(532 days)
Not Found
K936111/A
No
The device description focuses on automated mechanical and chemical processes for staining, with no mention of AI/ML for analysis or interpretation. The performance studies are based on histopathological assessment, not algorithmic analysis.
No
The description indicates the device is used for immunohistochemistry procedures and staining, which are diagnostic laboratory processes, not therapeutic interventions.
Yes
The device, described as an automated staining instrument that uses capillary action to add immunological or chemical reagents to test slides to standardize immunohistochemistry procedures, is part of a diagnostic process. It is used in histopathological studies to assess "positive or negative reactivity for the CD43" in various tissues, including lymphomas, which directly contributes to diagnosing certain conditions.
No
The device description explicitly details a mechanical arm, a PC-style computer with mouse and monitor, and reagent sets, indicating it is a system with significant hardware components, not solely software.
Based on the provided information, the BioTek Solutions ChemMate™ CD43 is likely an IVD (In Vitro Diagnostic).
Here's why:
- Device Description: It's a reagent (CD43 primary antibody) used in combination with an automated staining instrument (TechMate™) to perform immunohistochemistry procedures.
- Anatomical Site: It's used on tissue samples (suspected to contain T lymphocytes and their derivatives, normal lymphoid tissues, lymphomas, neoplastic and normal tissues of nonlymphoid origin).
- Summary of Performance Studies: The studies involve testing the reagent's performance on tissue samples to assess positive or negative reactivity for CD43. This is a key characteristic of diagnostic testing.
- Predicate Device(s): The predicate devices listed are "H & E Stain" and "Becton Dickinson CD43 antibody". Both of these are commonly used in diagnostic pathology laboratories for analyzing tissue samples.
- Reference Device(s): The reference devices are other reagents (Negative Control Reagent, Secondary Detection Kit, Standard Secondary Buffer Kit) that are used in conjunction with the CD43 antibody for the staining procedure. These are also typical components of IVD kits.
While the "Intended Use / Indications for Use" section is listed as "Not Found", the description of how the device is used, the types of samples it's applied to, and the nature of the performance studies strongly suggest that its purpose is to provide information about a patient's health status by examining samples taken from the human body. This aligns with the definition of an In Vitro Diagnostic device.
N/A
Intended Use / Indications for Use
Not Found
Product codes
Not Found
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 . 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.
Mentions image processing
Not Found
Mentions AI, DNN, or ML
Not Found
Input Imaging Modality
Not Found
Anatomical Site
Not Found
Indicated Patient Age Range
Not Found
Intended User / Care Setting
Not Found
Description of the training set, sample size, data source, and annotation protocol
Not Found
Description of the test set, sample size, data source, and annotation protocol
Not Found
Summary of Performance Studies (study type, sample size, AUC, MRMC, standalone performance, key results)
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. 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.
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.
Not Found
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.
K936111/A
Predetermined Change Control Plan (PCCP) - All Relevant Information
Not Found
§ 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).
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.
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.
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.
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BioTek Solutions ChemMate™ CD43 510(k) Premarket Notification