Cleared Traditional

COBAS-FP REAGENTS FOR VANCOMYCIN (K901759) - FDA 510(k) Clearance

Class II Chemistry device cleared through predicate-based substantial equivalence - typically does not require clinical trials.

K901759 · Roche Diagnostic Systems, Inc. · Chemistry device
Download Printable Device Report (PDF)
Optimized for regulatory review, auditing and printing
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 30
Devices cleared under the same product code (LEH) and FDA review panel - the closest regulatory comparables to K901759.
Atellica® CH Phencyclidine (Pcp), Atellica® CH Vancomycin (Vanc)
K222439 · Siemens Healthcare Diagnostics, Inc. · Aug 2023
Trinidad CH Vancomycin (Vanc), Trinidad CH Drug 3 Calibrator (DRUG3 CAL)
K160202 · Siemens Healthcare Diagnostics, Inc. · Apr 2016
IMMULITE 2000, IMMULITE 2500 VANCOMYCIN
K063045 · Diagnostic Products Corp. · Dec 2006
EMIT 2000 VANCOMYCIN ASSAY
K020692 · Dade Behring, Inc. · May 2002
AXSYM VANCOMYCIN II
K955851 · Abbott Laboratories · May 1996
ROCHE COBAS-FP REAGENTS FOR VANCOMYCIN
K953528 · Roche Diagnostic Systems, Inc. · Sep 1995