(115 days)
Vision BioSystems Estrogen Receptor Clone 6F11 (ER 6F11) is intended for in vitro diagnostic use for the qualitative detection of estrogen receptor in routinely processed tissues. ER 6F11 is indicated as an aid in the management, prognosis and prediction of therapy outcome of breast cancer within the context of the patient's clinical history and other diagnostic tests evaluated by a qualified pathologist.
Vision BioSystems Estrogen Receptor Clone 6F11 (ER 6F11) Mouse Monoclonal antibody is intended for laboratory use to qualitatively identify by light microscopy, estrogen receptor (ER) antigen in sections of formalin fixed, paraffin embedded tissue. Estrogen Receptor Clone 6F11 specifically binds to the ER antigen located in the nucleus of ER positive normal and neoplastic cells.
ER 6F11 is indicated as an aid in the management, prognosis and prediction of therapy outcome of breast cancer. The clinical interpretation of any staining or its absence should be complemented by morphological studies using proper controls and should be evaluated within the context of the patient's clinical history and other diagnostic tests by a qualified pathologist.
ER 6F11 is a monoclonal mouse antibody that detects a human estrogen receptor epitope located in the nucleus of ER positive cells.
The provided text is a 510(k) summary and associated FDA correspondence for the Vision BioSystems Estrogen Receptor Clone 6F11 (ER 6F11) device. It describes the device's intended use and substantial equivalence to predicate devices, but it does not contain information about acceptance criteria or a study proving the device meets those criteria, and therefore doesn't contain most of the information requested in your prompt. This is typical for 510(k) summaries, which focus on substantial equivalence rather than detailed performance studies and acceptance criteria as might be found in a PMA.
Therefore, I cannot populate the table or answer most of your detailed questions based on the provided text.
Here's a breakdown of what can be extracted and what is missing:
The document states: "ER 6F11 complies with the elements of FDA Guidance, "Guidance for Submission of Immunohistochemistry Applications to the FDA" and, "Guidance for Industry and FDA Staff - Use of Symbols on Labels and in Labeling of In Vitro Diagnostic Devices Intended for Professional Use." This implies the device meets certain regulatory expectations, but the specific performance acceptance criteria and study data are not included.
Information NOT present in the provided text:
- A table of acceptance criteria and reported device performance.
- Sample size used for the test set.
- Data provenance (e.g., country of origin, retrospective or prospective) for the test set.
- Number of experts used to establish ground truth for the test set.
- Qualifications of those experts.
- Adjudication method for the test set.
- Information on a multi-reader multi-case (MRMC) comparative effectiveness study, effect size.
- Whether a standalone (algorithm only) performance study was done.
- The type of ground truth used (expert consensus, pathology, outcomes data, etc.) for the test set.
- The sample size for the training set.
- How ground truth for the training set was established.
Information that can be inferred (though not directly stated as study results):
- Type of Ground Truth: Given the device is an immunohistochemistry reagent for detecting Estrogen Receptor in tissue, the ground truth would inherently be based on pathology (histopathological assessment of tissue samples).
Summary of what's provided related to your request:
| Feature | Description / Status |
|---|---|
| 1. Table of acceptance criteria and reported device performance | Not provided in the document. The document states "ER 6F11 complies with the elements of FDA Guidance, 'Guidance for Submission of Immunohistochemistry Applications to the FDA'," implying regulatory compliance but not specific performance criteria or results. |
| 2. Sample size and data provenance for test set | Not provided in the document. |
| 3. Number and qualifications of experts for ground truth (test set) | Not provided in the document. |
| 4. Adjudication method for test set | Not provided in the document. |
| 5. Multi Reader Multi Case (MRMC) comparative effectiveness study and effect size | Not provided in the document. This type of study is generally for AI/CAD devices, not for IHC reagents. |
| 6. Standalone (algorithm only) performance study | Not applicable. This device is an immunohistochemistry reagent, not an algorithm. |
| 7. Type of ground truth used | Inferred: Pathology (histopathological assessment of tissue samples). The device is an IHC reagent for tissue analysis, so ground truth would be based on expert pathological evaluation. |
| 8. Sample size for training set | Not provided in the document. (Training set concept likely not applicable in the same way for an IHC reagent as for a machine learning algorithm). |
| 9. How ground truth for training set was established | Not provided in the document. |
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MAY 2 5 2006
510(k) SUMMARY
:
| Date Prepared | January 27, 2006 |
|---|---|
| 510(k) Number | |
| Submitter | Vision BioSystems, Inc.700 Longwater DriveNorwell, MA 02061 |
| Contact | Ron LagerquistDirector, Regulatory Affairs |
| Device Name | Vision BioSystems Estrogen Receptor Clone 6F11(ER 6F11) |
| Common/Usual/Classification Name | Estrogen ReceptorImmunohistochemistry Reagents and Kits |
| Device Description | ER 6F11 is a monoclonal mouse antibody thatdetects a human estrogen receptor epitope locatedin the nucleus of ER positive cells. |
| Intended Use | ER 6F11 is intended for in vitro diagnostic use for thequalitative detection of estrogen receptor in routinelyprocessed tissues. ER 6F11 is indicated as an aid inthe management, prognosis and prediction oftherapy outcome of breast cancer within the contextof the patient's clinical history and other diagnostictests evaluated by a qualified pathologist. |
| Substantial Equivalence | ER 6F11 is substantially equivalent to commerciallyavailable immunohistochemistry ER antibodies suchas Ventana Medical Systems Estrogen ReceptorClone 6F11, and DAKO Corporation MouseMonoclonal Estrogen Receptor Clone 1D5.ER 6F11 complies with the elements of FDAGuidance, "Guidance for Submission ofImmunohistochemistry Applications to the FDA" and,"Guidance for Industry and FDA Staff - Use ofSymbols on Labels and in Labeling of In VitroDiagnostic Devices Intended for Professional Use. |
:
and the control concerner
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DEPARTMENT OF HEALTH & HUMAN SERVICES
Image /page/1/Picture/1 description: The image shows the seal of the U.S. Department of Health & Human Services. The seal features the department's name in a circular arrangement around a stylized emblem. The emblem consists of a stylized human figure embracing a globe, symbolizing the department's mission to protect and promote the health and well-being of Americans.
Public Health Service
Food and Drug Administration 2098 Gaither Road Rockville MD 20850
Ronald F. Lagerquist, RAC Director, Regulatory Affairs Vision BioSystems, Inc. 700 Longwater Drive Norwell. MA 02061
MAY 2 5 2006
Re: K060227
Trade/Device Name: Vision BioSystems Estrogen Receptor Clone 6F11 (ER 6F11) Regulation Number: 21 CFR § 864.1860 Regulation Name: Immunohistochemistry Reagents and Kits Regulatory Class: II Product Code: MYA Dated: May 11, 2006 Received: May 12, 2006
Dear Mr. Lagerquist:
We have reviewed your Section 510(k) premarket notification of intent to market the device referenced above and have determined the device is substantially equivalent (for the indications for use stated in the enclosure) to legally marketed predicate devices marketed in interstate commerce prior to May 28, 1976, the enactment date of the Medical Device Amendments, or to devices that have been reclassified in accordance with the provisions of the Federal Food, Drug, and Cosmetic Act (Act) that do not require approval of a premarket approval application (PMA). You may, therefore, market the device, subject to the general controls provisions of the Act. The general controls provisions of the Act include requirements for annual registration, listing of devices. good manufacturing practice, labeling, and prohibitions against misbranding and adulteration.
If your device is classified (see above) into either class II (Special Controls) or class III (PMA), it may be subject to such additional controls. Existing major regulations affecting your device can be found in Title 21, Code of Federal Regulations (CFR), Parts 800 to 895. In addition, FDA may publish further announcements concerning your device in the Federal Register.
Please be advised that FDA's issuance of a substantial equivalence determination does not mean that FDA has made a determination that your device complies with other requirements of the Act or any Federal statutes and regulations administered by other Federal agencies. You must comply with all the Act's requirements, including, but not limited to: registration and listing (21 CFR Part 807): labeling (21 CFR Parts 801 and 809); and good manufacturing practice requirements as set forth in the quality systems (QS) regulation (21 CFR Part 820). This letter will allow you to begin marketing your device as described in your Section 510(k) premarket notification. The FDA finding of substantial equivalence of your device to a legally marketed predicate device results in a classification for your device and thus, permits your device to proceed to the market.
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Page 2 -
If you desire specific information about the application of labeling requirements to your device, or questions on the promotion and advertising of your device, please contact the Office of In Vitro Diagnostic Device Evaluation and Safety at (240) 276-0484. Also, please note the regulation entitled, "Misbranding by reference to premarket notification" (21CFR Part 807.97). You may obtain other general information on your responsibilities under the Act from the Division of Small Manufacturers, International and Consumer Assistance at its toll-free number (800) 638-2041 or (301) 443-6597 or at its Internet address http://www.fda.gov/cdrh/industry/support/index.html
Sincerely yours,
lobatz Beckerh
Robert L. Becker, Jr., MD, PK. Director Division of Immunology and Hematology Office of In Vitro Diagnostic Device Evaluation and Safety Center for Devices and Radiological Health
Enclosure
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Indications for Use
510(k) Number K06027
Device Name:
Vision BioSystems Estrogen Receptor Clone 6F11 (ER 6F11)
- Lyophilized Mouse Monoclonal Antibody .
- Liquid Mouse Monoclonal Antibody .
- Ready to Use Mouse Monoclonal Antibody �
- Origin™ Mouse Monoclonal Antibody .
Indications for Use:
Vision BioSystems Estrogen Receptor Clone 6F11 (ER 6F11) Mouse Monoclonal antibody is intended for laboratory use to qualitatively identify by light microscopy, estrogen receptor (ER) antigen in sections of formalin fixed, paraffin embedded tissue. Estrogen Receptor Clone 6F11 specifically binds to the ER antigen located in the nucleus of ER positive normal and neoplastic cells.
ER 6F11 is indicated as an aid in the management, prognosis and prediction of therapy outcome of breast cancer. The clinical interpretation of any staining or its absence should be complemented by morphological studies using proper controls and should be evaluated within the context of the patient's clinical history and other diagnostic tests by a qualified pathologist.
Origin™ antibodies are optimized for use with the Ventana® Medical Systems. NexES® and BenchMark™ Immunohistochemistry Staining Systems in combination with Ventana® Detection Kits.
Prescription Use _____________________________________________________________________________________________________________________________________________________________
(PLEASE DO NOT WRITE BELOW THIS LINE-CONTINUE ON ANOTHER PAGE IF NEEDED)
Concurrence of CDRH, Office of Device Evaluation (ODE)
Division Sign Off
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Office of In Vitro Diagnostic Device Evaluation and Safety
KO 60227
§ 864.1860 Immunohistochemistry reagents and kits.
(a)
Identification. Immunohistochemistry test systems (IHC's) are in vitro diagnostic devices consisting of polyclonal or monoclonal antibodies labeled with directions for use and performance claims, which may be packaged with ancillary reagents in kits. Their intended use is to identify, by immunological techniques, antigens in tissues or cytologic specimens. Similar devices intended for use with flow cytometry devices are not considered IHC's.(b)
Classification of immunohistochemistry devices. (1) Class I (general controls). Except as described in paragraphs (b)(2) and (b)(3) of this section, these devices are exempt from the premarket notification requirements in part 807, subpart E of this chapter. This exemption applies to IHC's that provide the pathologist with adjunctive diagnostic information that may be incorporated into the pathologist's report, but that is not ordinarily reported to the clinician as an independent finding. These IHC's are used after the primary diagnosis of tumor (neoplasm) has been made by conventional histopathology using nonimmunologic histochemical stains, such as hematoxylin and eosin. Examples of class I IHC's are differentiation markers that are used as adjunctive tests to subclassify tumors, such as keratin.(2) Class II (special control, guidance document: “FDA Guidance for Submission of Immunohistochemistry Applications to the FDA,” Center for Devices and Radiologic Health, 1998). These IHC's are intended for the detection and/or measurement of certain target analytes in order to provide prognostic or predictive data that are not directly confirmed by routine histopathologic internal and external control specimens. These IHC's provide the pathologist with information that is ordinarily reported as independent diagnostic information to the ordering clinician, and the claims associated with these data are widely accepted and supported by valid scientific evidence. Examples of class II IHC's are those intended for semiquantitative measurement of an analyte, such as hormone receptors in breast cancer.
(3) Class III (premarket approval). IHC's intended for any use not described in paragraphs (b)(1) or (b)(2) of this section.
(c)
Date of PMA or notice of completion of a PDP is required. As of May 28, 1976, an approval under section 515 of the Federal Food, Drug, and Cosmetic Act is required for any device described in paragraph (b)(3) of this section before this device may be commercially distributed. See § 864.3.