Cleared Traditional

K921616 - CMV-VUE(TM) CMV ANTIGEN DETECTION KIT

K921616 is the FDA 510(k) clearance for CMV-VUE(TM) CMV ANTIGEN DETECTION KIT by Incstar Corp.. It is a Class 2 Microbiology device (product code LIN) cleared through the Traditional 510(k) pathway after a 127-day FDA review.

K921616 · Incstar Corp. · Microbiology device
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Aug 1992
Decision
127d
Days
Class 2
Risk

K921616 is an FDA 510(k) clearance for the CMV-VUE(TM) CMV ANTIGEN DETECTION KIT. Classified as Antisera, Conjugated Fluorescent, Cytomegalovirus (product code LIN), Class II - Special Controls.

Submitted by Incstar Corp. (Stillwater, US). The FDA issued a Cleared decision on August 11, 1992 after a review of 127 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 Incstar Corp. devices

Submission Details

510(k) Number K921616 FDA.gov
FDA Decision Cleared Substantially Equivalent - NSE Converted (SN)
Date Received April 06, 1992
Decision Date August 11, 1992
Days to Decision 127 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
25d slower than avg
Panel avg: 102d · This submission: 127d
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 11
Devices cleared under the same product code (LIN) and FDA review panel - the closest regulatory comparables to K921616.
D3 DFA CYTOMEGALOVIRUS IMMEDIATE EARLY ANTIGEN IDENTIFICATION KIT
K081164 · Diagnostic Hybrids, Inc. · Jun 2008
NUCLISENS CMV PP67
K983762 · Organon Teknika Corp. · Sep 1999
PATHODX CYTOMEGALOVIRUS
K934798 · Diagnostic Products Corp. · Mar 1994
CMV-EA MAB TEST
K912592 · Gull Laboratories, Inc. · Dec 1991
OPUS CMV TEST SYSTEM
K905257 · Pb Diagnostic Systems, Inc. · Apr 1991
BARTELS CYTOMEGALOVIRUS IMMED. EARLY ANTIGEN
K904036 · Baxter Healthcare Corp · Oct 1990