Cleared Traditional

K910487 - VISUWELL SYPHILIS ANTIGEN

K910487 is an FDA 510(k) clearance for VISUWELL SYPHILIS ANTIGEN, manufactured by Adi Diagnostics, Inc.. The device is a Class 2 Microbiology device with product code LIP cleared through the Traditional 510(k) pathway after a 138-day FDA review.

K910487 · Adi Diagnostics, Inc. · Microbiology device
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Jun 1991
Decision
138d
Days
Class 2
Risk

K910487 is an FDA 510(k) clearance for the VISUWELL SYPHILIS ANTIGEN. Classified as Enzyme Linked Immunoabsorption Assay, Treponema Pallidum (product code LIP), Class II - Special Controls.

Submitted by Adi Diagnostics, Inc. (Rexdale, Ontario, CA). The FDA issued a Cleared decision on June 24, 1991 after a review of 138 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 Adi Diagnostics, Inc. devices

FDA 510(k) Submission Details - K910487

510(k) Number K910487 FDA.gov
FDA Decision Cleared Substantially Equivalent - Traditional 510(k) (SESE)
Date Received February 06, 1991
Decision Date June 24, 1991
Days to Decision 138 days
Submission Type Traditional
Review Panel Microbiology (MI)
Summary -
Third-party Review No - reviewed directly by FDA
Regulatory Context
Review time vs. panel average
36d slower than avg
Panel avg: 102d · This submission: 138d
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 27
Devices cleared under the same product code (LIP) and FDA review panel - the closest regulatory comparables to K910487.
COPALIS TREPONEMAL ANTIGEN TOTAL ANTIBODY ASSAY
K992552 · DiaSorin, Inc. · Dec 1999
SYPHILIS IGM HUMAN SERUM CONTROLS
K961317 · Pyramid Biological Corp. · Jun 1996
SYPHILIS IGG HUMAN SERUM CONTROLS
K960493 · Pyramid Biological Corp. · Jun 1996
DCL SYPHILIS-M CATALOG NO. 600-80
K895964 · Diagnostic Chemicals, Ltd. (Usa) · Jan 1991
DCL - SYPHILIS-G ASSAY CATALOG NO. 600-70
K895965 · Diagnostic Chemicals, Ltd. (Usa) · Dec 1990
CAPTIA(R) SYPHILIS M, MODIFICATION
K904524 · Mercia Diagnostics , Ltd. · Dec 1990