(254 days)
DAKO HercepTest Kit (Product Code No. K5204, FDA PMA# P980018)
Not Found
No
The summary describes physical control slides for immunohistochemistry, with no mention of software, algorithms, or data processing that would suggest AI/ML.
No
Explanation: This device is an in vitro diagnostic control for laboratory use, designed to monitor the consistency of immunohistochemical staining for HER2/neu protein expression. It is not used for treating any condition but rather for quality control in diagnostic procedures.
No
The device, QCS HER2 ImmunoControls, is described as a control for semi-quantitative immunohistochemistry. Its intended use is "For in Vitro Diagnostic Use" as a control to "ensure that performance of immunohistochemical staining is consistent" and "aids in correlation with the results of other laboratories." It is not directly used to diagnose a patient but rather to validate the diagnostic process.
No
The device description clearly states that the product provides control slides prepared from breast cancer cell lines, which are physical, formalin-fixed, and paraffin-embedded slides. This indicates a hardware component, not a software-only device.
Yes, this device is an IVD (In Vitro Diagnostic).
Here's why:
- Intended Use: The "Intended Use / Indications for Use" section explicitly states "For in Vitro Diagnostic Use".
- Purpose: The device is intended to control semi-quantitative immunohistochemistry using HER2/neu antibodies, which is a laboratory test performed on biological samples (cell lines derived from breast cancer).
- Function: It provides control sections with known levels of HER2/neu protein expression to ensure the consistency and accuracy of the immunohistochemical staining process. This is a key function of a diagnostic control.
- Care Setting: The intended user is a "laboratory," which is where in vitro diagnostic tests are performed.
All of these points align with the definition of an In Vitro Diagnostic device.
N/A
Intended Use / Indications for Use
For in Vitro Diagnostic Use:
QCS HER2 ImmunoControls, are intended for laboratory use to control semi-quantitative immunohistochemistry using different Her2/neu antibodies. This control ensures that performance of immunohistochemical staining is consistent in one laboratory over time and also aids in correlation with the results of other laboratories.
Product codes (comma separated list FDA assigned to the subject device)
NJW
Device Description
QCS HER2 ImmunoControls: This product provides appropriate control for semi-quantitative immunohistochemistry using polyclonal or monoclonal HER2/neu antibodies. Each slide contains four control sections prepared from breast cancer cell lines that represent different levels of Her-2/neu protein expression (-, 1+, 2+, 3+). These cells are formalin-fixed and paraffin-embedded, the slide is positively charged.
Mentions image processing
Not Found
Mentions AI, DNN, or ML
Not Found
Input Imaging Modality
Not Found
Anatomical Site
Breast cancer cell lines
Indicated Patient Age Range
Not Found
Intended User / Care Setting
laboratory
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)
Antigen stability testing indicates that OCS HER2 ImmunoControls are stable for at least 6 months once manufactured.
Key Metrics (Sensitivity, Specificity, PPV, NPV, etc.)
Not Found
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.
DAKO HercepTest Kit (Product Code No. K5204, FDA PMA# P980018)
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.
Not Found
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).
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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JUN 1 8 2003
510 (K) SUMMARY
| Submitter: | Junqi Qian, M.D., President
QC Sciences, LLC
2807 N. Parham Road, Suite 114
Richmond, VA 23294
Tel: (804) 288-6564 |
|---------------------------|-----------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------|
| Date Summary
Prepared: | June 12, 2003 |
| Device Name: | Common Name: QCS control slides for HER2
immunohistochemistry.
Trade Name: QCS HER2 ImmunoControls
(Product No. C010). |
| Device
Classification: | Class I or Class II has been proposed for immunohistochemical
controls. |
| Panel: | The proposed device classification is under the Hematology
and Pathology devices panel. Division of Clinical Laboratory
Devices. |
| Predicate Device: | Control slides in DAKO HercepTest Kit (Product Code No.
K5204, FDA PMA# P980018). DAKO HercepTest is a semi-
quantitative immunohistochemical assay to determine HER2
overexpression in breast cancer. This kit includes primary
antibody against HER2, secondary polymer, substrate and control
slides prepared from cell lines. |
| Device Description: | QCS HER2 ImmunoControls: This product provides appropriate
control for semi-quantitative immunohistochemistry using
polyclonal or monoclonal HER2/neu antibodies. Each slide
contains four control sections prepared from breast cancer cell
lines that represent different levels of Her-2/neu protein expression
(-, 1+, 2+, 3+). These cells are formalin-fixed and paraffin-
embedded, the slide is positively charged. |
| Intended Use: | For in Vitro Diagnostic Use:
QCS HER2 ImmunoControls, are intended for laboratory use to
control semi-quantitative immunohistochemistry using different
Her2/neu antibodies. This control ensures that performance of
immunohistochemical staining is consistent in one laboratory over
time and also aids in correlation with the results of other
laboratories. |
1
Statement of substantial Equivalence:
Fach OCS HER2 control slide contains four control sections prepared from breast cancer cell lines that represent different levels of Her-2/neu protein expression (-, 1+, 2+, 3+). These cells are formalin-fixed and paraffin-embedded, the slide is positively charged.
OCS HER2 controls are comparable in use and technology to DAKO HER2 control slides in HercepTest Kit, which is currently in commercial distribution. Similarities between the QCS HER2 controls and the DAKO HER2 controls include: 1) both products are prepared from formalin-fixed and paraffin-embedded human breast cancer cell lines; 2) both products can be stained by HER2 polyclonal and monoclonal antibodies using the same protocol; 3) both products can be used as controls for semiquantitative immunohistochemistry; and 4) the scoring method of staining intensity is the same. The differences between the two products include: 1) Each QCS HER2 control slide contains 4 sections (-, 1+, 2+, 3+), while DAKO HER2 control slide contains 3 sections (-, 1+, 3+); 2) the cell lines in QCS controls (MDA-361, MDA-453 and MCF-7) are different from DAKO controls. Multiple studies demonstrate the following expected results as presented in Table 1.
| Antibodies | QCS HER2 Controls | DAKO HER2 Controls | |||||
|---|---|---|---|---|---|---|---|
| MDA-361 | MDA-453 | MDA-175 | MCF-7 | SK-BR-3 (3+)* | MDA-175 (1+)* | MDA23 1 (0)* | |
| CB11 | |||||||
| (Cell Marque)** | 3+ | 2+ | 1+ | - | 3+ | 1+ | - |
| HercepTest | |||||||
| (DAKO) | 3+ | 2+ | 1+ | - | 3+ | 1+ | - |
Table 1. Immunohistochemical Characteristics of Cell Lines in OCS and DAKO HER2 Controls
- Expected level of staining for valid results on the DAKO cell line control slide, as given in the HercepTest protocol (DAKO, Carpinteria, CA). All these 7 cell lines are human breast cancer cell lines.
**Representative HER2 ASR antibody.
Antigen stability testing indicates that OCS HER2 ImmunoControls are stable for at least 6 months once manufactured.
References:
- Rhodes A. Jasani B. Couturier J. McKinley MJ, Morgan JM, Dodson AR, Navabi H, Miller KD, Balaton AJ. A formalin-fixed, paraffin-processed cell line standard for quality control of immunohistochemical assay of HER-2/neu expression in breast cancer. Am J Clin Pathol. 2002 Jan;117(1):81-9. 2) Taylor CR. The total test approach to standardization of immunohistochemistry.
Arch Pathol Lab Med. 2000 Jul;124(7):945-51.
- Ruby SG, McNally AC. Quality control of proliferation marker (MIB-1) in image analysis systems utilizing cell culture-based control materials. Am J Clin Pathol. 1996 Nov;106(5):634-9.
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Image /page/2/Picture/1 description: The image is a black and white seal for the Department of Health & Human Services USA. The seal is circular with the text "DEPARTMENT OF HEALTH & HUMAN SERVICES USA" arranged around the perimeter. In the center of the seal is a stylized image of an eagle.
Food and Drug Administration 2098 Gaither Road Rockville MD 20850
JUN 1 8 2003
Junqi Qian, M.D. President OC Sciences, LLC 2807 N. Parham Road, Suite 114 Richmond, Virginia 23294
Re: K023335
Trade/Device Name: QCS ImmunoControl slides for HER2 Immunohistochemistry (Product Code C010) Regulation Number: 21 CFR & 864.1860 Regulation Name: Immunohistochemistry Reagents and Kits Regulatory Class: II Product Code: NJW Dated: May 15, 2003 Received: May 16, 2003
Dear Dr. Qian:
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 hetter 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 (301) 594-3084. 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/dsma/dsmamain.html.
Sincerely yours,
iteven Sutman
Steven I. Gutman, M.D., M.B.A. Director Office of In Vitro Diagnostic Device Evaluation and Safety Center for Devices and Radiological Health
Enclosure
4
510(K) Number (if known): K023335
Device Name:
QCS ImmunoControl slides for HER2 Immunohistochemistry (Product Code C010)
Indication For Use:
For in Vitro Diagnostic Use:
QCS HER2 ImmunoControls, are intended for a laboratory to control semi-quantitative immunohistochemistry using different HER2/neu antibodies. Each QCS HER2 control slide contains four control sections prepared from breast cancer ccll lines that represent different levels of Her-2/neu protein expression. The cells are formalin-fixed and paraffin-embedded. These controls ensure that performance of immunohistochemical staining is consistent in one laboratory over time and also aids in correlation with the results of other laboratories.
(PLEASE DO NOT WRITE BELOW THIS LINE-CONTINUE ON ANOTHER PAGE IF NEEDED)
Prescription Use /
(Per 21 CFR 801.109)
Concurrence of CDRH, Office of Device Evaluation (ODE)/
Division Sign-Off
Office of In Vitro Diagnostic Device
Evaluation and Safety
510(k) K023335
OR
Over-The-Counter Use __
(Optional Format 1-2-96)
immunoh
correlat
gga/inde
NOTI