(151 days)
Not Found
No
The summary describes a qualitative immunohistochemistry (IHC) test and associated reagents for manual light microscopic assessment. There is no mention of automated image analysis, algorithms, or any form of AI/ML technology.
No
The device is an in vitro diagnostic (IVD) test used to assess a protein for diagnostic purposes, not to treat or prevent a disease.
Yes
The document explicitly states that CINtec® Histology is an "in vitro diagnostic (IVD) use" and is "intended for use in the light microscopic assessment of the p16INK4a protein... to improve consistency in the diagnosis of cervical intraepithelial neoplasia (CIN)." This indicates its purpose is to aid in diagnosing a medical condition.
No
The device is described as an immunohistochemical (IHC) assay system comprised of an antibody, detection kit, and ancillary reagents, intended for use with an automated slide staining instrument. This clearly indicates it is a hardware and chemical-based in vitro diagnostic device, not a software-only device.
Yes, this device is an IVD (In Vitro Diagnostic).
Here's why:
- Explicit Statement: The "Intended Use / Indications for Use" section explicitly states: "Intended for in vitro diagnostic (IVD) use."
- Nature of the Test: The device is a qualitative immunohistochemistry (IHC) test performed on formalin-fixed, paraffin-embedded (FFPE) cervical punch biopsy tissues. This type of testing, which involves analyzing biological samples outside of the body to diagnose or provide information about a medical condition, falls under the definition of an in vitro diagnostic.
- Regulatory Context: The mention of "Prescription Use Only" and the reference to a predicate device with a K number (DEN160019) indicate that this device is subject to regulatory oversight for medical devices, specifically IVDs.
N/A
Intended Use / Indications for Use
CINtec® Histology is a qualitative immunohistochemistry (IHC) test using mouse monoclonal anti-p16 antibody clone E6H4, and is intended for use in the light microscopic assessment of the p16INK4a protein in formalin-fixed, paraffinembedded (FFPE) cervical punch biopsy tissues using OptiView DAB IHC Detection Kit on a VENTANA BenchMark ULTRA instrument. The test is indicated as an adjunct to examination of hematoxylin and eosin (H&E) stained slide(s), to improve consistency in the diagnosis of cervical intraepithelial neoplasia (CIN). Diagnosis of CIN presence or level should be based on H&E stained slide(s) and other clinical and laboratory test information.
Intended for in vitro diagnostic (IVD) use. Prescription Use Only.
Product codes (comma separated list FDA assigned to the subject device)
PRB
Device Description
CINtec® Histology is a single dispenser immunohistochemical (IHC) assay system comprised of an anti-p16 primary antibody optimized for use with the BenchMark ULTRA automated slide staining instrument and the OptiView DAB IHC Detection Kit. The antibody is diluted in a Tris-HCl buffer containing carrier protein and 0.1% ProClin 300 as a preservative and provided as a ready-to-use liquid in a FloLock dispenser. CINtec Histology is available in a 50-test size and a 250-test size.
The OptiView DAB IHC Detection Kit (OptiView) is an indirect, biotin-free system for detecting mouse IgG, mouse IgM, and rabbit IgG primary antibodies and is comprised of 6 dispensers packaged together in one box. The components of the OptiView DAB IHC Detection Kit are provide in Table 1.
Component: OptiView Peroxidase Inhibitor. Content: 3.0% hydrogen peroxide solution.
Component: OptiView HQ Universal Linker. Content: Cocktail of HQ-labeled antibodies (goat anti-mouse IgG, goat anti-mouse IgM, and goat anti-rabbit IgG) (
§ 864.1865 Cervical intraepithelial neoplasia (CIN) test system.
(a)
Identification. A cervical intraepithelial neoplasia (CIN) test system is a device used to detect a biomarker associated with CIN in human tissues. The device is indicated as an adjunct test and not to be used as a stand-alone device. The test results must be interpreted in the context of the patient's clinical history including, but not limited to, prior and current cervical biopsy results, Papanicolaou (Pap) test results, human papillomavirus (HPV) test results, and morphology on hematoxylin and eosin (H&E) stained sections. This device is not intended to detect the presence of HPV.(b)
Classification. Class II (special controls). The special controls for this device are:(1) Premarket notification submissions must include the following information:
(i) The indications for use must specify the biomarker that is intended to be identified and its adjunct use (
e.g., adjunct to examination of H&E stained slides) to improve consistency in the diagnosis of CIN.(ii) Summary of professional society recommendations, as applicable.
(iii) A detailed device description including:
(A) A detailed description of all test components, including all provided reagents and required, but not provided, ancillary reagents.
(B) A detailed description of instrumentation and equipment, including illustrations or photographs of non-standard equipment or manuals.
(C) If applicable, detailed documentation of the device software, including, but not limited to, stand-alone software applications and hardware-based devices that incorporate software.
(D) A detailed description of appropriate positive and negative controls that are recommended or provided.
(E) Detailed specifications for sample collection, processing, and storage.
(F) A detailed description of methodology and assay procedure.
(G) A description of the assay cutoff (the medical decision point between positive and negative) or other relevant criteria that distinguishes positive and negative results, including the rationale for the chosen cutoff or other relevant criteria and results supporting validation of the cutoff.
(H) Detailed specification of the criteria for test results interpretation and reporting.
(iv) Detailed information demonstrating the performance characteristics of the device, including:
(A) Analytical specificity studies such as, but not limited to, antibody characterization (
e.g., Western Blot, peptide inhibition analysis), studies conducted on panels of normal tissues and neoplastic tissues, interference by endogenous and exogenous substances as well as cross-reactivity, as applicable.(B) Device analytical sensitivity data generated by testing an adequate number of samples from individuals with the target condition including limit of blank, limit of detection, and limit of quantification, as applicable.
(C) Device precision/reproducibility data to evaluate within-run, between-run, between-day, between-lot, between-site, between-reader, within-reader and total precision, as applicable, using a panel of samples covering the device measuring range and/or the relevant disease categories (
e.g. No CIN, CIN1, CIN2, CIN3, cervical cancer) and testing in replicates across multiple, nonconsecutive days.(D) Device robustness/guardbanding studies to assess the tolerance ranges for various critical test and specimen parameters.
(E) Device stability data, including real-time stability and shipping stability under various storage times, temperatures, and freeze-thaw conditions.
(F) Data from a clinical study demonstrating clinical validity using well-characterized prospectively or retrospectively obtained clinical specimens, as appropriate, representative of the intended use population. The study must evaluate the consistency of the diagnosis of CIN, for example, by comparing the levels of agreements of diagnoses rendered by community pathologists to those rendered by a panel of expert pathologists. Agreement for each CIN diagnostic category (
e.g., No CIN, CIN1, CIN2, CIN3, cancer) and for alternate diagnostic categories (e.g., No CIN, low grade squamous intraepithelial lesion (LSIL)-histology, high grade squamous intraepithelial lesion (HSIL)-histology, cancer) between reference diagnosis by expert pathologist and community pathologist must be evaluated, as applicable. In addition, agreements for CIN binary categories as ≥CIN2 (i.e., CIN2 or CIN3 or cancer) and ≤CIN1 (i.e., No CIN or CIN1) between reference diagnosis by expert pathologist with H&E staining and community pathologist with H&E staining and agreements for alternate CIN binary categories as ≥HSIL-histology (i.e., HSIL-histology or cancer) and ≤LSIL-histology (i.e., No CIN or LSIL-histology) between reference diagnosis by an expert pathologist with H&E + [biomarker specified in paragraph (b)(1)(i) of this section] and a community pathologist with H&E + [biomarker specified in paragraph (b)(1)(i) of this section] must be evaluated and compared, as applicable.(G) The staining performance of the device as determined by the community pathologists during review of the study slides must be evaluated. The staining performance criteria assessed must include overall staining acceptability, background staining acceptability, and morphology acceptability, as applicable.
(H) Appropriate training requirements for users, including interpretation manual, as applicable.
(I) Identification of risk mitigation elements used by the device, including a description of all additional procedures, methods, and practices incorporated into the instructions for use that mitigate risks associated with testing.
(2) The device's 21 CFR 809.10(b) compliant labeling must include a detailed description of the protocol, including the information described in paragraph (b)(1)(ii) of this section, as applicable, and a detailed description of the performance studies performed and the summary of the results, including those that relate to paragraph (b)(1)(ii) of this section, as applicable.
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December 10, 2021
Ventana Medical Systems, Inc. Stacci Cronk, RAC Senior Manager, Regulatory Affairs 1910 E Innovation Park Drive Tucson, AZ 85755
Re: K212176
Trade/Device Name: CINtec Histology Regulation Number: 21 CFR 864.1865 Regulation Name: Cervical Intraepithelial Neoplasia (CIN) Test System Regulatory Class: Class II Product Code: PRB Dated: July 9, 2021 Received: July 12, 2021
Dear Stacci Cronk:
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. Although this letter refers to your product as a device, please be aware that some cleared products may instead be combination products. The 510(k) Premarket Notification Database located at https://www.accessdata.fda.gov/scripts/cdrh/cfdocs/cfpmn/pmn.cfm identifies combination product submissions. 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. Please note: CDRH does not evaluate information related to contract liability warranties. We remind you, however, that device labeling must be truthful and not misleading.
If your device is classified (see above) into either class II (Special Controls) or class III (PMA), it may be subject to 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
1
requirements, including, but not limited to: registration and listing (21 CFR Part 807); labeling (21 CFR Part 801 and Part 809); medical device reporting of medical device-related adverse events) (21 CFR 803) for devices or postmarketing safety reporting (21 CFR 4, Subpart B) for combination products (see https://www.fda.gov/combination-products/guidance-regulatory-information/postmarketing-safety-reportingcombination-products); good manufacturing practice requirements as set forth in the quality systems (OS) regulation (21 CFR Part 820) for devices or current good manufacturing practices (21 CFR 4, Subpart A) for combination products; and, if applicable, the electronic product radiation control provisions (Sections 531-542 of the Act); 21 CFR 1000-1050.
Also, please note the regulation entitled, "Misbranding by reference to premarket notification" (21 CFR Part 807.97). For questions regarding the reporting of adverse events under the MDR regulation (21 CFR Part 803), please go to https://www.fda.gov/medical-device-safety/medical-device-reportingmdr-how-report-medical-device-problems.
For comprehensive regulatory information about mediation-emitting products, including information about labeling regulations, please see Device Advice (https://www.fda.gov/medicaldevices/device-advice-comprehensive-regulatory-assistance) and CDRH Learn (https://www.fda.gov/training-and-continuing-education/cdrh-learn). Additionally, you may contact the Division of Industry and Consumer Education (DICE) to ask a question about a specific regulatory topic. See the DICE website (https://www.fda.gov/medical-device-advice-comprehensive-regulatoryassistance/contact-us-division-industry-and-consumer-education-dice) for more information or contact DICE by email (DICE@fda.hhs.gov) or phone (1-800-638-2041 or 301-796-7100).
Sincerely,
Soma Ghosh, Ph.D. Chief Molecular Pathology and Cytology Branch Division of Molecular Genetics and Pathology OHT7: Office of In Vitro Diagnostics and Radiological Health Office of Product Evaluation and Quality Center for Devices and Radiological Health
Enclosure
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Indications for Use
510(k) Number (if known) K212176
Device Name CINtec® Histology
Indications for Use (Describe)
ClNtec® Histology is a qualitative immunohistochemistry (IHC) test using mouse monoclonal anti-p16 antibody clone E6H4, and is intended for use in the light microscopic assessment of the p16INK4a protein in formalin-fixed, paraffinembedded (FFPE) cervical punch biopsy tissues using OptiView DAB IHC Detection Kit on a VENTANA BenchMark ULTRA instrument. The test is indicated as an adjunct to examination of hematoxylin and eosin (H&E) stained slide(s), to improve consistency in the diagnosis of cervical intraepithelial neoplasia (CIN). Diagnosis of CIN presence or level should be based on H&E stained slide(s) and other clinical and laboratory test information.
Intended for in vitro diagnostic (IVD) use. Prescription Use Only.
| Type of Use (Select one or both, as applicable) | |
|---|---|
| ------------------------------------------------- | -- |
X Prescription Use (Part 21 CFR 801 Subpart D)
| Over-The-Counter Use (21 CFR 801 Subpart C)
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CINtec® Histology 510(k) Summary
This summary of 510(k) safety and effectiveness information is being submitted in accordance with the requirements of 21 CFR 807.92.
| Submitter Name | Ventana Medical Systems, Inc. |
|---|---|
| Address | 1910 E Innovation Park |
| Drive Tucson, AZ., | |
| 85755 | |
| Contact | Stacci Cronk |
| Phone: (520) 302-2193 | |
| Email: Stacci.cronk@roche.com | |
| Date Prepared | June 30, 2021 |
| Proprietary Name | CINtec® Histology |
| Common Name | Immunohistochemistry, qualitative |
| Classification Name | A cervical intraepithelial neoplasia (CIN) test system |
| Product Codes | PRB, 21 CFR 864.1865 |
| Predicate Devices | CINtec® Histology (DEN160019) |
| Establishment | |
| Registration | Ventana Medical Systems, Inc., 2028492 |
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1. DEVICE DESCRIPTION
CINtec® Histology is a single dispenser immunohistochemical (IHC) assay system comprised of an anti-p16 primary antibody optimized for use with the BenchMark ULTRA automated slide staining instrument and the OptiView DAB IHC Detection Kit. The antibody is diluted in a Tris-HCl buffer containing carrier protein and 0.1% ProClin 300 as a preservative and provided as a ready-to-use liquid in a FloLock dispenser. CINtec Histology is available in a 50-test size and a 250-test size.
The OptiView DAB IHC Detection Kit (OptiView) is an indirect, biotin-free system for detecting mouse IgG, mouse IgM, and rabbit IgG primary antibodies and is comprised of 6 dispensers packaged together in one box. The components of the OptiView DAB IHC Detection Kit are provide in Table 1.
| Component | Content |
|---|---|
| OptiView Peroxidase | |
| Inhibitor | 3.0% hydrogen peroxide solution |
| OptiView HQ Universal | |
| Linker | Cocktail of HQ-labeled antibodies (goat |
| anti-mouse IgG, goat anti-mouse IgM, and goat anti-rabbit | |
| IgG) | |
| ( |