Cleared Traditional

K912592 - CMV-EA MAB TEST

K912592 is an FDA 510(k) clearance for CMV-EA MAB TEST, manufactured by Gull Laboratories, Inc.. The device is a Class 2 Microbiology device with product code LIN cleared through the Traditional 510(k) pathway after a 177-day FDA review.

K912592 · Gull Laboratories, Inc. · Microbiology device
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Dec 1991
Decision
177d
Days
Class 2
Risk

K912592 is an FDA 510(k) clearance for the CMV-EA MAB TEST. Classified as Antisera, Conjugated Fluorescent, Cytomegalovirus (product code LIN), Class II - Special Controls.

Submitted by Gull Laboratories, Inc. (Salt Lake City, US). The FDA issued a Cleared decision on December 4, 1991 after a review of 177 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 Gull Laboratories, Inc. devices

FDA 510(k) Submission Details - K912592

510(k) Number K912592 FDA.gov
FDA Decision Cleared Substantially Equivalent - Traditional 510(k) (SESE)
Date Received June 10, 1991
Decision Date December 04, 1991
Days to Decision 177 days
Submission Type Traditional
Review Panel Microbiology (MI)
Summary Summary PDF
Third-party Review No - reviewed directly by FDA
Combination Product No
PCCP Authorized No
Regulatory Context
Review time vs. panel average
75d slower than avg
Panel avg: 102d · This submission: 177d
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 K912592.
CMV BRITE ANTIGENEMIA TEST KIT
K951550 · Biotest Diagnostics Corp. · Jan 1996
PATHODX CYTOMEGALOVIRUS
K934798 · Diagnostic Products Corp. · Mar 1994
CMV-VUE(TM) CMV ANTIGEN DETECTION KIT
K921616 · Incstar Corp. · Aug 1992
OPUS CMV TEST SYSTEM
K905257 · Pb Diagnostic Systems, Inc. · Apr 1991
BARTELS CYTOMEGALOVIRUS IMMED. EARLY ANTIGEN
K904036 · Baxter Healthcare Corp · Oct 1990
CYTOMEGALOVIRUS FLUORESCENT MONOCLONAL ANTIBODY
K894002 · Baxter Healthcare Corp · Aug 1989