(61 days)
Not Found
None
No
The summary describes a standard immunohistochemistry assay using an antibody for detecting a specific protein (progesterone receptor) in tissue samples. There is no mention of AI, ML, image processing, or any other technology that would suggest the use of these methods for analysis or interpretation. The output is qualitative detection by light microscopy, which is a traditional method.
No
Explanation: The device is an immunohistochemical assay used for qualitative detection of PR in tissue sections to aid in assessing response to therapy, prognosis, and management of breast cancer patients. It is a diagnostic tool, not a device that applies therapy or treatment.
Yes
The device is intended as an aid in assessing the likelihood of response to therapy, prognosis, and management of breast cancer patients, which falls under the scope of diagnostic purposes.
No
The device is an immunohistochemical assay, which is a laboratory test involving antibodies and tissue samples, not a software-only device.
Yes, this device is an IVD (In Vitro Diagnostic).
Here's why:
- Intended Use: The intended use clearly states it's an "immunohistochemical (IHC) assay intended for laboratory use for the qualitative detection of PR by light microscopy in sections of formalin fixed, paraffin embedded normal and neoplastic tissues". This describes a test performed on biological samples (tissue sections) outside of the body to provide information about a patient's health.
- Indications for Use: It is indicated as "an aid in assessing the likelihood of response to therapy as well as in the prognosis and management of breast cancer patients." This further reinforces its role in providing diagnostic information for clinical decision-making.
- Device Description: The description "Immunohistochemistry Assay, Antibody, Progesterone Receptor. Antibody for detection of progesterone receptor in histological tissue sections" describes a reagent used in a laboratory test.
- Intended User / Care Setting: "Laboratory use" is a typical setting for IVDs.
All these elements align with the definition of an In Vitro Diagnostic device, which is used to examine specimens derived from the human body to provide information for diagnostic, monitoring, or compatibility purposes.
N/A
Intended Use / Indications for Use
NeoMarkers Rabbit Monoclonal anti-Human PR Antibody (Clone SP2) is an immunohistochemical (IHC) assay intended for laboratory use for the qualitative detection of PR by light microscopy in sections of formalin fixed, paraffin embedded normal and neoplastic tissues on a Lab Vision automated slide stainer. It is indicated as an aid in assessing the likelihood of response to therapy as well as in the prognosis and management of breast cancer patients.
Product codes
MXZ
Device Description
Not Found
Mentions image processing
Not Found
Mentions AI, DNN, or ML
Not Found
Input Imaging Modality
Light microscopy
Anatomical Site
Formalin fixed, paraffin embedded normal and neoplastic tissues (breast cancer)
Indicated Patient Age Range
Not Found
Intended User / Care Setting
Laboratory use.
Description of the training set, sample size, data source, and annotation protocol
Not Found
Description of the test set, sample size, data source, and annotation protocol
Not Found
Summary of Performance Studies (study type, sample size, AUC, MRMC, standalone performance, key results)
Not Found
Key Metrics (Sensitivity, Specificity, PPV, NPV, etc.)
Not Found
Predicate Device(s)
Not Found
Reference Device(s)
Not Found
Predetermined Change Control Plan (PCCP) - All Relevant Information
Not Found
§ 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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SECTION II
510(k) SUMMARY
This summary of 510(k) safety and effectiveness information is submitted in accordance with the requirements of SMDA 1990 and 21 CFR 807.92.
510(k) Number:
Submitter:
Lab Vision Corporation 47777 Warm Springs Blvd. Fremont, CA 94539 Telephone: (510) 991-2800 Facsimile: (510) 991-2826
Contact Person:
Grace Hsiao-Fen Chang Manager, Regulatory Affairs Telephone: (510) 991-2854 Facsimile: (510) 991-2826
Preparation Date:
February 21, 2006
Device Information:
| Device Classification Name: | Immunohistochemistry Assay, Antibody, Progesterone Receptor. |
|---|---|
| Common/Usual Name: | Antibody for detection of progesterone receptor in histological tissue sections |
| Proprietary Name: | NeoMarkers Rabbit Monoclonal Anti-Human Progesterone Receptor Antibody (Clone SP2) |
| Regulation Number: | 21 CFR§864.1860 |
| Product Code: | MXZ (for Progesterone Receptor antibody) |
| Regulatory Class: | Class II |
1
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 consists of a stylized caduceus, which is a symbol of medicine, with three horizontal bars above it. The words "DEPARTMENT OF HEALTH & HUMAN SERVICES USA" are arranged in a circle around the caduceus.
Public Health Service
ood and Drug Administratio 2098 Gaither Boad Rockville MD 20850
Ms. Grace Hsiao-Fen Chang Manager, Regulatory Affairs Lab Vision Corporation 47777 Warm Springs Boulevard Fremont, California 94539
2011 2 4 2005
Re: K060462
Trade/Device Name: NeoMarkers Rabbit Monoclonal Anti-Human PR Antibody (Clone SP2) Regulation Number: 21 CFR § 864.1860 Regulation Name: Immunohistochemistry reagents and kits Regulatory Class: II Product Code: MXZ Dated: February 21, 2006 Received: February 23, 2006
Dear Ms. Chang:
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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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.
Robert Becker Jr
Robert L. Becker, Jr., MD, PA 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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SECTION III
INDICATIONS FOR USE STATEMENT
510(k) Number (if known): Ko (o (0402
Device name: NeoMarkers Rabbit Monoclonal Anti-Human PR Antibody (Clone SP2)
Indications for Use:
NeoMarkers Rabbit Monoclonal anti-Human PR Antibody (Clone SP2) is an immunohistochemical (IHC) assay intended for laboratory use for the qualitative detection of PR by light microscopy in sections of formalin fixed, paraffin embedded normal and neoplastic tissues on a Lab Vision automated slide stainer. It is indicated as an aid in assessing the likelihood of response to therapy as well as in the prognosis and management of breast cancer patients.
Division Sign Off
Office of In Vitro Diagnostic Device Evaluation and Safety
510(k) K060462
PLEASE DO NOT WRITE BELOW THIS LINE CONTINUE ON ANOTHER PAGE IF NEEDED
Concurrence of CDRH, Office of Device Evaluation (ODE)
Prescription Use _
OR
Over-the Counter Use___________
(per 21 CFR §801.109)
(Optional Format 1-2-96)