(155 days)
Not Found
No
The summary describes automated analysis based on predefined rules for placing cursors based on peak separation, which is not indicative of AI/ML. There is no mention of training data, models, or learning processes.
No
The device is described as "For In Vitro Diagnostic Use" and is used for the identification and enumeration of lymphocyte populations in whole blood, which is a diagnostic purpose, not a therapeutic one.
Yes
The device is intended "For In Vitro Diagnostic Use" and allows simultaneous identification and enumeration of lymphocyte populations, which is a diagnostic purpose.
No
The device description explicitly states that the tetraONE™ SYSTEM combines software with a four-color fluorescent monoclonal antibody reagent, quality control reagents, and an optional absolute count reagent. These are physical components, not solely software.
Yes, this device is an IVD (In Vitro Diagnostic).
Here's why:
- Explicit Statement: The "Intended Use / Indications for Use" section explicitly states: "The system is intended 'For In Vitro Diagnostic Use'".
- Nature of the Device: The device is a system that includes reagents and software for analyzing biological samples (whole blood) to identify and enumerate specific cell populations (lymphocytes). This type of analysis performed on samples taken from the body is the definition of an in vitro diagnostic.
- Purpose of the Analysis: The analysis provides information about lymphocyte populations, which is used for diagnostic purposes (e.g., in the context of HIV, organ transplant, autoimmune disease).
N/A
Intended Use / Indications for Use
The tetraONE™ SYSTEM for EPICS® XL Flow Cytometry Systems and CYTO-STAT® tetraCHROME™ CD45-FITC/CD4-RD1/CD8-ECD/CD3-PC5 Monoclonal Antibody Reagent combines a four-color fluorescent monoclonal antibody reagent, four quality control reagents, an optional absolute count reagent, and software for automated analysis of lymphocyte populations in whole blood using EPICS® XL Flow Cytometry Systems with SYSTEM II™ Software. The system is intended "For In Vitro Diagnostic Use" and allows simultaneous identification and enumeration of total CD4+, total CD8+, total CD3+, dual-positive CD3+/CD4+ and dual-positive CD3+/CD8+ T lymphocytes percentages and absolute counts. The system also provides the T4/T8 ratio.
Product codes
GKZ
Device Description
The tetraONE™ SYSTEM for EPICS® XL Flow Cytometry Systems consists of a four-color fluorescent monoclonal antibody reagent, four quality control reagents, an optional absolute count reagent, and software for automated analysis of lymphocyte populations in whole blood. The system identifies and enumerates total CD4+, total CD8+, total CD3+, dual-positive CD3+/CD4+ and dual-positive CD3+/CD8+ T lymphocytes percentages and absolute counts, and also provides the T4/T8 ratio. The system utilizes flow cytometry for immunophenotyping with monoclonal antibodies. The tetraONE™ SYSTEM software provides advanced automated modes of operation and aims to increase accuracy, precision, and reliability of results. It also automatically places cursors based on the separation of positive and negative peaks to monitor and adjust for non-specific and non-targeted monoclonal antibody binding. The CD45/CD4/CD3 reagent contains a CD45 monoclonal antibody to identify a lymphocyte gate. The reagents use FITC, RD1, ECD, and PC5 for fluorescent labeling.
Mentions image processing
Not Found
Mentions AI, DNN, or ML
Not Found
Input Imaging Modality
Flow Cytometry
Anatomical Site
Not Found
Indicated Patient Age Range
18 to 85 years
Intended User / Care Setting
Not Found
Description of the training set, sample size, data source, and annotation protocol
Not Found
Description of the test set, sample size, data source, and annotation protocol
Normal and abnormal (e.g., Human Immunodeficiency Virus, organ transplant, autoimmune disease, low white blood cell count) whole blood specimens were collected from geographically diverse populations of males and females unselected as to race and ranging in age from 18 to 85 years. Specimens were divided, processed as lysed preparations and assayed in parallel with CD45/CD4/CD8/CD3, CD3/T4 and CD3/T8.
Summary of Performance Studies
Accuracy: Whole blood specimens (normal and abnormal from various patient populations) were processed as lysed preparations and assayed in parallel with CD45/CD4/CD8/CD3, CD3/T4, and CD3/T8. CD3+, CD4+, CD8+, CD3+/CD4+ and CD3+/CD8+ percentages (of total lymphocyte count) and absolute counts (cells/uL) were determined with EPICS® XL-MCL flow cytometers gated on lymphocytes. White blood cell counts and 5-part differentials were obtained. CD3/T4 and CD3/T8 values were corrected for lymphocyte purity. Results were analyzed using minimums, maximums, means +/- 1 SD, 95% confidence intervals, regression and correlation analyses, and analyses of variance. Results demonstrated that CD45/CD4/CD8/CD3, CD3/T4, and CD3/T8 identify and enumerate essentially identical numbers of targeted lymphocytes.
Linearity: Three replicate measurements were made on a concentrated COULTER™ CYTO-TROL™ Control Cells sample serially diluted to achieve a range of CD3+, CD4+ (CD3+/CD4+) and CD8+ (CD3+/CD8+) lymphocyte concentrations. Samples were assayed with CD45/CD4/CD3 and analyzed on an EPICS® XL-MCL flow cytometer gated on lymphocytes. Values were expressed in terms of absolute counts (cells/uL). Results analyzed using regression and correlation analyses for recovered versus expected absolute counts demonstrated linearity of the assay.
Within Run (Intralaboratory) Precision: Ten replicate measurements were made for each of three levels of CD3+, CD4+ (CD3+/CD4+) and CD8+ (CD3+/CD8+) lymphocyte concentrations using a COULTER EPICS® XL-MCL flow cytometer gated on lymphocytes. Levels were obtained by selective depletions of a normal whole blood specimen and assayed with CD45/CD4/CD8/CD3. Values were expressed in terms of % of the total lymphocyte count. Results analyzed using mean +/- 1 SD and CV demonstrated Within Run (Intralaboratory) Precision of the assay.
Interlaboratory Precision: Ten replicate measurements were made on the same day using different laboratories and EPICS® XL-MCL flow cytometers. All measurements were made on a single normal whole blood specimen divided and assayed with CD45/CD4/CD3. Values were expressed in terms of % of the total lymphocyte count. Results analyzed using mean +/- 1 SD and CV demonstrated Interlaboratory Precision of the assay.
Key Metrics
Accuracy: essentially identical numbers of the targeted lymphocytes.
Linearity: demonstrated linearity of the assay.
Precision: Within Run (Intralaboratory) Precision of the assay demonstrated; Interlaboratory Precision of the assay demonstrated.
Predicate Device(s)
Reference Device(s)
Not Found
Predetermined Change Control Plan (PCCP) - All Relevant Information
Not Found
§ 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.”
0
JAN 22 1997
| COULTER CORPORATION
P.O. BOX 169015
| Miami, Florida 33116-9015 USA | Date: | August 16, 1996 |
|---|---|---|
| Customer Service: (800) 526-7694 | ||
| Product Information: (800) 526-6932 | ||
| (305) 380-3800 | ||
| (800) 327-6531 | Title: | Summary of Safety and Effectiveness Information For 510(k) Premarket Notification |
| Coulter Corporation | ||
| Miami, Florida USA | Product: | tetraONE™ SYSTEM for EPICS® XL Flow Cytometry Systems and |
| CYTO-STAT® tetraCHROME™ CD45-FITC/CD4-RD1/CD8-ECD/CD3-PC5 | ||
| Monoclonal Antibody Reagent | ||
| Coulter Leasing Corporation | ||
| Miami, Florida USA | Company: | Coulter Corporation |
| 11800 SW 147 Avenue | ||
| Miami, FL 33196-2500 | ||
| Coulter Electronics, Pty. Ltd. | ||
| Sydney, Australia | Contact: | Dr. Marion S. Gaide (M/C: 31-B06) |
| Senior Regulatory Affairs Specialist | ||
| Corporate Regulatory Affairs | ||
| Coulter Electronics Ind. & Com.. Ltda. | ||
| Rio de Janeiro, Brazil | ||
| Coulter Electronics of Canada. Ltd. | ||
| Burlington, Ontario, Canada | Telephone: | 305-380-2594 |
| Coulter Electronics, Ltd. | ||
| Luton Bedfordshire England | Common or Usual or Classification Name: | Lymphocyte Immunophenotyping System |
| with Reagents and Software for Flow Cytometry | ||
| Coultronics France, S.A. | ||
| Margency. France | ||
| Coulter Electronics GmbH | ||
| Krefeld, Germany | ||
| Coulter Electronics (HK), Ltd. | ||
| Hong Kong | Product Classification: | Product Code: GKZ; C.F.R. Section: 864.5220; Classification |
| Panel: Hematology and Pathology Devices; Device Class: II | ||
| Coulter K. K. | ||
| Tokyo, Japan | ||
| Coulter de Mexico S.A., DE C.V. | ||
| Mexico City, Mexico | Intended Use: | The tetraONE™ SYSTEM for EPICS® XL Flow Cytometry Systems and CYTO- |
| STAT® tetraCHROME™ CD45-FITC/CD4-RD1/CD8-ECD/CD3-PC5 Monoclonal | ||
| Antibody Reagent combines a four-color fluorescent monoclonal antibody reagent, | ||
| four quality control reagents, an optional absolute count reagent, and software for | ||
| automated analysis of lymphocyte populations in whole blood using EPICS® XL | ||
| Flow Cytometry Systems with SYSTEM II™ Software. The system is intended "For | ||
| In Vitro Diagnostic Use" and allows simultaneous identification and enumeration of | ||
| total CD4+, total CD8+, total CD3+, dual-positive CD3+/CD4+ and dual- | ||
| positive CD3+/CD8+ T lymphocytes percentages and absolute counts. The system | ||
| also provides the T4/T8 ratio. | ||
| Coulter Electronics, Ltd. | ||
| Mijdrecht. Netherlands | Substantial Equivalence: | 510(k) Premarket Notification: |
| K922745 | ||
| CYTO-STAT®/COULTER CLONE® CD3(IgG1)-FITC/T4-RD1 | ||
| Monoclonal Antibody Reagent | ||
| Coulter Electronics, Pty. Ltd | ||
| Auckland, New Zealand | 510(k) Premarket Notification: | |
| K922744 | ||
| CYTO-STAT®/COULTER CLONE® CD3(IgG1)-FITC/T8-RD1 | ||
| Monoclonal Antibody Reagent | ||
| Coulter Electronics Sales of P.R. Inc. | ||
| San Juan Puerto Rico | Product Differences: | CD45/CD4/CD8/CD3, CD3/T4 and CD3/T8 are essentially identical with |
| respect to features and principles of operation. The new and comparator | ||
| systems use the same, well-established, state-of-the-art technologies of | ||
| immunophenotyping with monoclonal antibodies and flow cytometry to | ||
| Coulter Electronics, Ltd. | ||
| Venezuela | ||
| Coulter Elektronik A.S. | ||
| Istanbul, Turkey | ||
| Coulter Electronics S.A. | ||
| Caracas, Venezuela |
. measure cellular components in whole blood via immunofluorescence analysis. Further, the intended use of the new and comparator systems is the same. Also, each liquid reagent allows simultaneous identification and enumeration of more than one lymphocyte population in a single specimen using a single reagent.
Science Serving Humanity
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1
The new and comparator systems differ in only a few respects. One difference results from the more advanced software for the new tetraONE™ SYSTEM. The tetraONE™ SYSTEM software is designed to further simplify flow cytometric analysis by increasing automated modes of operation and the accuracy, precision and reliability of results. The new and comparator systems also differ in that the new tetraONE™ SYSTEM does not require an isotypic control for monitoring and adjusting for non-specific and nontargeted monoclonal antibody binding to irrelevant cellular populations. The tetraONE™ SYSTEM software monitors and adjusts for such binding by automatically placing cursors based on the separation of positive and negative peaks.
There are two differences between the reagents.
- Lymphocyte Gating: The CD45/CD4/CD3 reagent contains a monoclonal antibody, CD45, to a. identify a lymphocyte gate to allow CD3+, CD4+, CD8+, dual-positive CD3+/CD4+ and dualpositive CD3+/CD8+ measurements. In contrast, CD3/T4 and CD3/T8 require a separate reagent, Mo2-RD1/KC56 (T-200)-FITC, for this purpose.
Fluorescent Labeling: b.
CD45/CD4-RD1/CD8-ECD/CD3-PC5:
CD45: FITC (Fluorescein Isothiocyanate); CD4: RD1 (Phycoerythrin); CD8: ECD (Phycoerythria-Texas Red); CD3: PC5 (Phycoerythrin-Cy5).
CD3/T4 and CD3/T8:
CD3: FITC (Fluorescein Isothiocyanate); T4: RD1; T8: RD1 (Phycoerythrin).
- Product testing to assess the performance of CD45/CD4/CD3 is described below. Studies were Product Testing: designed in line with instructions for use given in the tetraONE™ SYSTEM Guide, Package Inserts, Product Manuals, and performance specifications. Specimens were assayed with CD3/T4 and CD3/CD8 for comparison purposes. The results of product testing demonstrated that CD45/CD4/CD8/CD3 met all performance specifications and provided mature T (CD3+), inducer T (CD4+; CD3+/CD4+) and suppressor/cytotoxic T (CD8+; CD3+/CD8+) lymphocyte values comparable to those of CD3/T4 and CD3/T8.
-
- Accuracy:
-
Normal and abnormal (e.g., Human Immunodeficiency Virus, organ transplant, autoimmune disease, low white blood cell count) whole blood specimens were collected from geographically diverse populations of males and females unselected as to race and ranging in age from 18 to 85 years. Specimens were divided, processed as lysed preparations and assayed in parallel with CD45/CD4/CD8/CD3, CD3/T4 and CD3/T8. The CD3+, CD4+, CD8+, CD3+/CD4+ and CD3+/CD8+ percentages expressed in terms of the total lymphocyte count and absolute counts (cells/uL) were determined with EPICS® XL-MCL flow cytometers gated on lymphocytes. White blood cell counts and 5-part differentials were obtained for all specimens. CD3/T4 and CD3/T8 values were corrected for lymphocyte purity (Lymphocyte Gate Limits: lymphocyte recovery ≥ 90%; lymphocyte purity ≥ 85%).
Results analyzed in terms of minimums, maximums, means ± 1 SD, confidence intervals with 95% limits, regression and correlation analyses, and analyses of variance demonstrated that CD45/CD4/CD8/CD3, CD3/T4 and CD3/T8 identify and enumerate essentially identical numbers of the targeted lymphocytes in whole blood specimens.
-
- Linearity:
Three replicate measurements were made on a concentrated COULTER™ CYTO-TROL™ Control Cells sample serially diluted to achieve a range of CD3+, CD4+ (CD3+/CD4+) and CD8+ (CD3+/CD8+) lymphocyte concentrations. Samples were assayed with CD45/CD4/CD3 and analyzed on an EPICS® XL-MCL flow cytometer gated on lymphocytes. Values were expressed in terms of absolute counts (cells/uL).
- Linearity:
Results analyzed in terms of regression and correlation analyses for recovered versus expected absolute counts demonstrated linearity of the assay.
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2
- Within Run (Intralaboratory) Precision: 3.
Ten replicate measurements were made for each of three levels of CD3+, CD4+ (CD3+/CD4+) and CD8+ (CD3+/CD8+) lymphocyte concentrations using a COULTER EPICS® XL-MCL flow cytometer gated on lymphocytes. Levels were obtained by selective depletions of a normal whole blood specimen and assayed with CD45/CD4/CD8/CD3. Values were expressed in terms of % of the total lymphocyte count.
Results analyzed in terms of mean ± 1 SD and CV demonstrated Within Run (Intralaboratory) Precision of the assay.
- Interlaboratory Precision: 4.
Ten replicate measurements were made on the same day using different laboratories and EPICS® XL-MCL flow cytometers. All measurements were made on a single normal whole blood specimen divided and assayed with CD45/CD4/CD3. Values were expressed in terms of % of the total lymphocyte count.
Results analyzed in terms of mean ± 1 SD and CV demonstrated Interlaboratory Precision of the assay.
Marion S. Gaide, Ph.D.
Senior Regulatory Affairs Specialist Corporate Regulatory Affairs
August 16, 1996
Date