510(k) Report

510(k) · Cleared

Cleared

Dimension RXL Max with Advia Modular Automation System (Amas)

K083339510(k) TraditionalCleared Mar 9, 2009117-day reviewClass II21 CFR 862.1145

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. · CIC Cresolphthalein Complexone, Calcium

Cleared on Mar 9, 2009 as substantially equivalent to K944093 (E.I. Dupont DE Nemours & Co., Inc., 1994) and 2 other predicates after a 117-day review. Its family tree reaches back 1 generation to 1986.

Decided
Mar 9, 2009
Review
117 days
Class
Class II
Product code
CIC
Recalls
None
Predicates
3

Its longest line of descent runs back 1 generation to K860021 (1986). 3 ancestors in all. No later device cites it as a predicate yet.

Other ancestors, by year cleared 2005: 1 other ancestor1994: 1 other ancestorK860021 · Dimension (TM) Clinical Chemistry System · E.I. Dupont DE Nemours & Co., Inc. · 1986 · recalled198519901995200020052010
Other ancestors, by generation 1 generation back: 2 other ancestors K860021 · Dimension (TM) Clinical Chemistry System · E.I. Dupont DE Nemours & Co., Inc. · 1986 · recalled0
  1. Root · 1 generation backK860021 Dimension (TM) Clinical Chemistry SystemE.I. Dupont DE Nemours & Co., Inc. · 1986 · Recalled
  2. This deviceK083339 Dimension RXL Max with Advia Modular Automation System (Amas)Siemens Healthcare Diagnostics, Inc. · 2009
View FIG. 1 as a table

Line of descent and top descendants

GenerationNumberDeviceApplicantDecidedRecalls
−1K860021Dimension (TM) Clinical Chemistry SystemE.I. Dupont DE Nemours & Co., Inc.19861
0 (this device)K083339Dimension RXL Max with Advia Modular Automation System (Amas)Siemens Healthcare Diagnostics, Inc.2009—

Other ancestors by year cleared

Year clearedDevicesWith a Class I recall
199410
200510
FIG. 1 — Lineage of K083339, 1986–2009Source: 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 CIC? 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
*K944093Dimension (R) XL Clinical Chemistry System
Summary page 1
…Product Code Dimension® XL Clinical JJE J K944093 Chemistry System Dimension® CA Flex Reagent CIC…
E.I. Dupont DE Nemours & Co., Inc.1994—
*K860021Dimension (TM) Clinical Chemistry System
Summary page 1
…Chemistry System Dimension® CA Flex Reagent CIC K860021 Cartridge 4. Device Description(s): The Dimension® RxL Max® Chemistry System is a continuous ope…
E.I. Dupont DE Nemours & Co., Inc.19861
*K043546Dimension RXL Max with Streamlab Analytical Workcell and Sample Transfer Module
Summary page 1
…10(k) filed in 1994 K944093). The Dimension& RxL Max® Chemistry System has also been cleared with StreamLab Analytical WorkCell and Sample Transfer Module (K043546) The ADVIA® Modular Automation System (AMAS) is a laboratory automation system (LAS) designed to automate sample…
Dade Behring, Inc.20053

Also cleared against K944093: 3 other devices →

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?

  • 2 of the 3 ancestors have a recall of any class.
  • 3 other devices also cite its predicate K944093.

How does its category compare?

All CIC devices

CIC Cresolphthalein Complexone, Calcium: FDA decisions, review times, recalls and adverse event reports over 20 years. 2009, this device’s year, is highlighted.

FDA decisions per year · CIC

1in 2013

2007: 12009: 12013: 1
2007high 1 (2007) · low 0 (2008)2026

2026 to Oct 25, outlined.

Median 510(k) review, days · CIC

Too few CIC 510(k)s in any year since 2007 to give a median.

Recalls per year · CIC

1in 2016

2009: 32010: 22016: 1
2007high 3 (2009) · low 0 (2007)2026

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

Adverse event reports per year · CIC

10in 2025

2009: 52010: 832011: 292012: 102013: 42014: 12016: 302017: 62018: 422021: 12023: 42024: 82025: 10
2007high 83 (2010) · low 0 (2007)2025

MAUDE reports naming product code CIC, 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
20071—00
20080—00
20091—35
20100—283
20110—029
20120—010
20131—04
20140—01
20150—00
20160—130
20170—06
20180—042
20190—00
20200—00
20210—01
20220—00
20230—04
20240—08
20250—010
20260—0—

What is it indicated for?

The Dimension® RxL Max® Clinical Chemistry System with Sample Transfer Module and the ADVIA® Modular Automation System is a discrete random access, microprocessor-controlled, integrated instrument/chemistry system that measures a variety of analytes, including enzyme activities in body fluids. The system menu will include assays, such as Calcium, along with other various assays that may be adaptable to the analyzer depending on the reagent used.

Calcium is intended to quantitatively measure Calcium in human serum or plasma. Calcium measurements are used in the diagnosis and treatment of parathyroid disease, a variety of bone diseases, chronic renal disease and tetany.

Indications for use as stated in the FDA summary.

Also cleared against K944093

3 other devices cite the same predicate.

  • K060266Dimension Iron CalibratorDade Behring, Inc. · 20061 recall
  • K060264Dimension Iron Flex Reagent Cartridge (Iron-DF85)Dade Behring, Inc. · 20062 recalls
  • K051087Dimension Vista Integrated SystemDade Behring, Inc. · 200532 recalls

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
  • P010007/S027IMMULITE Systems AFPSiemens Healthcare Diagnostics, Inc. · 2026

Recent decisions in CIC

The CIC category page

  • K130870Hitachi Clinical Analyzer S Test Reagent Cartridge Calcium (CA)Hitachi Chemical Diagnostics, Inc. · 2013
  • K070249Abx Pentra 400, Calcium CP, Creatinine CP, Phosphorus CP, Amylase CP, Urine Control L/HHoriba Abx · 20071 recall
  • K053401Spotchem II Chemistry Basic 1 and Chemistry Basic 2 TestsArkray, Inc. · 20061 Class I recall
  • K050077Spotchem II Calcium, Magnesium, and Blood Urea Nitrogen TestsArkray, Inc. · 2005
  • K041009Raichem Calcium (Ocpc) Liquid ReagentHemagen Diagnostics, Inc. · 20041 recall

https://510kreport.com/device/K083339 · printed Nov 5, 2026

Cite this page

510(k) Report. “K083339: Dimension RXL Max with Advia Modular Automation System (Amas).” Lineage record from FDA 510(k) data and the FDA summary. Updated Nov 3, 2026. Accessed Nov 5, 2026. https://510kreport.com/device/K083339

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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