Cleared Traditional

K060998 - QMS TOBRAMYCIN

K060998 is an FDA 510(k) clearance for QMS TOBRAMYCIN, manufactured by Seradyn, Inc.. The device is a Class 2 Chemistry device with product code LCR cleared through the Traditional 510(k) pathway after a 101-day FDA review.

K060998 · Seradyn, Inc. · Chemistry device
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Jul 2006
Decision
101d
Days
Class 2
Risk

K060998 is an FDA 510(k) clearance for the QMS TOBRAMYCIN. Classified as Fluorescent Immunoassay, Tobramycin (product code LCR), Class II - Special Controls.

Submitted by Seradyn, Inc. (Indianapolis, US). The FDA issued a Cleared decision on July 21, 2006 after a review of 101 days - within the typical 510(k) review window.

This device falls under the Chemistry FDA review panel, regulated under 21 CFR 862.3900 - the FDA in vitro diagnostics and chemistry 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 Chemistry review framework, consistent with the majority of Class II 510(k) submissions.

View all Seradyn, Inc. devices

FDA 510(k) Submission Details - K060998

510(k) Number K060998 FDA.gov
FDA Decision Cleared Substantially Equivalent - Traditional 510(k) (SESE)
Date Received April 11, 2006
Decision Date July 21, 2006
Days to Decision 101 days
Submission Type Traditional
Review Panel Chemistry (CH)
Summary Summary PDF
Third-party Review No - reviewed directly by FDA
Combination Product No
PCCP Authorized No
Regulatory Context
Review time vs. panel average
13d slower than avg
Panel avg: 88d · This submission: 101d
Pathway characteristics
Predicate-based equivalence. No clinical trials required.

LCR Device Classification - Class 2, Special Controls

Product Code LCR Fluorescent Immunoassay, Tobramycin
Device Class Class 2 - Special Controls
CFR Regulation 21 CFR 862.3900
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 Chemistry devices follow this clearance model.

Regulatory Peers - LCR Fluorescent Immunoassay, Tobramycin

All 15
Devices cleared under the same product code (LCR) and FDA review panel - the closest regulatory comparables to K060998.
ACS TOBRAMYCIN
K974029 · Chiron Diagnostics Corp. · Feb 1998
TOBRAMYCIN FLEX REAGENT CARTRIDGE
K962818 · Dade Intl., Inc. · Sep 1996
BECKMAN ARRAY TOBRAMYCIN (TOB) REAGENT
K952568 · Beckman Instruments, Inc. · Aug 1995
OPUS(R) TOBRAMYCIN
K911940 · Pb Diagnostic Systems, Inc. · Jul 1991
VAR AURAL GROM AG/S9,SD8.00.28.5/0.2 NS/S/6823 1.4
K911613 · Exmoor Plastics , Ltd. · Jun 1991
INTRAOCULAR PRESSURE REDUCER
K854873 · Mira, Inc. · Feb 1986