Cleared Traditional

K871548 - CAPTIA SYPHILIS-M

K871548 is the FDA 510(k) clearance for CAPTIA SYPHILIS-M by Mercia Diagnostics , Ltd.. It is a Class 2 Microbiology device (product code LIP) cleared through the Traditional 510(k) pathway after a 109-day FDA review.

K871548 · Mercia Diagnostics , Ltd. · Microbiology device
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Aug 1987
Decision
109d
Days
Class 2
Risk

K871548 is an FDA 510(k) clearance for the CAPTIA(R) SYPHILIS-M. Classified as Enzyme Linked Immunoabsorption Assay, Treponema Pallidum (product code LIP), Class II - Special Controls.

Submitted by Mercia Diagnostics , Ltd. (Guildford, Surrey England, GB). The FDA issued a Cleared decision on August 7, 1987 after a review of 109 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 Mercia Diagnostics , Ltd. devices

Submission Details

510(k) Number K871548 FDA.gov
FDA Decision Cleared Substantially Equivalent - Traditional 510(k) (SESE)
Date Received April 20, 1987
Decision Date August 07, 1987
Days to Decision 109 days
Submission Type Traditional
Review Panel Microbiology (MI)
Summary -
Third-party Review No - reviewed directly by FDA
Regulatory Context
Review time vs. panel average
7d slower than avg
Panel avg: 102d · This submission: 109d
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 19
Devices cleared under the same product code (LIP) and FDA review panel - the closest regulatory comparables to K871548.
DCL - SYPHILIS-G ASSAY CATALOG NO. 600-70
K895965 · Diagnostic Chemicals, Ltd. (Usa) · Dec 1990
ORTHO* SYPHILIS-M ANTIBODY ELISA TEST
K883938 · Ortho Diagnostic Systems, Inc. · Dec 1988
ORTHO* SYPHILIS-G ANTIBODY ELISA TEST
K883939 · Ortho Diagnostic Systems, Inc. · Dec 1988
CORDIA S4 -TREPONEMA PALLIDUM
K850329 · Cordis Corp. · Jul 1985