Cleared Traditional

K030860 - ACCUBIND NEONATAL T4 MICROPLATE EIA

K030860 is the FDA 510(k) clearance for ACCUBIND NEONATAL T4 MICROPLATE EIA by Monobind. It is a Class 2 Chemistry device (product code KLI) cleared through the Traditional 510(k) pathway after a 157-day FDA review.

K030860 · Monobind · Chemistry device
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Aug 2003
Decision
157d
Days
Class 2
Risk

K030860 is an FDA 510(k) clearance for the ACCUBIND NEONATAL T4 MICROPLATE EIA, MODEL 2625-300. Classified as Enzyme Immunoassay, Non-radiolabeled, Total Thyroxine (product code KLI), Class II - Special Controls.

Submitted by Monobind (Costa Mesa, US). The FDA issued a Cleared decision on August 22, 2003 after a review of 157 days - an extended review 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: Standard predicate-based submission. Standard predicate reliance. This clearance follows a standard predicate-based equivalence path within the Chemistry review framework, consistent with the majority of Class II 510(k) submissions.

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Submission Details

510(k) Number K030860 FDA.gov
FDA Decision Cleared Substantially Equivalent - Traditional 510(k) (SESE)
Date Received March 18, 2003
Decision Date August 22, 2003
Days to Decision 157 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
69d slower than avg
Panel avg: 88d · This submission: 157d
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 58
Devices cleared under the same product code (KLI) and FDA review panel - the closest regulatory comparables to K030860.
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K160495 · Ortho-Clinical Diagnostics, Inc. · Oct 2016
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