Cleared Traditional

K893469 - AMERLITE TBG ASSAY, LAN.0005/1005 240/144 TEST KIT

K893469 is an FDA 510(k) clearance for AMERLITE TBG ASSAY, manufactured by Amersham Corp.. The device is a Class 2 Toxicology device with product code CEE cleared through the Traditional 510(k) pathway after a 103-day FDA review.

K893469 · Amersham Corp. · Toxicology device
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Aug 1989
Decision
103d
Days
Class 2
Risk

K893469 is an FDA 510(k) clearance for the AMERLITE TBG ASSAY, LAN.0005/1005 240/144 TEST KIT. Classified as Radioimmunoassay, Thyroxine-binding Globulin (product code CEE), Class II - Special Controls.

Submitted by Amersham Corp. (Arlington Heights, US). The FDA issued a Cleared decision on August 15, 1989 after a review of 103 days - within the typical 510(k) review window.

This device falls under the Toxicology FDA review panel, regulated under 21 CFR 862.1685 - the FDA toxicology device framework. The Traditional 510(k) pathway establishes clearance through substantial equivalence to a legally marketed predicate device, without requiring clinical trial data.

Device pattern: Standard predicate-based submission. Standard predicate reliance. This clearance follows a standard predicate-based equivalence path within the Toxicology review framework, consistent with the majority of Class II 510(k) submissions.

View all Amersham Corp. devices

FDA 510(k) Submission Details - K893469

510(k) Number K893469 FDA.gov
FDA Decision Cleared Substantially Equivalent - Traditional 510(k) (SESE)
Date Received May 04, 1989
Decision Date August 15, 1989
Days to Decision 103 days
Submission Type Traditional
Review Panel Toxicology (TX)
Summary -
Third-party Review No - reviewed directly by FDA
Combination Product No
PCCP Authorized No
Regulatory Context
Review time vs. panel average
16d slower than avg
Panel avg: 87d · This submission: 103d
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 Toxicology devices follow this clearance model.

Regulatory Peers - CEE Radioimmunoassay, Thyroxine-binding Globulin

All 22
Devices cleared under the same product code (CEE) and FDA review panel - the closest regulatory comparables to K893469.
MICROZYME THYROID UPTAKE ENZYME IMMUNOASSAY KIT
K905777 · Immunotech Corp. · Jan 1991
DELFIA TBG KIT
K900240 · Pharmacia, Inc. · Mar 1990
ENZYMUN TEST(R) TBK
K896991 · Boehringer Mannheim Corp. · Mar 1990
T-UPTAKE MICROASSAY
K885034 · Diamedix Corp. · Feb 1989
FIAGEN TBG TIME-RESOLVED FLUOROIMMUNOASSAY KIT
K884201 · Cyberfluor, Inc. · Dec 1988
TECHNICON RA(R) ANALYTE (TBG) (30 C AND 37 C)
K874658 · Technicon Instruments Corp. · Dec 1987