Cleared Traditional

K923767 - PULSE IM RED CELL TEST

K923767 is an FDA 510(k) clearance for PULSE IM RED CELL TEST, manufactured by Pulse Scientific, Inc.. The device is a Class 2 Immunology device with product code KTN cleared through the Traditional 510(k) pathway after a 80-day FDA review.

K923767 · Pulse Scientific, Inc. · Immunology device
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Oct 1992
Decision
80d
Days
Class 2
Risk

K923767 is an FDA 510(k) clearance for the PULSE IM RED CELL TEST. Classified as System, Test, Infectious Mononucleosis (product code KTN), Class II - Special Controls.

Submitted by Pulse Scientific, Inc. (Burlington, Ont., Canada, CA). The FDA issued a Cleared decision on October 16, 1992 after a review of 80 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 - K923767

510(k) Number K923767 FDA.gov
FDA Decision Cleared Substantially Equivalent - Traditional 510(k) (SESE)
Date Received July 28, 1992
Decision Date October 16, 1992
Days to Decision 80 days
Submission Type Traditional
Review Panel Immunology (IM)
Summary Statement
Third-party Review No - reviewed directly by FDA
Combination Product No
PCCP Authorized No
Regulatory Context
Review time vs. panel average
25d faster than avg
Panel avg: 105d · This submission: 80d
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 K923767.
ACCUTEX IM LATEX TEST
K932551 · J.S. Medical Assoc. · Aug 1993
BIOSIGN(TM) MONO-INFECT MONO HETERO ANTIBODY TEST
K925183 · Princeton Biomedix · Feb 1993
ACCUTEX IM RBC TEST
K924037 · J.S. Medical Assoc. · Nov 1992
TECH SIMPLE INFECTIOUS MONONUCLEOSIS SERUM CONTROL
K922726 · Simplicity Diagnostics, Inc. · Oct 1992
IMFECTIOUS MONONUCLEOSIS IM LIQUID CARD TEST
K922296 · Ampcor, Inc. · Jul 1992
INFECTIOUS MONONUCLEOSIS QIK-DOT IM DRY CARD TEST
K922297 · Ampcor, Inc. · Jul 1992
K923767 · PULSE IM RED CELL TEST
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