510(k) Report

510(k) · Cleared

Cleared

ADVIA Chemistry Enzyme 1 Calibrator, ADVIA Chemistry Enzyme 2 Calibrator

K153365510(k) TraditionalCleared Dec 18, 201528-day reviewClass II21 CFR 862.1150

Data to Oct 25, 2026 (FDA decisions) Oct 12, 2026 (recalls) Sep 30, 2026 (MAUDE) refreshed weekly, last Nov 3, 2026

Siemens Healthcare Diagnostics, Inc. · JIX Calibrator, Multi-Analyte Mixture

Cleared on Dec 18, 2015 as substantially equivalent to K061923 (Dade Behring, Inc., 2006) and 1 other predicate after a 28-day review. Its family tree reaches back 3 generations to 1986.

Decided
Dec 18, 2015
Review
28 days
Class
Class II
Product code
JIX
Recalls
None
Predicates
2

Its longest line of descent runs back 3 generations to K860021 (1986). 4 ancestors in all. No later device cites it as a predicate yet.

Other ancestors, by year cleared 2006: 1 other ancestorK860021 · Dimension (TM) Clinical Chemistry System · E.I. Dupont DE Nemours & Co., Inc. · 1986 · recalledK061390 · Dimension Vista System ENZYME2 Calibrator, Model KC320 · Dade Behring, Inc. · 2006K103612 · Dimension Visa Enz 2 Cal · Siemens Healthcare Diagnostics, Inc. · 2011 · recalled1985199019952000200520102015
Other ancestors, by generation 1 generation back: 1 other ancestor K103612 · Dimension Visa Enz 2 Cal · Siemens Healthcare Diagnostics, Inc. · 2011 · recalledK061390 · Dimension Vista System ENZYME2 Calibrator, Model KC320 · Dade Behring, Inc. · 2006K860021 · Dimension (TM) Clinical Chemistry System · E.I. Dupont DE Nemours & Co., Inc. · 1986 · recalled0
  1. Root · 3 generations backK860021 Dimension (TM) Clinical Chemistry SystemE.I. Dupont DE Nemours & Co., Inc. · 1986 · Recalled
  2. 2 generations backK061390 Dimension Vista System ENZYME2 Calibrator, Model KC320Dade Behring, Inc. · 2006
  3. 1 generation backK103612 Dimension Visa Enz 2 CalSiemens Healthcare Diagnostics, Inc. · 2011 · Recalled
  4. This deviceK153365 ADVIA Chemistry Enzyme 1 Calibrator, ADVIA Chemistry Enzyme 2…Siemens Healthcare Diagnostics, Inc. · 2015
View FIG. 1 as a table

Line of descent and top descendants

GenerationNumberDeviceApplicantDecidedRecalls
−3K860021Dimension (TM) Clinical Chemistry SystemE.I. Dupont DE Nemours & Co., Inc.19861
−2K061390Dimension Vista System ENZYME2 Calibrator, Model KC320Dade Behring, Inc.2006—
−1K103612Dimension Visa Enz 2 CalSiemens Healthcare Diagnostics, Inc.20111
0 (this device)K153365ADVIA Chemistry Enzyme 1 Calibrator, ADVIA Chemistry Enzyme 2 CalibratorSiemens Healthcare Diagnostics, Inc.2015—

Other ancestors by year cleared

Year clearedDevicesWith a Class I recall
200610
FIG. 1 — Lineage of K153365, 1986–2015Source: 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 JIX? 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
Get a 510(k) Report

What was it cleared against? (2)

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
*K061923Dimension Vista Enzyme 1 Calibrator (Enz 1 Cal - KC310)
Summary page 5
…Class II Product Code: JIX Panel: Clinical Chemistry 6. Predicate Device: Device Name: Dimension® Vista ENZ 1 CAL; Dimension® Vista ENZ 2 CAL 510(k) Number: k061923; k103612 Manufacturer: Siemens Healthcare Diagnostics Inc. 7. Intended Use: See Indications for Use 8. Indications for…
Dade Behring, Inc.20061
*K103612Dimension Visa Enz 2 Cal
Summary page 5
…Product Code: JIX Panel: Clinical Chemistry 6. Predicate Device: Device Name: Dimension® Vista ENZ 1 CAL; Dimension® Vista ENZ 2 CAL 510(k) Number: k061923; k103612 Manufacturer: Siemens Healthcare Diagnostics Inc. 7. Intended Use: See Indications for Use 8. Indications for Use:…
Siemens Healthcare Diagnostics, Inc.20111

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 4.9 years on median.
  • 3 of the 4 ancestors have a recall of any class.

How does its category compare?

All JIX devices

JIX Calibrator, Multi-Analyte Mixture: FDA decisions, review times, recalls and adverse event reports over 20 years. 2015, this device’s year, is highlighted.

FDA decisions per year · JIX

1in 2016

2007: 62008: 52009: 42010: 52011: 72012: 22013: 42014: 12015: 32016: 1
2007high 7 (2011) · low 0 (2017)2026

2026 to Oct 25, outlined.

Median 510(k) review, days · JIX

29in 2015

2007: 53 days median2008: 69 days median2009: 121 days median2010: 100 days median2011: 77 days median2013: 50 days median2015: 29 days median
2007high 121 (2009) · low 29 (2015)2026

Receipt to decision; years with fewer than 3 clearances left blank.

Recalls per year · JIX

7in 2023

2007: 22008: 32009: 22010: 12011: 22012: 12014: 12016: 12017: 12018: 12019: 12020: 22023: 72026 (partial year): 1
2007high 7 (2023) · low 0 (2013)2026

Class I (0 since 2007) Class II/III not classified

Adverse event reports per year · JIX

18in 2025

2007: 1402008: 1732009: 392011: 92012: 32013: 242014: 352015: 42016: 62017: 172018: 162019: 122020: 222021: 92022: 112023: 132024: 152025: 18
2007high 173 (2008) · low 0 (2010)2025

MAUDE reports naming product code JIX, 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
20076532140
20085693173
20094121239
2010510010
201177729
20122—13
2013450024
20141—135
201532904
20161—16
20170—117
20180—116
20190—112
20200—222
20210—09
20220—011
20230—713
20240—015
20250—018
20260—1—

What is it indicated for?

ADVIA Chemistry Enzyme 1 Calibrator is intended for in vitro diagnostic use in the calibration of Gamma-Glutamyl Transferase (GGT), Lactate Dehydrogenase P-L (LDPL), Lactate Dehydrogenase L-P (LDLP), Cholinesterase (CHE), an& Lipase (LIP) assays on the ADVIA Chemistry systems. ADVIA® Chemistry Enzyme 2 Calibrator is intended for in vitro diagnostic use in the calibration of Alanine Aminotransferase (ALT); Alanine Aminotransferase, Concentrated Reagents…

Read the full statement (97 words)

ADVIA Chemistry Enzyme 1 Calibrator is intended for in vitro diagnostic use in the calibration of Gamma-Glutamyl

Transferase (GGT), Lactate Dehydrogenase P-L (LDPL), Lactate Dehydrogenase L-P (LDLP), Cholinesterase (CHE), an&

Lipase (LIP) assays on the ADVIA Chemistry systems.

ADVIA® Chemistry Enzyme 2 Calibrator is intended for in vitro diagnostic use in the calibration of Alanine

Aminotransferase (ALT); Alanine Aminotransferase, Concentrated Reagents (ALT_c); Alanine Aminotransferase (P5P)

(ALTPSP); Alanine Aminotransferase (P5P), Concentrated Reagents (ALTP_c); Aspartate Aminotransferase (AST);

Aspartate Aminotransferase, Concentrated Reagents (AST_c); Aspartate Aminotransferase (P5SP) (ASTP5P); and

Aspartate Aminotransferase (P5P), Concentrated Reagents (ASTP_c) assays on the ADVIA Chemistry systems.

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

More from Siemens Healthcare Diagnostics, Inc.

281 FDA decisions under this applicant name. See the company

  • P930027/S041IMMULITE Systems PSASiemens Healthcare Diagnostics, Inc. · 2026
  • P010007/S028IMMULITE Systems AFPSiemens Healthcare Diagnostics, Inc. · 2026
  • P240021/S001Atellica IM Total PSA II (tPSAII)Siemens Healthcare Diagnostics, Inc. · 2026
  • P930027/S040IMMULITE Systems PSASiemens Healthcare Diagnostics, Inc. · 2026
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Recent decisions in JIX

The JIX category page

  • K161140VITROS Chemistry Products Calibrator Kit 3Ortho-Clinical Diagnostics, Inc. · 2016
  • K151552ELITech Clinical Systems ELICAL 2, ELITech Clinical Systems ELITROL I, ELITech Clinical Systems ELITROL IIElitechgroup · 2015
  • K140790Dimension Vista Chemistry 1 Calibrator (CHEM 1 CAL), Dimension Vista Magnesium Flex reagent cartridge (MG)Siemens Healthcare Diagnostics · 20152 recalls
  • K141388System CalibraterBeckman Coulter Ireland, Inc. · 2014
  • K133330C.F.a.S. Proteins, C.F.a.S. Pac, Precicontrol Clinchem Multi 1 & 2, Precinorm Protein & Precipath ProteinRoche Diagnostics · 2013

https://510kreport.com/device/K153365 · printed Nov 5, 2026

Cite this page

510(k) Report. “K153365: ADVIA Chemistry Enzyme 1 Calibrator, ADVIA Chemistry Enzyme 2 Calibrator.” Lineage record from FDA 510(k) data and the FDA summary. Updated Nov 3, 2026. Accessed Nov 5, 2026. https://510kreport.com/device/K153365

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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