Cleared Traditional

K936130 - COBAS-FP REAGENT FOR PHENOBARBITAL AND COBAS-FP PHENOBARBITAL CALIBRATORS

K936130 is an FDA 510(k) clearance for COBAS-FP REAGENT FOR PHENOBARBITAL AND ..., manufactured by Roche Diagnostic Systems, Inc.. The device is a Class 2 Toxicology device with product code LGQ cleared through the Traditional 510(k) pathway after a 78-day FDA review.

K936130 · Roche Diagnostic Systems, Inc. · Toxicology device
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Mar 1994
Decision
78d
Days
Class 2
Risk

K936130 is an FDA 510(k) clearance for the COBAS-FP REAGENT FOR PHENOBARBITAL AND COBAS-FP PHENOBARBITAL CALIBRATORS. Classified as Fluorescence Polarization Immunoassay, Phenobarbital (product code LGQ), Class II - Special Controls.

Submitted by Roche Diagnostic Systems, Inc. (Branchburg, US). The FDA issued a Cleared decision on March 11, 1994 after a review of 78 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

FDA 510(k) Submission Details - K936130

510(k) Number K936130 FDA.gov
FDA Decision Cleared Substantially Equivalent - Traditional 510(k) (SESE)
Date Received December 23, 1993
Decision Date March 11, 1994
Days to Decision 78 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
9d faster than avg
Panel avg: 87d · This submission: 78d
Pathway characteristics
Predicate-based equivalence. No clinical trials required.

LGQ Device Classification - Class 2, Special Controls

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

All 9
Devices cleared under the same product code (LGQ) and FDA review panel - the closest regulatory comparables to K936130.
INNOFLUOR GENTAMICIN ASSAY SYSTEM
K972331 · Oxis Intl., Inc. · Aug 1997
INNOFLUOR PHENOBARBITAL ASSAY SYSTEM
K972330 · Oxis Intl., Inc. · Jul 1997
AXSYM PHENOBARBITAL
K940596 · Abbott Laboratories · Jun 1994
MODIFIED ACCUFLUOR PHENOBARBITAL REAGENT & CALIBRA
K900704 · Innotron of Oregon, Inc. · Apr 1990
COBAS FP REAGENTS FOR PHENO & COBAS FP PHENO CALI.
K872397 · Roche Diagnostic Systems, Inc. · Jul 1987
PHENOBARBITAL-FPIA FLUORES. POLAR. IMMUNOASSAY KIT
K863625 · Windsor Laboratories, Inc. · Nov 1986