Cleared Traditional

K883924 - CAPTIA RUBELLA-G

K883924 is the FDA 510(k) clearance for CAPTIA RUBELLA-G by Mercia Diagnostics , Ltd.. It is a Class 2 Microbiology device (product code LFX) cleared through the Traditional 510(k) pathway after a 333-day FDA review.

K883924 · Mercia Diagnostics , Ltd. · Microbiology device
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Aug 1989
Decision
333d
Days
Class 2
Risk

K883924 is an FDA 510(k) clearance for the CAPTIA(R) RUBELLA-G. Classified as Enzyme Linked Immunoabsorbent Assay, Rubella (product code LFX), Class II - Special Controls.

Submitted by Mercia Diagnostics , Ltd. (Guildford, Surrey England, GB). The FDA issued a Cleared decision on August 15, 1989 after a review of 333 days - an unusually long review period, suggesting complex equivalence evaluation.

This device falls under the Microbiology FDA review panel, regulated under 21 CFR 866.3510 - 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. Elevated predicate reliance profile. 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 K883924 FDA.gov
FDA Decision Cleared Substantially Equivalent - Traditional 510(k) (SESE)
Date Received September 16, 1988
Decision Date August 15, 1989
Days to Decision 333 days
Submission Type Traditional
Review Panel Microbiology (MI)
Summary -
Third-party Review No - reviewed directly by FDA
Regulatory Context
Review time vs. panel average
231d slower than avg
Panel avg: 102d · This submission: 333d
Pathway characteristics
Predicate-based equivalence. No clinical trials required.

Device Classification

Product Code LFX Enzyme Linked Immunoabsorbent Assay, Rubella
Device Class Class 2 - Special Controls
CFR Regulation 21 CFR 866.3510
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 - LFX Enzyme Linked Immunoabsorbent Assay, Rubella

All 63
Devices cleared under the same product code (LFX) and FDA review panel - the closest regulatory comparables to K883924.
PLATELIA RUBELLA IGG KIT
K894946 · Kallestad Diag, A Div. of Erbamont, Inc. · Dec 1989
DETECTADOT(TM) SYSTEM 2000 RUBELLA IGG TEST
K892202 · Gull Laboratories, Inc. · Sep 1989
BIOTROL RUB-E.I.A. TEST G
K894544 · Biotrol, USA, Inc. · Aug 1989
RUBELLA ELISA TEST SYSTEM
K891783 · Zeus Scientific, Inc. · Aug 1989
IMX RUBELLA IGM, MICROPART. ENZYME IMMUNOASSAY
K885295 · Abbott Laboratories · Jun 1989
IMX RUBELLA IGG, MICROPARTICLE ENZYME IMMUNOASSAY
K885297 · Abbott Laboratories · Jun 1989