(172 days)
Not Found
No
The device description details a microarray-based gene expression analysis that correlates a sample profile to a fixed template (mean expression of 44 tumors). This is a statistical comparison to a predefined standard, not a system that learns or adapts from data, which is characteristic of AI/ML. The text explicitly states "Mentions AI, DNN, or ML: Not Found".
No.
The device is an in vitro diagnostic test that provides prognostic information to physicians; it does not directly treat or prevent a disease.
Yes
The "Intended Use / Indications for Use" section explicitly states that "MammaPrint is a qualitative in vitro diagnostic test service."
No
The device description explicitly details hardware components and processes like microarray hybridization, scanning, and data acquisition, indicating it is not solely software.
Yes, this device is an IVD (In Vitro Diagnostic).
Here's why:
- Explicitly stated in the Intended Use: The very first sentence of the "Intended Use / Indications for Use" section clearly states: "MammaPrint is a qualitative in vitro diagnostic test service...".
- Performed in a laboratory: The description mentions the test is "performed in a single laboratory".
- Analyzes biological samples: The test uses "fresh breast cancer tissue samples" and involves "isolation of RNA from frozen tumor tissue sections".
- Provides diagnostic information: The test assesses a patient's "risk for distant metastasis" and the result is indicated for use by physicians as a "prognostic marker".
All of these points align with the definition of an In Vitro Diagnostic device, which is a medical device intended for use in vitro for the examination of specimens derived from the human body solely or principally for the purpose of providing information concerning a physiological or pathological state, or concerning a congenital abnormality, or to determine the compatibility of a potential recipient with other medical products, or to monitor therapeutic measures.
N/A
Intended Use / Indications for Use
MammaPrint is a qualitative in vitro diagnostic test service, performed in a single laboratory, using the gene expression profile of fresh breast cancer tissue samples to assess a patient's risk for distant metastasis.
The test is performed for breast cancer patients who are less than 61 years old, with Stage I or Stage II disease, with tumor size
§ 866.6040 Gene expression profiling test system for breast cancer prognosis.
(a)
Identification. A gene expression profiling test system for breast cancer prognosis is a device that measures the ribonucleic acid (RNA) expression level of multiple genes and combines this information to yield a signature (pattern or classifier or index) to aid in prognosis of previously diagnosed breast cancer.(b)
Classification. Class II (special controls). The special control is FDA's guidance document entitled “Class II Special Controls Guidance Document: Gene Expression Profiling Test System for Breast Cancer Prognosis.” See § 866.1(e) for the availability of this guidance document.
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Section 5: 510(k) Summary
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Assigned 510(k) number The assigned 510(k) number is
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Company
umber is K0800252
21 2008
Agendia BV Slotervaart Medical Center 9D Louwesweg 6, 1066EC Amsterdam The Netherlands Telephone : 31 20 512 9161 Facsimile : 31 20 5129162
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Contact Guido Brink, Director Quality Management and Regulatory Affairs
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Date Prepared January 21, 2008
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Proprietary Name MammaPrint®
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Classification Name Gene expression profiling test system, for breast cancer prognosis.
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Common Name Multivariate device for cancer prognosis
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Classification Class II, regulated under 21 CFR 866.6040, product code NYI
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Predicate Device Agendia BV's MammaPrint (K070675)
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10. Device Description
The MammaPrint service is a microarray based gene expression analysis of a tumor. The analysis is based on several processes: isolation of RNA from frozen turnor tissue sections, DNA'se treatment of isolated RNA, linear amplification and labeling of DNA'se treated RNA, cRNA purification, hybridization of the cRNA to the MammaPrint microarray, scanning the MammaPrint microarray and data acquisition (feature extraction), calculation and determination of the risk of recurrence in breast cancer patients.
The MammaPrint analysis is designed to determine the gene activity of specific genes in a tissue sample compared to a reference standard. The result is an expression profile, or fingerprint, of the sample.
The correlation of the sample expression profile to a template (the mean expression profile of 44 tumors with a known good clinical outcome) is calculated and the molecular profile of the sample is determined (Low Risk, High Risk).
11. Intended Use
MammaPrint is a qualitative in vitro diagnostic test service, performed in a single laboratory, using the gene expression profile of fresh breast cancer tissue samples to assess a patient's risk for distant metastasis.
The test is performed for breast cancer patients who are less than 61 years old, with Stage I or Stage II disease, with tumor size