Cleared Traditional

K915479 - CAPTIA CMV-TA

K915479 is the FDA 510(k) clearance for CAPTIA CMV-TA by Mercia Diagnostics , Ltd.. It is a Class 2 Microbiology device (product code LFZ) cleared through the Traditional 510(k) pathway after a 150-day FDA review.

K915479 · Mercia Diagnostics , Ltd. · Microbiology device
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May 1992
Decision
150d
Days
Class 2
Risk

K915479 is an FDA 510(k) clearance for the CAPTIA CMV-TA. Classified as Enzyme Linked Immunoabsorbent Assay, Cytomegalovirus (product code LFZ), Class II - Special Controls.

Submitted by Mercia Diagnostics , Ltd. (Guildford, Surrey England, GB). The FDA issued a Cleared decision on May 4, 1992 after a review of 150 days - an extended review cycle.

This device falls under the Microbiology FDA review panel, regulated under 21 CFR 866.3175 - 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 K915479 FDA.gov
FDA Decision Cleared Substantially Equivalent - Traditional 510(k) (SESE)
Date Received December 06, 1991
Decision Date May 04, 1992
Days to Decision 150 days
Submission Type Traditional
Review Panel Microbiology (MI)
Summary Summary PDF
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 LFZ Enzyme Linked Immunoabsorbent Assay, Cytomegalovirus
Device Class Class 2 - Special Controls
CFR Regulation 21 CFR 866.3175
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 - LFZ Enzyme Linked Immunoabsorbent Assay, Cytomegalovirus

All 43
Devices cleared under the same product code (LFZ) and FDA review panel - the closest regulatory comparables to K915479.
BARTELS CYTOMEGALOVIRUS IGG EIA
K922582 · Baxter Diagnostics, Inc. · Apr 1993
CMV ELISA TEST SYSTEM
K924096 · Zeus Scientific, Inc. · Apr 1993
VIDAS CMV IGG ASSAY
K920661 · Vitek Systems, Inc. · Feb 1993
ENZYGNOST(R) ANTI-CMV IGG
K913910 · Behring Diagnostics, Inc. · Apr 1992
ENZYGNOST(R) ANTI-CMV/IGM
K913693 · Behring Diagnostics, Inc. · Feb 1992
CMV IGG ELISA TEST
K915892 · Gull Laboratories, Inc. · Feb 1992