Cleared Traditional

K964670 - ROCHE COBAS-FP REAGENTS FOR TOBRAMYCIN

K964670 is an FDA 510(k) clearance for ROCHE COBAS-FP REAGENTS FOR TOBRAMYCIN, manufactured by Roche Diagnostic Systems, Inc.. The device is a Class 2 Toxicology device with product code LFW cleared through the Traditional 510(k) pathway after a 75-day FDA review.

K964670 · Roche Diagnostic Systems, Inc. · Toxicology device
Download Printable Device Report (PDF)
Optimized for regulatory review, auditing and printing
Feb 1997
Decision
75d
Days
Class 2
Risk

K964670 is an FDA 510(k) clearance for the ROCHE COBAS-FP REAGENTS FOR TOBRAMYCIN. Classified as Fluorescence Polarization Immunoassay, Tobramycin (product code LFW), Class II - Special Controls.

Submitted by Roche Diagnostic Systems, Inc. (Somerville, US). The FDA issued a Cleared decision on February 4, 1997 after a review of 75 days - a notably fast clearance cycle.

This device falls under the Toxicology FDA review panel, regulated under 21 CFR 862.3900 - 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: 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 Roche Diagnostic Systems, Inc. devices

FDA 510(k) Submission Details - K964670

510(k) Number K964670 FDA.gov
FDA Decision Cleared Substantially Equivalent - Traditional 510(k) (SESE)
Date Received November 21, 1996
Decision Date February 04, 1997
Days to Decision 75 days
Submission Type Traditional
Review Panel Toxicology (TX)
Summary Statement
Third-party Review No - reviewed directly by FDA
Regulatory Context
Review time vs. panel average
12d faster than avg
Panel avg: 87d · This submission: 75d
Pathway characteristics
Predicate-based equivalence. No clinical trials required.

LFW Device Classification - Class 2, Special Controls

Product Code LFW Fluorescence Polarization 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 Toxicology devices follow this clearance model.

Regulatory Peers - LFW Fluorescence Polarization Immunoassay, Tobramycin

All 7
Devices cleared under the same product code (LFW) and FDA review panel - the closest regulatory comparables to K964670.
TOBRAMYCIN FPIA REAGENT SET AND CALIBRATOR
K944371 · Sigma Diagnostics, Inc. · Nov 1994
AXSYM TOBRAMYCIN
K941614 · Abbott Laboratories · Aug 1994
CEDIA(R) TOBRAMYCIN ASSAY
K912143 · Microgenics Corp. · Jul 1991
MODIFIED ACCUFLUOR TOBRAMYCIN REAGENT & CALIBRATOR
K900707 · Innotron of Oregon, Inc. · Apr 1990
INNOTRON INNOFLUOR TOBRAMYCIN REAGENT SET
K872562 · Innotron of Oregon, Inc. · Aug 1987
TOBRAMYCIN KIT(FPIA)FLUORESCENCE POLARIZATION IMMU
K854392 · Windsor Laboratories, Inc. · Dec 1985