Cleared Traditional

K904524 - CAPTIA(R) SYPHILIS M, MODIFICATION

K904524 is an FDA 510(k) clearance for CAPTIA SYPHILIS M, manufactured by Mercia Diagnostics , Ltd.. The device is a Class 2 Microbiology device with product code LIP cleared through the Traditional 510(k) pathway after a 90-day FDA review.

K904524 · Mercia Diagnostics , Ltd. · Microbiology device
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Dec 1990
Decision
90d
Days
Class 2
Risk

K904524 is an FDA 510(k) clearance for the CAPTIA(R) SYPHILIS M, MODIFICATION. 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 December 26, 1990 after a review of 90 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

FDA 510(k) Submission Details - K904524

510(k) Number K904524 FDA.gov
FDA Decision Cleared Substantially Equivalent - Traditional 510(k) (SESE)
Date Received September 27, 1990
Decision Date December 26, 1990
Days to Decision 90 days
Submission Type Traditional
Review Panel Microbiology (MI)
Summary -
Third-party Review No - reviewed directly by FDA
Combination Product No
PCCP Authorized No
Regulatory Context
Review time vs. panel average
12d faster than avg
Panel avg: 102d · This submission: 90d
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 26
Devices cleared under the same product code (LIP) and FDA review panel - the closest regulatory comparables to K904524.
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
MODIFIED CAPTIA(R) SYPHILIS-M
K900654 · Mercia Diagnostics , Ltd. · Mar 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