Cleared Traditional

K922726 - TECH SIMPLE INFECTIOUS MONONUCLEOSIS SERUM CONTROL

K922726 is an FDA 510(k) clearance for TECH SIMPLE INFECTIOUS MONONUCLEOSIS SE..., manufactured by Simplicity Diagnostics, Inc.. The device is a Class 2 Immunology device with product code KTN cleared through the Traditional 510(k) pathway after a 122-day FDA review.

K922726 · Simplicity Diagnostics, Inc. · Immunology device
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Oct 1992
Decision
122d
Days
Class 2
Risk

K922726 is an FDA 510(k) clearance for the TECH SIMPLE INFECTIOUS MONONUCLEOSIS SERUM CONTROL. Classified as System, Test, Infectious Mononucleosis (product code KTN), Class II - Special Controls.

Submitted by Simplicity Diagnostics, Inc. (Hatboro, US). The FDA issued a Cleared decision on October 5, 1992 after a review of 122 days - within the typical 510(k) review window.

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: 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 Simplicity Diagnostics, Inc. devices

FDA 510(k) Submission Details - K922726

510(k) Number K922726 FDA.gov
FDA Decision Cleared Substantially Equivalent - Traditional 510(k) (SESE)
Date Received June 05, 1992
Decision Date October 05, 1992
Days to Decision 122 days
Submission Type Traditional
Review Panel Immunology (IM)
Summary Statement
Third-party Review No - reviewed directly by FDA
Regulatory Context
Review time vs. panel average
17d slower than avg
Panel avg: 105d · This submission: 122d
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 K922726.
EYE SPOT IM TEST
K932688 · J.S. Medical Assoc. · Sep 1993
ACCUTEX IM LATEX TEST
K932551 · J.S. Medical Assoc. · Aug 1993
ACCUTEX IM RBC TEST
K924037 · J.S. Medical Assoc. · Nov 1992
CARDS O.S. MONO
K902510 · Pacific Biotech, Inc. · Jul 1990
MONO-LEX SYSTEM: INFECTIOUS MONONUCLEOSIS LATEX
K902541 · Trinity Laboratories, Inc. · Jun 1990
MONO-PLUS POSITIVE AND NEGATIVE CONTROL SET
K900625 · Armkel, LLC · Feb 1990