Cleared Traditional

K131515 - ACE -GT REAGENT

Also marketed or referenced as:
ACE LIPASE RAGENT ACE T4 REAGENT

K131515 is an FDA 510(k) clearance for ACE -GT REAGENT, manufactured by Alfa Wassermann. The device is a Class 2 Chemistry device with product code KLI cleared through the Traditional 510(k) pathway after a 78-day FDA review.

K131515 · Alfa Wassermann · Chemistry device
Download Printable Device Report (PDF)
Optimized for regulatory review, auditing and printing
Aug 2013
Decision
78d
Days
Class 2
Risk

K131515 is an FDA 510(k) clearance for the ACE -GT REAGENT. Classified as Enzyme Immunoassay, Non-radiolabeled, Total Thyroxine (product code KLI), Class II - Special Controls.

Submitted by Alfa Wassermann (West Caldwell, US). The FDA issued a Cleared decision on August 14, 2013 after a review of 78 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 Alfa Wassermann devices

FDA 510(k) Submission Details - K131515

510(k) Number K131515 FDA.gov
FDA Decision Cleared Substantially Equivalent - Traditional 510(k) (SESE)
Date Received May 28, 2013
Decision Date August 14, 2013
Days to Decision 78 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
10d faster than avg
Panel avg: 88d · This submission: 78d
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 70
Devices cleared under the same product code (KLI) and FDA review panel - the closest regulatory comparables to K131515.
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ADVIA CENTAUR SYSTEM WITH STREAMLAB ANALYTICAL WORKCELL
K082638 · Siemens Healthcare Diagnostics, Inc. · Feb 2009
ACCUBIND NEONATAL T4 MICROPLATE EIA, MODEL 2625-300
K030860 · Monobind · Aug 2003
ACCESS TOTAL T4 ASSAY
K023369 · Beckman Coulter, Inc. · Dec 2002
SYVA EMIT 2000 THYROXINE ASSAY, CALIBRATORS
K000600 · Syva Co., Dade Behring, Inc. · Mar 2000