510(k) Report

510(k) · Cleared

Cleared

Wiener Lab. Got (Ast) UV AA. Weiner Lab. Got (Ast) UV Unitest, Models 10 * 20 ML Cat. NR. 1751302 and 20 * 2 ML Cat NR.

K013145510(k) TraditionalCleared Nov 27, 200168-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

Wiener Laboratories Saic · CIT Nadh Oxidation/Nad Reduction, Ast/Sgot

Cleared on Nov 27, 2001 after a 68-day review. The FDA summary names its predicate without a number.

Decided
Nov 27, 2001
Review
68 days
Class
Class II
Product code
CIT
Recalls
None
Predicates
0

The FDA summary names its predicate without a number.

FIG. 1 — Lineage of K013145Source: FDA 510(k) database · 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
*—RANDOX AST ASAT GOT OPT. test system
Named without a submission number
—

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.

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—

What is it indicated for?

The “Wiener lab. GOT (AST) UV” test system is an in vitro diagnostic device intended to be used in the quantitative determination of aspartate amino transferase (AST or GOT) in human serum and plasma. Aspartate amino transferase measurements are used in the diagnosis and treatment of certain types of liver and heart diseases.

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

More from Wiener Laboratories Saic

24 FDA decisions under this applicant name. See the company

  • K023889Wiener Lab. Chagatest Elisa Recomninante V.3.0, Model 96 Tests Cat. NR. 1203254Wiener Laboratories Saic · 20041 recall
  • K024305Wiener Lab. Calibrator a Plus, Model 2X3 ML Cat. NR. 1918006Wiener Laboratories Saic · 2003
  • K024116Wiener Lab. Bilirubina Direct AAWiener Laboratories Saic · 2003
  • K023992Wiener Lab Colinesterasa AAWiener Laboratories Saic · 2003
  • K023744Wiener Lab. CK-MB DS UV Unitest, Model 28 X 2.5 ML Cat. NR. 1271354Wiener Laboratories Saic · 2003

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/K013145 · printed Nov 6, 2026

Cite this page

510(k) Report. “K013145: Wiener Lab. Got (Ast) UV AA. Weiner Lab. Got (Ast) UV Unitest, Models 10 * 20 ML Cat. NR. 1751302 and 20 * 2 ML Cat NR..” Lineage record from FDA 510(k) data and the FDA summary. Updated Nov 3, 2026. Accessed Nov 6, 2026. https://510kreport.com/device/K013145

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Record history
  • FDA decision record loaded May 2, 2026
  • Summary read Oct 30, 2026 (extraction version 2d9447fa9ea4)
  • Page last updated Nov 3, 2026