510(k) · Cleared

Cleared

Aspartate Aminotransferase (Ast)

K981225510(k) TraditionalCleared Apr 23, 199820-day reviewClass II21 CFR 862.1100

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 Apr 23, 1998 as substantially equivalent to K924244 (Roche Diagnostic Systems, Inc., 1993) after a 20-day review. Its family tree reaches back 1 generation to 1993.

Decided: Apr 23, 1998
Review: 20 days
Class: Class II
Product code: CIT
Recalls: None
Predicates: 1

Its longest line of descent runs back 1 generation to K924244 (1993). No later device cites it as a predicate yet.

By dateBy generation

Root · 1 generation backK924244 Roche Reagent for AstRoche Diagnostic Systems, Inc. · 1993
This deviceK981225 Aspartate Aminotransferase (Ast)Abbott Laboratories · 1998

View FIG. 1 as a table

Line of descent and top descendants

Generation	Number	Device	Applicant	Decided	Recalls
−1	K924244	Roche Reagent for Ast	Roche Diagnostic Systems, Inc.	1993	—
0 (this device)	K981225	Aspartate Aminotransferase (Ast)	Abbott Laboratories	1998	—

FIG. 1 — Lineage of K981225, 1993–1998Source: 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
*	K924244	Roche Reagent for Ast Summary page 2 …quivalence: The Aspartate Aminotransferase assay is substantially equivalent to the Roche® Cobas Mira® Plus Automated Chemistry System Aspartate Aminotransferase assay (K924244). Both assays yield similar Performance Characteristics. Similarities: + Both assays are in vitro clinical chemistry methods.…	Roche Diagnostic Systems, Inc.	1993	—

Also cleared against K924244: 1 other device →

What descends from it?

No later submission names this one as a predicate yet.

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?

Its one ancestor has no recall.
1 other device also cites its predicate K924244.

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?

The Aspartate Aminotransferase (AST) assay is used for the quantitation of

aspartate aminotransferase in human serum or plasma. Aspartate aminotransferase

measurements are used in the diagnosis and treatment of certain types of liver and

heart disease.

Indications for use read by OCR from a scanned FDA summary, so letters may be misread. Check the PDF before quoting it.

https://510kreport.com/device/K981225 · printed Nov 6, 2026

Cite this page

510(k) Report. “K981225: Aspartate Aminotransferase (Ast).” Lineage record from FDA 510(k) data and the FDA summary. Updated Nov 3, 2026. Accessed Nov 6, 2026. https://510kreport.com/device/K981225

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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