Cleared Traditional

K843827 - COBAS REAGENTS FOR GENTAMICIN & CALIBRAT

K843827 is an FDA 510(k) clearance for COBAS REAGENTS FOR GENTAMICIN & CALIBRAT, manufactured by Roche Diagnostic Systems, Inc.. The device is a Class 2 Toxicology device with product code LCQ cleared through the Traditional 510(k) pathway after a 126-day FDA review.

K843827 · Roche Diagnostic Systems, Inc. · Toxicology device
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Feb 1985
Decision
126d
Days
Class 2
Risk

K843827 is an FDA 510(k) clearance for the COBAS REAGENTS FOR GENTAMICIN & CALIBRAT. Classified as Fluorescent Immunoassay Gentamicin (product code LCQ), Class II - Special Controls.

Submitted by Roche Diagnostic Systems, Inc. (Mchenry, US). The FDA issued a Cleared decision on February 1, 1985 after a review of 126 days - within the typical 510(k) review window.

This device falls under the Toxicology FDA review panel, regulated under 21 CFR 862.3450 - the FDA toxicology 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 Toxicology review framework, consistent with the majority of Class II 510(k) submissions.

View all Roche Diagnostic Systems, Inc. devices

FDA 510(k) Submission Details - K843827

510(k) Number K843827 FDA.gov
FDA Decision Cleared Substantially Equivalent - Traditional 510(k) (SESE)
Date Received September 28, 1984
Decision Date February 01, 1985
Days to Decision 126 days
Submission Type Traditional
Review Panel Toxicology (TX)
Summary -
Third-party Review No - reviewed directly by FDA
Combination Product No
PCCP Authorized No
Regulatory Context
Review time vs. panel average
39d slower than avg
Panel avg: 87d · This submission: 126d
Pathway characteristics
Predicate-based equivalence. No clinical trials required.

LCQ Device Classification - Class 2, Special Controls

Product Code LCQ Fluorescent Immunoassay Gentamicin
Device Class Class 2 - Special Controls
CFR Regulation 21 CFR 862.3450
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 Toxicology devices follow this clearance model.

Regulatory Peers - LCQ Fluorescent Immunoassay Gentamicin

All 12
Devices cleared under the same product code (LCQ) and FDA review panel - the closest regulatory comparables to K843827.
OPUS GENTAMICIN
K905721 · Pb Diagnostic Systems, Inc. · Feb 1991
'TDXFLX ANALYZER
K904226 · Abbott Laboratories · Oct 1990
GENTAMICIN KIT(FPIA)
K852013 · Windsor Laboratories, Inc. · Jun 1985
SYVA ADVANCE SYST. EMIT-AMD GENT. ASSAY
K820285 · Syva Co. · Feb 1982
GENTAMICIN FLUORESCENT IMMUNOASSAY
K813539 · American Diagnostic Corp. · Dec 1981
AMES TDA GENTAMICIN TEST
K810942 · Miles Laboratories, Inc. · Apr 1981