Cleared Traditional

K901759 - COBAS-FP REAGENTS FOR VANCOMYCIN

K901759 is the FDA 510(k) clearance for COBAS-FP REAGENTS FOR VANCOMYCIN by Roche Diagnostic Systems, Inc.. It is a Class 2 Chemistry device (product code LEH) cleared through the Traditional 510(k) pathway after a 14-day FDA review.

K901759 · Roche Diagnostic Systems, Inc. · Chemistry device
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May 1990
Decision
14d
Days
Class 2
Risk

K901759 is an FDA 510(k) clearance for the COBAS-FP REAGENTS FOR VANCOMYCIN. Classified as Radioimmunoassay, Vancomycin (product code LEH), Class II - Special Controls.

Submitted by Roche Diagnostic Systems, Inc. (Montclair, US). The FDA issued a Cleared decision on May 2, 1990 after a review of 14 days - a notably fast clearance cycle.

This device falls under the Chemistry FDA review panel, regulated under 21 CFR 862.3950 - 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: 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

Submission Details

510(k) Number K901759 FDA.gov
FDA Decision Cleared Substantially Equivalent - Traditional 510(k) (SESE)
Date Received April 18, 1990
Decision Date May 02, 1990
Days to Decision 14 days
Submission Type Traditional
Review Panel Chemistry (CH)
Summary -
Third-party Review No - reviewed directly by FDA
Combination Product No
PCCP Authorized No
Regulatory Context
Review time vs. panel average
74d faster than avg
Panel avg: 88d · This submission: 14d
Pathway characteristics
Predicate-based equivalence. No clinical trials required.

Device Classification

Product Code LEH Radioimmunoassay, Vancomycin
Device Class Class 2 - Special Controls
CFR Regulation 21 CFR 862.3950
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 - LEH Radioimmunoassay, Vancomycin

All 20
Devices cleared under the same product code (LEH) and FDA review panel - the closest regulatory comparables to K901759.
ROCHE COBAS-FP REAGENTS FOR VANCOMYCIN
K953528 · Roche Diagnostic Systems, Inc. · Sep 1995
CIBA CORNING ACS VANCOMYCIN IMMUNOASSAY
K951059 · Ciba Corning Diagnostics Corp. · Jun 1995
AXSYM VANCOMYCIN
K940595 · Abbott Laboratories · Jun 1994
ACA VANCOMYCIN (VANC) METHOD
K892900 · E.I. Dupont DE Nemours & Co., Inc. · May 1989
EMIT VANCOMYCIN ASSAY
K881040 · Syva Co. · Apr 1988
STRATUS VANCOMYCIN FLUOROMETRIC ENZYME IMMUNOASSAY
K874438 · Baxter Healthcare Corp · Jan 1988