(739 days)
The input "Not Found" does not contain any K/DEN numbers. Therefore, I cannot extract any.
Not Found
No
The device is an antibody used for staining tissue samples on an automated slide stainer. There is no mention of AI/ML in the description or performance studies.
No.
The device is described as an antibody used for staining tissue samples on an automated slide stainer for diagnostic purposes, not for treating a condition.
Yes
The device is an antibody used to stain tissue samples to detect keratins, which can aid in the diagnosis of epithelial cancers, as indicated by its application in comparative studies with normal and pathologic samples including breast carcinomas, melanomas, and squamous cell carcinomas.
No
The device description explicitly states it is a "Primary Antibody" for use on an "Automated Slide Stainer," indicating it is a physical reagent and not software.
Based on the provided information, this device is an IVD (In Vitro Diagnostic).
Here's why:
- Device Description: It's a primary antibody used for staining on an automated slide stainer. Antibodies used for staining tissue samples are a common component of IVD tests, specifically immunohistochemistry (IHC).
- Test Set Description: The description details testing on paraffin-embedded preparations from normal and pathologic samples. This involves analyzing biological specimens in vitro (outside the body).
- Summary of Performance Studies: The performance studies involve evaluating staining intensity and comparing results to a commercially available keratin antibody. This is typical for validating the performance of an IVD reagent.
- Key Metrics: The mention of "Specificity and sensitivity" are key performance metrics for IVD tests.
- Predicate Device: The comparison to a "commercially available anti-human cytokeratin (clone CAM 5.2)" further indicates that this device is intended for a diagnostic purpose, as it's being compared to an existing diagnostic product.
While the "Intended Use / Indications for Use" section is listed as "Not Found," the other sections strongly suggest that this antibody is intended for use in a laboratory setting to aid in the diagnosis of diseases by staining tissue samples, which is the definition of an In Vitro Diagnostic device.
N/A
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
510(k) Summary of Safety and Effectiveness
MAR 22 1996
This summary of 510(k) safety and effectiveness information is being submitted in accordance with the requirements of SMDA 1990 and 21 CFR 807.92.
Ventana Medical Systems, Inc. developed Ventana Anti-Keratin-AE1 Primary Antibody (Clone AE1) for use on the Ventana ES Automated Slide Stainer. Ventana Anti-Keratin-AE1 Primary Antibody (Clone AE1) is substantially equivalent to a commercially available anti-human cytokeratin (clone CAM 5.2).
Comparative Study
Supporting data for the equivalence statement is shown by literature and the following study. Paraffin embedded preparations from normal and pathologic samples were tested using Ventana Anti-Keratin-AE1 Primary Antibody. Samples were obtained from excess tissues obtained for reasons other than the present study. Pathologic tissues evaluated for staining included breast carcinomas, melanomas, squamous cell carcinomas, carcinoids, and leiomyosarcomas. Normal tissues examined were breast, ureter, thyroid, skin, small intestine, stomach, liver, smooth muscle, prostate, tonsil, pituitary, thymus, esophagus, ovary, testes, pancreas, cardiac muscle, spinal cord, spleen, adenoid, and kidney. Slides were processed on the Ventana ES Automated Slide Stainer and prepared for examination, then evaluated for specific staining intensity and background staining. These results were compared to data generated using a commercially available keratin antibody CAM 5.2.
Results
Specificity and sensitivity of both antibodies was shown by appropriate staining of cells of epithelial origin and no staining of cells of mesodermal or endodermal origin. The antigenic sites for the Clone AE1 antibody have a different mix of subfamilies than the antigens detected by CAM 5.2, but there is crossover staining between the two antibodies. In the present study Anti-Keratin-AE1 Primary Antibody (Clone AE1) stained positively in 18 of 18 epithelial cancers compared to Anti-Keratin Primary Antibody (Clone CAM 5.2) which stained positively with 31 of 36 carcinomas tested.
Inter-run reproducibility of staining was based on samples of the same tissue on 15 different instrument runs with Anti-Keratin Anitbody Clone AE1 and Ventana DAB detection kit and intra-run reproducibility of staining was based on 10 samples of the same tissue within one run, with Anti-Keratin-AE1 Primary Antibody (Clone AE1) and Ventana DAB detection kit. All slides stained with equivalent staining intensity.
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