Cleared Traditional

K992552 - COPALIS TREPONEMAL ANTIGEN TOTAL ANTIBO...

K992552 is the FDA 510(k) clearance for COPALIS TREPONEMAL ANTIGEN TOTAL ANTIBO... by DiaSorin, Inc.. It is a Class 2 Microbiology device (product code LIP) cleared through the Traditional 510(k) pathway after a 139-day FDA review.

K992552 · DiaSorin, Inc. · Microbiology device
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Dec 1999
Decision
139d
Days
Class 2
Risk

K992552 is an FDA 510(k) clearance for the COPALIS TREPONEMAL ANTIGEN TOTAL ANTIBODY ASSAY. Classified as Enzyme Linked Immunoabsorption Assay, Treponema Pallidum (product code LIP), Class II - Special Controls.

Submitted by DiaSorin, Inc. (Columbia, US). The FDA issued a Cleared decision on December 16, 1999 after a review of 139 days - within the typical 510(k) review window.

This device falls under the Microbiology FDA review panel, regulated under 21 CFR 866.3830 - the FDA microbiology 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 Microbiology review framework, consistent with the majority of Class II 510(k) submissions.

View all DiaSorin, Inc. devices

Submission Details

510(k) Number K992552 FDA.gov
FDA Decision Cleared Substantially Equivalent - Traditional 510(k) (SESE)
Date Received July 30, 1999
Decision Date December 16, 1999
Days to Decision 139 days
Submission Type Traditional
Review Panel Microbiology (MI)
Summary Summary PDF
Third-party Review No - reviewed directly by FDA
Combination Product No
PCCP Authorized No
Regulatory Context
Review time vs. panel average
37d slower than avg
Panel avg: 102d · This submission: 139d
Pathway characteristics
Predicate-based equivalence. No clinical trials required.

Device Classification

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 Microbiology devices follow this clearance model.

Regulatory Peers - LIP Enzyme Linked Immunoabsorption Assay, Treponema Pallidum

All 18
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