Cleared Traditional

K802309 - MS-2 IDENTIFICATION SYSTEM

K802309 is an FDA 510(k) clearance for MS-2 IDENTIFICATION SYSTEM, manufactured by Abbott Laboratories. The device is a Class 1 Microbiology device with product code JXB cleared through the Traditional 510(k) pathway after a 69-day FDA review.

K802309 · Abbott Laboratories · Microbiology device
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Dec 1980
Decision
69d
Days
Class 1
Risk

K802309 is an FDA 510(k) clearance for the MS-2 IDENTIFICATION SYSTEM. Classified as Kit, Identification, Yeast (product code JXB), Class I - General Controls.

Submitted by Abbott Laboratories (Abbott Park, US). The FDA issued a Cleared decision on December 1, 1980 after a review of 69 days - a notably fast clearance cycle.

This device falls under the Microbiology FDA review panel, regulated under 21 CFR 866.2660 - 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 Abbott Laboratories devices

FDA 510(k) Submission Details - K802309

510(k) Number K802309 FDA.gov
FDA Decision Cleared Substantially Equivalent - Traditional 510(k) (SESE)
Date Received September 23, 1980
Decision Date December 01, 1980
Days to Decision 69 days
Submission Type Traditional
Review Panel Microbiology (MI)
Summary -
Third-party Review No - reviewed directly by FDA
Combination Product No
PCCP Authorized No
Regulatory Context
Review time vs. panel average
33d faster than avg
Panel avg: 102d · This submission: 69d
Pathway characteristics
Predicate-based equivalence.

JXB Device Classification - Class 1, General Controls

Product Code JXB Kit, Identification, Yeast
Device Class Class 1 - General Controls
CFR Regulation 21 CFR 866.2660
What this classification means

Class I devices are subject to general controls only and most are exempt from 510(k) premarket notification. They represent the lowest regulatory burden in the FDA device framework.

Regulatory Peers - JXB Kit, Identification, Yeast

All 8
Devices cleared under the same product code (JXB) and FDA review panel - the closest regulatory comparables to K802309.
VITEK YEAST BIOCHEMICAL CARD
K881925 · Vitek Systems, Inc. · Jun 1988
YEAST IDENTIFICATION PANEL
K860575 · American Micro Scan · May 1986
YEAST IDENT
K830286 · Analytical Products, Inc. · Apr 1983
NITRATE SWAB-RAPID TEST
K800803 · Remel Co. · Jul 1980
CAPIK-CANDIDA ALBICANS IDENT. KIT.
K800908 · Immuno-Mycologics, Inc. · Jun 1980
AMS YEAST BIOCHEMICAL CARD
K792231 · Vitek Systems, Inc. · Dec 1979