(435 days)
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No
The device description and performance studies focus on chemical reagents and staining protocols, with no mention of AI/ML or image processing.
No
The device is used for in-vitro diagnostic (IVD) purposes to aid in the diagnosis of pathophysiological processes by visualizing tissue antigens, not for direct therapy or treatment.
Yes
Explanation: The "Intended Use / Indications for Use" section states that the device's results "aid in the diagnosis of pathophysiological processes."
No
The device description clearly outlines a kit containing physical reagents (antibodies, enzymes, chromogens, etc.) used for immunohistochemical staining, which are hardware components.
Yes, this device is an IVD (In Vitro Diagnostic).
Here's why:
- Intended Use: The intended use explicitly states that the techniques "allow for the qualitative identification of tissue antigens" and that "Results aid in the diagnosis of pathophysiological processes." This clearly indicates the device is used to examine specimens from the human body to provide information for diagnostic purposes.
- Device Description: The description details a kit used for immunohistochemical staining, a common laboratory technique for identifying specific components in tissue samples.
- Anatomical Site: The listed anatomical sites (tissues, blood smears, etc.) are all types of human specimens.
- Performance Studies: The performance studies describe testing done on human tissue samples to evaluate the device's performance in comparison to predicate devices.
All of these points align with the definition of an In Vitro Diagnostic device, which is used to examine specimens from the human body to provide information for the diagnosis, treatment, or prevention of disease.
N/A
Intended Use / Indications for Use
lmmunoenzymatic/immunohistochemical (IHC) staining techniques allow for the qualitative identification of tissue antigens. Antigens are visualized via the sequential application of a specific antibody to the antigen (primary antibody) and a detection system. Immunohistochemical detection systems usually consist of a secondary antibody to the primary antibody (link antibody), an enzyme complex and a chromogenic substrate. The enzymatic activation of the chromogen yields a visible reaction product at the antigen site. Results aid in the diagnosis of pathophysiological processes which may or may not be associated with a particular antigen.
Product codes (comma separated list FDA assigned to the subject device)
K0677, K1390, K1391
Device Description
The DAKO LSAB® 2 Kit, HRP (Code No. K0677) is based on a modified labeled avidin-biotin (LAB) technique in which a biotinylated secondary antibody forms a complex with peroxidase-conjugated streptavidin molecules. This kit is very similar to the original DAKO LSAB® Kit, HRP (K0680) previously cleared in submission K924726. Refinements to the LSAB® 2 Kit include the elimination of a separate protein blocking reagent incubation and reconfigured substrate-chromogen reagents.
The DAKO Envision™ Systems, HRP, contains a Peroxidase Blocking Reagent similar to the Hydrogen Peroxide provided with the LSAB® and LSAB® 2 Kit, the Envision™ System does not require a protein blocking reagent incubation. The Envision™ System also eliminates the sequential applications of link antibody and streptavidin common to the LSAB® 2 Kits. A polymer, labeled with goat anti-mouse and goat anti-rabbit immunoglobulins conjugated to horseradish peroxidase eliminates these steps. The DAKO Envision™ System offers the user a choice of two protocols. Protocol #1 consecutively incubates the primary antibody and Peroxidase Labeled Polymer for ten (10) minutes. Protocol #2 increases the staining intensity of the Envision™ System by lengthening the incubations of the primary antibody and the labeled polymer to thirty (30) minutes. The DAKO Envision™ System. HRP, is available with DAB (Code No. K1390) or Ready-to-Use AEC substrate-chromogen (Code No. K1391). Both systems use the same Peroxidase Blocking Reagent and Peroxidase Labeled Polymer.
Concentrated primary rabbit/mouse antibodies or DAKO® Ready-to-Use N-Series Primary Antibodies and Negative Control Reagents are suitable for use with the DAKO LSAB® 2 Kit and DAKQ Envision™ Systems. Primary antibodies are not included with the DAKO LSAB® 2 Kit, HRP or DAKO Envision™ Systems, and must be purchased separately by the user.
Mentions image processing
Not Found
Mentions AI, DNN, or ML
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Input Imaging Modality
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Anatomical Site
formalin-fixed, paraffin embedded tissues, acetone-fixed, frozen tissues, blood smears, liver, kidney, lymphoid tissues, tonsil, melanoma, bone marrow
Indicated Patient Age Range
Not Found
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
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Summary of Performance Studies (study type, sample size, AUC, MRMC, standalone performance, key results)
Concurrent testing was done with the DAKO LSAB® Kit, HRP and the DAKO LSAB® 2 Kit, HRP using formalin-fixed, paraffin embedded tissues. Equivalent interpretive results were observed in all test specimens.
Similar concurrent testing was done with the DAKO LSAB® 2 Kit, HRP and the DAKO Envision™ System, HRP with Ready-To-Use AEC substrate-chromogen (K1391) using formalin-fixed, paraffin embedded tissues. Equivalent interpretive results were observed in all test specimens.
This test procedure was repeated using the DAKO LSAB® 2 Kit, HRP and the DAKO Envision™ System, HRP with liguid DAB substrate-chromogen (K1390). Equivalent interpretive results were observed in all test specimens.
Additional testing was done with the DAKO LSAB® 2 Kit, HRP and the DAKO Envision™ System, HRP with Ready-To-Use AEC substrate-chromogen (K1391) using acetone-fixed, frozen tissues and blood smears. Results were equivalent.
Results obtained from comparative testing of the DAKO Envision™ System, HRP with Ready-to-Use AEC substrate-chromogen using Protocols #1 and #2 support package insert claims for Protocol #2. Protocol #2 increases the staining intensity of the DAKO Envision™ System. Concentrated Primary antibodies used with protocol #2 may be diluted up to twenty tmes the optimal dilution used with Protocol #1.
Comparison testing of LSAB2 with 2 component AEC versus ready-to-use AEC was performed using LCA (N1514), UCHL1 (N1520), and HMB45 (N1545). The tissues tested included tonsil (N1514, and N1520) and melanoma (N1545). Results showed that the same level of staining was obtained with both product configurations for N1545 and N1520. Slightly more intense staining (2 component AEC staining = 3-3.5 vs ready-to-use AEC staining = 4 + ) was noted for ready-to-use AEC with N1514. Background staining of both negative controls and positively stained tissues was evaluated as negative i.e., no staining. Thus, the LSAB2 with the ready-to-use AEC is similar or better in performance to LSAB2 with the 2-component AEC.
Key Metrics (Sensitivity, Specificity, PPV, NPV, etc.)
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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.
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.
Not Found
Predetermined Change Control Plan (PCCP) - All Relevant Information for the subject device only (e.g. presence / absence, what scope was granted / cleared under the PCCP, any restrictions, etc).
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
Summary of Safery and Effectiveness
DAKO LSA8® 2 Kit, HRP DAKO ENVISION™ SYSTEMS, HRP
1. Introduction
lmmunoenzymatic/immunohistochemical (IHC) staining techniques allow for the qualitative identification of tissue antigens. Antigens are visualized via the sequential application of a specific antibody to the antigen (primary antibody) and a detection system. Immunohistochemical detection systems usually consist of a secondary antibody to the primary antibody (link antibody), an enzyme complex and a chromogenic substrate. The enzymatic activation of the chromogen yields a visible reaction product at the antigen site. Results aid in the diagnosis of pathophysiological processes which may or may not be associated with a particular antigen.
II. Device Descriptions
The DAKO LSAB® 2 Kit, HRP (Code No. K0677) is based on a modified labeled avidin-biotin (LAB) technique in which a biotinylated secondary antibody forms a complex with peroxidase-conjugated streptavidin molecules. This kit is very similar to the original DAKO LSAB® Kit, HRP (K0680) previously cleared in submission K924726. Refinements to the LSAB® 2 Kit include the elimination of a separate protein blocking reagent incubation and reconfigured substrate-chromogen reagents.
The DAKO Envision™ Systems, HRP, contains a Peroxidase Blocking Reagent similar to the Hydrogen Peroxide provided with the LSAB® and LSAB® 2 Kit, the Envision™ System does not require a protein blocking reagent incubation. The Envision™ System also eliminates the sequential applications of link antibody and streptavidin common to the LSAB® 2 Kits. A polymer, labeled with goat anti-mouse and goat anti-rabbit immunoglobulins conjugated to horseradish peroxidase eliminates these steps. The DAKO Envision™ System offers the user a choice of two protocols. Protocol #1 consecutively incubates the primary antibody and Peroxidase Labeled Polymer for ten (10) minutes. Protocol #2 increases the staining intensity of the Envision™ System by lengthening the incubations of the primary antibody and the labeled polymer to thirty (30) minutes. The DAKO Envision™ System. HRP, is available with DAB (Code No. K1390) or Ready-to-Use AEC substrate-chromogen (Code No. K1391). Both systems use the same Peroxidase Blocking Reagent and Peroxidase Labeled Polymer.
Concentrated primary rabbit/mouse antibodies or DAKO® Ready-to-Use N-Series Primary Antibodies and Negative Control Reagents are suitable for use with the DAKO LSAB® 2 Kit and DAKQ Envision™ Systems. Primary antibodies are not included with the DAKO LSAB® 2 Kit, HRP or DAKO Envision™ Systems, and must be purchased separately by the user.
III. Experimental Data
Concurrent testing was done with the DAKO LSAB® Kit, HRP and the DAKO LSAB® 2 Kit, HRP using formalin-fixed, paraffin embedded tissues. Equivalent interpretive results were observed in all test specimens.
Summary of Safety & Effectiveness/ rev. C/ p. 1
2
1
Experimental Data, continued III.
Similar concurrent testing was done with the DAKO LSAB® 2 Kit, HRP and the DAKO Envision™ System, HRP with Ready-To-Use AEC substrate-chromogen (K1391) using formalin-fixed, paraffin embedded tissues. Equivalent interpretive results were observed in all test specimens.
This test procedure was repeated using the DAKO LSAB® 2 Kit, HRP and the DAKO Envision™ System, HRP with liguid DAB substrate-chromogen (K1390). Equivalent interpretive results were observed in all test specimens.
Additional testing was done with the DAKO LSAB® 2 Kit, HRP and the DAKO Envision™ System, HRP with Ready-To-Use AEC substrate-chromogen (K1391) using acetone-fixed, frozen tissues and blood smears. Results were equivalent.
Results obtained from comparative testing of the DAKO Envision™ System, HRP with Ready-to-Use AEC substrate-chromogen using Protocols #1 and #2 support package insert claims for Protocol #2. Protocol #2 increases the staining intensity of the DAKO Envision™ System. Concentrated Primary antibodies used with protocol #2 may be diluted up to twenty tmes the optimal dilution used with Protocol #1.
Comparison testing of LSAB2 with 2 component AEC versus ready-to-use AEC was performed using LCA (N1514), UCHL1 (N1520), and HMB45 (N1545). The tissues tested included tonsil (N1514, and N1520) and melanoma (N1545). Results showed that the same level of staining was obtained with both product configurations for N1545 and N1520. Slightly more intense staining (2 component AEC staining = 3-3.5 vs ready-to-use AEC staining = 4 + ) was noted for ready-to-use AEC with N1514. Background staining of both negative controls and positively stained tissues was evaluated as negative i.e., no staining. Thus, the LSAB2 with the ready-to-use AEC is similar or better in performance to LSAB2 with the 2-component AEC.
IV. Product Specific Limitations
DAKO LSAB® 2, Kit (K0677):
Endogenous avidin-binding activity (EABA) has been noted in frozen sections of liver (entire hepatic nodule) and kidney (tubular epithelium), as well as in frozen and formalin-fixed lymphoid tissues (paracortical histiocytes). EABA can be suppressed by sequential 20-minute incubations, first with 0.1% avidin and then with 0.01% biotin in 0.05 M Tris-HC1 buffer, pH 7.2-7.6 prior to the application of the primary antibody, or use DAKO® Biotin Blocking System (code no. X0590).
DAKO Envision™ System, HRP (K1390, K1391):
Some primary antibodies may require proteolytic digestion and target retrieval to achieve optimal staining results. Protocol #2 is recommended for use. Contact DAKO Technical Services at 800/424-0021 for additional information.
Endogenous peroxidase or pseudoperoxidase activity can be found in hemoproteins such as hemoglobin, myoglobin, cytochrome, and catalase as well as in eosinophils. This activity can be inhibited by incubating specimens with Peroxidase Blocking Reagent Bottle #1 of the DAKO Envision™ System, HRP for five (5 ± 1) minutes prior to the application of the primary antibody. Blood and bone marrow smears and frozen tissues can also be treated with this reagent. However, this procedure does not abolish the reddish-brown pigment of hemoproteins. Alternatively, a solution of methanol-hydrogen peroxide can be used. Some antigens may become denatured with this procedure.