Cleared Traditional

K801306 - CLINETICS PCA COLUMN

K801306 is an FDA 510(k) clearance for CLINETICS PCA COLUMN, manufactured by Clinetics Corp.. The device is a Class 2 Immunology device with product code DHX cleared through the Traditional 510(k) pathway after a 115-day FDA review.

K801306 · Clinetics Corp. · Immunology device
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Sep 1980
Decision
115d
Days
Class 2
Risk

K801306 is an FDA 510(k) clearance for the CLINETICS PCA COLUMN. Classified as System, Test, Carcinoembryonic Antigen (product code DHX), Class II - Special Controls.

Submitted by Clinetics Corp. (Mchenry, US). The FDA issued a Cleared decision on September 26, 1980 after a review of 115 days - within the typical 510(k) review window.

This device falls under the Immunology FDA review panel, regulated under 21 CFR 866.6010 - the FDA immunology 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 Immunology review framework, consistent with the majority of Class II 510(k) submissions.

View all Clinetics Corp. devices

FDA 510(k) Submission Details - K801306

510(k) Number K801306 FDA.gov
FDA Decision Cleared Substantially Equivalent - Traditional 510(k) (SESE)
Date Received June 03, 1980
Decision Date September 26, 1980
Days to Decision 115 days
Submission Type Traditional
Review Panel Immunology (IM)
Summary -
Third-party Review No - reviewed directly by FDA
Regulatory Context
Review time vs. panel average
10d slower than avg
Panel avg: 105d · This submission: 115d
Pathway characteristics
Predicate-based equivalence. No clinical trials required.

DHX Device Classification - Class 2, Special Controls

Product Code DHX System, Test, Carcinoembryonic Antigen
Device Class Class 2 - Special Controls
CFR Regulation 21 CFR 866.6010
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 Immunology devices follow this clearance model.