Cleared Traditional

K844289 - SERIES I/S INFECTIONS

K844289 is an FDA 510(k) clearance for SERIES I/S INFECTIONS, manufactured by American Dade. The device is a Class 2 Immunology device with product code KTN cleared through the Traditional 510(k) pathway after a 14-day FDA review.

K844289 · American Dade · Immunology device
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Nov 1984
Decision
14d
Days
Class 2
Risk

K844289 is an FDA 510(k) clearance for the SERIES I/S INFECTIONS. Classified as System, Test, Infectious Mononucleosis (product code KTN), Class II - Special Controls.

Submitted by American Dade (Santa Ana, US). The FDA issued a Cleared decision on November 19, 1984 after a review of 14 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.

FDA 510(k) Submission Details - K844289

510(k) Number K844289 FDA.gov
FDA Decision Cleared Substantially Equivalent - Traditional 510(k) (SESE)
Date Received November 05, 1984
Decision Date November 19, 1984
Days to Decision 14 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
91d faster than avg
Panel avg: 105d · This submission: 14d
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 58
Devices cleared under the same product code (KTN) and FDA review panel - the closest regulatory comparables to K844289.
CARD THREE IM TEST ITEM #2035, CARD ONE IM #2036
K853144 · Preco, Inc. · Oct 1985
IMMUNO-IM
K853105 · Immunostics Co., Inc. · Sep 1985
MONOSTICON UNI-DOT
K853388 · Organon, Inc. · Aug 1985
MONO-TEC
K841863 · Medilab Corp. · Jun 1984
LEAP MONO TEST KIT
K840822 · Cooper Biomedical, Inc. · Apr 1984
IM-CHECK
K834345 · Diagnostic Technology, Inc. · Feb 1984
K844289 · SERIES I/S INFECTIONS
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