Cleared Traditional

K993554 - YEASTEST

K993554 is an FDA 510(k) clearance for YEASTEST, manufactured by Diagnostic Markers, Inc.. The device is a Class 1 Microbiology device with product code JXB cleared through the Traditional 510(k) pathway after a 113-day FDA review.

K993554 · Diagnostic Markers, Inc. · Microbiology device
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Feb 2000
Decision
113d
Days
Class 1
Risk

K993554 is an FDA 510(k) clearance for the YEASTEST. Classified as Kit, Identification, Yeast (product code JXB), Class I - General Controls.

Submitted by Diagnostic Markers, Inc. (Irvine, US). The FDA issued a Cleared decision on February 10, 2000 after a review of 113 days - within the typical 510(k) review window.

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: Standard predicate-based submission. Standard predicate reliance. This clearance follows a standard predicate-based equivalence path within the Microbiology review framework, consistent with the majority of Class II 510(k) submissions.

View all Diagnostic Markers, Inc. devices

FDA 510(k) Submission Details - K993554

510(k) Number K993554 FDA.gov
FDA Decision Cleared Substantially Equivalent - Traditional 510(k) (SESE)
Date Received October 20, 1999
Decision Date February 10, 2000
Days to Decision 113 days
Submission Type Traditional
Review Panel Microbiology (MI)
Summary Statement
Third-party Review No - reviewed directly by FDA
PCCP Authorized No
Regulatory Context
Review time vs. panel average
11d slower than avg
Panel avg: 102d · This submission: 113d
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 11
Devices cleared under the same product code (JXB) and FDA review panel - the closest regulatory comparables to K993554.
YEAST TRAFFIC LIGHT PNA FISH
K080719 · Advandx, Inc. · Sep 2008
C. ALBICANS PNA FISH
K062461 · Advandx, Inc. · Oct 2006
BACTICARD CANDIDA
K935124 · Remel Co. · Feb 1994
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