Cleared Traditional

ELECSYS T4 ASSAY (K961490) - FDA 510(k) Clearance

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

K961490 · Boehringer Mannheim Corp. · Chemistry device
Download Printable Device Report (PDF)
Optimized for regulatory review, auditing and printing
Jun 1996
Decision
56d
Days
Class 2
Risk

K961490 is an FDA 510(k) clearance for the ELECSYS T4 ASSAY. Classified as Radioimmunoassay, Total Thyroxine (product code CDX), Class II - Special Controls.

Submitted by Boehringer Mannheim Corp. (Concord, US). The FDA issued a Cleared decision on June 13, 1996 after a review of 56 days - a notably fast clearance cycle.

This device falls under the Chemistry FDA review panel, regulated under 21 CFR 862.1700 - 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

Submission Details

510(k) Number K961490 FDA.gov
FDA Decision Cleared Substantially Equivalent - Traditional 510(k) (SESE)
Date Received April 18, 1996
Decision Date June 13, 1996
Days to Decision 56 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
32d faster than avg
Panel avg: 88d · This submission: 56d
Pathway characteristics
Predicate-based equivalence. No clinical trials required.

Device Classification

Product Code CDX Radioimmunoassay, Total Thyroxine
Device Class Class 2 - Special Controls
CFR Regulation 21 CFR 862.1700
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 - CDX Radioimmunoassay, Total Thyroxine

All 36
Devices cleared under the same product code (CDX) and FDA review panel - the closest regulatory comparables to K961490.
AXSYM(TM) TOTAL T4
K934384 · Abbott Laboratories · Jun 1994
TOTAL T4 FPIA REAGENT SET/CALIBRATOR #T-1039,T-116
K932980 · Sigma Diagnostics, Inc. · Oct 1993
ABBOTT IMX T4
K925110 · Abbott Laboratories · Jan 1993
ABBOTT TDX/TDXFLX TT4
K925109 · Abbott Laboratories · Jan 1993
TECHNICON DAX SYSTEM THYROXINE (T4) METHOD
K922945 · Heraeus Kulzer, Inc. · Oct 1992
MILENIA TOTAL T4, CATALOG: MKT41,5
K912541 · Diagnostic Products Corp. · Aug 1991