Cleared Traditional

K850329 - CORDIA S4 -TREPONEMA PALLIDUM

K850329 is an FDA 510(k) clearance for CORDIA S4 -TREPONEMA PALLIDUM, manufactured by Cordis Corp.. The device is a Class 2 Immunology device with product code LIP cleared through the Traditional 510(k) pathway after a 155-day FDA review.

K850329 · Cordis Corp. · Immunology device
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Jul 1985
Decision
155d
Days
Class 2
Risk

K850329 is an FDA 510(k) clearance for the CORDIA S4 -TREPONEMA PALLIDUM. Classified as Enzyme Linked Immunoabsorption Assay, Treponema Pallidum (product code LIP), Class II - Special Controls.

Submitted by Cordis Corp. (Miami, US). The FDA issued a Cleared decision on July 2, 1985 after a review of 155 days - an extended review cycle.

This device falls under the Immunology FDA review panel, regulated under 21 CFR 866.3830 - 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 Cordis Corp. devices

FDA 510(k) Submission Details - K850329

510(k) Number K850329 FDA.gov
FDA Decision Cleared Substantially Equivalent - Traditional 510(k) (SESE)
Date Received January 28, 1985
Decision Date July 02, 1985
Days to Decision 155 days
Submission Type Traditional
Review Panel Immunology (IM)
Summary -
Third-party Review No - reviewed directly by FDA
Combination Product No
PCCP Authorized No
Regulatory Context
Review time vs. panel average
51d slower than avg
Panel avg: 104d · This submission: 155d
Pathway characteristics
Predicate-based equivalence. No clinical trials required.

LIP Device Classification - Class 2, Special Controls

Product Code LIP Enzyme Linked Immunoabsorption Assay, Treponema Pallidum
Device Class Class 2 - Special Controls
CFR Regulation 21 CFR 866.3830
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.