Cleared Traditional

K972974 - ACCUWELL T4-EIA

K972974 is the FDA 510(k) clearance for ACCUWELL T4-EIA by Neometrics, Inc.. It is a Class 2 Chemistry device (product code KLI) cleared through the Traditional 510(k) pathway after a 56-day FDA review.

K972974 · Neometrics, Inc. · Chemistry device
Download Printable Device Report (PDF)
Optimized for regulatory review, auditing and printing
Oct 1997
Decision
56d
Days
Class 2
Risk

K972974 is an FDA 510(k) clearance for the ACCUWELL T4-EIA. Classified as Enzyme Immunoassay, Non-radiolabeled, Total Thyroxine (product code KLI), Class II - Special Controls.

Submitted by Neometrics, Inc. (E. Northport, US). The FDA issued a Cleared decision on October 6, 1997 after a review of 56 days - a notably fast clearance cycle.

This device falls under the Chemistry FDA review panel, regulated under 21 CFR 862.1700 - 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 Neometrics, Inc. devices

Submission Details

510(k) Number K972974 FDA.gov
FDA Decision Cleared Substantially Equivalent - Traditional 510(k) (SESE)
Date Received August 11, 1997
Decision Date October 06, 1997
Days to Decision 56 days
Submission Type Traditional
Review Panel Chemistry (CH)
Summary Statement
Third-party Review No - reviewed directly by FDA
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 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 49
Devices cleared under the same product code (KLI) and FDA review panel - the closest regulatory comparables to K972974.
ADVIA CENTAUR SYSTEM WITH STREAMLAB ANALYTICAL WORKCELL
K082638 · Siemens Healthcare Diagnostics, Inc. · Feb 2009
ACCESS TOTAL T4 ASSAY
K023369 · Beckman Coulter, Inc. · Dec 2002
ABBOTT ARCHITECT TOTAL T4
K983440 · Abbott Laboratories · Nov 1998
DSL ACTIVE T4 EIA
K971269 · Diagnostic Systems Laboratories, Inc. · May 1997
SYNCHRON SYSTEMS THYROXINE REAGENT
K971203 · Beckman Instruments, Inc. · May 1997
RADIAS NEONATAL T4 ENZYME IMMUNOASSAY
K951321 · Bio-Rad · Aug 1995