Cleared Traditional

K862109 - ENZYMUN TEST TBG

K862109 is an FDA 510(k) clearance for ENZYMUN TEST TBG, manufactured by Boehringer Mannheim Corp.. The device is a Class 2 Chemistry device with product code CEE cleared through the Traditional 510(k) pathway after a 27-day FDA review.

K862109 · Boehringer Mannheim Corp. · Chemistry device
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Jun 1986
Decision
27d
Days
Class 2
Risk

K862109 is an FDA 510(k) clearance for the ENZYMUN TEST TBG. Classified as Radioimmunoassay, Thyroxine-binding Globulin (product code CEE), Class II - Special Controls.

Submitted by Boehringer Mannheim Corp. (Indianapolis, US). The FDA issued a Cleared decision on June 30, 1986 after a review of 27 days - a notably fast clearance cycle.

This device falls under the Chemistry FDA review panel, regulated under 21 CFR 862.1685 - 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 - K862109

510(k) Number K862109 FDA.gov
FDA Decision Cleared Substantially Equivalent - Traditional 510(k) (SESE)
Date Received June 03, 1986
Decision Date June 30, 1986
Days to Decision 27 days
Submission Type Traditional
Review Panel Chemistry (CH)
Summary -
Third-party Review No - reviewed directly by FDA
Combination Product No
PCCP Authorized No
Regulatory Context
Review time vs. panel average
61d faster than avg
Panel avg: 88d · This submission: 27d
Pathway characteristics
Predicate-based equivalence. No clinical trials required.

CEE Device Classification - Class 2, Special Controls

Product Code CEE Radioimmunoassay, Thyroxine-binding Globulin
Device Class Class 2 - Special Controls
CFR Regulation 21 CFR 862.1685
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 - CEE Radioimmunoassay, Thyroxine-binding Globulin

All 17
Devices cleared under the same product code (CEE) and FDA review panel - the closest regulatory comparables to K862109.
AMERLITE TBG ASSAY, LAN.0005/1005 240/144 TEST KIT
K893469 · Amersham Corp. · Aug 1989
T-UPTAKE MICROASSAY
K885034 · Diamedix Corp. · Feb 1989
TECHNICON RA(R) ANALYTE (TBG) (30 C AND 37 C)
K874658 · Technicon Instruments Corp. · Dec 1987
TBG RIA
K842167 · Syncor Intl. Corp. · Jul 1984
THYROXINE-BINDING GLOBULIN RADIOUMMU
K842010 · Nichols Institute Diagnostics · Jun 1984
VENTREZYME T4U IMMUNOASSAY T4U
K841024 · Ventrex Laboratories, Inc. · May 1984