# K974651: Abbott Axsym System

- Pathway: 510(k) (Traditional)
- Applicant: Abbott Laboratories
- Decided: Feb 12, 1998 after 66 days
- Product code: JJE (Analyzer, Chemistry (Photometric, Discrete), For Clinical Use)
- Device class: 1
- Regulation: 21 CFR 862.2160
- Recalls of this device: 5 (0 Class I)
- Data: FDA decisions to Oct 25, 2026; recalls to Oct 12, 2026

## Lineage
No predicates in its family tree.
No later device cites it as a predicate yet.
0 of 1 device in its family (counting itself) have a Class I recall.

## Predicates on the family tree (from the FDA summary)
- None. The FDA summary names its predicate without a number.
- (no number) Abbott AxSYM II System: named in the summary without a submission number

## Recalls of this device
- Feb 18, 2009 · Not classified · Z-2317-2009: Bottle labels from lot 211974, AxSYM System Tubing Decontamination Solution (List Number 7B05-09), were found to be missing the following information: lot number, date of manufacture, and expiration d
- Sep 8, 2006 · Not classified · Z-0117-2007: Increase in complaints regarding controls out of range, calibration errors, and discrepant patient results with the AxSYM Troponin-I ADV assay.
- Oct 29, 2003 · Not classified · Z-0274-04: Potential for a contaminated Reaction Vessel (RV) or previously used RV to remain on the AxSYM System.
- Dec 18, 2002 · Not classified · Z-0421-03: Gas Springs supporting processing center cover lose pressure after repeated usage causing the cover to unexpectedly close.
- Jun 6, 2002 · Not classified · Z-0173-04: Clamp can cause misaligned seating of heater block resulting in inaccurate dispension of MEIA Wash Buffer or MUP into the reaction cell. Causes inconsistent results.

## Indications for use
A discrete photometric chemistry analyzer for clinical use is a device intended to duplicate manual analytical procedures by performing automatically various steps such as pipetting, preparing filtrates, heating, and measuring color intensity. This device is intended for use in conjunction with certain materials to measure a variety of analytes. Different models of the device incorporate various instrumentation such as micro analysis apparatus, double beam, single, or dual channel photometers, and bichromatic 2-wavelength photometers. Some models of the device may include reagent-containing components that may also serve as reaction units.

Source page: https://510kreport.com/device/K974651
Methodology: https://510kreport.com/methodology