Cleared Traditional

K950588 - T4 MICROWELL EIA (ENZYME IMMUNOASSAY0

K950588 is an FDA 510(k) clearance for T4 MICROWELL EIA (ENZYME IMMUNOASSAY0, manufactured by Biomerica, Inc.. The device is a Class 2 Chemistry device with product code KLI cleared through the Traditional 510(k) pathway after a 140-day FDA review.

K950588 · Biomerica, Inc. · Chemistry device
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Jun 1995
Decision
140d
Days
Class 2
Risk

K950588 is an FDA 510(k) clearance for the T4 MICROWELL EIA (ENZYME IMMUNOASSAY0. Classified as Enzyme Immunoassay, Non-radiolabeled, Total Thyroxine (product code KLI), Class II - Special Controls.

Submitted by Biomerica, Inc. (Newport Beach, US). The FDA issued a Cleared decision on June 29, 1995 after a review of 140 days - within the typical 510(k) review window.

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.

View all Biomerica, Inc. devices

FDA 510(k) Submission Details - K950588

510(k) Number K950588 FDA.gov
FDA Decision Cleared Substantially Equivalent - Traditional 510(k) (SESE)
Date Received February 09, 1995
Decision Date June 29, 1995
Days to Decision 140 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
52d slower than avg
Panel avg: 88d · This submission: 140d
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 61
Devices cleared under the same product code (KLI) and FDA review panel - the closest regulatory comparables to K950588.
VITROS IMMUNODIAGNOSTICS PRODUCTS TOTAL T4 REAGENT PACK (GEM.1005) TOTAL T4 CALIBRATORS (GEM.C005)
K964721 · Johnson & Johnson Clinical Diagnostics, Inc. · Dec 1996
ISOLAB'S T4 TEST KIT
K951014 · Isolab, Inc. · Oct 1996
RADIAS NEONATAL T4 ENZYME IMMUNOASSAY
K951321 · Bio-Rad · Aug 1995
RADIAS TOTAL T4 ENZYME IMMUNOASSAY
K946163 · Bio-Rad · Feb 1995
THYROXINE ENZYME IMMUNOASSAY
K944703 · Diagnostic Reagents, Inc. · Dec 1994
CEDIA T4 MAB ASSAY
K943019 · Microgenics Corp. · Oct 1994