CHEMMATE(TM) CD43

K950148 · Biotek Solutions, Inc. · DEH · Jul 2, 1996 · Immunology

Device Facts

• Record ID: K950148
• Device Name: CHEMMATE(TM) CD43
• Applicant: Biotek Solutions, Inc.
• Product Code: DEH · Immunology
• Decision Date: Jul 2, 1996
• Decision: SESE
• Submission Type: Traditional
• Regulation: 21 CFR 866.5550
• Device Class: Class 2

Device Story

The BioTek Solutions ChemMate™ CD43 is an immunohistochemistry reagent used with the automated TechMate™ staining instrument. The system utilizes capillary action to apply immunological reagents to tissue slides in a standardized, automated sequence. The instrument consists of a mechanical arm, workstation, and PC-based controller. It automates slide movement, reagent application, washing, and incubation timing. The device is intended for use in clinical laboratory settings by trained personnel. By standardizing the immunohistochemistry procedure, the device provides consistent staining of CD43 antigens, allowing pathologists to identify T lymphocytes and their derivatives in tissue samples, thereby aiding in the diagnosis of lymphomas.

Clinical Evidence

Methods comparison study performed on 281 tissue samples (61 lymphoid, 220 non-lymphoid). Results showed 100% (6/6) positive reactivity in normal lymphoid tissues and 85.5% (47/55) in lymphomas, consistent with literature (88%). Non-lymphoid tissues showed 100% (220/220) negative reactivity. Reproducibility studies were conducted over three days. No clinical diagnostic outcomes were reported; study focused on analytical staining performance.

Technological Characteristics

Automated immunohistochemistry staining system utilizing capillary action principle. System includes mechanical arm, slide holder, and PC-style computer interface. Reagents include CD43 primary antibody, Negative Control Reagent, Secondary Detection Kit (Peroxidase/DAB), and Standard Secondary Buffer Kit. Standardizes incubation time, reagent volume, and washing procedures.

Indications for Use

Indicated for the detection of CD43 antigen in tissues suspected to contain T lymphocytes and their derivatives, specifically for use in immunohistochemistry procedures to aid in the identification of lymphomas and normal lymphoid tissues.

Regulatory Classification

Identification

An immunoglobulin (light chain specific) immunological test system is a device that consists of the reagents used to measure by immunochemical techniques both kappa and lambda types of light chain portions of immunoglobulin molecules in serum, other body fluids, and tissues. In some disease states, an excess of light chains are produced by the antibody-forming cells. These free light chains, unassociated with gamma globulin molecules, can be found in a patient's body fluids and tissues. Measurement of the various amounts of the different types of light chains aids in the diagnosis of multiple myeloma (cancer of antibody-forming cells), lymphocytic neoplasms (cancer of lymphoid tissue), Waldenstrom's macroglobulinemia (increased production of large immunoglobulins), and connective tissue diseases such as rheumatoid arthritis or systemic lupus erythematosus.

Predicate Devices

• Becton Dickinson CD43 antibody

Reference Devices

• H & E Stain
• Secondary Detection Kit - Peroxidase/DAB (SDK605) (K936111/A)
• Standard Secondary Buffer Kit (SDK601A) (K936111/A)

Submission Summary (Full Text)

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K950148

# IV. 510(k) Summary of Safety and Effectiveness

**Device Description:** The BioTek Solutions ChemMate™ CD43 is used in combination with the automated TechMate™ staining instrument. The instrumentation and methods employ the capillary action principle, covered by U.S. patent 4,731,335 (and others) and are held by BioTek Solutions, Inc. The instrumentation consists of two parts; the instrument's mechanical arm with its associated work station and the PC-style computer with mouse and color monitor. The mechanical arm picks up and places the slide holder containing test slides on the appropriate "tile" or platform. Solutions and pads are mounted on the tiles in a pattern described by the protocol. The instrument performs the following functions:

a. Moves the slide holder(s) from one tile position (containing chemistry or pad) to another.
b. By capillary action adds immunological or chemical reagents in proper sequence as dictated by the protocol instructions.
c. Employs uniform washing procedures between reagent steps, as per the loaded protocol.
d. Keeps immunologic reaction conditions uniform by controlling time of incubation and volume of reagent used.
e. Records real time for incubation steps with the reagent used for the specific step.
f. Standardizes the immunohistochemistry procedure.

There are two reagent sets in addition to the CD43 (primary antibody) and the Negative Control Reagent. These are the Secondary Detection Kit - Peroxidase/DAB (SDK605) and the Standard Secondary Buffer Kit (SDK601A). All of the ChemMate™ reagents are designed for use with the TechMate™ instrument.

**Note:** The Negative Control Reagent, Secondary Detection Kit - Peroxidase/DAB (SDK605) and the Standard Secondary Buffer Kit (SDK601A) have previously been included in BioTek's 510(k) K936111/A and are awaiting final review and clearance. They are enclosed in this ChemMate™ CD43 510(k) as supportive reference.

BioTek Solutions ChemMate™ CD43 510(k) Premarket Notification | 933 | 9

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Equivalence: The ChemMate™ CD43 has undergone testing to demonstrate equivalence to predicate devices. Histopathological studies included a methods comparison study (ChemMate™ CD43 vs. H & E) on tissues suspected to contain T lymphocytes and their derivatives. Additionally, reproducibility staining studies were performed on these same tissues on three separate days. Positive or negative reactivity for the CD43 was assessed for each of the slides stained.

Of the 281 tissues tested, there were 61 lymphomas and normal tissues of lymphoid origin stained with CD43. As expected, all 6 of the normal lymphoid tissues (tonsil and spleen) stained positively for CD43. Of the remaining 55 lymphomas, 47 stained positively with CD43. This ratio, when viewed against the literature summary which revealed an 88% reactivity (188/224), is consistent with the reported positive immunoreactivity profile represented in the current published findings.

Of the 281 tissues tested, there were 220 neoplastic and normal tissues of non-lymphoid origin expected to be negative for CD43 which did stain negatively. Analysis of staining results yielded a ratio of 117/117 for the normal, non-lymphoid tissues which stained negatively for CD43 and a ratio of 103/103 for the pathological, non-lymphoid tissues which stained negatively for CD43. These ratios are also consistent with reported nonreactive immunoreactivity profiles represented in the current published findings.

Based on the performance comparison detailed in section VI. and its conformance with the immunoreactivity profile established in published studies, as well as the similarity in features of the ChemMate™ CD43 with both the H & E Stain and Becton Dickinson CD43 antibody, substantial equivalence of the ChemMate™ CD43 has been demonstrated. Please see pages 27-31 of Section V. for specific details of the literature summaries referenced above.

BioTek Solutions ChemMate™ CD43 510(k) Premarket Notification
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