Cleared Traditional

K874678 - I.M.N. LATEX

K874678 is an FDA 510(k) clearance for I.M.N. LATEX, manufactured by Biokit USA, Inc.. The device is a Class 2 Immunology device with product code KTN cleared through the Traditional 510(k) pathway after a 31-day FDA review.

K874678 · Biokit USA, Inc. · Immunology device
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Dec 1987
Decision
31d
Days
Class 2
Risk

K874678 is an FDA 510(k) clearance for the I.M.N. LATEX. Classified as System, Test, Infectious Mononucleosis (product code KTN), Class II - Special Controls.

Submitted by Biokit USA, Inc. (Barcelona, Spain, US). The FDA issued a Cleared decision on December 14, 1987 after a review of 31 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 Biokit USA, Inc. devices

FDA 510(k) Submission Details - K874678

510(k) Number K874678 FDA.gov
FDA Decision Cleared Substantially Equivalent - Traditional 510(k) (SESE)
Date Received November 13, 1987
Decision Date December 14, 1987
Days to Decision 31 days
Submission Type Traditional
Review Panel Immunology (IM)
Summary -
Third-party Review No - reviewed directly by FDA
Regulatory Context
Review time vs. panel average
74d faster than avg
Panel avg: 105d · This submission: 31d
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 43
Devices cleared under the same product code (KTN) and FDA review panel - the closest regulatory comparables to K874678.
OXOID INFECTIOUS MONONUCLEOSIS KIT
K883540 · Unipath , Ltd. · Oct 1988
V-TREND IM DRY-SPOT TEST
K880399 · Texas Immunology, Inc. · Feb 1988
DIFFERENTIAL I.M. SCREENING TEST
K873297 · Sclavo, Inc. · Dec 1987
VENTRESCREEN (TM) MONO
K872032 · Ventrex Laboratories, Inc. · Jun 1987
DISPOSABLE TEST CARDS/GAMMA SLIDE TEST INFECT MONO
K864207 · Gamma Biologicals, Inc. · Dec 1986
MONO-LATEX (TM) SLIDE TEST
K862008 · Armkel, LLC · Jul 1986