Cleared Traditional

K880918 - CAPTIA TOXO-G

K880918 is the FDA 510(k) clearance for CAPTIA TOXO-G by Mercia Diagnostics , Ltd.. It is a Class 2 Microbiology device (product code LGD) cleared through the Traditional 510(k) pathway after a 150-day FDA review.

K880918 · Mercia Diagnostics , Ltd. · Microbiology device
Download Printable Device Report (PDF)
Optimized for regulatory review, auditing and printing
Aug 1988
Decision
150d
Days
Class 2
Risk

K880918 is an FDA 510(k) clearance for the CAPTIA TOXO-G. Classified as Enzyme Linked Immunoabsorbent Assay, Toxoplasma Gondii (product code LGD), Class II - Special Controls.

Submitted by Mercia Diagnostics , Ltd. (Guildford, Surrey England, GB). The FDA issued a Cleared decision on August 1, 1988 after a review of 150 days - an extended review cycle.

This device falls under the Microbiology FDA review panel, regulated under 21 CFR 866.3780 - 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 K880918 FDA.gov
FDA Decision Cleared Substantially Equivalent - Traditional 510(k) (SESE)
Date Received March 04, 1988
Decision Date August 01, 1988
Days to Decision 150 days
Submission Type Traditional
Review Panel Microbiology (MI)
Summary -
Third-party Review No - reviewed directly by FDA
Regulatory Context
Review time vs. panel average
48d slower than avg
Panel avg: 102d · This submission: 150d
Pathway characteristics
Predicate-based equivalence. No clinical trials required.

Device Classification

Product Code LGD Enzyme Linked Immunoabsorbent Assay, Toxoplasma Gondii
Device Class Class 2 - Special Controls
CFR Regulation 21 CFR 866.3780
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 - LGD Enzyme Linked Immunoabsorbent Assay, Toxoplasma Gondii

All 77
Devices cleared under the same product code (LGD) and FDA review panel - the closest regulatory comparables to K880918.
IMX TOXO IGM ANTIBODY ASSAY
K890032 · Abbott Laboratories · Jun 1989
ORTHO* TOXOPLASMA-G ANTIBODY ELISA TEST
K883937 · Ortho Diagnostic Systems, Inc. · Feb 1989
ORTHO* TOXOPLASMA-M ANTIBODY ELISA TEST
K883936 · Ortho Diagnostic Systems, Inc. · Oct 1988
BIOTROL TOXO ELISA TEST M
K873293 · Biotrol, USA, Inc. · Apr 1988
BIOTROL TOXO ELISA TEST G
K873294 · Biotrol, USA, Inc. · Apr 1988
DETECTADOT SYSTEM 2000 TOXO IGG TEST
K875109 · Gull Laboratories, Inc. · Mar 1988