Cleared Traditional

K961489 - ELECSYS FT4 ASSAY

K961489 is an FDA 510(k) clearance for ELECSYS FT4 ASSAY, manufactured by Boehringer Mannheim Corp.. The device is a Class 2 Chemistry device with product code CEC cleared through the Traditional 510(k) pathway after a 54-day FDA review.

K961489 · Boehringer Mannheim Corp. · Chemistry device
Download Printable Device Report (PDF)
Optimized for regulatory review, auditing and printing
Jun 1996
Decision
54d
Days
Class 2
Risk

K961489 is an FDA 510(k) clearance for the ELECSYS FT4 ASSAY. Classified as Radioimmunoassay, Free Thyroxine (product code CEC), Class II - Special Controls.

Submitted by Boehringer Mannheim Corp. (Concord, US). The FDA issued a Cleared decision on June 11, 1996 after a review of 54 days - a notably fast clearance cycle.

This device falls under the Chemistry FDA review panel, regulated under 21 CFR 862.1695 - 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 Boehringer Mannheim Corp. devices

FDA 510(k) Submission Details - K961489

510(k) Number K961489 FDA.gov
FDA Decision Cleared Substantially Equivalent - Traditional 510(k) (SESE)
Date Received April 18, 1996
Decision Date June 11, 1996
Days to Decision 54 days
Submission Type Traditional
Review Panel Chemistry (CH)
Summary Summary PDF
Third-party Review No - reviewed directly by FDA
Combination Product No
PCCP Authorized No
Regulatory Context
Review time vs. panel average
34d faster than avg
Panel avg: 88d · This submission: 54d
Pathway characteristics
Predicate-based equivalence. No clinical trials required.

CEC Device Classification - Class 2, Special Controls

Product Code CEC Radioimmunoassay, Free Thyroxine
Device Class Class 2 - Special Controls
CFR Regulation 21 CFR 862.1695
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 - CEC Radioimmunoassay, Free Thyroxine

All 66
Devices cleared under the same product code (CEC) and FDA review panel - the closest regulatory comparables to K961489.
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