Cleared Traditional

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

K921616 is an FDA 510(k) clearance for CMV-VUE(TM) CMV ANTIGEN DETECTION KIT, manufactured by Incstar Corp.. The device is a Class 2 Microbiology device with 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

FDA 510(k) Submission Details - K921616

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.

LIN Device Classification - Class 2, Special Controls

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 14
Devices cleared under the same product code (LIN) and FDA review panel - the closest regulatory comparables to K921616.
CYTOMEGALOVIRUS DIRECT IMMUNOFLUORESCENCE ASSAY
K951821 · Light Diagnostics · Jun 1996
CMV BRITE ANTIGENEMIA TEST KIT
K951550 · Biotest Diagnostics Corp. · Jan 1996
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