ZYMMUNE AUTOREADER-F FLUORESCENCE MICROPLATE READER

K962499 · Bartels, Inc. · JZT · Sep 5, 1996 · Immunology

Device Facts

• Record ID: K962499
• Device Name: ZYMMUNE AUTOREADER-F FLUORESCENCE MICROPLATE READER
• Applicant: Bartels, Inc.
• Product Code: JZT · Immunology
• Decision Date: Sep 5, 1996
• Decision: SESE
• Submission Type: Traditional
• Regulation: 21 CFR 866.4520
• Device Class: Class 1

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.

Device Story

Zymmune™ Auto-Reader F is a fluorescence microplate reader for 96-well plates. Device measures relative fluorescence signals from samples. Integrated software processes these signals using specific algorithms to calculate and report CD4 and CD8 T-lymphocyte counts and CD4/CD8 ratios. Used in clinical laboratory settings. Healthcare providers use the output to monitor T-cell levels, aiding in the assessment of patient immune status. Benefits include automated conversion of raw fluorescent data into clinically relevant cell counts, reducing manual calculation errors compared to predicate methods.

Clinical Evidence

Correlation study comparing Autoreader-F to predicate Fluoroskan using 70 clinical samples. Primary endpoints were CD4 count, CD8 count, and CD4/CD8 ratio. Linear regression analysis showed high correlation: CD4 (r=0.994, slope=1.018), CD8 (r=0.992, slope=1.035), and ratio (r=0.989, slope=0.982).

Technological Characteristics

Fluorescence microplate reader for 96-well plates. Fixed excitation/emission optics optimized for fluorescein. Integrated software for signal processing and quantification. Standalone system.

Indications for Use

Indicated for in vitro quantification and monitoring of T-cell levels (CD4 and CD8) in clinical samples when used with approved microplate assay kits.

Regulatory Classification

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.

Predicate Devices

• Flow Laboratories Fluoroskan Reader

Reference Devices

• Zymmune™ CD4/CD8 Cell Monitoring Kit (K933878)

Submission Summary (Full Text)

{0}

Bartels Inc.
THE DIAGNOSTICS DIVISION OF INTRACEL CORPORATION
SEP 5 1996
Bartels Inc./Division of Intracel
Autoreader-F 510(k)
Appendix C
K962499

# 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 fluorescence signal from samples in 96-well microplates. There are two differences between the Autoreader-F and the Fluoroskan:

1. The Autoreader is designed to read excitation an emission maxima consist with the measurement of fluorescein. The Fluoroskan can be operator-selected to read more than one wavelength, allowing its use in applications other than selectively reading the fluorescein signals associated with the Zymmune™ CD4/CD8 Cell Monitoring Kit.

Bartels Inc. • 2005 NW Sammamish Road, Suite 107 • Issaquah, Washington 98027 USA • Tel. [phone] • Fax. [phone]

{1}

Bartels Inc./Division of Intracel
Autoreader-F 510(k)
Appendix C
Page 2

2) 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-lymphocyte 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