Cleared Traditional

CARDS O.S. MONO (K902510) - FDA 510(k) Clearance

Class II Microbiology device cleared through predicate-based substantial equivalence - typically does not require clinical trials.

K902510 · Pacific Biotech, Inc. · Microbiology device
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Jul 1990
Decision
41d
Days
Class 2
Risk

K902510 is an FDA 510(k) clearance for the CARDS O.S. MONO. Classified as System, Test, Infectious Mononucleosis (product code KTN), Class II - Special Controls.

Submitted by Pacific Biotech, Inc. (San Diego, US). The FDA issued a Cleared decision on July 16, 1990 after a review of 41 days - a notably fast clearance cycle.

This device falls under the Microbiology FDA review panel, regulated under 21 CFR 866.5640 - the FDA microbiology 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 Pacific Biotech, Inc. devices

Submission Details

510(k) Number K902510 FDA.gov
FDA Decision Cleared Substantially Equivalent - Traditional 510(k) (SESE)
Date Received June 05, 1990
Decision Date July 16, 1990
Days to Decision 41 days
Submission Type Traditional
Review Panel Microbiology (MI)
Summary -
Third-party Review No - reviewed directly by FDA
Regulatory Context
Review time vs. panel average
61d faster than avg
Panel avg: 102d · This submission: 41d
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 Microbiology 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 K902510.
OSOM Mono Test
K181436 · SEKISUI Diagnostics, LLC · Jun 2018
BIORAPID MONONUCLEOSIS
K030215 · Instrumentation Laboratory CO · Feb 2003
COLOR-MONOGEN
K012901 · Instrumentation Laboratory CO · Sep 2001
CORDIA IM
K812540 · Cordis Corp. · Sep 1981
TEST, MONO., CARD (MACRO-VUE)
K760040 · Bd Becton Dickinson Vacutainer Systems Preanalytic · Aug 1976