510(k) · Cleared

Recalled · 2008

Activated Aspartate Aminotransferase

K071525510(k) TraditionalCleared Mar 19, 2008289-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

Abbott Laboratories · CIT Nadh Oxidation/Nad Reduction, Ast/Sgot

Cleared on Mar 19, 2008 as substantially equivalent to K981221 (Abbott Laboratories, 1998) after a 289-day review. Its family tree reaches back 2 generations to 1986. It has been recalled once.

Decided: Mar 19, 2008
Review: 289 days
Class: Class II
Product code: CIT
Recalls: 1
Predicates: 1

Its longest line of descent runs back 2 generations to K861792 (1986). No later device cites it as a predicate yet.

By dateBy generation

Root · 2 generations backK861792 Twin Got-Ast Ifcc/GPT-Alt IfccBoehringer Mannheim Corp. · 1986
1 generation backK981221 Aspartate Aminotransferase Activated ( Ast Activated)Abbott Laboratories · 1998
This deviceK071525 Activated Aspartate AminotransferaseAbbott Laboratories · 2008

View FIG. 1 as a table

Line of descent and top descendants

Generation	Number	Device	Applicant	Decided	Recalls
−2	K861792	Twin Got-Ast Ifcc/GPT-Alt Ifcc	Boehringer Mannheim Corp.	1986	—
−1	K981221	Aspartate Aminotransferase Activated ( Ast Activated)	Abbott Laboratories	1998	—
0 (this device)	K071525	Activated Aspartate Aminotransferase	Abbott Laboratories	2008	—

FIG. 1 — Lineage of K071525, 1986–2008Source: 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
*	K981221	Aspartate Aminotransferase Activated ( Ast Activated) Summary page 2 …Equivalence: The Abbott Laboratories Active ted AST assay on the Abbott AEROSET and ARCHITECT cSystems is substantially equivalent to the Abbott AST Activated (K981221) assay on the AEROSET System. Both assays yield similar Performance Characteristics. Similarities: * Both assays use N…	Abbott Laboratories	1998	—

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
Jun 30, 2008	Not classified	Z-1447-2012	Nonconforming Material/Component	This letter is to inform you that some samples may generate A-AST results of less than (<) 5 U/L or results within the reference range when actual concentration exceeds the non-Flex linearity of 1985 U/L. In other cases the following…

No ancestor or descendant has a Class I recall.

What does this lineage say?

The line of descent spans 22 years and passes through 2 companies; a new generation was cleared every 11.7 years on median.
None of the 2 ancestors has a recall.

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. 2008, this device’s year, is highlighted.

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?

Activated Aspartate Aminotransferase (AST/SGOT) test system is a device intended to measure the activity of the enzyme aspartate aminotransferase (AST) (also known as a serum glutamic oxaloacetic transferase or SGOT) in serum and plasma. Aspartate aminotransferase measurements are used in the diagnosis and treatment of certain types of liver and heart disease.

Indications for use as stated in the FDA summary.

https://510kreport.com/device/K071525 · printed Nov 5, 2026

Cite this page

510(k) Report. “K071525: Activated Aspartate Aminotransferase.” Lineage record from FDA 510(k) data and the FDA summary. Updated Nov 3, 2026. Accessed Nov 5, 2026. https://510kreport.com/device/K071525

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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