Cleared Traditional

K843138 - CMV TEST

K843138 is the FDA 510(k) clearance for CMV TEST by Microbiological Research Corp.. It is a Class 2 Microbiology device (product code LIN) cleared through the Traditional 510(k) pathway after a 173-day FDA review.

K843138 · Microbiological Research Corp. · Microbiology device
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Jan 1985
Decision
173d
Days
Class 2
Risk

K843138 is an FDA 510(k) clearance for the CMV TEST. Classified as Antisera, Conjugated Fluorescent, Cytomegalovirus (product code LIN), Class II - Special Controls.

Submitted by Microbiological Research Corp. (Bountiful, US). The FDA issued a Cleared decision on January 29, 1985 after a review of 173 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 Microbiological Research Corp. devices

Submission Details

510(k) Number K843138 FDA.gov
FDA Decision Cleared Substantially Equivalent - Traditional 510(k) (SESE)
Date Received August 09, 1984
Decision Date January 29, 1985
Days to Decision 173 days
Submission Type Traditional
Review Panel Microbiology (MI)
Summary -
Third-party Review No - reviewed directly by FDA
Regulatory Context
Review time vs. panel average
71d slower than avg
Panel avg: 102d · This submission: 173d
Pathway characteristics
Predicate-based equivalence. No clinical trials required.

Device Classification

Product Code LIN Antisera, Conjugated Fluorescent, 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 - LIN Antisera, Conjugated Fluorescent, Cytomegalovirus

All 12
Devices cleared under the same product code (LIN) and FDA review panel - the closest regulatory comparables to K843138.
CMV IGG ANTIBODY TEST (INDIRECT ENZYME TEST)
K893467 · Immuno Concepts, Inc. · Jul 1989
CMV IGG ANTIBODY TEST (INDIRECT FLUORESCENT TEST)
K893468 · Immuno Concepts, Inc. · Jul 1989
CYTOMEGALOVIRUS DIRECT FLUORESCENT ANTIBODY KIT
K860279 · Bartels Immunodiagnostic Supplies, Inc. · May 1986
CYLOMEGALOVIRUS DIRECT FLUORESCENT ANTI
K820895 · Bartels Immunodiagnostic Supplies, Inc. · May 1982