(146 days)
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No
The device is a monoclonal antibody used for immunohistochemistry, a laboratory technique for staining tissue samples. The description focuses on the biological and technical aspects of the antibody and its use with staining systems, with no mention of AI or ML for image analysis or interpretation.
No
This device is an antibody used for diagnostic purposes (identifying PGR antigen in tissue) and as an aid in the management, prognosis, and prediction of therapy outcome for breast cancer. It does not directly provide therapy or treatment to a patient.
Yes
Explanation: The device is an "aid in the management, prognosis and prediction of therapy outcome of breast cancer," and its "clinical interpretation...should be evaluated within the context of the patient's clinical history and other diagnostic tests by a qualified pathologist," indicating its role in diagnosis.
No
The device is a monoclonal antibody, which is a biological reagent used in laboratory procedures, not a software program. The description clearly indicates it is a physical substance intended for use with light microscopy and staining systems.
Yes, this device is an IVD (In Vitro Diagnostic).
Here's why:
- Intended Use: The intended use clearly states that the antibody is for "laboratory use to qualitatively identify... progesterone receptor (PGR) antigen in sections of formalin fixed, paraffin embedded tissue." This is a classic description of an in vitro diagnostic test performed on biological samples (tissue).
- Clinical Interpretation: The indication for use explicitly states it is "an aid in the management, prognosis and prediction of therapy outcome of breast cancer." This demonstrates a clinical purpose for the test results.
- User and Setting: The intended user is a "qualified pathologist" in a "laboratory" setting, which is typical for IVD tests.
- Predicate Device: The mention of a "Predicate Device" (DAKO Corporation Mouse Monoclonal Progesterone Receptor PgR 636) strongly suggests that this device is being submitted for regulatory review as an IVD, as predicate devices are used for comparison in the regulatory process for IVDs.
The device performs a test in vitro (outside the body) on a biological sample (tissue) to provide information that aids in clinical decision-making. This aligns perfectly with the definition of an In Vitro Diagnostic device.
N/A
Intended Use / Indications for Use
PGR Clone 16 is intended for in vitro diagnostic use for the qualitative detection of progesterone receptor in formalin-fixed paraffin embedded tissues. PGR Clone 16 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 Progesterone Receptor Clone 16 (PGR Clone 16) Mouse Monoclonal antibody is intended for laboratory use to qualitatively identify by light microscopy, progesterone receptor (PGR) antigen in sections of formalin fixed, paraffin embedded tissue. PGR Clone 16 specifically binds to the PGR antigen located in the nucleus of PGR positive normal and neoplastic cells.
PGR Clone 16 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.
Novocastra™ antibodies are intended for manual use. Origin™ antibodies are optimized for use with the Ventana® Medical Systems, NexES® and BenchMark™ Immunohistochemistry Staining Systems in combination with Ventana® Defection Kits. Bond™ Ready-to-Use Primary Antibodies are optimized for use on the Vision BioSystems Bond-max™ system.
Product codes (comma separated list FDA assigned to the subject device)
MXZ
Device Description
PGR Clone 16 is a monoclonal mouse antibody that detects a human progesterone receptor epitope located in the nucleus of PGR positive cells.
Mentions image processing
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Mentions AI, DNN, or ML
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Input Imaging Modality
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Anatomical Site
Breast
Indicated Patient Age Range
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Intended User / Care Setting
qualified pathologist
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)
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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.
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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.
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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).
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§ 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.
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JAN 2 9 2007
510(k) SUMMARY
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| Date Prepared | August 25, 2006 |
|---|---|
| 510(k) Number | |
| Submitter | Vision BioSystems, Inc. |
| 1833 Portola Rd. | |
| Ventura, CA 93003 | |
| Contact | Ron Lagerquist |
| Director, Regulatory Affairs | |
| Device Name | Vision BioSystems Progesterone Receptor Clone 16 |
| Common/Usual/ | |
| Classification Name | Progesterone Receptor |
| Immunohistochemistry Reagents and Kits | |
| Device Description | PGR Clone 16 is a monoclonal mouse antibody that |
| detects a human progesterone receptor epitope | |
| located in the nucleus of PGR positive cells. | |
| Intended Use | PGR Clone 16 is intended for in vitro diagnostic use |
| for the qualitative detection of progesterone receptor | |
| in formalin-fixed paraffin embedded tissues. PGR | |
| Clone 16 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. | |
| Substantial Equivalence | PGR Clone 16 is substantially equivalent to DAKO |
| Corporation Mouse Monoclonal Progesterone | |
| Receptor PgR 636 |
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DEPARTMENT OF HEALTH & HUMAN SERVICES
Image /page/1/Picture/1 description: The image shows the logo for the U.S. Department of Health & Human Services. The logo features a stylized caduceus, a symbol often associated with medicine and healthcare. The words "DEPARTMENT OF HEALTH & HUMAN SERVICES USA" are arranged in a circular fashion around the caduceus.
Public Health Service
Food and Drug Administration 2098 Gaither Road Rockville MD 20850
JAN 2 9 2007
Re: K062615
VISION Biosystems Inc.
C/O Ronald F. Lagerquist
Ventura, California 93003
1833 Portola Road
Trade/Device Name: Vision BioSystems Progesterone Receptor Clone 16 Regulation Number: 21 CFR 864.1860 Regulation Name: Immunohistochemistry Reagents and Kits Regulatory Class: Class II Product Code: MXZ Dated: August 25, 2006 Received: September 5, 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 the Code of Federal Regulations, Title 21, Parts 800 to 898. 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 Part 801); good manufacturing practice requirements as set forth in the quality systems (QS) regulation (21 CFR Part 820); and if applicable, the electronic product radiation control provisions (Sections 531-542 of the Act); 21 CFR 1000-1050. 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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If you desire specific advice for your device on our labeling regulation (21 CFR Part 801), please contact the Office of Compliance at (240) 276-0450. 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 (240) 276-3150 or at its Internet address http://www.fda.gov/cdrh/industry/support/index.html.
Sincerely yours,
Rafa Becker/
Robert L. Becker, Jr., MD, PhD 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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cc: HFZ-401 DMC
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HFZ-404 510(k) Staff HFZ- 440 Division
and the comments of the comments of
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Indications for Use
510(k) Number K062615
Device Name:
Vision BioSystems Progesterone Receptor Clone 16 (PGR Clone16)
- Novocastra™ Lyophilized Mouse Monoclonal Antibody .
- Novocastra™ Liquid Mouse Monoclonal Antibody
- Novocastra™ Ready-to-Use Primary Antibody .
- Origin™ Ready-to-Use Primary Antibody
- Bond™ Ready-to-Use Primary Antibody
Indications for Use:
Vision BioSystems Progesterone Receptor Clone 16 (PGR Clone 16) Mouse Monoclonal antibody is intended for laboratory use to qualitatively identify by light microscopy, progesterone receptor (PGR) antigen in sections of formalin fixed, paraffin embedded tissue. PGR Clone 16 specifically binds to the PGR antigen located in the nucleus of PGR positive normal and neoplastic cells.
PGR Clone 16 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.
Novocastra™ antibodies are intended for manual use. Origin™ antibodies are optimized for use with the Ventana® Medical Systems, NexES® and BenchMark™ Immunohistochemistry Staining Systems in combination with Ventana® Defection Kits. Bond™ Ready-to-Use Primary Antibodies are optimized for use on the Vision BioSystems Bond-max™ system.
Prescription Use
(PLEASE DO NOT WRITE BELOW THIS LINE-CONTINUE ON ANOTHER PAGE IF NEEDED)
PAGE IF NEEDED)
Division Sigh-Off Concurrence of CDRH, Office of Device Evaluation (ODE)
Office of In Vitro Diagnostic Device Evaluation and Safety
510(k) K062615