Cleared Traditional

K220163 - Her-2, ER, PR IHControls (FDA 510(k) Clearance)

Class II Pathology device cleared through predicate-based substantial equivalence - typically does not require clinical trials.

K220163 · Boston Cell Standards, Inc. · Pathology device
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Aug 2022
Decision
207d
Days
Class 2
Risk

K220163 is an FDA 510(k) clearance for the Her-2, ER, PR IHControls. Classified as Control Material, Her-2/neu, Immunohistochemistry (product code NJW), Class II - Special Controls.

Submitted by Boston Cell Standards, Inc. (Sharon, US). The FDA issued a Cleared decision on August 15, 2022 after a review of 207 days - an extended review cycle.

This device falls under the Pathology FDA review panel, regulated under 21 CFR 864.1860 - the FDA pathology device framework. The Traditional 510(k) pathway establishes clearance through substantial equivalence to a legally marketed predicate device, without requiring clinical trial data.

Device pattern: Standard predicate-based submission. Standard predicate reliance. This clearance follows a standard predicate-based equivalence path within the Pathology review framework, consistent with the majority of Class II 510(k) submissions.

View all Boston Cell Standards, Inc. devices

Submission Details

510(k) Number K220163 FDA.gov
FDA Decision Cleared Substantially Equivalent - Traditional 510(k) (SESE)
Date Received January 20, 2022
Decision Date August 15, 2022
Days to Decision 207 days
Submission Type Traditional
Review Panel Pathology (PA)
Summary Summary PDF
Third-party Review No - reviewed directly by FDA
Combination Product No
PCCP Authorized No
Regulatory Context
Review time vs. panel average
130d slower than avg
Panel avg: 77d · This submission: 207d
Pathway characteristics
Predicate-based equivalence. No clinical trials required.

Device Classification

Product Code NJW Control Material, Her-2/neu, Immunohistochemistry
Device Class Class 2 - Special Controls
CFR Regulation 21 CFR 864.1860
Definition Accessory To Immunohistochemistry Assays For Her2-neu. Control Material Intended For Laboratory Use To Control Her2-neu Immunohistochemistry Assays.
What this classification means

Class II devices require demonstration of substantial equivalence to a legally marketed predicate device. This pathway does not require clinical trials - it relies on engineering equivalence and performance data. Most Pathology devices follow this clearance model.

Regulatory Consultant

Radcliffe Consulting, Inc.
Gail E. Radcliffe

The regulatory consultant manages the 510(k) submission process on behalf of the applicant - coordinating technical documentation, predicate strategy and FDA communications. Identifying the consultant behind a submission is a key signal for competitive regulatory intelligence.