Cleared Traditional

K831154 - STRATUS PHENYTOIN FLUOROMETRIC ENZYME

K831154 is the FDA 510(k) clearance for STRATUS PHENYTOIN FLUOROMETRIC ENZYME by American Dade. It is a Class 2 Immunology device (product code LES) cleared through the Traditional 510(k) pathway after a 38-day FDA review.

K831154 · American Dade · Immunology device
Download Printable Device Report (PDF)
Optimized for regulatory review, auditing and printing
May 1983
Decision
38d
Days
Class 2
Risk

K831154 is an FDA 510(k) clearance for the STRATUS PHENYTOIN FLUOROMETRIC ENZYME. Classified as Fluorescent Immunoassay, Diphenylhydantoin (product code LES), Class II - Special Controls.

Submitted by American Dade (Walker, US). The FDA issued a Cleared decision on May 16, 1983 after a review of 38 days - a notably fast clearance cycle.

This device falls under the Immunology FDA review panel, regulated under 21 CFR 862.3350 - the FDA immunology 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 K831154 FDA.gov
FDA Decision Cleared Substantially Equivalent - Traditional 510(k) (SESE)
Date Received April 08, 1983
Decision Date May 16, 1983
Days to Decision 38 days
Submission Type Traditional
Review Panel Immunology (IM)
Summary -
Third-party Review No - reviewed directly by FDA
Combination Product No
PCCP Authorized No
Regulatory Context
Review time vs. panel average
66d faster than avg
Panel avg: 104d · This submission: 38d
Pathway characteristics
Predicate-based equivalence. No clinical trials required.

Device Classification

Product Code LES Fluorescent Immunoassay, Diphenylhydantoin
Device Class Class 2 - Special Controls
CFR Regulation 21 CFR 862.3350
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 Immunology devices follow this clearance model.

Regulatory Peers - LES Fluorescent Immunoassay, Diphenylhydantoin

Devices cleared under the same product code (LES) and FDA review panel - the closest regulatory comparables to K831154.
IMMPULSE COATED TUBE PHENYTOIN ASSAY REAGENTS
K865102 · Sclavo, Inc. · Jan 1987
SYVA ADVANCE EMIT PHENYTOIN ASSAY
K844990 · Syva Co. · Jan 1985
SYVA ADVANCE SYS. EMIT,(R)-AED(R) PHENY
K820187 · Syva Co. · Feb 1982
PHENYTOIN FLUORESCENT IMMUNOASSAY
K813538 · American Diagnostic Corp. · Dec 1981
AMES TDA TM PHENYTOIN TEST
K811025 · Miles Laboratories, Inc. · Apr 1981
AMES TDA TM PHENYTOIN TEST
K801736 · Miles Laboratories, Inc. · Aug 1980