Cleared Traditional

K915194 - CEDIA T4

K915194 is an FDA 510(k) clearance for CEDIA T4, manufactured by Boehringer Mannheim Corp.. The device is a Class 2 Chemistry device with product code KLI cleared through the Traditional 510(k) pathway after a 20-day FDA review.

K915194 · Boehringer Mannheim Corp. · Chemistry device
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Dec 1991
Decision
20d
Days
Class 2
Risk

K915194 is an FDA 510(k) clearance for the CEDIA T4. Classified as Enzyme Immunoassay, Non-radiolabeled, Total Thyroxine (product code KLI), Class II - Special Controls.

Submitted by Boehringer Mannheim Corp. (Indianapolis, US). The FDA issued a Cleared decision on December 9, 1991 after a review of 20 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

FDA 510(k) Submission Details - K915194

510(k) Number K915194 FDA.gov
FDA Decision Cleared Substantially Equivalent - Traditional 510(k) (SESE)
Date Received November 19, 1991
Decision Date December 09, 1991
Days to Decision 20 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
68d faster than avg
Panel avg: 88d · This submission: 20d
Pathway characteristics
Predicate-based equivalence. No clinical trials required.

KLI Device Classification - Class 2, Special Controls

Product Code KLI Enzyme Immunoassay, Non-radiolabeled, 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 - KLI Enzyme Immunoassay, Non-radiolabeled, Total Thyroxine

All 57
Devices cleared under the same product code (KLI) and FDA review panel - the closest regulatory comparables to K915194.
VIDAS THYROXINE (T4) ASSAY (T4)
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VISTA THYROXINE (T-4) ASSAY -- MODIFICATION
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MEDIX BIOTECH THROXINE ENZYME IMMUNOASSAY TEST KIT
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TECHNICON IMMUNO 1 TM SYSTEM ADDITIONAL ANALYTES
K912616 · Technicon Instruments Corp. · Sep 1991
IL THYROXINE (T4) ASSAY SYSTEM
K903095 · Instrumentation Laboratory CO · Aug 1990
NDS THYROXINE TEST KIT & NDS THYROXINE CALIBRATOR
K897072 · Kallestad Diag, A Div. of Erbamont, Inc. · Mar 1990