Cleared Traditional

K992552 - COPALIS TREPONEMAL ANTIGEN TOTAL ANTIBODY ASSAY

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

K992552 · DiaSorin, Inc. · Microbiology device
Download Printable Device Report (PDF) Official FDA 510(k) Summary (PDF)
Optimized for regulatory review, auditing and printing
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.

FDA 510(k) Submission Details - K992552

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.

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 Microbiology devices follow this clearance model.

Regulatory Peers - LIP Enzyme Linked Immunoabsorption Assay, Treponema Pallidum

All 34
Devices cleared under the same product code (LIP) and FDA review panel - the closest regulatory comparables to K992552.
CAPTIAM SYPHILIS-G ASSAY
K014233 · Trinity Biotech, Plc · Jan 2002
CAPTIA SYPHILIS-G ELISA TEST SYSTEM
K001525 · Trinity Biotech, Plc · Nov 2000
TREPCHEK TREPONEMAL ANTIBODY EIA
K001552 · Phoenix Biotech Corp. · Oct 2000
SYPHILIS IGM HUMAN SERUM CONTROLS
K961317 · Pyramid Biological Corp. · Jun 1996
SYPHILIS IGG HUMAN SERUM CONTROLS
K960493 · Pyramid Biological Corp. · Jun 1996
VISUWELL SYPHILIS ANTIBODY
K932453 · Biomira Diagnostics, Inc. · Jul 1995
K992552 · COPALIS TREPONEMAL ANTIGEN TOTAL ANTIBODY ASSAY
Download PDF FDA Summary DiaSorin, Inc.