(42 days)
K 925274
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No
The summary describes a system for setting up and monitoring flow cytometers using beads and software to adjust instrument settings and compensation. There is no mention of AI or ML in the intended use, device description, or performance studies. The focus is on standard calibration and quality control procedures for flow cytometry.
No
The device is described as being used for flow cytometer setup, monitoring instrument performance, and adjusting instrument settings, not for treating any medical condition or disease.
No
The device is used for setting up and monitoring the performance of flow cytometers, not for diagnosing medical conditions in patients. It optimizes the instrument settings and verifies the instrument's capabilities, acting as a calibration tool.
No
The device description explicitly states that the product is a "Kit, comprising unstained, FITC, PE and PerCP beads" in addition to the software. This indicates the device includes physical components (beads) and is not solely software.
Based on the provided information, this device is likely an IVD (In Vitro Diagnostic).
Here's why:
- Intended Use: The intended use is "For flow cytometer set up and monitoring of instrument performance." While this doesn't directly diagnose a disease, it is a crucial step in ensuring the proper functioning of a flow cytometer, which is a device used for in vitro diagnostic testing of biological samples (like blood).
- Device Description: The description explicitly states that the product is used to "optimally adjust instrument settings, to monitor the sensitivity, and to set the compensation of flow cytometers for spectral overlap of fluorescent dyes." These are all calibration and quality control steps essential for accurate in vitro diagnostic results obtained from the flow cytometer.
- Context of Use: The product is recommended for "instrument set up prior to running Becton Dickinson software applications for flow cytometers." These applications are typically used for analyzing biological samples for diagnostic purposes.
- Predicate Device: The predicate device listed (K925274; CaliBRITE Beads with AutoCOMPTM) is also a calibration and quality control product for flow cytometry, and such products are generally considered IVDs because they are essential for the performance of the diagnostic instrument.
While the device itself doesn't directly analyze a patient sample or provide a diagnostic result, its function is to ensure the accuracy and reliability of a diagnostic instrument (the flow cytometer) when performing in vitro diagnostic tests. Therefore, it falls under the scope of an IVD as a reagent or calibrator used with an IVD instrument.
N/A
Intended Use / Indications for Use
For flow cytometer set up and monitoring of instrument performance.
Product codes
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Device Description
Becton Dickinson CaliBRITE 3 Color and FACSComp are intended for use on the Becton Dickinson flow cytometers FACScan™ or FACSort or FACSCalibur™. FACSComp Software and CaliBRITE 3 Color Beads are used to optimally adjust instrument settings, to monitor the sensitivity, and to set the compensation of flow cytometers for spectral overlap of fluorescent dyes. FACSComp Software and CaliBRITE 3 Color Beads are used to set up and verify the separation of system noise from forward and side scatter and to set fluorescence compensation on flow cytometers with three FL channels. FACSComp Software and CaliBRITE 3 Color Beads are used for setting the photomultiplier tube (PMT) voltages, setting the fluorescence compensation, and checking instrument sensitivity on thow cytometers. This product is recommended for instrument set up prior to running Becton Dickinson software applications for flow cytometers. CaliBRITE 3 Color will be provided as a Kit, comprising unstained, FITC, PE and PerCP beads. CaliBRITE PerCP beads will also be provided as a separate product, to be used with CaliBRITE Kits having unstained FITC and PE beads only.
Mentions image processing
Not Found
Mentions AI, DNN, or ML
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Input Imaging Modality
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Anatomical Site
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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
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Summary of Performance Studies (study type, sample size, AUC, MRMC, standalone performance, key results)
Several studies were performed:
- Stability was measured: Storage stability was determined to be 8 months under the conditions of use. Once diluted, the three-bead preparation is stable for 1 hour after dilution.
- Reproducibility was measured: Within instrument over 30 days and Between lot. Reproducibility was found to be within that for the predicate device.
Key Metrics (Sensitivity, Specificity, PPV, NPV, etc.)
Not Found
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.
K 925274
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
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
Attachment D Summary of Safety & Effectiveness
JUN - 7
Submitter Information (21 CFR 807,92(2)(1)),
- 维度
Becton Dickinson Immunocytometry Systems Submitter: 2350 Qume Drive San Jose, CA 95131-1807
Anna Longwell, Esq. Contact: Director, Regulatory Affairs-Corporate (408) 954-2254
Summary date: April 24, 1996
Name of Device and Classification (21 CFR 807.92(e)(2))
CaliBRITE™ 3 Color and FACSComp™ Name:
Classification: Accessory to a Class II Device
Predicate Device (21 CFR 807,92(a)(3))
CaliBRITE™ 3 Color and FACSComp™ is substantially equivalent to CaliBRITE™ Beads with AutoCOMPTM (K 925274), cleared to market in September, 1994.
Description of the Device (21 CFR 807-92(e)(4))
Becton Dickinson CaliBRITE 3 Color and FACSComp are intended for use on the Becton Dickinson flow cytometers FACScan™ or FACSort or FACSCalibur™. FACSComp Software and CaliBRITE 3 Color Beads are used to optimally adjust instrument settings, to monitor the sensitivity, and to set the compensation of flow cytometers for spectral overlap of fluorescent dyes. FACSComp Software and CaliBRITE 3 Color Beads are used to set up and verify the separation of system noise from forward and side scatter and to set fluorescence compensation on flow cytometers with three FL channels. FACSComp Software and CaliBRITE 3 Color Beads are used for setting the photomultiplier tube (PMT) voltages, setting the fluorescence compensation, and checking instrument sensitivity on thow cytometers. This product is recommended for instrument set up prior to running Becton Dickinson software applications for flow cytometers. CaliBRITE 3 Color will be provided as a Kit, comprising unstained, FITC, PE and PerCP beads. CaliBRITE PerCP beads will also be provided as a separate product, to be used with CaliBRITE Kits having unstained FITC and PE beads only.
Intended Use (21 CFR 807,92(a)(5))
For flow cytometer set up and monitoring of instrument performance.
1
Indications for Use
The procedure employs a Becton Dickinson flow cytometer and recommended computer hardware and software.
Clinical Urility
Flow Cytometry has been found useful in monitoring some forms of immune disease.
Comparison to Predicate Device (21 CFR 807.92(2)(6))
CaliBRITE 3 Color with FACSComp is substantially equivalent to CaliBRITE Beads with AutoCOMP, (K925274). The product is composed of a bead kit with three components identical to that of the predicate, and one new bead, conjugated with PerCP, to check sensitivity of the FL3 channel.
Performance Data (21 CFR 807.92(b)(2))
Performance of this product was established by testing at Becton Dickinson Immunocytometry Systems laboratories in San Jose, California.
Several studies were performed:
- · Stability was measured
Storage stability was determined to be 8 months under the conditions of use.
Once diluted, the three-bead preparation is stable for 1 hour after dilution.
· Reproducibility was measured
Within instrument over 30 days
Between lot
Reproducibility was found to be within that for the predicate device.
Performance Data-Conclusions (21 CFR 807,92(b)(3))
The results of the design verification studies demonstrate that the device is as safe and effective as the predicate device.
2
Lina Longree
Anna Longwell, Esq. Director, Regulatory Affairs - Corporate
4/24/96
Date
CaliBRITE 3 Color