# K092705: Abbott M2000SP and Abbott M2000RT, Models 9K14-01 (G-Series), 9K14-02 (E-Series), 9K1501

- Pathway: 510(k) (Traditional)
- Applicant: Abbott Molecular, Inc.
- Decided: May 28, 2010 after 267 days
- Product code: OOI (Real Time Nucleic Acid Amplification System)
- Device class: 2
- Regulation: 21 CFR 862.2570
- Recalls of this device: 7 (0 Class I)
- Data: FDA decisions to Oct 25, 2026; recalls to Oct 12, 2026

## Lineage
Longest line of descent: 3 generations back to K922906 (1993). 5 ancestors in all.
2 later devices descend from it; 2 cite it directly.
0 of 8 devices in its family (counting itself) have a Class I recall.

## Predicates on the family tree (from the FDA summary)
- K012966: Roche Cobas Taqman Analyzer, Roche Molecular Systems, Inc. (2002) Summary page 4.

## Most influential descendants
- K123955: Quantstudio DX Real-Time PCR Instrument (2013), 0 descendants of its own
- K113319: Rotor-Gene Q MDX (2012), 0 descendants of its own

## Recalls of this device
- Oct 23, 2014 · Class II · Z-0463-2015: Some versions of Application Specifications (App Spec) are incompatible with m2000sp system software version 6.0 and 7.0. This issue will cause Error Code 9000 (An unexpected error has occurred: Softw
- Jun 19, 2014 · Class II · Z-2169-2014: Abbott Molecular identified that some of the 5 ml Reaction Vessels (RVs) contained in lots 56944001, 57026001, 57059001, and 57673001 (original vendor lot 2198077) may have an insufficient rim. An RV 
- Nov 23, 2013 · Class II · Z-0948-2015: The x-drive assembly may fail prematurely. This could cause the manipulator or liquid handling arm to contact an object, shake and drip, or improperly pipet.
- Dec 4, 2012 · Class II · Z-0634-2013: An issue with the m2000sp Instrument software has been identified whereby, after a series of steps, if changes are made to the control or calibrator information on the Sample Extraction Assay Details 
- Jan 31, 2012 · Class II · Z-2013-2012: In the Abbott Molecular Bar Code Scanner User's Guide, List Number 6L88-02/09, the section Modifying the Keyboard Format for Bar Code Scanner LN 6L89-01 contains incorrect bar codes that can prevent t
- Oct 11, 2011 · Not classified · Z-0365-2012: Abbott Molecular has received reports in which the liquid waste sensor and components in the m2000sp lower instrument cabinet overheated and/or caught fire.
- Sep 8, 2011 · Not classified · Z-0048-2012: The Abbott m2000rt System software has software bug which can affect customers who manually enter a Test Order onto the m2000rt and sorts a column on the calibration or control grids of the Test Order

## Indications for use
The Abbott m2000 system is intended for in vitro diagnostic use in performing FDA cleared and approved nucleic acid testing in clinical laboratories. It comprises the Abbott m2000sp and the Abbott m2000rt instruments. The Abbott m2000sp is an automated system for performing sample preparation for nucleic acid testing. The Abbott m2000rt is an automated system for performing fluorescence-based POR to provide quantitative and qualitative detection of nucleic acid sequences.

Source page: https://510kreport.com/device/K092705
Methodology: https://510kreport.com/methodology