Cleared Traditional

K801306 - CLINETICS PCA COLUMN

K801306 is the FDA 510(k) clearance for CLINETICS PCA COLUMN by Clinetics Corp.. It is a Class 2 Immunology device (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

Submission Details

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
11d slower than avg
Panel avg: 104d · This submission: 115d
Pathway characteristics
Predicate-based equivalence. No clinical trials required.

Device Classification

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.