Cleared Traditional

K831343 - CMV RQ BIO-ENZABEAD KIT

K831343 is an FDA 510(k) clearance for CMV RQ BIO-ENZABEAD KIT, manufactured by Litton Bionetics. The device is a Class 2 Immunology device with product code LFZ cleared through the Traditional 510(k) pathway after a 105-day FDA review.

K831343 · Litton Bionetics · Immunology device
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Aug 1983
Decision
105d
Days
Class 2
Risk

K831343 is an FDA 510(k) clearance for the CMV RQ BIO-ENZABEAD KIT. Classified as Enzyme Linked Immunoabsorbent Assay, Cytomegalovirus (product code LFZ), Class II - Special Controls.

Submitted by Litton Bionetics (Mchenry, US). The FDA issued a Cleared decision on August 8, 1983 after a review of 105 days - within the typical 510(k) review window.

This device falls under the Immunology FDA review panel, regulated under 21 CFR 866.3175 - the FDA immunology 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 Immunology review framework, consistent with the majority of Class II 510(k) submissions.

View all Litton Bionetics devices

FDA 510(k) Submission Details - K831343

510(k) Number K831343 FDA.gov
FDA Decision Cleared Substantially Equivalent - Traditional 510(k) (SESE)
Date Received April 25, 1983
Decision Date August 08, 1983
Days to Decision 105 days
Submission Type Traditional
Review Panel Immunology (IM)
Summary -
Third-party Review No - reviewed directly by FDA
Regulatory Context
Review time vs. panel average
At panel average
Panel avg: 105d · This submission: 105d
Pathway characteristics
Predicate-based equivalence. No clinical trials required.

LFZ Device Classification - Class 2, Special Controls

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 Immunology devices follow this clearance model.

Regulatory Peers - LFZ Enzyme Linked Immunoabsorbent Assay, Cytomegalovirus

All 51
Devices cleared under the same product code (LFZ) and FDA review panel - the closest regulatory comparables to K831343.
SERODOT CMV (CYTOMEGALOVIRUS) IGG TEST KIT
K875361 · Disease Detection International, Inc. · May 1988
ENZYGNOST + ANTI-CMV IGG TEST
K852478 · Behring Diagnostics, Inc. · Sep 1985
YBBOTT CMV TOTAL AB EIA
K832221 · Abbott Laboratories · Oct 1983
CORDIA CMV
K823123 · Cordis Corp. · Dec 1982