Cleared Traditional

K924037 - ACCUTEX IM RBC TEST

K924037 is the FDA 510(k) clearance for ACCUTEX IM RBC TEST by J.S. Medical Assoc.. It is a Class 2 Immunology device (product code KTN) cleared through the Traditional 510(k) pathway after a 83-day FDA review.

K924037 · J.S. Medical Assoc. · Immunology device
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Nov 1992
Decision
83d
Days
Class 2
Risk

K924037 is an FDA 510(k) clearance for the ACCUTEX IM RBC TEST. Classified as System, Test, Infectious Mononucleosis (product code KTN), Class II - Special Controls.

Submitted by J.S. Medical Assoc. (Natick, US). The FDA issued a Cleared decision on November 2, 1992 after a review of 83 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 J.S. Medical Assoc. devices

Submission Details

510(k) Number K924037 FDA.gov
FDA Decision Cleared Substantially Equivalent - Traditional 510(k) (SESE)
Date Received August 11, 1992
Decision Date November 02, 1992
Days to Decision 83 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
21d faster than avg
Panel avg: 104d · This submission: 83d
Pathway characteristics
Predicate-based equivalence. No clinical trials required.

Device Classification

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 28
Devices cleared under the same product code (KTN) and FDA review panel - the closest regulatory comparables to K924037.
CLEARVIEW IM
K981946 · Unipath , Ltd. · Dec 1998
BIOSIGN MONO-PLUS WB,BIOSIGN MONO WB,MONO-PLUS WB,ACCUSIGN MONO WB
K961024 · Princeton BioMeditech Corp. · Feb 1997
IMMUNOCARD MONO
K930778 · Meridian Diagnostics, Inc. · Dec 1993
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