510(k) · Cleared
Recalled · Class II · 2020Accelerator Aps
Data to Oct 25, 2026 (FDA decisions) Oct 12, 2026 (recalls) Sep 30, 2026 (MAUDE) refreshed weekly
Abbott Laboratories · CEM Electrode, Ion Specific, Potassium
Cleared on Feb 19, 2010 as substantially equivalent to K980367 (Abbott Laboratories, 1998) and 1 other predicate after a 119-day review. Its family tree reaches back 5 generations to 1990. 3 later devices descend from it. It has been recalled 2 times.
- Decided
- Feb 19, 2010
- Review
- 119 days
- Class
- Class II
- Product code
- CEM
- Recalls
- 2
- Predicates
- 2
Its longest line of descent runs back 5 generations to K902336 (1990). 9 ancestors in all, the oldest K872494 (1987). 3 later devices descend from it, 2 citing it directly.
- Root · 5 generations backK902336 Ciba Corning Acs:180 Automated ChemiluminescenceCiba Corning Diagnostics Corp. · 1990
- 4 generations backK971418 Chiron Diagnostics Automated Chemiluminescence System (Asc) Centaur…Chiron Diagnostics Corp. · 1997 · Recalled
- 3 generations backK032525 Bayer Advia Centaur Automated Chemiluminescence AnalyzerBayer Healthcare, LLC · 2003
- 2 generations backK041133 Modification to Bayer Advia Centaur Automated Chemiluminescence…Bayer Healthcare, LLC · 2004 · Recalled
- 1 generation backK082638 Advia Centaur System with Streamlab Analytical WorkcellSiemens Healthcare Diagnostics, Inc. · 2009 · Recalled
- This deviceK093318 Accelerator ApsAbbott Laboratories · 2010
- Descendant · cites it directly · 1 of its ownK213486 GLP systems TrackAbbott Laboratories · 2022
- Descendant · 2 generations on · 0 of its ownK230937 Alinity i Total ß-hCG Reagent Kit, GLP systems TrackAbbott Laboratories · 2023
- Descendant · cites it directly · 0 of its ownK121012 Flexlab 3.6, Accelerator A3600Inpeco S.P.A. · 2012 · Recalled
Most influential descendants
Showing 3 of 3 · See allView FIG. 1 as a table
Line of descent and top descendants
| Generation | Number | Device | Applicant | Decided | Recalls |
|---|---|---|---|---|---|
| −5 | K902336 | Ciba Corning Acs:180 Automated Chemiluminescence | Ciba Corning Diagnostics Corp. | 1990 | — |
| −4 | K971418 | Chiron Diagnostics Automated Chemiluminescence System (Asc) Centaur Analyzer | Chiron Diagnostics Corp. | 1997 | 4 |
| −3 | K032525 | Bayer Advia Centaur Automated Chemiluminescence Analyzer | Bayer Healthcare, LLC | 2003 | — |
| −2 | K041133 | Modification to Bayer Advia Centaur Automated Chemiluminescence Analyzer | Bayer Healthcare, LLC | 2004 | 8 |
| −1 | K082638 | Advia Centaur System with Streamlab Analytical Workcell | Siemens Healthcare Diagnostics, Inc. | 2009 | 3 |
| 0 (this device) | K093318 | Accelerator Aps | Abbott Laboratories | 2010 | — |
| +1 | K213486 | GLP systems Track | Abbott Laboratories | 2022 | — |
| +2 | K230937 | Alinity i Total ß-hCG Reagent Kit, GLP systems Track | Abbott Laboratories | 2023 | — |
| +1 | K121012 | Flexlab 3.6, Accelerator A3600 | Inpeco S.P.A. | 2012 | 33 |
Other ancestors by year cleared
| Year cleared | Devices | With a Class I recall |
|---|---|---|
| 1987 | 1 | 0 |
| 1991 | 1 | 0 |
| 1998 | 1 | 0 |
| 2005 | 1 | 0 |
Descendants by year cleared
| Year cleared | Devices | With a Class I recall |
|---|---|---|
| 2012 | 1 | 0 |
| 2022 | 1 | 0 |
| 2023 | 1 | 0 |
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 CEM? A 510(k) Report weighs predicate choices, recall history and review times for a new device like this one.
Top candidate predicates for a new CEM device
- #1 K253491 ISE indirect K for Gen.2; ISE indirect Na for…score 11.4 · 3 generations · no Class I recall
- #2 Held for the reportin the report
- #3 Held for the reportin the 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.
| Type | Number | Device | Decided |
|---|---|---|---|
| * | K980367 | Aeroset SystemSummary page 1…Product Code Assay _ _ _ _ _ _ _ _ _ ARCHITECT cSOOO System K980367/A002 JJE Clinical Chemistry ICT - K980367… | 1998 |
| * | K082638 | Advia Centaur System with Streamlab Analytical WorkcellSummary page 1…K980367 JQS,CEM,CGZ Sodium, Potassium, Chloride ADVIA Centaur. with K082638 JJE StreamLAB Analytical -W orkcell _ _ _ _… | 2009 |
What descends from it? (3)
2 later devices cite it directly; ranked here by how many devices descend from each in turn.
Has anything in its family been recalled? (0 Class I)
Recalls of this device
| Date | Class | Recall | Root cause | Reason |
|---|---|---|---|---|
| Apr 2, 2020 | Class II | Z-2251-2020 | Software Design Change | In the case of an AQM clot detection error a portion of the distilled water from the Aliquoter Module hydraulic circuit may be dispensed into the Primary Tube leading to sample dilution, which could lead to incorrect results. |
| Sep 7, 2018 | Class II | Z-2755-2019 | Component change control | The firm identified customer sites where modules which the safety pacemaker label is missing. Information regarding the label included in the Operations Manual has been updated to specify: 1) the risk of malfunction applies to anyone with… |
No ancestor or descendant has a Class I recall.
What does this lineage say?
- The line of descent spans 20 years and passes through 5 companies; a new generation was cleared every 4.7 years on median.
- 5 of the 9 ancestors have a recall of any class.
- Of its descendants, K213486 (Abbott Laboratories, 2022) has gone furthest, with 1 descendant of its own.
- 2 other devices also cite its predicate K980367.
How does its category compare?
All CEM devicesCEM Electrode, Ion Specific, Potassium: FDA decisions, review times, recalls and adverse event reports over 20 years. 2010, this device’s year, is highlighted.
FDA decisions per year · CEM
1in 2025
2026 to Oct 25, outlined.
Median 510(k) review, days · CEM
180in 2012
Receipt to decision; years with fewer than 3 clearances left blank.
Recalls per year · CEM
4in 2025
Class I (0 since 2007) Class II/III not classified
Adverse event reports per year · CEM
29in 2025
MAUDE reports naming product code CEM, not matched to any one device; reports are not rates.
View these four charts as a table
| Year | Decisions | Median 510(k) review, days | Recalls (Class I) | MAUDE reports |
|---|---|---|---|---|
| 2007 | 1 | — | 0 | 66 |
| 2008 | 0 | — | 1 | 245 |
| 2009 | 1 | — | 0 | 79 |
| 2010 | 3 | 195 | 12 | 113 |
| 2011 | 3 | 74 | 6 | 126 |
| 2012 | 4 | 180 | 0 | 45 |
| 2013 | 0 | — | 0 | 37 |
| 2014 | 0 | — | 0 | 4 |
| 2015 | 0 | — | 0 | 7 |
| 2016 | 0 | — | 1 | 6 |
| 2017 | 0 | — | 0 | 32 |
| 2018 | 0 | — | 0 | 13 |
| 2019 | 0 | — | 1 | 25 |
| 2020 | 1 | — | 3 | 27 |
| 2021 | 0 | — | 1 | 18 |
| 2022 | 0 | — | 0 | 16 |
| 2023 | 2 | — | 2 | 30 |
| 2024 | 0 | — | 0 | 42 |
| 2025 | 1 | — | 4 | 29 |
| 2026 | 1 | — | 0 | — |
What is it indicated for?
The ACCELERATOR APS (Automated Processing Systems) is a modular system designed to automate pre-analytical processing, sample handling, and processing in the clinical laboratory. The system consolidates multiple analytical instruments into a unified workstation by employing a common sample processing capability. The ARCHITECT cSOOO System is a discrete photometric chemistry analyzer for clinical use. The device is intended to duplicate manual analytical…
Read the full statement (140 words)
The ACCELERATOR APS (Automated Processing Systems) is a modular system designed to automate pre-analytical processing, sample handling, and processing in the clinical laboratory. The system consolidates multiple analytical instruments into a unified workstation by employing a common sample processing capability.
The ARCHITECT cSOOO System is a discrete photometric chemistry analyzer for clinical use. The device is intended to duplicate manual analytical procedures by performing various steps such as pipetting, heating, and measuring color intensity. This device is intended for use in conjunction with certain materials to measure a variety of analytes that may be adaptable to the analyzer depending on the reagent used. The ARCHITECT c8000 System also has a solid state Ion-Selective Electrode module, utilizing potentiomnetry, for electrolyte determinations for Sodium, Potassium and Chloride. Sodium, Potassium and Chloride measurements are used inthe diagnosis and treatment diseases involving electrolyte imbalance.
Indications for use as stated in the FDA summary.
https://510kreport.com/device/K093318 · printed Nov 4, 2026
Cite this page
510(k) Report. “K093318: Accelerator Aps.” Lineage record from FDA 510(k) data and the FDA summary. Updated Nov 3, 2026. Accessed Nov 4, 2026. https://510kreport.com/device/K093318
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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