Cleared Traditional

MODIFIED ACCUFLUOR CARBAMAZEPINE REAGENT & CALIBRA (K900702) - FDA 510(k) Clearance

Class II Toxicology device cleared through predicate-based substantial equivalence - typically does not require clinical trials.

K900702 · Innotron of Oregon, Inc. · Toxicology device
Download Printable Device Report (PDF)
Optimized for regulatory review, auditing and printing
Apr 1990
Decision
59d
Days
Class 2
Risk

K900702 is an FDA 510(k) clearance for the MODIFIED ACCUFLUOR CARBAMAZEPINE REAGENT & CALIBRA. Classified as Fluorescence Polarization Immunoassay, Carbamazepine (product code LGI), Class II - Special Controls.

Submitted by Innotron of Oregon, Inc. (Portland, US). The FDA issued a Cleared decision on April 12, 1990 after a review of 59 days - a notably fast clearance cycle.

This device falls under the Toxicology FDA review panel, regulated under 21 CFR 862.3645 - 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 Innotron of Oregon, Inc. devices

Submission Details

510(k) Number K900702 FDA.gov
FDA Decision Cleared Substantially Equivalent - Traditional 510(k) (SESE)
Date Received February 12, 1990
Decision Date April 12, 1990
Days to Decision 59 days
Submission Type Traditional
Review Panel Toxicology (TX)
Summary -
Third-party Review No - reviewed directly by FDA
Regulatory Context
Review time vs. panel average
28d faster than avg
Panel avg: 87d · This submission: 59d
Pathway characteristics
Predicate-based equivalence. No clinical trials required.

Device Classification

Product Code LGI Fluorescence Polarization Immunoassay, Carbamazepine
Device Class Class 2 - Special Controls
CFR Regulation 21 CFR 862.3645
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.