(71 days)
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No
The description focuses on automated gating based on established flow cytometry principles (CD45 gating, side scatter) and compares performance to a manual method. There is no mention of AI, ML, or related concepts.
No
This device is described as accessory software for in vitro diagnostic reagents used for identification and enumeration of lymphocyte subsets, indicating its role in diagnosis rather than direct therapy.
Yes
The device "identif[ies] and enumerat[es] percentages of lymphocyte subsets in human peripheral blood," which is used in conjunction with in vitro diagnostic reagents. This enumeration of specific cell populations can aid in diagnosing various conditions related to immune function or hematological disorders. The predicate device is also an "in vitro diagnostic accessory."
Yes
The device is described as "accessory software" and its function is to analyze data generated by flow cytometry, which is a separate hardware system. The description focuses solely on the software's method of identifying and enumerating lymphocyte subsets based on the input data.
Yes, this device is an IVD (In Vitro Diagnostic).
Here's why:
- Intended Use: The "Intended Use / Indications for Use" section explicitly states that MultiSET is an "accessory software to in vitro diagnostic reagents." It also describes its purpose as "identification and enumeration of lymphocyte subsets in human peripheral blood," which is a diagnostic activity performed on a biological sample outside of the body.
- Device Description: The description further clarifies that it's a "three-color, direct immunofluorescence method for identifying and enumerating percentages of lymphocyte subsets in erythrocyte-lysed whole blood." This confirms it's used for analyzing a biological sample (whole blood) to obtain diagnostic information.
- Input Imaging Modality: Flow cytometry is a technique commonly used in IVD testing for analyzing cells in a fluid sample.
- Anatomical Site: "Human peripheral blood" is a biological sample used for diagnostic purposes.
While the software itself is an accessory, its function is directly tied to and supports the performance of in vitro diagnostic reagents and the overall diagnostic process of identifying and enumerating lymphocyte subsets. Therefore, it falls under the definition of an IVD device.
N/A
Intended Use / Indications for Use
MultiSET is an accessory software to in vitro diagnostic reagents employing CD45 gating for identification and enumeration of lymphocyte subsets in human peripheral blood.
Product codes
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Device Description
Becton Dickinson MultiSET software is a three-color, direct immunofluorescence method for identifying and enumerating percentages of lymphocyte subsets in erythrocyte-lysed whole blood. The software is an accessory to reagent products which use CD45 gating for immunophenotyping by flow cytometry.
Both the manual CELLQuest software and the automated MultiSET software rely on a lymphocyte gate drawn for the CD45+ leucocytes with low side scatter. Lymphocyte subsets as a percent of total lymphocytes are then identified as a proportion of events included in the lymphocyte gate.
Mentions image processing
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Mentions AI, DNN, or ML
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Input Imaging Modality
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Anatomical Site
human peripheral blood
Indicated Patient Age Range
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Intended User / Care Setting
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Description of the training set, sample size, data source, and annotation protocol
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Description of the test set, sample size, data source, and annotation protocol
Accuracy was determined by comparison of results from the automated MultiSET software with results from the predicate manual software. Lysed whole blood samples from 41 donors, including 17 normals and 24 abnormals, were analyzed by the automated and manual softwares.
Summary of Performance Studies (study type, sample size, AUC, MRMC, standalone performance, key results)
Performance of the product was established by testing at Becton Dickinson Immunocytometry Systems laboratories in San Jose, California.
Accuracy was determined by comparison of results from the automated MultiSET software with results from the predicate manual software. Lysed whole blood samples from 41 donors, including 17 normals and 24 abnormals, were analyzed by the automated and manual softwares. Accuracy data demonstrated that MultiSET software provides equivalent results to the manual CELLQuest software.
The results of the evaluation studies demonstrate that the device is as safe and effective as the predicate device.
Key Metrics (Sensitivity, Specificity, PPV, NPV, etc.)
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Predicate Device(s): If the device was cleared using the 510(k) pathway, identify the Predicate Device(s) K/DEN number used to claim substantial equivalence and list them here in a comma separated list exactly as they appear in the text. List the primary predicate first in the list.
Reference Device(s): Identify the Reference Device(s) K/DEN number and list them here in a comma separated list exactly as they appear in the text.
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Predetermined Change Control Plan (PCCP) - All Relevant Information
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§ 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.”
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Attachment E Summary of Safety and Effectiveness
Submitter Information (21 CFR 807.92(a)(1))
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Submitter: Becton Dickinson Immunocytometry Systems 2350 Qume Drive San Jose, CA 95131-1807
DEC 1 2 1996 -
Contact: Cindy Morrow Senior Regulatory Specialist (408) 954-2694
September 30, 1996 Summary date:
Name of Device and Classification (21 CFR 807.92(@)(2)),
Name: MultiSETTM software
Classification: Class II
Predicate Device (21 CFR 807.92(a)(3))
MultiSET software for automated flow cytometric analysis of TriTEST reagents is substantially equivalent to the predicate software, CELLQuest™, which was described in 510(k) K946055.
Description of the Device (21 CFR 807,92(a)(4))
Becton Dickinson MultiSET software is a three-color, direct immunofluorescence method for identifying and enumerating percentages of lymphocyte subsets in erythrocyte-lysed whole blood. The software is an accessory to reagent products which use CD45 gating for immunophenotyping by flow cytometry.
Both the manual CELLQuest software and the automated MultiSET software rely on a lymphocyte gate drawn for the CD45+ leucocytes with low side scatter. Lymphocyte subsets as a percent of total lymphocytes are then identified as a proportion of events included in the lymphocyte gate.
Intended Use (21 CFR 807,92(a)(5))
MultiSET is an accessory software to in vitro diagnostic reagents employing CD45 gating for identification and enumeration of lymphocyte subsets in human peripheral blood.
Clinical Utility
The determination of lymphocyte subsets have been found useful in monitoring some forms of immunodeficiency and autoimmune disease.
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Comparison to Predicate Device (21 CFR 807.92(a)(6))
The MultiSET automated software is substantially equivalent to the CELLQuest software in that they share the same intended uses and similar methodologies. Results demonstrate that the products yield essentially equivalent performance. The products differ in that MultiSET software automates the steps used to determine analysis gates to identify the lymphocyte populations.
Performance Data (21 CFR 807,92(b)(2))
Performance of the product was established by testing at Becton Dickinson Immunocytometry Systems laboratories in San Jose, California.
Accuracy was determined by comparison of results from the automated MultiSET software with results from the predicate manual software. Lysed whole blood samples from 41 donors, including 17 normals and 24 abnormals, were analyzed by the automated and manual softwares. Accuracy data demonstrated that MultiSET software provides equivalent results to the manual CELLQuest software.
Performance Data - Conclusions (21 CFR 807.92(b)(3))
The results of the evaluation studies demonstrate that the device is as safe and effective as the predicate device.