(42 days)
No
The description details a standard immunohistochemical assay process using antibodies and an automated slide stainer, with no mention of AI or ML for image analysis or interpretation.
No
The device is an in-vitro diagnostic (IVD) assay used for detecting ER antigen, aiding in assessment of therapy response and prognosis, but it does not directly treat or prevent a disease.
Yes
The "Intended Use / Indications for Use" section explicitly states that the device 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 indicates its role in disease diagnosis and management.
No
The device is a laboratory assay involving antibodies, reagents, and an automated slide stainer, which are physical components, not software.
Yes, this device is an IVD (In Vitro Diagnostic).
Here's why:
- Intended Use: The intended use explicitly states it's an "immunohistochemical (IHC) assay intended for laboratory use for the qualitative detection of ER antigen... 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 clearly describes a test performed in vitro (outside the body) on patient samples (tissue sections) to provide information for medical diagnosis and management.
- Device Description: The description details a process of binding antibodies to a target in a tissue sample and visualizing the reaction. This is a typical in vitro diagnostic technique.
- Laboratory Use: The intended user is specified as "laboratory use," which is consistent with IVDs.
- Predicate Device: The mention of a predicate device (Ventana ER Primary Antibody) with a K number (K984567) strongly suggests this device is undergoing or has undergone regulatory review as an IVD.
The information provided aligns perfectly with the definition and characteristics of an In Vitro Diagnostic device.
N/A
Intended Use / Indications for Use
NeoMarkers Rabbit Monoclonal Anti-Human ER Antibody (Clone SP1) is an immunohistochemical (IHC) assay intended for laboratory use for the qualitative detection of ER antigen 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
MYA
Device Description
Lab Vision's NeoMarkers Rabbit Monoclonal Anti-Human Estrogen Receptor (ER) Antibody (Clone SP1) binds to ER in the paraffin embedded tissue section. The specific antibody is localized by a biotin conjugated secondary antibody formulation that recognizes rabbit immunoglobulins. This step is followed by the addition of an avidin/streptavidin enzyme conjugate that binds to the biotin present on the secondary antibody. The specific antibody secondary antibody avidin/streptavidin enzyme complex is then visualized with a precipitating enzyme reaction product, which is readily detected by light microscopy. Each step is incubated for a precise time and at room temperature. At the end of each incubation step, the Lab Vision automated slide stainer (Lab Vision Autostainer) washes the sections to stop the reaction and remove unbound material that would interfere the desired reaction in subsequent steps.
Mentions image processing
Not Found
Mentions AI, DNN, or ML
Not Found
Input Imaging Modality
light microscopy
Anatomical Site
Tissue (Breast), normal and neoplastic tissues
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)
Reference Device(s)
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.
0
SECTION II
JUN 2 7 2006
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:
May 11, 2006
Device Information:
| Device Classification Name: | Immunohistochemistry Assay, Antibody, Estrogen Receptor |
|---|---|
| Common/Usual Name: | Antibody for detection of estrogen receptor in histological tissue sections |
| Proprietary Name: | NeoMarkers Rabbit Monoclonal Anti-Human Estrogen Receptor Antibody (Clone SP1) |
| Regulation Number: | 21 CFR§864.1860 |
| Product Code: | MYA |
| Regulatory Class: | Class II |
Predicate Devices:
NeoMarkers Rabbit Monoclonal Anti-Human Estrogen Receptor Antibody (Clone SP1) is substantially equivalent to the Ventana ER Primary Antibody (Clone 6F11) (K984567) for its stated intended use.
1
Device Description:
Lab Vision's NeoMarkers Rabbit Monoclonal Anti-Human Estrogen Receptor (ER) Antibody (Clone SP1) binds to ER in the paraffin embedded tissue section. The specific antibody is localized by a biotin conjugated secondary antibody formulation that recognizes rabbit immunoglobulins. This step is followed by the addition of an avidin/streptavidin enzyme conjugate that binds to the biotin present on the secondary antibody. The specific antibody secondary antibody avidin/streptavidin enzyme complex is then visualized with a precipitating enzyme reaction product, which is readily detected by light microscopy. Each step is incubated for a precise time and at room temperature. At the end of each incubation step, the Lab Vision automated slide stainer (Lab Vision Autostainer) washes the sections to stop the reaction and remove unbound material that would interfere the desired reaction in subsequent steps.
Intended Use:
NeoMarkers Rabbit Monoclonal Anti-Human ER Antibody (Clone SP1) is an immunohistochemical (IHC) assay intended for laboratory use for the qualitative detection of ER antigen 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.
Comparison to Predicate Device(s);
NeoMarkers Rabbit Monoclonal Anti-Human ER Antibody (Clone SP1) is substantially equivalent to the Ventana ER Primary Antibody (Clone 6F11) (K984567) for its stated intended use.
2
| Device | Subject Device | Predicate Device |
|---|---|---|
| Characteristics | (K984567) (K990618) | |
| Intended Use | NeoMarkers Rabbit Monoclonal Anti- | |
| Human ER Antibody (Clone SP1) is | ||
| an immunohistochemical (IHC) assay | ||
| intended for laboratory use for the | ||
| qualitative detection of ER antigen 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. | Ventana ER Primary Antibody (Clone | |
| 6F11) is intended for laboratory use | ||
| for the qualitative detection of ER | ||
| antigen in sections of formalin fixed, | ||
| paraffin embedded tissue of a Ventana | ||
| automated immunohistochemistry | ||
| slide staining device. It is indicated as | ||
| an aid in the management, prognosis | ||
| and prediction of therapy outcome of | ||
| breast cancer. | ||
| Target Epitop | Estrogen Receptor | Estrogen Receptor |
| Clone | Rabbit Monoclonal Ab (Clone SP1) | Murine Monoclonal Ab (Clone 6F11) |
| Matrix | Tissue (Breast) | Tissue (Breast) |
| Storage | 2℃ to 8℃ until expiration date | 2℃ to 8℃ until expiration date |
| Stability | Until expiration date noted package | Until expiration date noted on |
| package |
3
Summary:
The information provided in this pre-market notification demonstrates that NeoMarkers Rabbit Monoclonal Anti-Human ER Antibody (Clone SP1) is substantially equivalent to the Ventana ER Primary Antibody (Clone 6F11), the previously cleared predicate device (K984567). Substantial equivalence was demonstrated through comparison of intended use and physical properties to the commercially available predicate device. The information supplied in this pre-market notification provides reasonable assurance that NeoMarkers Rabbit Monoclonal Anti-Human ER Antibody (Clone SP1) is safe and effective for it's stated intended use.
4
Image /page/4/Picture/1 description: The image shows the logo for the U.S. Department of Health and Human Services (HHS). The logo features a stylized depiction of an eagle with three lines forming its body and wings. The eagle is facing to the left. The logo is surrounded by text that reads "U.S. Department of Health and Human Services" in a circular arrangement.
Public Health Service
Food and Drug Administration 2098 Gaither Road Rockville MD 20850
Ms. Grace Hsiao-Fen Chang Manager, Regulatory Affairs Lab Vision Corporation 47777 Warm Springs Boulevard Fremont, California 94539
JUN 27 2006
Re: K061360 Trade/Device Name: NeoMarkers Rabbit Monoclonal Anti-Human ER Antibody (Clone SPI) Regulation Number: 21 CFR § 864.1860 Regulation Name: Immunohistochemistry Regulatory Class: II Product Code: MYA Dated: May 11, 2006 Received: May 16, 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.
5
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 ne (800) 638-2041 or (301) 443-6597 or at its Internet address http://www.fda.gov/cdrh/industry/support/index.html
Sincerely yours,
lobetz Beckerh
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
6
SECTION III
INDICATIONS FOR USE STATEMENT
KOOLBOO 510(k) Number (if known):
Device name: NeoMarkers Rabbit Monoclonal Anti-Human ER Antibody (Clone SP1).
Indications for Use:
NeoMarkers Rabbit Monoclonal anti-Human ER Antibody (Clone SP1) is an immunohistochemical (IHC) assay intended for laboratory use for the qualitative detection of ER antigen 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.
PLEASE DO NOT WRITE BELOW THIS LINE CONTINUE ON ANOTHER PAGE IF NEEDED
Concurrence of CDRH, Office of Device Evaluation (ODE)
Prescription Use 1
OR
Over-the Counter Use
(per 21 CFR §801.109)
(Optional Format 1-2-96)
Division Sigh-Off
Office of In Vitro Diagnostic Device Evaluation and Safety
(k) K06136C