510(k) Report

510(k) · Cleared

Cleared

Ast Incorporating DST

K961114510(k) TraditionalCleared May 23, 199664-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

Trace Scientific, Ltd. · CIT Nadh Oxidation/Nad Reduction, Ast/Sgot

Cleared on May 23, 1996 after a 64-day review. FDA lists a 510(k) statement for it but has not posted the file, so its predicates are not known. 2 later devices descend from it.

Decided
May 23, 1996
Review
64 days
Class
Class II
Product code
CIT
Recalls
None
Predicates
0

2 later devices descend from it, 2 citing it directly.

Descendants, by year cleared 1998: 1 descendant cleared1999: 1 descendant cleared1995200020052010201520202025
  1. This deviceK961114 Ast Incorporating DSTTrace Scientific, Ltd. · 1996
  2. Descendant · cites it directly · 0 of its ownK992801 Sigma Diagnostics Infinity Astbun Reagent, Model 51-25, Sigma…Sigma Diagnostics, Inc. · 1999
  3. Descendant · cites it directly · 0 of its ownK980666 Infinity Ast Reagent (Procedure NO. 51)Sigma Diagnostics, Inc. · 1998

Most influential descendants

Showing 2 of 2 · See all
  • K992801Sigma Diagnostics Infinity Astbun Reagent, Model 51-25, Sigma Diagnostics Infinity Ast…Sigma Diagnostics, Inc. · 1999 · cites it directly0descendants
  • K980666Infinity Ast Reagent (Procedure NO. 51)Sigma Diagnostics, Inc. · 1998 · cites it directly0descendants
View FIG. 1 as a table

Line of descent and top descendants

GenerationNumberDeviceApplicantDecidedRecalls
0 (this device)K961114Ast Incorporating DSTTrace Scientific, Ltd.1996—
+1K992801Sigma Diagnostics Infinity Astbun Reagent, Model 51-25, Sigma Diagnostics…Sigma Diagnostics, Inc.1999—
+1K980666Infinity Ast Reagent (Procedure NO. 51)Sigma Diagnostics, Inc.1998—

Descendants by year cleared

Year clearedDevicesWith a Class I recall
199810
199910
FIG. 1 — Lineage of K961114, 1996–1999Source: FDA 510(k) summaries, read by 510(k) Report · How lineage is built

Get the monthly Device Review Tracker

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

Sources: FDA 510(k) database (decision fields), 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?

FDA lists a 510(k) statement for it but has not posted the file, so its predicates are not known.

What descends from it? (2)

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

NumberDeviceApplicantDecidedDescendants
K992801Sigma Diagnostics Infinity Astbun Reagent, Model 51-25, Sigma Diagnostics Infinity Ast…Sigma Diagnostics, Inc.19990
K980666Infinity Ast Reagent (Procedure NO. 51)Sigma Diagnostics, Inc.19980

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?

  • Of its descendants, K992801 (Sigma Diagnostics, Inc., 1999) 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

2007: 22008: 22010: 1
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

2008: 32012: 12013: 12014: 12023: 1
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

2007: 232008: 172010: 12011: 72012: 22015: 12017: 22018: 12019: 22020: 12021: 52022: 22023: 22024: 82025: 10
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
YearDecisionsMedian 510(k) review, daysRecalls (Class I)MAUDE reports
20072—023
20082—317
20090—00
20101—01
20110—07
20120—12
20130—10
20140—10
20150—01
20160—00
20170—02
20180—01
20190—02
20200—01
20210—05
20220—02
20230—12
20240—08
20250—010
20260—0—

More from Trace Scientific, Ltd.

55 FDA decisions under this applicant name. See the company

  • K982121Enzymatic Mitochondrial Antibody (M2) ReagentTrace Scientific, Ltd. · 1998
  • K981123UREATrace Scientific, Ltd. · 1998
  • K962890Cholesterol-Incorporating Dynamic Stab Tech (DST)Trace Scientific, Ltd. · 1996
  • K961123Alt Incorporating DSTTrace Scientific, Ltd. · 1996
  • K952488Trace Cobas Mira RangeTrace Scientific, Ltd. · 1995

Recent decisions in CIT

The CIT category page

  • K093883Ast/Got 4+1 SL, Ast/Got 4+1 SL, Elical 2, Elitrol I, Elitrol II, Model Assl-0250, Assl-0455, Cali-0580…Seppim S.A.S. · 2010
  • K080485Aspartate Amino Transferase (Ast/Sgot) Test System, Asat (Got) FSDiasys Diagnostics Systems GmbH · 2008
  • K071525Activated Aspartate AminotransferaseAbbott Laboratories · 20081 recall
  • K071580Ast/Got (Ifcc), Pyridoxal Phosphate, Ecal, Nortrol and AbtrolThermofisher Scientific OY · 2007
  • K071211Cobas C 111 AnalyzerRoche Diagnostics · 20073 recalls

https://510kreport.com/device/K961114 · printed Nov 5, 2026

Cite this page

510(k) Report. “K961114: Ast Incorporating DST.” Lineage record from FDA 510(k) data and the FDA summary. Updated Nov 3, 2026. Accessed Nov 5, 2026. https://510kreport.com/device/K961114

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Record history
  • FDA decision record loaded May 2, 2026
  • Lineage and recalls computed Nov 3, 2026
  • Page last updated Nov 3, 2026