Cleared Traditional

K900654 - MODIFIED CAPTIA SYPHILIS-M

K900654 is the FDA 510(k) clearance for MODIFIED 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 27-day FDA review.

K900654 · Mercia Diagnostics , Ltd. · Microbiology device
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Mar 1990
Decision
27d
Days
Class 2
Risk

K900654 is an FDA 510(k) clearance for the MODIFIED 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 March 8, 1990 after a review of 27 days - a notably fast clearance cycle.

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: Fast-track predicate clearance. Standard predicate reliance. The short review cycle indicates strong predicate alignment - the FDA found sufficient equivalence without extended technical review.

View all Mercia Diagnostics , Ltd. devices

Submission Details

510(k) Number K900654 FDA.gov
FDA Decision Cleared Substantially Equivalent - Traditional 510(k) (SESE)
Date Received February 09, 1990
Decision Date March 08, 1990
Days to Decision 27 days
Submission Type Traditional
Review Panel Microbiology (MI)
Summary -
Third-party Review No - reviewed directly by FDA
Regulatory Context
Review time vs. panel average
75d faster than avg
Panel avg: 102d · This submission: 27d
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 K900654.
COPALIS TREPONEMAL ANTIGEN TOTAL ANTIBODY ASSAY
K992552 · DiaSorin, Inc. · Dec 1999
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
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