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TRUCOUNT Absoluce Count Tubes are intended for use as an accessory to TriTEST in vitro diagnostics, such as that described in K965053 (CD3/CD4/CD45), to allow computation of positive cells per known volume of blood, using flow cytometty.

The TRUCOUNT Counting Control Beads are provided in three levels, and are intended to provide a means to check the reproducibility and accuracy of volumeric pipetting of blood samples. They are an accessory to TriTEST reagens, when used with TRUCOUNT Absolute Count Tubes to obtain absolute counts of positive cells using flow cytomerry.

Indications for Use:

• For erythrocyte lysed whole blood .
• For use with FACS Loader ●
• For use with IVD immunophenotyping reagents .
• For use on flow cytometers with designated detection ranges ●
• For use to obtain absolute counts by flow cytometry ◆

TRUCOUNT Absolute Count Tubes are fluorescent particles supplied as a peller in a rube. The peller contains a known number of beads. A blood sample of known volume is added to the rube. Then the appropriate reagent is added to the mixture. By comparing the number of positive cell events to the number of bead events in the flow cytomerry data ourpur, posicive cells per unit volume of blood sample can be computed.

TRUCOUNT Counting Control Beads are fluorescent particles supplied as suspensions in three bead concentrations, High, Medium and Low. The fluorescence of these beads is similar to that of the Absolute Count Tube in FL1 and FL3, but is different in FL2, so that both beads may be run in the same sample, and distinguished from one another. Control beads are added to samples of normal blood prepared with TriTEST reagents and Absolute Count Tubes. The Concrol Bead count is obtained by comparison to the count of the Absolute Count Tubes. These experimental counts are compared to the expected count on the Control Bead label, to check the accuracy of pipetting.

The provided document, K970836, is a 510(k) submission for the TRUCOUNT Absolute Count Tubes and TRUCOUNT Counting Control Beads by Becton Dickinson Immunocytometry Systems, cleared in 1997. It describes the device, its intended use, comparison to predicate devices, and performance data. However, the document does not present a typical "acceptance criteria and study that proves the device meets the acceptance criteria" in the format commonly seen for contemporary medical devices. Instead, it describes performance testing completed to support the device's claims for substantial equivalence.

Here's an analysis of the provided information within the requested framework, highlighting where information is not explicitly stated or is inferred from the context of an older 510(k) submission.

1. Table of Acceptance Criteria and Reported Device Performance

The document does not explicitly present a table of "acceptance criteria" with quantitative targets. Instead, it describes performance characteristics that were assessed and found "acceptable" to support the device's claims. The reported performance is qualitative for stability and accuracy.

• TRUCOUNT Counting Control Beads: Found acceptable to support a six-month shelf life.
• Absolute Count Tubes: Remain stable after foil pouch opened if stored closed at room temperature with blue desiccant. |
  | Accuracy/Reproducibility | Support ranges for acceptable performance cited in the Package Insert. | - Counting Control Beads: Determined and found acceptable to support the ranges for acceptable performance cited in the Package Insert. |
  | Functionality (with FACS Loader) | Function as expected when used with FACS Loader and manually. | - Absolute Count Tubes and Counting Control Beads: Seen to function as expected when used with the FACS Loader, as well as manually. |

2. Sample Size Used for the Test Set and Data Provenance

The document states: "Performance of the product was established by testing at Becton Dickinson Immunocytometry Systems laboratories in San Jose, California."

• Test Set Sample Size: Not explicitly stated. The document doesn't provide numerical sample sizes for any of the performance tests (stability, accuracy, reproducibility, or functionality).
• Data Provenance:
  • Country of Origin: United States (San Jose, California).
  • Retrospective or Prospective: Not explicitly stated, but the description of "testing at Becton Dickinson Immunocytometry Systems laboratories" suggests prospective internal testing conducted for the submission.

3. Number of Experts Used to Establish the Ground Truth for the Test Set and Qualifications of Those Experts

Not applicable. This device (TRUCOUNT Absolute Count Tubes and Counting Control Beads) is a calibration/control accessory for flow cytometry. Its performance is based on intrinsic physical and chemical properties and its ability to provide a known count of beads for volumetric measurements. Ground truth for its performance would typically be established through manufacturing controls, certified reference materials, and metrological standards, rather than expert consensus on clinical images or interpretations.

4. Adjudication Method for the Test Set

Not applicable. As noted above, the performance assessment is based on quantifiable physical properties and functional checks, not on interpretation by human experts that would require adjudication.

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, and is not applicable for this type of device. An MRMC study is typically used for diagnostic interpretation devices where human readers' performance is being evaluated, especially with and without AI assistance. This device is an accessory that assists in counting cells, not in interpreting diagnostic images or clinical data.

6. If a Standalone (i.e. algorithm only without human-in-the-loop performance) was done

Parts of the testing could be considered "standalone" in the sense that the device's intrinsic characteristics (like bead count, fluorescence, stability) are being evaluated. However, the device's ultimate "performance" is as an accessory used with other devices (flow cytometers and reagents) and by human operators. The document mentions "functions as expected when used with the FACS Loader, as well as manually," indicating an evaluation of its performance in conjunction with other components of the workflow, rather than a purely standalone algorithm.

7. The Type of Ground Truth Used

The ground truth for the device's performance is implicitly tied to:

• Manufacturing Specifications / Certified Bead Counts: For the TRUCOUNT Absolute Count Tubes, the "known number of beads" in the tube constitutes a pre-defined ground truth established during manufacturing and rigorously controlled.
• Expected Counts (for Control Beads): For the TRUCOUNT Counting Control Beads, the "expected count on the Control Bead label" serves as the ground truth against which experimental counts are compared to check pipetting accuracy.
• Established Analytical Methods: Stability is assessed against established protocols for degradation (e.g., measuring physical or chemical changes over time).

This is an analytical ground truth based on device design and manufacturing controls, not clinical outcomes, pathology, or expert consensus on a diagnostic finding.

8. The Sample Size for the Training Set

Not applicable. This device is a consumable accessory for flow cytometry, not an AI/ML algorithm that requires a training set. The performance testing described is for product validation, not algorithm training.

9. How the Ground Truth for the Training Set was Established

Not applicable, as there is no training set for this type of device.

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