Cleared Traditional

K821386 - SERO/TEX MONO TEST

K821386 is an FDA 510(k) clearance for SERO/TEX MONO TEST, manufactured by Texas Immunology, Inc.. The device is a Class 2 Immunology device with product code KTN cleared through the Traditional 510(k) pathway after a 53-day FDA review.

K821386 · Texas Immunology, Inc. · Immunology device
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Jul 1982
Decision
53d
Days
Class 2
Risk

K821386 is an FDA 510(k) clearance for the SERO/TEX MONO TEST. Classified as System, Test, Infectious Mononucleosis (product code KTN), Class II - Special Controls.

Submitted by Texas Immunology, Inc. (Mchenry, US). The FDA issued a Cleared decision on July 2, 1982 after a review of 53 days - a notably fast clearance cycle.

This device falls under the Immunology FDA review panel, regulated under 21 CFR 866.5640 - 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: Fast-track predicate clearance. Standard predicate reliance. The short review cycle indicates strong predicate alignment - the FDA found sufficient equivalence without extended technical review.

View all Texas Immunology, Inc. devices

FDA 510(k) Submission Details - K821386

510(k) Number K821386 FDA.gov
FDA Decision Cleared Substantially Equivalent - Traditional 510(k) (SESE)
Date Received May 10, 1982
Decision Date July 02, 1982
Days to Decision 53 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
52d faster than avg
Panel avg: 105d · This submission: 53d
Pathway characteristics
Predicate-based equivalence. No clinical trials required.

KTN Device Classification - Class 2, Special Controls

Product Code KTN System, Test, Infectious Mononucleosis
Device Class Class 2 - Special Controls
CFR Regulation 21 CFR 866.5640
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.

Regulatory Peers - KTN System, Test, Infectious Mononucleosis

All 42
Devices cleared under the same product code (KTN) and FDA review panel - the closest regulatory comparables to K821386.
SERIES I/S INFECTIONS
K844289 · American Dade · Nov 1984
LEAP MONO TEST KIT
K840822 · Cooper Biomedical, Inc. · Apr 1984
IM-CHECK
K834345 · Diagnostic Technology, Inc. · Feb 1984
CORDIA IM
K812540 · Cordis Corp. · Sep 1981
AGGLUTINOTEST-INFECTIOUS MONONUCLEOSIS
K791455 · Volu Sol Medical Industries · Dec 1979
MONOSTICON TEST
K771397 · Organon, Inc. · Aug 1977