510(k) Report

510(k) · Cleared

Cleared

Ast/Got 4+1 SL, Ast/Got 4+1 SL, Elical 2, Elitrol I, Elitrol II, Model Assl-0250, Assl-0455, Cali-0580, Cont-0080, Cont-

K093883510(k) TraditionalCleared Sep 20, 2010276-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

Seppim S.A.S. · CIT Nadh Oxidation/Nad Reduction, Ast/Sgot

Cleared on Sep 20, 2010 as substantially equivalent to K060318 (Horiba Abx, 2006) and 3 other predicates after a 276-day review. Its family tree reaches back 3 generations to 1981.

Decided
Sep 20, 2010
Review
276 days
Class
Class II
Product code
CIT
Recalls
None
Predicates
4

Its longest line of descent runs back 3 generations to K811832 (1981). 8 ancestors in all, the oldest K801118 (1980). No later device cites it as a predicate yet.

Other ancestors, by year cleared 2006: 1 other ancestor2003: 1 other ancestor1998: 1 other ancestor1999: 1 other ancestor1980: 1 other ancestorK811832 · Precinorm U & Precipath U Human Serum · Boehringer Mannheim Corp. · 1981K992900 · Precinorm Universal and Precipath Universal Control Sera · Roche Diagnostics Corp. · 1999K041227 · Modification to:Roche Diagnostics Precinorm Universal and Precipath Universal Control Sera · Roche Diagnostics Corp. · 20041980198519901995200020052010
Other ancestors, by generation 1 generation back: 3 other ancestors2 generations back: 2 other ancestors K041227 · Modification to:Roche Diagnostics Precinorm Universal and Precipath Universal Control Sera · Roche Diagnostics Corp. · 2004K992900 · Precinorm Universal and Precipath Universal 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 backK992900 Precinorm Universal and Precipath Universal Control SeraRoche Diagnostics Corp. · 1999
  3. 1 generation backK041227 Modification to:Roche Diagnostics Precinorm Universal and Precipath…Roche Diagnostics Corp. · 2004
  4. This deviceK093883 Ast/Got 4+1 SL, Ast/Got 4+1 SL, Elical 2, Elitrol I, Elitrol II…Seppim S.A.S. · 2010
View FIG. 1 as a table

Line of descent and top descendants

GenerationNumberDeviceApplicantDecidedRecalls
−3K811832Precinorm U & Precipath U Human SerumBoehringer Mannheim Corp.1981—
−2K992900Precinorm Universal and Precipath Universal Control SeraRoche Diagnostics Corp.1999—
−1K041227Modification to:Roche Diagnostics Precinorm Universal and Precipath Universal…Roche Diagnostics Corp.2004—
0 (this device)K093883Ast/Got 4+1 SL, Ast/Got 4+1 SL, Elical 2, Elitrol I, Elitrol II, Model…Seppim S.A.S.2010—

Other ancestors by year cleared

Year clearedDevicesWith a Class I recall
198010
199810
199910
200310
200610
FIG. 1 — Lineage of K093883, 1981–2010Source: 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? (4)

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
*K060318Hepatic Enzymes on Abx Pentra 400 Clinical Chemistry Analyzer
Summary page 1
…nalyzer for Clinical Use (21 CFR 862.2160) Product Code: JJE Predicate devices ABX PENTRA AST OP (KO060318) Vitalab Flexor (973628) Device description The reagent device for this submission is…
Horiba Abx20061
*K973628Vitalab Flexor/Vitalab Selectra 2/Vitalab Viva
Summary page 1
…(21 CFR 862.2160) Product Code: JJE Predicate devices ABX PENTRA AST OP (KO060318) Vitalab Flexor (973628) Device description The reagent device for this submission is available as kit only. It consists of…
Vital Scientific N.V.19985
*K033501Modification to Calibrator for Automatic Systems (Cfas)
Summary page 4
…e JIT- Calibrator, secondary Predicate device Roche Diagnostics Calibrator for Automated Systems (Clfa~s) (K(033501) Device description ELiTech Clinical Systems ELICAL 2 is a lyophilized calibrator based on…
Roche Diagnostics Corp.2003—
*K041227Modification to:Roche Diagnostics Precinorm Universal and Precipath Universal Control Sera
Summary page 6
…862.1660) Product code JJX- Single (specified) analyte control. (assayed) Predicate device Roche Diagnostics Precinorm U (K041227) Roche Diagnostics Precipath U (K041227) Device description ELiTech Clinical Systems ELITROL…
Roche Diagnostics Corp.2004—

Also cleared against K060318: 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 29 years and passes through 3 companies; a new generation was cleared every 6.3 years on median.
  • 2 of the 8 ancestors have a recall of any class.
  • 1 other device also cites its predicate K060318.

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. 2010, 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?

The Vital Scientific Selectra Junior Analyzer (also trademarked as the Vital Scientific Flexor Junior Analyzer) is a discrete photometric chemistry analyzer for in vitro diagnostic use. ELiTech Clinical Systems AST/GOT 4+1 SL reagent is for the quantitative in vitro diagnostic determination of the activity of the enzyme Aspartate amino transferase in human serum and plasma on the Vital Scientific Selectra/Flexor Analyzers. Aspartate Amino Transferase…

Read the full statement (197 words)

The Vital Scientific Selectra Junior Analyzer (also trademarked as the Vital Scientific Flexor Junior Analyzer) is a discrete photometric chemistry analyzer for in vitro diagnostic use.

ELiTech Clinical Systems AST/GOT 4+1 SL reagent is for the quantitative in vitro diagnostic determination of the activity of the enzyme Aspartate amino transferase in human serum and plasma on the Vital Scientific Selectra/Flexor Analyzers. Aspartate Amino Transferase (AST) measurements are used in the diagnosis and treatment of certain types of liver and heart disease.

ELiTech Clinical Systems ELICAL 2 is a single parameter calibrator for in vitro diagnostic use in the calibration of quantitative ELiTech Clinical Systems methods on the Vital Scientific Selectra Junior Analyzer and the Vital Scientific Flexor Junior Analyzer.

ELiTech Clinical Systems ELITROL I is a single parameter control serum for in vitro diagnostic use in accuracy control of quantitative ELITech Clinical Systems methods on the Vital Scientific Selectra Junior Analyzer and the Vital Scientific Flexor Junior Analyzer.

ELiTech Clinical Systems ELITROL 11 is a single parameter control serum for in vitro diagnostic use in accuracy control of quantitative ELiTech Clinical Systems methods on the Vital Scientific Selectra Junior analyzer and the Vital Scientific Flexor Junior analyzers.

Indications for use as stated in the FDA summary.

Also cleared against K060318

1 other device cites the same predicate.

  • K102647Elitech Clinical Systems Selectra Prom/Elical 2/Elitrol I and Elitrol II/Ast/Got 4+1 SL/Potassium, Sodium…Elitechgroup Vital Scientific BV · 20114 recalls

More from Seppim S.A.S.

6 FDA decisions under this applicant name. See the company

  • K103376Elitech Clinical Systems Creatinne Pap SL Model CRSL-0250, Clitech Clinical Systems Elical 2 Model…Seppim S.A.S. · 2011
  • K102993Elitech Clinical Systems Triglycerides SL, Elitech Clinical Systems Cholesterol SLSeppim S.A.S. · 2011
  • K100547Elitech Clinical Systems HBA1C Reagent, Elitech Clincal System HBA1C Calibrator Set, Elitech ClinicalSeppim S.A.S. · 2011
  • K100263Elitech Clinical Systems Phosphorus, Uric Acid Mono SL and Urea UV SL ReagentsSeppim S.A.S. · 2011
  • K100525Elitech Clinical Systems Glucose Pap SL Elitech Clinical Systems Elical 2, Elitech Clinical Systems Elitrol…Seppim S.A.S. · 20104 recalls

Recent decisions in CIT

The CIT category page

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

https://510kreport.com/device/K093883 · printed Nov 4, 2026

Cite this page

510(k) Report. “K093883: Ast/Got 4+1 SL, Ast/Got 4+1 SL, Elical 2, Elitrol I, Elitrol II, Model Assl-0250, Assl-0455, Cali-0580, Cont-0080, Cont-.” Lineage record from FDA 510(k) data and the FDA summary. Updated Nov 3, 2026. Accessed Nov 4, 2026. https://510kreport.com/device/K093883

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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