FDA 510(k) Search - By Innolitics (SaMD and AI Experts)

CYTO-STAT® triCHROME™ CD8-FITC/CD4-RD1/CD3-PC5 Monoclonal Antibody Reagent is a three-color fluorescent reagent comprised of three murine monoclonal antibodies. Each antibody is labeled with a different color fluorochrome. The reagent allows simultaneous identification and enumeration of total CD3+, total CD4+, total CD8+, dual CD3+/CD4+ and dual CD3+/CD8+ lymphocytes in whole blood by flow cytometry. An isotypic control, CYTO-STAT® triCHROME™ MsIgG1-FITC/MsIgG1-RD1/MsIgG1-PC5, is used to monitor nonspecific staining. CYTO-STAT® triCHROME™ MsIgG1-FITC/MsIgG1-RD1/MsIgG1-PC5 Isotypic Control is a three-color fluorescent reagent comprised of three murine monoclonal antibodies. Each antibody is labeled with a different color fluorochrome. This product is intended for use as a quality control reagent to monitor the levels of nonspecific antibody binding in cell surface staining procedures which use CYTO-STAT® triCHROME™ CD8-FITC/CD4-RD1/CD3-PC5 Monoclonal Antibody Reagent to identify and enumerate total CD3+, total CD4+, total CD8+, dual CD3+/CD4+ and dual CD3+/CD8+ lymphocytes in whole blood by flow cytometry.

Device Description

AI/ML Overview

Here's an analysis of the provided text regarding the acceptance criteria and the study proving the device meets those criteria, structured according to your requested information:

Device: CYTO-STAT® triCHROME™ CD8-FITC/CD4-RD1/CD3-PC5 Monoclonal Antibody Reagent with CYTO-STAT® triCHROME™ MsIgG1-FITC/MsIgG1-RD1/MsIgG1-PC5 Isotypic Control

1. Table of Acceptance Criteria and Reported Device Performance

The acceptance criteria are not explicitly stated as quantitative thresholds in the provided text. Instead, the study's goal was to demonstrate comparability and performance against a predicate device (CYTO-STAT®/COULTER CLONE® CD3-ECD/T4-RD1/T8-FITC Monoclonal Antibody Reagent). The reported device performance is described in terms of statistical analyses showing this comparability and meeting general performance specifications.

Acceptance Criteria Category	Description of Criteria (Implied)	Reported Device Performance
Accuracy	Device identifies and enumerates targeted lymphocytes comparably to the predicate device.	"CD8/CD4/CD3 and CD3/T4/T8 identify and enumerate essentially identical numbers of the targeted lymphocytes in whole blood specimens."
Linearity	Device accurately measures lymphocyte concentrations across a range.	"Results analyzed in terms of regression and correlation analyses for recovered versus expected absolute counts demonstrated linearity of the assay."
Within Run (Intralaboratory) Precision	Device provides consistent results within a single laboratory and run.	"Results analyzed in terms of mean ± 1 SD and CV demonstrated Within Run (Intralaboratory) Precision of the assay."
Interlaboratory Precision	Device provides consistent results across different laboratories and instruments.	"Results analyzed in terms of mean ± 1 SD and CV demonstrated Interlaboratory Precision of the assay."

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

Sample Size: The text does not provide a specific number for the sample size of "normal and abnormal... whole blood specimens." It mentions "Specimens were divided, processed as lysed preparations and assayed in parallel with CD8/CD4/CD3 and CD3/T4/T8."
Data Provenance:
- Country of origin: Not explicitly stated, though Coulter Corporation has global entities listed, the specimens were "collected from geographically diverse populations." Given the main company address is in Miami, Florida, USA, and no other specific countries are mentioned for specimen collection, a primary US origin (but with diversity) is plausible.
- Retrospective or Prospective: Not explicitly stated. The description "Specimens were collected" usually implies a prospective collection for the purpose of the study, but without more detail, it's not definitive.
- Patient Characteristics: Males and females, unselected as to race, aged 18 to 85 years. Includes "Normal and abnormal (e.g., Human Immunodeficiency Virus, organ transplant, autoimmune disease, low white blood cell count)" blood specimens.

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

Not applicable. The study compares the performance of the new device against a predicate device and established flow cytometry methods, rather than relying on human expert interpretation to establish ground truth for each case. The "ground truth" for lymphocyte populations is determined by the flow cytometer itself, based on established immunological markers and gating strategies.

4. Adjudication Method for the Test Set

Not applicable. There was no human adjudication process described to establish a ground truth.

5. If a Multi Reader Multi Case (MRMC) Comparative Effectiveness Study was done, If so, what was the effect size of how much human readers improve with AI vs without AI assistance

Not applicable. This is a study comparing a new monoclonal antibody reagent to a predicate reagent for immunophenotyping using flow cytometry. It is not an AI-assisted diagnostic study involving human readers.

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

The device itself (monoclonal antibody reagent) is a laboratory consumable used with a flow cytometer. The "performance" being evaluated is of the reagent in conjunction with the instrument. The core of the evaluation described is a "standalone" or algorithm-only (instrument-only) performance, in the sense that human interpretation errors beyond initial sample preparation and instrument operation are not the primary variable. The output (lymphocyte percentages and absolute counts) is generated directly by the instrument data analysis.

7. The Type of Ground Truth Used

The ground truth is established by:

Comparative method: The predicate device (CYTO-STAT®/COULTER CLONE® CD3-ECD/T4-RD1/T8-FITC Monoclonal Antibody Reagent), which is presumed to be an accepted method for determining lymphocyte populations.
Flow Cytometry: The COULTER® EPICS® XL-MCL flow cytometer, utilizing established principles of immunofluorescence and gating on lymphocytes.
Clinical laboratory measurements: White blood cell counts and 5-part differentials obtained using the COULTER® STKS, plus absolute counts calculated via Standard (Indirect) and Flow-Count (Direct) methods.
Correction for lymphocyte purity: Values were corrected based on lymphocyte recovery (≥ 90%) and purity (≥ 85%).

Therefore, it's a form of reference method comparison or analytical ground truth based on established laboratory techniques and a predicate device.

8. The Sample Size for the Training Set

Not applicable. This device is a monoclonal antibody reagent and not a machine learning or AI algorithm that requires a training set in the conventional sense. The "training" of the reagent is implicit in its chemical and biological development and formulation, not through data learning.

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

Not applicable, as there is no training set in the context of a machine learning algorithm.

Summary

Regulation Number and Section

§ 864.5220 Automated differential cell counter.

(a)
Identification. An automated differential cell counter is a device used to identify one or more of the formed elements of the blood. The device may also have the capability to flag, count, or classify immature or abnormal hematopoietic cells of the blood, bone marrow, or other body fluids. These devices may combine an electronic particle counting method, optical method, or a flow cytometric method utilizing monoclonal CD (cluster designation) markers. The device includes accessory CD markers.(b)
Classification. Class II (special controls). The special control for this device is the FDA document entitled “Class II Special Controls Guidance Document: Premarket Notifications for Automated Differential Cell Counters for Immature or Abnormal Blood Cells; Final Guidance for Industry and FDA.”