Cleared Traditional

K896194 - CAPTIA CMV-G

K896194 is the FDA 510(k) clearance for CAPTIA CMV-G by Mercia Diagnostics , Ltd.. It is a Class 2 Microbiology device (product code LFZ) cleared through the Traditional 510(k) pathway after a 132-day FDA review.

K896194 · Mercia Diagnostics , Ltd. · Microbiology device
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Mar 1990
Decision
132d
Days
Class 2
Risk

K896194 is an FDA 510(k) clearance for the CAPTIA(R) CMV-G. 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 March 6, 1990 after a review of 132 days - within the typical 510(k) review window.

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 K896194 FDA.gov
FDA Decision Cleared Substantially Equivalent - Traditional 510(k) (SESE)
Date Received October 25, 1989
Decision Date March 06, 1990
Days to Decision 132 days
Submission Type Traditional
Review Panel Microbiology (MI)
Summary -
Third-party Review No - reviewed directly by FDA
Regulatory Context
Review time vs. panel average
30d slower than avg
Panel avg: 102d · This submission: 132d
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 K896194.
IMX CMV IGM ANTIBODY ASSAY
K900473 · Abbott Laboratories · Jul 1990
IMX CMV IGG ANTIBODY ASSAY
K900474 · Abbott Laboratories · Jul 1990
CMV IGG ELISA TEST
K900796 · Gull Laboratories, Inc. · May 1990
CMV IGM ELISA TEST SYSTEM
K896355 · Zeus Scientific, Inc. · Feb 1990
DETECTADOT TM SYSTEM 2000 CMV IGM TEST
K893230 · Gull Laboratories, Inc. · Dec 1989
VIRONOSTIKA(TM) ANTI-CMV IGM MICROELISA SYSTEM
K890610 · Organon Teknika Corp. · Jun 1989