Cleared Traditional

K884842 - CMV-CUBE(TM)

K884842 is an FDA 510(k) clearance for CMV-CUBE(TM), manufactured by Difco Laboratories, Inc.. The device is a Class 2 Microbiology device with product code LFZ cleared through the Traditional 510(k) pathway after a 141-day FDA review.

K884842 · Difco Laboratories, Inc. · Microbiology device
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Apr 1989
Decision
141d
Days
Class 2
Risk

K884842 is an FDA 510(k) clearance for the CMV-CUBE(TM). Classified as Enzyme Linked Immunoabsorbent Assay, Cytomegalovirus (product code LFZ), Class II - Special Controls.

Submitted by Difco Laboratories, Inc. (Detroit, US). The FDA issued a Cleared decision on April 11, 1989 after a review of 141 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 Difco Laboratories, Inc. devices

FDA 510(k) Submission Details - K884842

510(k) Number K884842 FDA.gov
FDA Decision Cleared Substantially Equivalent - Traditional 510(k) (SESE)
Date Received November 21, 1988
Decision Date April 11, 1989
Days to Decision 141 days
Submission Type Traditional
Review Panel Microbiology (MI)
Summary -
Third-party Review No - reviewed directly by FDA
Combination Product No
PCCP Authorized No
Regulatory Context
Review time vs. panel average
39d slower than avg
Panel avg: 102d · This submission: 141d
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 Microbiology devices follow this clearance model.

Regulatory Peers - LFZ Enzyme Linked Immunoabsorbent Assay, Cytomegalovirus

All 50
Devices cleared under the same product code (LFZ) and FDA review panel - the closest regulatory comparables to K884842.
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
CMV ELISA TEST SYSTEM
K891081 · Zeus Scientific, Inc. · Jun 1989
MODIFIED DDI SEROCARD CMV IGG TEST KIT
K884248 · Disease Detection International, Inc. · Apr 1989
UBI MAGIWEL CMV IGG QUANTITATIVE
K883399 · United Biotech, Inc. · Mar 1989
SERODOT CMV (CYTOMEGALOVIRUS) IGG TEST KIT
K875361 · Disease Detection International, Inc. · May 1988