Cleared Traditional

K872397 - COBAS FP REAGENTS FOR PHENO & COBAS FP ...

K872397 is the FDA 510(k) clearance for COBAS FP REAGENTS FOR PHENO & COBAS FP ... by Roche Diagnostic Systems, Inc.. It is a Class 2 Toxicology device (product code LGQ) cleared through the Traditional 510(k) pathway after a 29-day FDA review.

K872397 · Roche Diagnostic Systems, Inc. · Toxicology device
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Jul 1987
Decision
29d
Days
Class 2
Risk

K872397 is an FDA 510(k) clearance for the COBAS FP REAGENTS FOR PHENO & COBAS FP PHENO CALI.. Classified as Fluorescence Polarization Immunoassay, Phenobarbital (product code LGQ), Class II - Special Controls.

Submitted by Roche Diagnostic Systems, Inc. (Belleville, US). The FDA issued a Cleared decision on July 21, 1987 after a review of 29 days - a notably fast clearance cycle.

This device falls under the Toxicology FDA review panel, regulated under 21 CFR 862.3660 - 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

Submission Details

510(k) Number K872397 FDA.gov
FDA Decision Cleared Substantially Equivalent - Traditional 510(k) (SESE)
Date Received June 22, 1987
Decision Date July 21, 1987
Days to Decision 29 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
58d faster than avg
Panel avg: 87d · This submission: 29d
Pathway characteristics
Predicate-based equivalence. No clinical trials required.

Device Classification

Product Code LGQ Fluorescence Polarization Immunoassay, Phenobarbital
Device Class Class 2 - Special Controls
CFR Regulation 21 CFR 862.3660
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 - LGQ Fluorescence Polarization Immunoassay, Phenobarbital

Devices cleared under the same product code (LGQ) and FDA review panel - the closest regulatory comparables to K872397.
AXSYM PHENOBARBITAL
K940596 · Abbott Laboratories · Jun 1994
COBAS-FP REAGENT FOR PHENOBARBITAL AND COBAS-FP PHENOBARBITAL CALIBRATORS
K936130 · Roche Diagnostic Systems, Inc. · Mar 1994
IMMPULSE PHENOBARBITAL ASSAY REAGENTS
K862528 · Sclavo, Inc. · Jul 1986
TDX BARBITURATES
K854044 · Abbott Laboratories · Oct 1985
COBAS REAGENTS PHENOBARBITAL & PHENOBAR
K843825 · Roche Diagnostic Systems, Inc. · Feb 1985