510(k) Report

510(k) · Cleared

Cleared

Aspartate Amino Transferase (Ast/Sgot) Test System, Asat (Got) FS

K080485510(k) TraditionalCleared Dec 4, 2008286-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

Diasys Diagnostics Systems GmbH · CIT Nadh Oxidation/Nad Reduction, Ast/Sgot

Cleared on Dec 4, 2008 as substantially equivalent to K924244 (Roche Diagnostic Systems, Inc., 1993) and 2 other predicates after a 286-day review. Its family tree reaches back 3 generations to 1981.

Decided
Dec 4, 2008
Review
286 days
Class
Class II
Product code
CIT
Recalls
None
Predicates
3

Its longest line of descent runs back 3 generations to K811832 (1981). 5 ancestors in all. No later device cites it as a predicate yet.

Other ancestors, by year cleared 1999: 1 other ancestor1993: 1 other ancestorK811832 · Precinorm U & Precipath U Human Serum · Boehringer Mannheim Corp. · 1981K993360 · Precinorm Universal Plus and Precipath Universal Plus Control Sera · Roche Diagnostics Corp. · 1999K042389 · Modification to Precinorm Universal Plus and Precipath Universal Plus Control Sera · Roche Diagnostics Corp. · 20041980198519901995200020052010
Other ancestors, by generation 1 generation back: 2 other ancestors K042389 · Modification to Precinorm Universal Plus and Precipath Universal Plus Control Sera · Roche Diagnostics Corp. · 2004K993360 · Precinorm Universal Plus and Precipath Universal Plus Control Sera · Roche Diagnostics Corp. · 1999K811832 · Precinorm U & Precipath U Human Serum · Boehringer Mannheim Corp. · 19810
  1. Root · 3 generations backK811832 Precinorm U & Precipath U Human SerumBoehringer Mannheim Corp. · 1981
  2. 2 generations backK993360 Precinorm Universal Plus and Precipath Universal Plus Control SeraRoche Diagnostics Corp. · 1999
  3. 1 generation backK042389 Modification to Precinorm Universal Plus and Precipath Universal…Roche Diagnostics Corp. · 2004
  4. This deviceK080485 Aspartate Amino Transferase (Ast/Sgot) Test System, Asat (Got) FSDiasys Diagnostics Systems GmbH · 2008
View FIG. 1 as a table

Line of descent and top descendants

GenerationNumberDeviceApplicantDecidedRecalls
−3K811832Precinorm U & Precipath U Human SerumBoehringer Mannheim Corp.1981—
−2K993360Precinorm Universal Plus and Precipath Universal Plus Control SeraRoche Diagnostics Corp.1999—
−1K042389Modification to Precinorm Universal Plus and Precipath Universal Plus Control…Roche Diagnostics Corp.2004—
0 (this device)K080485Aspartate Amino Transferase (Ast/Sgot) Test System, Asat (Got) FSDiasys Diagnostics Systems GmbH2008—

Other ancestors by year cleared

Year clearedDevicesWith a Class I recall
199310
199910
FIG. 1 — Lineage of K080485, 1981–2008Source: FDA 510(k) summaries, read by 510(k) Report · How lineage is built

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

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? (3)

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.

TypeNumberDeviceApplicantDecidedRecalls
*K924244Roche Reagent for Ast
Summary page 2
…Page 1 D. Predicate Device Roche/Hitachi AST (ASAT/GOT) Aspartate aminotransferase ace. to IFCC with/without pynidoxal phosphate activation (k924244) Roche Calibrator for automated systems (C.f.a.s.) (k990460). Roche Precinorm Universal Plus and Precipath Universal Plus contr…
Roche Diagnostic Systems, Inc.1993—
*K990460Calibrator for Automated Systems (C.F.a.S.)
Summary page 2
…/Hitachi AST (ASAT/GOT) Aspartate aminotransferase ace. to IFCC with/without pynidoxal phosphate activation (k924244) Roche Calibrator for automated systems (C.f.a.s.) (k990460). Roche Precinorm Universal Plus and Precipath Universal Plus controls (k042389). E. Device Description and Explanation of the…
Roche Diagnostics Corp.1999—
*K042389Modification to Precinorm Universal Plus and Precipath Universal Plus Control Sera
Summary page 2
…doxal phosphate activation (k924244) Roche Calibrator for automated systems (C.f.a.s.) (k990460). Roche Precinorm Universal Plus and Precipath Universal Plus controls (k042389). E. Device Description and Explanation of the Test The DiaSys ASAT (GOT) FS assay is based on NADH reduction to NAD, as shown…
Roche Diagnostics Corp.2004—

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?

  • The line of descent spans 27 years and passes through 3 companies; a new generation was cleared every 4.8 years on median.
  • None of the 5 ancestors has a 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. 2008, this device’s year, is highlighted.

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—

What is it indicated for?

ASAT (GOT) FS The ASAT (GOT) FS assay is intended for quantitative in vitro diagnostic determination of the activity of the enzyme aspartate amino transferase (AST) in human serum and lithium heparin plasma on the Hitachi 917 instrument. Measurement of aspartate amino transferase levels aids in the diagnosis and treatment of certain types of liver and heart disease. TruCal U For In vitro diagnostic use on the Hitachi 917 instrument. TruCal U is used as a…

Read the full statement (124 words)

ASAT (GOT) FS

The ASAT (GOT) FS assay is intended for quantitative in vitro diagnostic determination of the activity of the enzyme aspartate amino transferase (AST) in human serum and lithium heparin plasma on the Hitachi 917 instrument. Measurement of aspartate amino transferase levels aids in the diagnosis and treatment of certain types of liver and heart disease.

TruCal U

For In vitro diagnostic use on the Hitachi 917 instrument. TruCal U is used as a calibrator for the DiaSys ASAT (GOT) FS assay.

TruLab N and TruLab P Controls

For in vitro diagnostic use for quantitative testing on the Hitachi 917 instrument. TruLab N and TruLab P control sera are used to monitor accuracy and precision for the DiaSys ASAT (GOT) FS assay.

Indications for use as stated in the FDA summary.

Also cleared against K924244

1 other device cites the same predicate.

  • K981225Aspartate Aminotransferase (Ast)Abbott Laboratories · 1998

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
  • 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
  • K060318Hepatic Enzymes on Abx Pentra 400 Clinical Chemistry AnalyzerHoriba Abx · 20061 recall

https://510kreport.com/device/K080485 · printed Nov 3, 2026

Cite this page

510(k) Report. “K080485: Aspartate Amino Transferase (Ast/Sgot) Test System, Asat (Got) FS.” Lineage record from FDA 510(k) data and the FDA summary. Updated Nov 3, 2026. Accessed Nov 3, 2026. https://510kreport.com/device/K080485

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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