Cleared Traditional

K830701 - STRATUS PHENOBARBITAL FLUOROMETRIC ENZ

K830701 is the FDA 510(k) clearance for STRATUS PHENOBARBITAL FLUOROMETRIC ENZ by American Dade. It is a Class 2 Toxicology device (product code LET) cleared through the Traditional 510(k) pathway after a 67-day FDA review.

K830701 · American Dade · Toxicology device
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May 1983
Decision
67d
Days
Class 2
Risk

K830701 is an FDA 510(k) clearance for the STRATUS PHENOBARBITAL FLUOROMETRIC ENZ. Classified as Fluorescent Immunoassay, Phenobarbital (product code LET), Class II - Special Controls.

Submitted by American Dade (Mchenry, US). The FDA issued a Cleared decision on May 13, 1983 after a review of 67 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 American Dade devices

Submission Details

510(k) Number K830701 FDA.gov
FDA Decision Cleared Substantially Equivalent - Traditional 510(k) (SESE)
Date Received March 07, 1983
Decision Date May 13, 1983
Days to Decision 67 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
20d faster than avg
Panel avg: 87d · This submission: 67d
Pathway characteristics
Predicate-based equivalence. No clinical trials required.

Device Classification

Product Code LET Fluorescent 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 - LET Fluorescent Immunoassay, Phenobarbital

All 7
Devices cleared under the same product code (LET) and FDA review panel - the closest regulatory comparables to K830701.
MODIFIED OPUS PHENOBARBITAL TEST SYSTEM
K901537 · Pb Diagnostic Systems, Inc. · Jun 1990
IMMPULSE COATED TUBE PHENOBARBITAL ASSAY REAGENTS
K865000 · Sclavo, Inc. · Feb 1987
AMES TDA PHENOBARBITAL TEST
K842592 · Miles Laboratories, Inc. · Aug 1984
PHENOBARBITAL FLUORESCENT IMMUNO
K821408 · American Diagnostic Corp. · May 1982
PHENOBARBITAL ASSAY
K820188 · Syva Co. · Feb 1982
AMES TDA TM PHENOBARBITAL TEST
K810994 · Miles Laboratories, Inc. · Apr 1981