(71 days)
No
The summary describes a standard microplate reader and software that performs calculations based on fluorescence signals, without mentioning any AI or ML techniques.
No
The device is a microplate reader intended for in vitro quantification and monitoring of T-cell levels, which is a diagnostic function, not a therapeutic one. It measures fluorescence signals and reports them, but does not directly treat or alleviate a medical condition.
Yes
The device is intended for "in vitro quantification and monitoring of T-cell levels," which indicates its use in diagnosing or monitoring medical conditions based on the quantification of these biomarkers. The performance studies also show that it provides "CD4 and CD8 T-lymphocyte counts and a CD4/CD8 ratio," which are diagnostic indicators.
No
The device description explicitly states it is a "microplate reader that measures relative fluorescence signals" and is designed to be used with integrated software. This indicates the device includes hardware components (the microplate reader) in addition to the software.
Yes, this device is an IVD (In Vitro Diagnostic).
Here's why:
- Intended Use: The intended use explicitly states it's for "in vitro quantification and monitoring of T-cell levels" in combination with approved microplate tests. "In vitro" means "in glass" or outside of a living organism, which is a key characteristic of IVDs.
- Device Description: The device measures fluorescence signals from samples in a microplate. This is a common method used in laboratory tests performed on biological samples (like blood or other bodily fluids) outside of the body.
- Performance Studies: The performance studies describe testing with "clinical samples" and comparing results to a "predicate device" used for similar measurements. This further supports its use in a laboratory setting for diagnostic purposes.
- Predicate Device: The predicate device is a "Fluoroskan fluorescence reader," which is a type of instrument commonly used in IVD testing.
- Reference Device: The reference device is an "Assay Kit," which is a reagent kit used in IVD testing to perform specific measurements.
All of these points align with the definition and characteristics of an In Vitro Diagnostic device. The device is designed to analyze samples taken from the body to provide information about a person's health status (in this case, T-cell levels).
N/A
Intended Use / Indications for Use
In combination with approved microplate tests (such as the Bartels manufactured, Zymmune™ CD4/CD8 Cell monitoring assay kit) the Zymmune™ Auto-Reader F [with software] is intended for use for in vitro quantification and monitoring of T-cell levels.
Product codes
KG62499
Device Description
The Zymmune™ Auto-Reader F is a microplate reader that measures relative fluorescence signals from samples in a 96-well microplate. The Auto-Reader F is designed to be used with integrated software which collects and reports the measurements made by the microplate reader.
Mentions image processing
Not Found
Mentions AI, DNN, or ML
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Input Imaging Modality
Not Found
Anatomical Site
Not Found
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
A correlation study evaluated the Autoreader-F in comparison to the Fluoroskan fluorescence reader. 70 clinical samples were used to validate the performance of the Autoreader-F. Samples were tested on the Autoreader-F which provided the operator with CD4 and CD8 T-Ivmphocyte counts and a CD4/CD8 ratio. The same samples were tested using the predicate device. The predicate device provided fluorescent readings which were then manually converted into CD4 and CD8 T-lymphocyte cell counts using the algorithms provided in the CD4 and CD8 cell monitoring assay kit labeling (Bartels’ manufactured, Zymmune™ CD4/CD8 Cell Monitoring Kit, FDA reviewed as 510(k) K933878).
Summary of Performance Studies (study type, sample size, AUC, MRMC, standalone performance, key results)
Non-clinical operational qualifications of the Autoreader-F were completed as part of a comprehensive software validation. The Autoreader-F was documented to meet operational criteria similar to that of the predicate device.
A correlation study evaluated the Autoreader-F in comparison to the Fluoroskan fluorescence reader. 70 clinical samples were used to validate the performance of the Autoreader-F. Samples were tested on the Autoreader-F which provided the operator with CD4 and CD8 T-Ivmphocyte counts and a CD4/CD8 ratio. The same samples were tested using the predicate device. The predicate device provided fluorescent readings which were then manually converted into CD4 and CD8 T-lymphocyte cell counts using the algorithms provided in the CD4 and CD8 cell monitoring assay kit labeling (Bartels’ manufactured, Zymmune™ CD4/CD8 Cell Monitoring Kit, FDA reviewed as 510(k) K933878).
T-lymphocyte counts obtained using the Autoreader-F with software and the Fluoroskan with manual calculations (tests run using Bartels’ Zymmune™ CD4/CD8 Cell Monitoring Assay) were compared though linear regression analysis. Analysis showed excellent correlation between the two devices, Summary of results is as follows:
(n=70) | Slope | Intercept | Correlation Coefficient
CD4 T-lymphocyte | 1.018 | 3.6 | 0.994
CD8 T-lymphocyte | 1.035 | -3.8 | 0.992
CD4/CD8 ratio | 0.982 | 0 | 0.989
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.
Flow Laboratories Fluoroskan Reader
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.
Predetermined Change Control Plan (PCCP) - All Relevant Information
Not Found
§ 866.4520 Immunofluorometer equipment.
(a)
Identification. Immunofluorometer equipment for clinical use with its electrical power supply is a device used to measure the fluorescence of fluorochrome-labeled antigen-antibody complexes. The concentration of these complexes may be measured by means of reflected light. A beam of light is passed through a solution in which a fluorochrome has been selectively attached to serum protein antibody molecules in suspension. The amount of light emitted by the fluorochrome label is detected by a photodetector, which converts light energy into electrical energy. The amount of electrical energy registers on a readout system such as a digital voltmeter or a recording chart. This electrical readout is called the fluorescence value and is used to measure the concentration of antigen-antibody complexes.(b)
Classification. Class I (general controls). The device is exempt from the premarket notification procedures in subpart E of part 807 of this chapter subject to the limitations in § 866.9.
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Image /page/0/Picture/0 description: The image shows the logo for Bartels Inc., a diagnostics division of Intracel Corporation. The logo is in black and white and features a stylized eye in place of the 'o' in Bartels. Below the company name, in smaller font, is the text 'THE DIAGNOSTICS DIVISION OF INTRACEL CORPORATION'.
EP 5 1996
Bartels Inc./Division of Intracel Autoreader-F 510(k)
KG62499
510(k) SUMMARY
Premarket Notification- Summary of Safety and Effectiveness (per 21 CFR § 807.92(c))
| Trade Name: | Zymmune™ Auto-Reader F
Fluorescence Microplate Reader
[with software] |
|----------------------|-----------------------------------------------------------------------------|
| Common/Usual Name: | Immunological Fluorometer |
| Classification Name: | Immunofluorometer equipment
(per 21 CFR §866.4520) |
| Predicate Device: | Flow Laboratories Fluoroskan Reader |
Device Description:
The Zymmune™ Auto-Reader F is a microplate reader that measures relative fluorescence signals from samples in a 96-well microplate. The Auto-Reader F is designed to be used with integrated software which collects and reports the measurements made by the microplate reader.
Intended Use:
In combination with approved microplate tests (such as the Bartels manufactured, Zymmune™ CD4/CD8 Cell monitoring assay kit) the Zymmune™ Auto-Reader F [with software] is intended for use for in vitro quantification and monitoring of T-cell levels.
Technological Comparison with Predicate Device
Similar to the predicate device, identified as the Fluoroskan fluorescence reader, the Zymmune™ Autoreader F reads relative fluroscence signal from samples in 96-well microplates. There are two differences between the Autoreader-F and the Fluoroskan:
-
- The Autoreader is designed to read excitation an emission maxima consist with the measurement of fluorescein. The Fluoroskan can be operatorselected to read more than one wavelength, allowing its use in applications other than selectively reading the fluorescein signals associated with the Zvmmune™ CD4/CD8 Cell Monitoring Kit.
1
- The Autoreader-F includes an integrated software element that utilizes the algorithms appearing in the Zymmune™ CD4/CD8 Monitoring kit to convert the fluorescent signals into relative CD4 and CD8 levels in the specimen.
Non-Clinical Performance Comparison with Predicate Device
Non-clinical operational qualifications of the Autoreader-F were completed as part of a comprehensive software validation. The Autoreader-F was documented to meet operational criteria similar to that of the predicate device.
Clinical Performance Comparison with Predicate Device
A correlation study evaluated the Autoreader-F in comparison to the Fluoroskan fluorescence reader. 70 clinical samples were used to validate the performance of the Autoreader-F. Samples were tested on the Autoreader-F which provided the operator with CD4 and CD8 T-Ivmphocyte counts and a CD4/CD8 ratio. The same samples were tested using the predicate device. The predicate device provided fluorescent readings which were then manually converted into CD4 and CD8 T-lymphocyte cell counts using the algorithms provided in the CD4 and CD8 cell monitoring assay kit labeling (Bartels' manufactured, Zymmune™ CD4/CD8 Cell Monitoring Kit, FDA reviewed as 510(k) K933878).
Conclusion from Performance Comparison Data
T-lymphocyte counts obtained using the Autoreader-F with software and the Fluoroskan with manual calculations (tests run using Bartels' Zymmune™ CD4/CD8 Cell Monitoring Assay) were compared though linear regression analysis. Analysis showed excellent correlation between the two devices, Summary of results is as follows:
| (n=70) | Slope | Intercept | Correlation
Coefficient |
|------------------|-------|-----------|----------------------------|
| CD4 T-lymphocyte | 1.018 | 3.6 | 0.994 |
| CD8 T-lymphocyte | 1.035 | -3.8 | 0.992 |
| CD4/CD8 ratio | 0.982 | 0 | 0.989 |
Contact
Rebecca D. Fuller, Director of Regulatory Affairs & Quality Assurance Bartels, Inc. /A Division of INTRACEL Corp. 2005 NW Sammamish Road, Suite 107 Issaquah, WA 98027 USA