# K093318: Accelerator Aps

- Pathway: 510(k) (Traditional)
- Applicant: Abbott Laboratories
- Decided: Feb 19, 2010 after 119 days
- Product code: CEM (Electrode, Ion Specific, Potassium)
- Device class: 2
- Regulation: 21 CFR 862.1600
- Recalls of this device: 2 (0 Class I)
- Data: FDA decisions to Oct 25, 2026; recalls to Oct 12, 2026

## Lineage
Longest line of descent: 5 generations back to K902336 (1990). 9 ancestors in all.
3 later devices descend from it; 2 cite it directly.
0 of 13 devices in its family (counting itself) have a Class I recall.

## Predicates on the family tree (from the FDA summary)
- K980367: Aeroset System, Abbott Laboratories (1998) Summary page 1.
- K082638: Advia Centaur System with Streamlab Analytical Workcell, Siemens Healthcare Diagnostics, Inc. (2009) Summary page 1.

## Most influential descendants
- K213486: GLP systems Track (2022), 1 descendant of its own
- K230937: Alinity i Total ß-hCG Reagent Kit, GLP systems Track (2023), 0 descendants of its own
- K121012: Flexlab 3.6, Accelerator A3600 (2012), 0 descendants of its own

## Recalls of this device
- Apr 2, 2020 · Class II · Z-2251-2020: 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 l
- Sep 7, 2018 · Class II · Z-2755-2019: 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

## Indications for use
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.

Source page: https://510kreport.com/device/K093318
Methodology: https://510kreport.com/methodology