(164 days)
COULTER TQ-Prep Workstation: Intended to prepare leukocytes from whole blood for In Vitro Diagnostic (IVD) Use when used with the COULTER ImmunoPrep Reagent System and cleared Beckman Coulter IVD applications on cleared Beckman Coulter flow cytometers. Indication for Use: 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 Diagnostic Use Only.
COULTER PrepPlus 2: Intended Use: The COULTER PrepPlus 2, when used in combinations with the COULTER TQ-Prep Workstation, is intended to prepare human whole blood for In Vitro Diagnostic (IVD) Use with cleared Beckman Coulter IVD applications on cleared Beckman Coulter flow cytometers. Indications for Use: Pipetting blood, cleared Beckman Coulter IVD 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 In Vitro Diagnostic Use Only.
The COULTER TO-Prep Workstation is used with the COULTER ImmunoPrep Reagent System to prepare leukocytes from whole blood for measurement on flow cytometers. The COULTER PrepPlus 2 is a microprocessor-controlled pipetting and diluting system, designed for automating sample preparation or assay methods. It is capable of aspirating and dispensing liquid samples.
The provided document describes the K130253 510(k) submission for the COULTER TQ-Prep Sample Preparation Workstation and COULTER PrepPlus 2 Workstations. These devices are intended for preparing human whole blood for in vitro diagnostic use with specific Beckman Coulter IVD applications on cleared Beckman Coulter flow cytometers. The submission focuses on demonstrating substantial equivalence to predicate devices through performance studies.
Here's an analysis of the acceptance criteria and supporting studies based on the provided text:
1. Table of Acceptance Criteria and Reported Device Performance
| Study Type | Acceptance Criteria (Implied by study design goal) | Reported Device Performance |
|---|---|---|
| Accuracy | Comparable results to the predicate device. (Based on CLSI EP09-A2) | TQ-Prep: Demonstrated comparable results to the predicate device with CYTO-STAT tetraCHROME Reagents. |
| PrepPlus2: Demonstrated comparable results to the predicate device with CYTO-STAT tetraCHROME Reagents. | ||
| Precision | Acceptable results. (Based on CLSI EP5-A2) | TQ-Prep and PrepPlus 2: Demonstrated acceptable results with CYTO-STAT tetraCHROME Reagents. |
| Gravimetrics | Acceptable accuracy and precision for dispensing specified fluids. | TQ-Prep: Demonstrated acceptable accuracy and precision results for dispensing ImmunoPrep reagents. |
| PrepPlus2: Demonstrated acceptable accuracy and precision results for delivering blood, reagents, controls, and Flow-Count Fluorospheres. | ||
| Carryover | Acceptable carryover performance for specimen and reagent. (Based on CLSI Document: H26-A2) | Complete Systems (TQ-Prep, PrepPlus 2, FC 500 with tetraCXP software): Demonstrated acceptable carryover performance for specimen and reagent. |
2. Sample Sizes Used for the Test Set and Data Provenance
The document does not explicitly state the sample sizes used for the test sets in the accuracy, precision, gravimetrics, or carryover studies.
Regarding data provenance, the document does not specify the country of origin of the data or whether the studies were retrospective or prospective. It only mentions that the studies were conducted to support the 510(k) submission.
3. Number of Experts Used to Establish Ground Truth for the Test Set and Qualifications
This information is not provided in the document. The studies described are performance evaluations of an automated pipetting and diluting system, comparing its dispense accuracy, precision, and carryover to predicate devices or established standards. These types of studies typically do not involve "ground truth" established by human experts in the same way, for example, an image analysis study would. The ground truth here would be the actual dispensed volumes or analytical measurements from the flow cytometers.
4. Adjudication Method for the Test Set
The document does not describe an adjudication method for the test set. Given the nature of a pipetting and diluting system, the "truth" is determined by objective measurements (e.g., gravimetric analysis for dispensed volume, flow cytometer readings for accuracy and precision of sample preparation). Adjudication by human experts is not relevant in this context.
5. If a Multi-Reader Multi-Case (MRMC) Comparative Effectiveness Study was Done
No, a Multi-Reader Multi-Case (MRMC) comparative effectiveness study was not done. This type of study is relevant for diagnostic devices where human readers interpret results, often with and without AI assistance, to assess the impact on diagnostic accuracy. The devices in this submission are automated sample preparation workstations, which do not involve human interpretation of medical images or diagnostic outputs in the manner an MRMC study would evaluate.
6. If a Standalone (Algorithm Only Without Human-in-the-Loop Performance) Was Done
Yes, the studies conducted are standalone performance evaluations of the devices (TQ-Prep and PrepPlus 2 workstations). The "performance" being evaluated is the accuracy, precision, and carryover of their automated functions (pipetting, diluting, reagent addition, mixing) as compared to predicate devices or established guidelines (CLSI documents). There is no "human-in-the-loop" aspect to the fundamental performance of these automated systems.
7. The Type of Ground Truth Used
The "ground truth" in these studies refers to:
- For Accuracy and Precision (with reagents): The actual analytical measurements obtained from flow cytometers after sample preparation, which are then compared to results from predicate devices. The assumption is that the predicate devices produce acceptable analytical results.
- For Gravimetrics: The actual weight of dispensed liquids, which directly correlates to the volume dispensed. This is an objective, measurable truth.
- For Carryover: Analytical measurements demonstrating the absence or presence of unwanted sample transfer, using established methods to quantify carryover.
It is not expert consensus, pathology, or outcomes data in the clinical sense, but rather objective technical and analytical measurements.
8. The Sample Size for the Training Set
The document does not specify a training set sample size. These devices are automated workstations, not AI/ML algorithms that typically require a distinct training set for model development. The reported studies are performance validation studies.
9. How the Ground Truth for the Training Set Was Established
As these are automated workstations and not AI/ML models in the typical sense, there is no "training set" or "ground truth for the training set" established in the conventional AI/ML context. The devices are programmed with specific operational parameters, and their performance is then validated through the studies described.
§ 862.2750 Pipetting and diluting system for clinical use.
(a)
Identification. A pipetting and diluting system for clinical use is a device intended to provide an accurately measured volume of liquid at a specified temperature for use in certain test procedures. This generic type of device system includes serial, manual, automated, and semi-automated dilutors, pipettors, dispensers, and pipetting stations.(b)
Classification. Class I (general controls). The device is exempt from the premarket notification procedures in subpart E of part 807 of this chapter subject to § 862.9.