510(k) · Cleared

Cleared

Sigma Diagnostics Infinity Astbun Reagent, Model 51-25, Sigma Diagnostics Infinity Ast Reagent, Models 51-100P,51-500P,5

K992801510(k) TraditionalCleared Sep 28, 199940-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

Sigma Diagnostics, Inc. · CIT Nadh Oxidation/Nad Reduction, Ast/Sgot

Cleared on Sep 28, 1999 as substantially equivalent to K961114 (Trace Scientific, Ltd., 1996) after a 40-day review. Its family tree reaches back 1 generation to 1996.

Decided: Sep 28, 1999
Review: 40 days
Class: Class II
Product code: CIT
Recalls: None
Predicates: 1

Its longest line of descent runs back 1 generation to K961114 (1996). No later device cites it as a predicate yet.

By dateBy generation

Root · 1 generation backK961114 Ast Incorporating DSTTrace Scientific, Ltd. · 1996
This deviceK992801 Sigma Diagnostics Infinity Astbun Reagent, Model 51-25, Sigma…Sigma Diagnostics, Inc. · 1999

View FIG. 1 as a table

Line of descent and top descendants

Generation	Number	Device	Applicant	Decided	Recalls
−1	K961114	Ast Incorporating DST	Trace Scientific, Ltd.	1996	—
0 (this device)	K992801	Sigma Diagnostics Infinity Astbun Reagent, Model 51-25, Sigma Diagnostics…	Sigma Diagnostics, Inc.	1999	—

FIG. 1 — Lineage of K992801, 1996–1999Source: 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
*	K961114	Ast Incorporating DST Summary page 1 …s INFINITY™ AST Reagent Kit (Procedure No. 51-uv) is substantially equivalent to, and is the same product as the TRACE Scientific AST (DST) Reagent Kit cleared by FDA as K961114. Correlation studies to Sigma Diagnostics AST Reagent, Procedure No. 58 (K954839) using plasma samples yielded a regression equa…	Trace Scientific, Ltd.	1996	—
†	K954839	Aspartate Aminotransferase Procedure NO.. 58-UV	Sigma Diagnostics, Inc.	1996	—

Also cleared against K961114: 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 K961114.

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?

Sigma Diagnostics INFINITY™ AST Reagent is intended for the in vitro quantitative

determination of AST (Aspartate Aminotransferase EC2.6.1.1) in human serum and plasma on

both automated and manual systems.

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/K992801 · printed Nov 5, 2026

Cite this page

510(k) Report. “K992801: Sigma Diagnostics Infinity Astbun Reagent, Model 51-25, Sigma Diagnostics Infinity Ast Reagent, Models 51-100P,51-500P,5.” Lineage record from FDA 510(k) data and the FDA summary. Updated Nov 3, 2026. Accessed Nov 5, 2026. https://510kreport.com/device/K992801

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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