Cleared Traditional

K023335 - QCS HER2 IMMUNOCONTROLS (PRODUCT NO. C010) (FDA 510(k) Clearance)

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

K023335 · Qc Sciences, LLC · Pathology device
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Jun 2003
Decision
254d
Days
Class 2
Risk

K023335 is an FDA 510(k) clearance for the QCS HER2 IMMUNOCONTROLS (PRODUCT NO. C010). Classified as Control Material, Her-2/neu, Immunohistochemistry (product code NJW), Class II - Special Controls.

Submitted by Qc Sciences, LLC (Richmond, US). The FDA issued a Cleared decision on June 18, 2003 after a review of 254 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.

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Submission Details

510(k) Number K023335 FDA.gov
FDA Decision Cleared Substantially Equivalent - Traditional 510(k) (SESE)
Date Received October 07, 2002
Decision Date June 18, 2003
Days to Decision 254 days
Submission Type Traditional
Review Panel Pathology (PA)
Summary Summary PDF
Third-party Review No - reviewed directly by FDA
Regulatory Context
Review time vs. panel average
177d slower than avg
Panel avg: 77d · This submission: 254d
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.