510(k) Report

510(k) · Cleared

Cleared

Ast/Got (Ifcc), Pyridoxal Phosphate, Ecal, Nortrol and Abtrol

K071580510(k) TraditionalCleared Oct 3, 2007117-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

Thermofisher Scientific OY · CIT Nadh Oxidation/Nad Reduction, Ast/Sgot

Cleared on Oct 3, 2007 as substantially equivalent to K992136 (Bayer Corp., 1999) after a 117-day review. Its family tree reaches back 1 generation to 1999.

Decided
Oct 3, 2007
Review
117 days
Class
Class II
Product code
CIT
Recalls
None
Predicates
1

Its longest line of descent runs back 1 generation to K992136 (1999). No later device cites it as a predicate yet.

K992136 · Bayer Advia Integrated Modular System (Ims) · Bayer Corp. · 19991996199820002002200420062008
K992136 · Bayer Advia Integrated Modular System (Ims) · Bayer Corp. · 19990
  1. Root · 1 generation backK992136 Bayer Advia Integrated Modular System (Ims)Bayer Corp. · 1999
  2. This deviceK071580 Ast/Got (Ifcc), Pyridoxal Phosphate, Ecal, Nortrol and AbtrolThermofisher Scientific OY · 2007
View FIG. 1 as a table

Line of descent and top descendants

GenerationNumberDeviceApplicantDecidedRecalls
−1K992136Bayer Advia Integrated Modular System (Ims)Bayer Corp.1999—
0 (this device)K071580Ast/Got (Ifcc), Pyridoxal Phosphate, Ecal, Nortrol and AbtrolThermofisher Scientific OY2007—
FIG. 1 — Lineage of K071580, 1999–2007Source: 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? (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.

TypeNumberDeviceApplicantDecidedRecalls
*K992136Bayer Advia Integrated Modular System (Ims)
Summary page 3
…marketed in United States. We claim equivalence to the Bayer ADVIA IMS Aspartate Aminotransferase (AST) assay (K992136). Therl o Fisher Scientific Ov Rataslie 2 -358 (9) 329 1ICtel Y-tunnus 0921547-0 d.. ..... o..…
Bayer Corp.1999—

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.

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. 2007, 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?

AST I GOT (IFCC) The AST/ GOT (IFCC) test system is intended for quantitative in-vitro diagnostic determination of the activity of the enzyme aspartate amino transferase (AST) (also known as a serum glutamic oxaloacetic transferase or SGOT) in serum and plasma on T60 instrument. Measurement of aspartate amino transferase levels aids in tile diagnosis and treatment of certain types of liver and heart disease Auxiliary product: Pyridoxal Phosphate…

Read the full statement (220 words)

AST I GOT (IFCC)

The AST/ GOT (IFCC) test system is intended for quantitative in-vitro diagnostic determination of the activity of the enzyme aspartate amino transferase (AST) (also known as a serum glutamic oxaloacetic transferase or SGOT) in serum and plasma on T60 instrument. Measurement of aspartate amino transferase levels aids in tile diagnosis and treatment of certain types of liver and heart disease

Auxiliary product: Pyridoxal Phosphate

Auxiliary reagent for in vitro diagnostic use in the quantitative determination of AST (GOT) codes 981363 and 981771, activity according to the IFCC recommendations with 3-reagent method on T60 instrument.

eCal!

For in vitro diagnostic use on T60 instrument. eCal is used as a calibrator for enzyme tests using methods defined by Thermo Fisher Scientific Oy

Nortrol

For in vitro diagnostic use for quantitative testing on T60 instrument. Nortrol is a control serum to monitor precision of the analytes listed in the separate Nortrol value sheet. The given values are valid for T60 Clinical Chemistry Instruments using methods defined by Thermo Fisher Scientific Oy.

Abtrol

For in vitro diagnostic use for quantitative testing on T60 instrument. Abtrol is a control serum to monitor precision of the analytes listed in the separate Abtrol value sheet. The given values are valid for T60 Clinical Chemistry Instruments using methods defined by Thermo Fisher Scientific Oy.

Indications for use as stated in the FDA summary.

More from Thermofisher Scientific OY

8 FDA decisions under this applicant name. See the company

  • K110035IndikoThermofisher Scientific OY · 20111 recall
  • K073295Urea/Bun, Scal, Nortrol, AbtrolThermofisher Scientific OY · 2008
  • K073612Uric Acid (Aox), Scal, Nortrol, AbtrolThermofisher Scientific OY · 2008
  • K073355Calcium, Scal, Nortrol, AbtrolThermofisher Scientific OY · 2008
  • K073191Alkaline Phosphatase (Ifcc) Plus, Ecal, Nortrol, AbtrolThermofisher Scientific OY · 2008

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
  • K071211Cobas C 111 AnalyzerRoche Diagnostics · 20073 recalls
  • K060318Hepatic Enzymes on Abx Pentra 400 Clinical Chemistry AnalyzerHoriba Abx · 20061 recall

https://510kreport.com/device/K071580 · printed Nov 4, 2026

Cite this page

510(k) Report. “K071580: Ast/Got (Ifcc), Pyridoxal Phosphate, Ecal, Nortrol and Abtrol.” Lineage record from FDA 510(k) data and the FDA summary. Updated Nov 3, 2026. Accessed Nov 4, 2026. https://510kreport.com/device/K071580

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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