CHEMMATE(TM) CD43 by BIOTEK SOLUTIONS, INC.

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:

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

AI/ML Overview

Here's a breakdown of the acceptance criteria and study information for the BioTek Solutions ChemMate™ CD43, based on the provided text:

Acceptance Criteria and Device Performance

The acceptance criteria are implied by the "consistency" with reported literature and expected staining patterns. The device performance is presented as ratios of positive or negative staining for specific tissue types.

Acceptance Criteria (Implied)	Reported Device Performance (ChemMate™ CD43)
For tissues expected to stain positively for CD43:
- Normal lymphoid tissues: 100% positive staining expected.	- 6/6 normal lymphoid tissues (tonsil and spleen) stained positively (100%).
- Lymphomas: Consistent with literature (approx. 88% reactivity).	- 47/55 lymphomas stained positively (approx. 85.5%).
For tissues expected to stain negatively for CD43:
- Normal non-lymphoid tissues: 100% negative staining expected.	- 117/117 normal non-lymphoid tissues stained negatively (100%).
- Pathological non-lymphoid tissues: 100% negative staining expected.	- 103/103 pathological non-lymphoid tissues stained negatively (100%).

Study Information

Sample size used for the test set and the data provenance:
- Total tissues tested: 281
- Lymphoid origin: 61 (6 normal lymphoid, 55 lymphomas)
- Non-lymphoid origin: 220 (117 normal non-lymphoid, 103 pathological non-lymphoid)
- Data Provenance: The document does not explicitly state the country of origin or whether the data was retrospective or prospective. It refers to "histopathological studies" and "reproducibility staining studies," implying these were conducted specifically for this submission.
Number of experts used to establish the ground truth for the test set and the qualifications of those experts:
- The document does not specify the number of experts used or their qualifications. It mentions "histopathological studies" and assessment of "positive or negative reactivity," which typically involves expert review, but no details are provided.
Adjudication method for the test set:
- The document does not specify an adjudication method.
If a multi-reader multi-case (MRMC) comparative effectiveness study was done, If so, what was the effect size of how much human readers improve with AI vs without AI assistance:
- This is not applicable as the device is a staining reagent and instrument, not an AI-based diagnostic tool for human reader improvement. The study compares the ChemMate™ CD43 staining to H&E staining and published literature, not to human readers with or without AI assistance.
If a standalone (i.e. algorithm only without human-in-the-loop performance) was done:
- This is not applicable as the device is a staining system, not an algorithm. The performance described is of the staining reagent and instrument system itself.
The type of ground truth used:
- The ground truth appears to be based on expert histopathological assessment (as implied by "histopathological studies" and assessment of "reactivity") and conformance with established immunoreactivity profiles from published literature.
The sample size for the training set:
- This is not applicable as the ChemMate™ CD43 is a chemical reagent and instrument for staining, not an AI/ML algorithm that requires a "training set." The development process for such a device would involve chemical formulation, quality control, and testing, but not a "training set" in the computational sense.
How the ground truth for the training set was established:
- This is not applicable for the reasons stated above (not an AI/ML algorithm).

Summary

{0}------------------------------------------------

950148

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:

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

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.

{1}------------------------------------------------

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 nonlymphoid origin expected to be negative for CD43 which did stain negatively. Analysis of staining results yielded a ratio of 117/117 for the normal, nonlymphoid 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 immunoreactivy 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.

54 10

BioTek Solutions ChemMate™ CD43 510(k) Premarket Notification

Regulation Number and Section

§ 866.5550 Immunoglobulin (light chain specific) immunological test system.

(a)
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.(b)
Classification. Class II (performance standards).