Cleared Traditional

K881373 - AMERLITE TT3 ASSAY

K881373 is the FDA 510(k) clearance for AMERLITE TT3 ASSAY by Amersham Corp.. It is a Class 2 Chemistry device (product code CDP) cleared through the Traditional 510(k) pathway after a 56-day FDA review.

K881373 · Amersham Corp. · Chemistry device
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May 1988
Decision
56d
Days
Class 2
Risk

K881373 is an FDA 510(k) clearance for the AMERLITE TT3 ASSAY, LAN.0003/2003 240/144 KIT. Classified as Radioimmunoassay, Total Triiodothyronine (product code CDP), Class II - Special Controls.

Submitted by Amersham Corp. (Arlington Heights, US). The FDA issued a Cleared decision on May 27, 1988 after a review of 56 days - a notably fast clearance cycle.

This device falls under the Chemistry FDA review panel, regulated under 21 CFR 862.1710 - 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 Amersham Corp. devices

Submission Details

510(k) Number K881373 FDA.gov
FDA Decision Cleared Substantially Equivalent - Traditional 510(k) (SESE)
Date Received April 01, 1988
Decision Date May 27, 1988
Days to Decision 56 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
32d faster than avg
Panel avg: 88d · This submission: 56d
Pathway characteristics
Predicate-based equivalence. No clinical trials required.

Device Classification

Product Code CDP Radioimmunoassay, Total Triiodothyronine
Device Class Class 2 - Special Controls
CFR Regulation 21 CFR 862.1710
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 - CDP Radioimmunoassay, Total Triiodothyronine

All 100
Devices cleared under the same product code (CDP) and FDA review panel - the closest regulatory comparables to K881373.
DELFIA TRIIODOTHYRONINE (T3) KIT
K883810 · Pharmacia, Inc. · Dec 1988
STRATUS TOTAL TRIIODOTHYRONINE T3 FLUORO. ENZYME
K883479 · Baxter Healthcare Corp · Oct 1988
IMMPULSE T, ASSAY REAGENTS
K881214 · Sclavo, Inc. · May 1988
ABBOTT IMX T3
K880087 · Abbott Laboratories · Apr 1988
CIBA CORNING MAGIC LITE T3 IMMUNOASSAY
K873945 · Ciba Corning Diagnostics Corp. · Nov 1987
AMERLITE TT3 ASSAY, LAN.0003/1003/2003
K873858 · Amersham Corp. · Nov 1987