I recall |
|---|---|---|
| 1990 | 2 | 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 CIX? 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 CIX device
- #1 K251157 Core Metabolicscore 11.0 · 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? (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 |
|---|---|---|---|
| * | K896235 | Cobas Ready Albumin ReagentSummary page 2…Substantially equivalent Submission device Predicate device ABX PENTRA Albumin CP K896235 ABX PENTRA Micro-albumin CP K903123 ABX PENTRA Total Protein CP K896230… | 1990 |
| * | K903123 | Raichem (TM) Spia (TM) Microalbulmin ReagentSummary page 2…bmission device Predicate device ABX PENTRA Albumin CP K896235 ABX PENTRA Micro-albumin CP K903123 ABX PENTRA Total Protein CP K896230 HORIBA ABX, FRANCE… | 1990 |
| * | K896230 | Cobas Ready Total Protein ReagentSummary page 2…PENTRA Albumin CP K896235 ABX PENTRA Micro-albumin CP K903123 ABX PENTRA Total Protein CP K896230 HORIBA ABX, FRANCE Section 5-2 Description: Al… | 1990 |
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 |
|---|---|---|---|
| K191245 | Yumizen C1200 ALP, Yumizen C1200 Albumin | 2019 | 0 |
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?
- None of the 3 ancestors has a recall.
- Of its descendants, K191245 (Horiba Abx Sas, 2019) has gone furthest, with 0 descendants of its own.
How does its category compare?
All CIX devicesCIX Bromcresol Green Dye-Binding, Albumin: FDA decisions, review times, recalls and adverse event reports over 20 years. 2007, this device’s year, is highlighted.
FDA decisions per year · CIX
2in 2021
2026 to Oct 25, outlined.
Median 510(k) review, days · CIX
168in 2011
Receipt to decision; years with fewer than 3 clearances left blank.
Recalls per year · CIX
1in 2020
Class I (0 since 2007) Class II/III not classified
Adverse event reports per year · CIX
4in 2025
MAUDE reports naming product code CIX, 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 | — | 0 | 1 |
| 2008 | 1 | — | 1 | 0 |
| 2009 | 1 | — | 0 | 0 |
| 2010 | 0 | — | 1 | 74 |
| 2011 | 3 | 168 | 0 | 8 |
| 2012 | 1 | — | 0 | 2 |
| 2013 | 1 | — | 1 | 0 |
| 2014 | 0 | — | 0 | 0 |
| 2015 | 0 | — | 0 | 0 |
| 2016 | 0 | — | 0 | 1 |
| 2017 | 0 | — | 0 | 6 |
| 2018 | 1 | — | 0 | 2 |
| 2019 | 1 | — | 1 | 0 |
| 2020 | 0 | — | 1 | 1 |
| 2021 | 2 | — | 0 | 3 |
| 2022 | 0 | — | 0 | 1 |
| 2023 | 0 | — | 0 | 4 |
| 2024 | 0 | — | 0 | 3 |
| 2025 | 0 | — | 0 | 4 |
| 2026 | 1 | — | 0 | — |
What is it indicated for?
Proteins 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 Albumin CP reagent, with associated calibrators and controls, is a diagnostic reagent for quantitative determination of Albumin in serum and plasma by colorimetry. Albumin measurements are used in the diagnosis and treatment of numerous diseases involving primarily the liver or…
Read the full statement (279 words)
Proteins 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 Albumin CP reagent, with associated calibrators and controls, is a diagnostic reagent for quantitative determination of Albumin in serum and plasma by colorimetry.
Albumin measurements are used in the diagnosis and treatment of numerous diseases involving primarily the liver or kidneys.
ABX PENTRA Total Protein CP reagent, with associated calibrators 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.
ABX PENTRA Micro-albumin CP reagent, with associated calibrators and controls, is a diagnostic reagent for quantitative in-vitro determination of Albumin in urine (pALB) at low concentration by immunoturbidimetric assay.
Measurements of albumin aids in the diagnosis of diabetic nephritis and other kidney and intestinal diseases.
The ABX PENTRA p-Alb Cal is a calibrator for use in the calibration of quantitative Horiba ABX PENTRA Micro-albumin CP method on Horiba ABX clinical chemistry analyzers.
The ABX PENTRA p-Alb Control L/H is for use in quality control by monitoring accuracy and precision for the quantitative ABX PENTRA Micro-albumin CP method.
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/K060434 · printed Nov 4, 2026
Cite this page
510(k) Report. “K060434: Abx Pentra Albumin CP, Abx Pentra Micro-Albumin CP, Abx Pentra Total Protein CP, Abx Pentra Multical.” Lineage record from FDA 510(k) data and the FDA summary. Updated Nov 3, 2026. Accessed Nov 4, 2026. https://510kreport.com/device/K060434
Report an extraction error
Are you the manufacturer?
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