Cleared Traditional

MILENIA TOTAL T4, CATALOG: MKT41,5 (K912541) - FDA 510(k) Clearance

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

K912541 · Diagnostic Products Corp. · Chemistry device
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Aug 1991
Decision
63d
Days
Class 2
Risk

K912541 is an FDA 510(k) clearance for the MILENIA TOTAL T4, CATALOG: MKT41,5. Classified as Radioimmunoassay, Total Thyroxine (product code CDX), Class II - Special Controls.

Submitted by Diagnostic Products Corp. (Los Angeles, US). The FDA issued a Cleared decision on August 12, 1991 after a review of 63 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 Diagnostic Products Corp. devices

Submission Details

510(k) Number K912541 FDA.gov
FDA Decision Cleared Substantially Equivalent - Traditional 510(k) (SESE)
Date Received June 10, 1991
Decision Date August 12, 1991
Days to Decision 63 days
Submission Type Traditional
Review Panel Chemistry (CH)
Summary Statement
Third-party Review No - reviewed directly by FDA
Combination Product No
PCCP Authorized No
Regulatory Context
Review time vs. panel average
25d faster than avg
Panel avg: 88d · This submission: 63d
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 120
Devices cleared under the same product code (CDX) and FDA review panel - the closest regulatory comparables to K912541.
ELECSYS T4 ASSAY
K961490 · Boehringer Mannheim Corp. · Jun 1996
AXSYM(TM) TOTAL T4
K934384 · Abbott Laboratories · Jun 1994
ABBOTT IMX T4
K925110 · Abbott Laboratories · Jan 1993
ABBOTT TDX/TDXFLX TT4
K925109 · Abbott Laboratories · Jan 1993
THYROXINE MONOCLONAL ANTIBODY SOLID PHASE RADIOIMM
K904816 · Bd Becton Dickinson Vacutainer Systems Preanalytic · Jan 1991
CLINICAL ASSAYS(TM) GAMMACOAT(TM) M [125I] T4
K901475 · Baxter Healthcare Corp · Jun 1990