Cleared Traditional

K831711 - CMV IGM TEST

K831711 is an FDA 510(k) clearance for CMV IGM TEST, manufactured by Gull Laboratories, Inc.. The device is a Class 2 Immunology device with product code LKQ cleared through the Traditional 510(k) pathway after a 153-day FDA review.

K831711 · Gull Laboratories, Inc. · Immunology device
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Oct 1983
Decision
153d
Days
Class 2
Risk

K831711 is an FDA 510(k) clearance for the CMV IGM TEST. Classified as Antibody Igm,if, Cytomegalovirus Virus (product code LKQ), Class II - Special Controls.

Submitted by Gull Laboratories, Inc. (Mchenry, US). The FDA issued a Cleared decision on October 27, 1983 after a review of 153 days - an extended review cycle.

This device falls under the Immunology FDA review panel, regulated under 21 CFR 866.3175 - the FDA immunology 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 Immunology review framework, consistent with the majority of Class II 510(k) submissions.

View all Gull Laboratories, Inc. devices

FDA 510(k) Submission Details - K831711

510(k) Number K831711 FDA.gov
FDA Decision Cleared Substantially Equivalent - Traditional 510(k) (SESE)
Date Received May 27, 1983
Decision Date October 27, 1983
Days to Decision 153 days
Submission Type Traditional
Review Panel Immunology (IM)
Summary -
Third-party Review No - reviewed directly by FDA
Combination Product No
PCCP Authorized No
Regulatory Context
Review time vs. panel average
48d slower than avg
Panel avg: 105d · This submission: 153d
Pathway characteristics
Predicate-based equivalence. No clinical trials required.

LKQ Device Classification - Class 2, Special Controls

Product Code LKQ Antibody Igm,if, Cytomegalovirus Virus
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 Immunology devices follow this clearance model.