Cleared Traditional

K904683 - STRATUS PRIMIDONE FLUOROMETRIC ENZYME

K904683 is the FDA 510(k) clearance for STRATUS PRIMIDONE FLUOROMETRIC ENZYME by Baxter Healthcare Corp. It is a Class 2 Chemistry device (product code LFT) cleared through the Traditional 510(k) pathway after a 44-day FDA review.

K904683 · Baxter Healthcare Corp · Chemistry device
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Nov 1990
Decision
44d
Days
Class 2
Risk

K904683 is an FDA 510(k) clearance for the STRATUS PRIMIDONE FLUOROMETRIC ENZYME. Classified as Fluorescent Immunoassay, Primidone (product code LFT), Class II - Special Controls.

Submitted by Baxter Healthcare Corp (Miami, US). The FDA issued a Cleared decision on November 28, 1990 after a review of 44 days - a notably fast clearance cycle.

This device falls under the Chemistry FDA review panel, regulated under 21 CFR 862.3680 - 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 Baxter Healthcare Corp devices

Submission Details

510(k) Number K904683 FDA.gov
FDA Decision Cleared Substantially Equivalent - Traditional 510(k) (SESE)
Date Received October 15, 1990
Decision Date November 28, 1990
Days to Decision 44 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
44d faster than avg
Panel avg: 88d · This submission: 44d
Pathway characteristics
Predicate-based equivalence. No clinical trials required.

Device Classification

Product Code LFT Fluorescent Immunoassay, Primidone
Device Class Class 2 - Special Controls
CFR Regulation 21 CFR 862.3680
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 - LFT Fluorescent Immunoassay, Primidone

Devices cleared under the same product code (LFT) and FDA review panel - the closest regulatory comparables to K904683.
PRIMIDONE FPIA REAGENT SET AND CALIBRATORS
K950028 · Sigma Diagnostics, Inc. · Mar 1995
COBAS FP REAGEN FOR PRIMIDONE & PRIMI CALIBRATORS
K852318 · Roche Diagnostic Systems, Inc. · Jun 1985
STRATUS PRIMIDONE FLOROMETRIC ENZY
K842196 · American Dade · Jul 1984
ADVANCE EMIT-AED PRIMEDONE ASSAY
K823741 · Syva Co. · Jan 1983
PRIMIDONE FLUORESCENT IMMUNOASSAY
K822229 · American Diagnostic Corp. · Aug 1982
AMES TDA TM PRIMIDONE TEST
K811007 · Miles Laboratories, Inc. · Apr 1981