510(k) Report

510(k) · Cleared

Cleared

Abx Pentra Bilirubin, Direct CP, Abx Pentra Bilirubin, Total CP, Abx Pentra Multical, Abx Pentra N Control, Abx Pentra P

K060325510(k) TraditionalCleared Aug 16, 2006188-day reviewClass II21 CFR 862.1110

Data to Oct 25, 2026 (FDA decisions) Oct 12, 2026 (recalls) Sep 30, 2026 (MAUDE) refreshed weekly, last Nov 3, 2026

Horiba Abx · CIG Diazo Colorimetry, Bilirubin

Cleared on Aug 16, 2006 as substantially equivalent to K910593 (Roche Diagnostic Systems, Inc., 1991) and 1 other predicate after a 188-day review. Its family tree reaches back 1 generation to 1991. 2 later devices descend from it.

Decided
Aug 16, 2006
Review
188 days
Class
Class II
Product code
CIG
Recalls
None
Predicates
2

Its longest line of descent runs back 1 generation to K910593 (1991). 2 ancestors in all. 2 later devices descend from it, 2 citing it directly.

Other ancestors, by year clearedDescendants, by year cleared 1991: 1 other ancestor2017: 1 descendant cleared2011: 1 descendant clearedK910593 · Roche Reagent for Direct Bilirubin · Roche Diagnostic Systems, Inc. · 19911990200020102020
Other ancestors, by generationDescendants, by generation 1 generation back: 1 other ancestor 1 generation forward: 2 descendants K910593 · Roche Reagent for Direct Bilirubin · Roche Diagnostic Systems, Inc. · 19910
  1. Root · 1 generation backK910593 Roche Reagent for Direct BilirubinRoche Diagnostic Systems, Inc. · 1991
  2. This deviceK060325 Abx Pentra Bilirubin, Direct CP, Abx Pentra Bilirubin, Total CP, Abx…Horiba Abx · 2006
  3. Descendant · cites it directly · 0 of its ownK171401 ELITech Clinical Systems BILIRUBIN TOTAL 4+1, ELITech Clinical…Elitechgroup · 2017
  4. Descendant · cites it directly · 0 of its ownK110780 Elitech Clinical Systems Bilirubin Total 4+1, Elitech Clinical…Elitechgroup · 2011

Most influential descendants

Showing 2 of 2 · See all
  • K171401ELITech Clinical Systems BILIRUBIN TOTAL 4+1, ELITech Clinical Systems BILIRUBIN DIRECT…Elitechgroup · 2017 · cites it directly0descendants
  • K110780Elitech Clinical Systems Bilirubin Total 4+1, Elitech Clinical Systems Elical 2, Elitech…Elitechgroup · 2011 · cites it directly0descendants
View FIG. 1 as a table

Line of descent and top descendants

GenerationNumberDeviceApplicantDecidedRecalls
−1K910593Roche Reagent for Direct BilirubinRoche Diagnostic Systems, Inc.1991—
0 (this device)K060325Abx Pentra Bilirubin, Direct CP, Abx Pentra Bilirubin, Total CP, Abx Pentra…Horiba Abx2006—
+1K171401ELITech Clinical Systems BILIRUBIN TOTAL 4+1, ELITech Clinical Systems…Elitechgroup2017—
+1K110780Elitech Clinical Systems Bilirubin Total 4+1, Elitech Clinical Systems Elical…Elitechgroup2011—

Other ancestors by year cleared

Year clearedDevicesWith a Class I recall
199110

Descendants by year cleared

Year clearedDevicesWith a Class I recall
201110
201710
FIG. 1 — Lineage of K060325, 1991–2017Source: FDA 510(k) summaries, read by 510(k) Report · How lineage is built

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Notable FDA decisions, review times and new Class I recalls. See an issue.

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 CIG? 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 CIG device

  1. #1 K251998 Atellica CH Diazo Total Bilirubin (D_TBil)score 11.8 · 4 generations · no Class I recall
  2. #2 Held for the reportin the report
  3. #3 Held for the reportin the report
Get a 510(k) Report

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.

TypeNumberDeviceApplicantDecidedRecalls
*K910593Roche Reagent for Direct Bilirubin
Summary page 2
…Substantially equivalent Submission device Predicate device ABX PENTRA Bilirubin, Direct CP K910593 ABX PENTRA Bilirubin, Total CP K910591 Description: All the reagents, controls and calibrators include…
Roche Diagnostic Systems, Inc.1991—
*K910591Roche Reagent for Total Bilirubin
Summary page 2
…ssion device Predicate device ABX PENTRA Bilirubin, Direct CP K910593 ABX PENTRA Bilirubin, Total CP K910591 Description: All the reagents, controls and calibrators included in this submission are for use on the ABX PENTRA 400 (K052007…
Roche Diagnostic Systems, Inc.1991—

Also cleared against K910593: 3 other devices →

What descends from it? (2)

2 later devices cite it directly; ranked here by how many devices descend from each in turn.

NumberDeviceApplicantDecidedDescendants
K171401ELITech Clinical Systems BILIRUBIN TOTAL 4+1, ELITech Clinical Systems BILIRUBIN DIRECT…Elitechgroup20170
K110780Elitech Clinical Systems Bilirubin Total 4+1, Elitech Clinical Systems Elical 2, Elitech…Elitechgroup20110

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 2 ancestors has a recall.
  • Of its descendants, K171401 (Elitechgroup, 2017) has gone furthest, with 0 descendants of its own.
  • 3 other devices also cite its predicate K910593.

How does its category compare?

All CIG devices

CIG Diazo Colorimetry, Bilirubin: FDA decisions, review times, recalls and adverse event reports over 20 years.

FDA decisions per year · CIG

2in 2023

2007: 12008: 32009: 22010: 12011: 22013: 52015: 12017: 12019: 12022: 12023: 22026 (partial year): 1
2007high 5 (2013) · low 0 (2012)2026

2026 to Oct 25, outlined.

Median 510(k) review, days · CIG

64in 2013

2008: 199 days median2013: 64 days median
2007high 199 (2008) · low 64 (2013)2026

Receipt to decision; years with fewer than 3 clearances left blank.

Recalls per year · CIG

1in 2019

2009: 32013: 32019: 1
2007high 3 (2009) · low 0 (2007)2026

Class I (0 since 2007) Class II/III not classified

Adverse event reports per year · CIG

52in 2025

2007: 22008: 82009: 32010: 62011: 382012: 142013: 82014: 32015: 72016: 42017: 112018: 232019: 252020: 312021: 222022: 262023: 342024: 392025: 52
2007high 52 (2025) · low 2 (2007)2025

MAUDE reports naming product code CIG, not matched to any one device; reports are not rates.

View these four charts as a table
YearDecisionsMedian 510(k) review, daysRecalls (Class I)MAUDE reports
20071—02
2008319908
20092—33
20101—06
20112—038
20120—014
201356438
20140—03
20151—07
20160—04
20171—011
20180—023
20191—125
20200—031
20210—022
20221—026
20232—034
20240—039
20250—052
20261—0—

What is it indicated for?

ABX PENTRA Bilirubin, Direct CP reagent with associated calibrators and controls are for quantitative in vitro diagnostic determination of direct bilirubin in human serum and plasma based on a photometric test using 2,4-dichloroaniline (DCA) for use on ABX PENTRA 400 Clinical Chemistry Analyzer. ABX PENTRA Bilirubin, Total CP reagent with associated calibrators and controls are for quantitative in vitro diagnostic determination of total bilirubin in…

Read the full statement (186 words)

ABX PENTRA Bilirubin, Direct CP reagent with associated calibrators and controls are for quantitative in vitro diagnostic determination of direct bilirubin in human serum and plasma based on a photometric test using 2,4-dichloroaniline (DCA) for use on ABX PENTRA 400 Clinical Chemistry Analyzer.

ABX PENTRA Bilirubin, Total CP reagent with associated calibrators and controls are for quantitative in vitro diagnostic determination of total bilirubin in human serum and plasma based on a photometric test using 2,4-dichloroaniline (DCA) and detergents for use on ABX PENTRA 400 Clinical Chemistry Analyzer.

Measurements of the levels of bilirubin (direct or total), an organic compound formed during the normal and abnormal destruction of red blood cells, are used in the diagnosis and treatment of liver, hemolytic hematological, and metabolic disorders, including hepatitis and gall bladder block.

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.

Also cleared against K910593

3 other devices cite the same predicate.

  • K050266Direct Bilirubin Liquicolor and Total Bilirubin LiquicolorStanbio Laboratory · 2005
  • K991175Modification to Alcyon Direct BilirubinAbbott Laboratories · 1999
  • K981222Direct Bilirubin (Dbil)Abbott Laboratories · 1998

More from Horiba Abx

19 FDA decisions under this applicant name. See the company

  • K073309Abx Pentra HBA1C WB, Calibrator, Control and Hemolysis ReagentHoriba Abx · 2008
  • K081276Abx Pentra Glucose HK CP, Abx Pentra Uric Acid CP, Abx Pentra Urine Control L/HHoriba Abx · 20081 recall
  • K071779Abx Pentra Urine CalHoriba Abx · 2008
  • K072115Abx Pentra Creatinine 120 CP, Total Protein 100 CP, Multical, N and P Controls, and Urine Control L/HHoriba Abx · 20071 recall
  • K070146Abx Pentra Glucose HK CP, Urea CP, Uric Acid CPHoriba Abx · 2007

Recent decisions in CIG

The CIG category page

  • K251998Atellica CH Diazo Total Bilirubin (D_TBil)Siemens Healthcare Diagnostics, Inc. · 2026
  • K223078Atellica® CH Diazo Direct Bilirubin (D_DBil)Siemens Healthcare Diagnostics, Inc. · 2023
  • K222104Atellica® CH Diazo Total Bilirubin (D_TBil)Siemens Healthcare Diagnostics, Inc. · 2023
  • K223324Total Bilirubin2Abbott Ireland Diagnostics Division · 2022
  • K190807VITROS XT Chemistry Products TBIL-ALKP SlidesOrtho-Clinical Diagnostics, Inc. · 20193 recalls

https://510kreport.com/device/K060325 · printed Nov 5, 2026

Cite this page

510(k) Report. “K060325: Abx Pentra Bilirubin, Direct CP, Abx Pentra Bilirubin, Total CP, Abx Pentra Multical, Abx Pentra N Control, Abx Pentra P.” Lineage record from FDA 510(k) data and the FDA summary. Updated Nov 3, 2026. Accessed Nov 5, 2026. https://510kreport.com/device/K060325

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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