Identifiers
- 510(k) Number
- K220163 FDA 510(k)
- FDA Product Code
- NJW FDA 510(k)
Classification
- Device Class
- Class II FDA 510(k)
- Legislation / Framework
- 21 CFR Part 864.1860 FDA 510(k)
- Regulation Number
- 864.1860 FDA 510(k)
- Advisory Committee
- Hematology FDA 510(k)
- FDA Decision
- SESE Substantially Equivalent FDA 510(k)
The Her-2, ER, PR IHControls are Control Material designed for use in immunohistochemistry (IHC) assays. These controls are intended to monitor and validate the performance of staining processes for HER2, estrogen receptor (ER), and progesterone receptor (PR) in tissue samples, ensuring consistent and reliable diagnostic results. Classified under product code NJW, they serve as reference standards to assess assay accuracy and reproducibility in pathology laboratories.
Supplied as Class II devices under FDA 510(k) clearance (K220163), these controls are intended for single-use in IHC workflows. They are not sterile and require proper storage as per manufacturer guidelines to maintain stability. The device adheres to Special Controls for immunohistochemistry controls, with regulatory oversight by the Hematology Expert Panel (HE). No additional sterility or MRI safety considerations apply, as they are non-invasive and non-imaging-related.
Frequently asked questions
What are the Her-2, ER, PR IHControls used for?
These controls are designed for immunohistochemistry (IHC) assays to monitor and validate staining performance for HER2, estrogen receptor (ER), and progesterone receptor (PR) in tissue samples. They serve as reference standards to assess assay accuracy and reproducibility, ensuring reliable diagnostic results in pathology laboratories.
Are the Her-2, ER, PR IHControls sterile?
No, the Her-2, ER, PR IHControls are not sterile. They are intended for single-use in IHC workflows and should be handled according to the manufacturer’s storage guidelines to maintain stability and performance.
How should these controls be stored?
Proper storage is critical to maintain the stability of the Her-2, ER, PR IHControls. Follow the manufacturer’s instructions for storage conditions, which typically include protecting the controls from extreme temperatures, light exposure, and contamination to preserve their integrity for accurate assay validation.
Are these controls reusable?
No, the Her-2, ER, PR IHControls are intended for single-use only. Each package is designed for one-time use in an IHC assay to ensure consistent and reliable diagnostic results without carryover or degradation from repeated use.
What regulatory pathway does this device follow?
The Her-2, ER, PR IHControls are classified as Class II devices under the FDA’s 510(k) clearance pathway, specifically under product code NJW. They were reviewed by the Hematology Expert Panel (HE) and are substantially equivalent to a predicate device, as determined by the FDA.
This description and any FAQs above were generated automatically from registry data and have not been verified by the manufacturer or by deviCERTS. Always check the official registry entry and the manufacturer's instructions for use before relying on them. Sources consulted: K220163 - Her-2, ER, PR IHControls - Pathology, Home - Boston Cell Standards, FDA clears Boston Cell Standards IHC controls for HER2, ER, PR, K220163 - Her-2, ER, PR IHControls - Pathology
Authorization Coverage (1 country)
Regulatory Authorizations
FDA_510K
| Source | Region | Type | Cert / Approval No. | Class | Status |
|---|---|---|---|---|---|
| FDA 510(k) | United States | FDA_510K | K220163 | Class II | Active |
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Manufacturer
- Manufacturer
- Boston Cell Standards, Inc.
Sources (1)
- FDA 510(k) K220163 24 fields · synced Oct 1, 2026