510(k) · Cleared

Recalled · Class II · 2012

Hepatic Enzymes on Abx Pentra 400 Clinical Chemistry Analyzer

K060318510(k) TraditionalCleared Aug 8, 2006181-day reviewClass II21 CFR 862.1100Recalls 1

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

Horiba Abx · CIT Nadh Oxidation/Nad Reduction, Ast/Sgot

Cleared on Aug 8, 2006 as substantially equivalent to K801118 (Roche Analytical Instruments, Inc., 1980) after a 181-day review. Its family tree reaches back 1 generation to 1980. 2 later devices descend from it. It has been recalled once.

Decided: Aug 8, 2006
Review: 181 days
Class: Class II
Product code: CIT
Recalls: 1
Predicates: 1

Its longest line of descent runs back 1 generation to K801118 (1980). 2 later devices descend from it, 2 citing it directly.

By dateBy generation

Root · 1 generation backK801118 Cobas Reagent for Ast (Sgot)Roche Analytical Instruments, Inc. · 1980
This deviceK060318 Hepatic Enzymes on Abx Pentra 400 Clinical Chemistry AnalyzerHoriba Abx · 2006
Descendant · cites it directly · 0 of its ownK102647 Elitech Clinical Systems Selectra Prom/Elical 2/Elitrol I and…Elitechgroup Vital Scientific BV · 2011 · Recalled
Descendant · cites it directly · 0 of its ownK093883 Ast/Got 4+1 SL, Ast/Got 4+1 SL, Elical 2, Elitrol I, Elitrol II…Seppim S.A.S. · 2010

Most influential descendants

Showing 2 of 2 · See all

K102647Elitech Clinical Systems Selectra Prom/Elical 2/Elitrol I and Elitrol II/Ast/Got 4+1…Elitechgroup Vital Scientific BV · 2011 · cites it directly0descendants
K093883Ast/Got 4+1 SL, Ast/Got 4+1 SL, Elical 2, Elitrol I, Elitrol II, Model Assl-0250…Seppim S.A.S. · 2010 · cites it directly0descendants

View FIG. 1 as a table

Line of descent and top descendants

Generation	Number	Device	Applicant	Decided	Recalls
−1	K801118	Cobas Reagent for Ast (Sgot)	Roche Analytical Instruments, Inc.	1980	—
0 (this device)	K060318	Hepatic Enzymes on Abx Pentra 400 Clinical Chemistry Analyzer	Horiba Abx	2006	—
+1	K102647	Elitech Clinical Systems Selectra Prom/Elical 2/Elitrol I and Elitrol…	Elitechgroup Vital Scientific BV	2011	4
+1	K093883	Ast/Got 4+1 SL, Ast/Got 4+1 SL, Elical 2, Elitrol I, Elitrol II, Model…	Seppim S.A.S.	2010	—

Descendants by year cleared

Year cleared	Devices	With a Class I recall
2010	1	0
2011	1	0

FIG. 1 — Lineage of K060318, 1980–2011Source: FDA 510(k) summaries, read by 510(k) Report · How lineage is built

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 CIT? A 510(k) Report weighs predicate choices, recall history and review times for a new device like this one.

Candidate predicates for a device like this, rankedin the report
Recall history across each candidate’s familyin the report

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What was it cleared against? (1)

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	Applicant	Decided	Recalls
*	K801118	Cobas Reagent for Ast (Sgot) Summary page 2 …Substantially equivalent Submission device predicate device ABXPENTRA AST CP K801118 Description: All the reagents, controls and calibrators included in this submission are for use on the ABX PENTRA 400 (K052007…	Roche Analytical Instruments, Inc.	1980	—

What descends from it? (2)

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

Number	Device	Applicant	Decided	Descendants
K102647	Elitech Clinical Systems Selectra Prom/Elical 2/Elitrol I and Elitrol II/Ast/Got 4+1…	Elitechgroup Vital Scientific BV	2011	0
K093883	Ast/Got 4+1 SL, Ast/Got 4+1 SL, Elical 2, Elitrol I, Elitrol II, Model Assl-0250…	Seppim S.A.S.	2010	0

Has anything in its family been recalled? (0 Class I)

Recalls of this device

Date	Class	Recall	Root cause	Reason
Oct 10, 2012	Class II	Z-0632-2013	Software design	Horiba Medical is recalling the ABX PENTRA AST CP because during the AST application validation on the Pentra C200 using an Audit Systems linearity kit, it was determined that two higher values for AST (expected at 800 U/L and 1000 U/L)…

No ancestor or descendant has a Class I recall.

What does this lineage say?

Its one ancestor has no recall.
Of its descendants, K102647 (Elitechgroup Vital Scientific BV, 2011) has gone furthest, with 0 descendants of its own.

How does its category compare?

All CIT devices

CIT Nadh Oxidation/Nad Reduction, Ast/Sgot: FDA decisions, review times, recalls and adverse event reports over 20 years.

FDA decisions per year · CIT

1in 2010

2007high 2 (2007) · low 0 (2009)2026

2026 to Oct 25, outlined.

Median 510(k) review, days · CIT

Too few CIT 510(k)s in any year since 2007 to give a median.

Recalls per year · CIT

1in 2023

2007high 3 (2008) · low 0 (2007)2026

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

Adverse event reports per year · CIT

10in 2025

2007high 23 (2007) · low 0 (2009)2025

MAUDE reports naming product code CIT, 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	2	—	0	23
2008	2	—	3	17
2009	0	—	0	0
2010	1	—	0	1
2011	0	—	0	7
2012	0	—	1	2
2013	0	—	1	0
2014	0	—	1	0
2015	0	—	0	1
2016	0	—	0	0
2017	0	—	0	2
2018	0	—	0	1
2019	0	—	0	2
2020	0	—	0	1
2021	0	—	0	5
2022	0	—	0	2
2023	0	—	1	2
2024	0	—	0	8
2025	0	—	0	10
2026	0	—	0	—

What is it indicated for?

Hepatic Enzymes 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 AST CP reagent with associated calibrators and controls are for quantitative in vitro diagnostic determination of aspartate aminotransferase in human serum and plasma based on a UV test using L-aspartate and 2-oxoglutarate. Aspartate aminotransferase measurements are used in…

Read the full statement (132 words)

Hepatic Enzymes 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 AST CP reagent with associated calibrators and controls are for

quantitative in vitro diagnostic determination of aspartate aminotransferase in human

serum and plasma based on a UV test using L-aspartate and 2-oxoglutarate. Aspartate

aminotransferase measurements are used in the diagnosis and treatment of certain

types of liver and heart diseases.

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 PENIRA 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/K060318 · printed Nov 6, 2026

Cite this page

510(k) Report. “K060318: Hepatic Enzymes on Abx Pentra 400 Clinical Chemistry Analyzer.” Lineage record from FDA 510(k) data and the FDA summary. Updated Nov 3, 2026. Accessed Nov 6, 2026. https://510kreport.com/device/K060318

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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