Cleared Traditional

K930778 - IMMUNOCARD MONO

K930778 is an FDA 510(k) clearance for IMMUNOCARD MONO, manufactured by Meridian Diagnostics, Inc.. The device is a Class 2 Immunology device with product code KTN cleared through the Traditional 510(k) pathway after a 314-day FDA review.

K930778 · Meridian Diagnostics, Inc. · Immunology device
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Dec 1993
Decision
314d
Days
Class 2
Risk

K930778 is an FDA 510(k) clearance for the IMMUNOCARD MONO. Classified as System, Test, Infectious Mononucleosis (product code KTN), Class II - Special Controls.

Submitted by Meridian Diagnostics, Inc. (Cincinnati, US). The FDA issued a Cleared decision on December 27, 1993 after a review of 314 days - an unusually long review period, suggesting complex equivalence evaluation.

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. Elevated predicate reliance profile. 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 Meridian Diagnostics, Inc. devices

FDA 510(k) Submission Details - K930778

510(k) Number K930778 FDA.gov
FDA Decision Cleared Substantially Equivalent - Traditional 510(k) (SESE)
Date Received February 16, 1993
Decision Date December 27, 1993
Days to Decision 314 days
Submission Type Traditional
Review Panel Immunology (IM)
Summary Summary PDF
Third-party Review No - reviewed directly by FDA
Regulatory Context
Review time vs. panel average
209d slower than avg
Panel avg: 105d · This submission: 314d
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 K930778.
GENZYME DIAGNOSTICS CONTRAST MONO
K963425 · Genzyme Diagnostics · Feb 1997
BIOSIGN MONO-PLUS WB,BIOSIGN MONO WB,MONO-PLUS WB,ACCUSIGN MONO WB
K961024 · Princeton BioMeditech Corp. · Feb 1997
QUALITROL MONO CONTROL SERUM SET
K961550 · Consolidated Technologies, Inc. · Sep 1996
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