# K130253: TQ-Prep Workstation, Prepplus 2 Workstation

- Pathway: 510(k) (Traditional)
- Applicant: Beckman Coulter, Inc.
- Decided: Jul 15, 2013 after 164 days
- Product code: PER (Automated Pipetting, Diluting And Specimen Processing Workstations For Flow Cytometric Analysis)
- Device class: 1
- Regulation: 21 CFR 862.2750
- 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: 1 generation back to K874188 (1988). 1 ancestor in all.
No later device cites it as a predicate yet.
0 of 2 devices in its family (counting itself) have a Class I recall.

## Predicates on the family tree (from the FDA summary)
- K874188: Coulter Immunoprep Leukocyte/Q-Prep Immuno WRK Sta, Coulter Electronics, Inc. (1988) Summary page 1.
- (no number) Manual Pipette: named in the summary without a submission number

## Recalls of this device
- May 22, 2017 · Class II · Z-2690-2017: When samples are prepared using the PrepPlus or PrepPlus 2 sample preparation systems and then run on a Flow cytometer, there is an imprecision in the absolute counts on only the first tube in a run.
- May 22, 2017 · Class II · Z-2689-2017: When samples are prepared using the PrepPlus or PrepPlus 2 sample preparation systems and then run on a Flow cytometer, there is an imprecision in the absolute counts on only the first tube in a run.

## Indications for use
The COULTER TQ-Prep Workstation is intended to prepare leukocytes from whole blood for In Vitro Diagnostic (IVD) Use when used with the COULTER ImmunoPrep Reagent Systemi and cleared Beckman Coulter IVD applications on cleared Beckman Coulter flow cytometers. Pipetting of ImmunoPrep Reagent System (lyse, stabilizer, and fixative reagents) to samples prepared either manually or with the COULTER PrepPlus 2 sample preparation device to achieve lysis of whole blood samples. Use of COULTER TQ-Prep with cleared Beckman Coulter flow cytometers is described In each application's Instructions for Use. For In Vitro Diagnosic Use Only The COULTER PrepPlus 2, when used in combinations with the COULTER TO-Prep Workstation, is intended to prepare human whole blood for In Vitro Diagnostic (IVD) Use with cleared Beckman Coulter IVO applications on cleared Beckman Coulter flow cytometers. Pipetting blood, cleared Beckman Coulter IVO reagents and Flow-Count Fluorospheres to prepare samples for flow cytometric analysis. Use of the PrepPlus 2 with cleared Beckman Coulter flow cytometers is described in each application Instructions for Use. For InVitro Diagnostic Use Only

Source page: https://510kreport.com/device/K130253
Methodology: https://510kreport.com/methodology