Cleared Traditional

K020548 - FREE T4 (THYTOXINE) MICROPLATE EIA TEST MODELS # 1225-300

K020548 is an FDA 510(k) clearance for FREE T4 (THYTOXINE) MICROPLATE EIA TEST..., manufactured by Monobind. The device is a Class 2 Chemistry device with product code CEC cleared through the Traditional 510(k) pathway after a 45-day FDA review.

K020548 · Monobind · Chemistry device
Download Printable Device Report (PDF)
Optimized for regulatory review, auditing and printing
Apr 2002
Decision
45d
Days
Class 2
Risk

K020548 is an FDA 510(k) clearance for the FREE T4 (THYTOXINE) MICROPLATE EIA TEST MODELS # 1225-300. Classified as Radioimmunoassay, Free Thyroxine (product code CEC), Class II - Special Controls.

Submitted by Monobind (Costa Mesa, US). The FDA issued a Cleared decision on April 5, 2002 after a review of 45 days - a notably fast clearance cycle.

This device falls under the Chemistry FDA review panel, regulated under 21 CFR 862.1695 - 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 Monobind devices

FDA 510(k) Submission Details - K020548

510(k) Number K020548 FDA.gov
FDA Decision Cleared Substantially Equivalent - Traditional 510(k) (SESE)
Date Received February 19, 2002
Decision Date April 05, 2002
Days to Decision 45 days
Submission Type Traditional
Review Panel Chemistry (CH)
Summary Statement
Third-party Review No - reviewed directly by FDA
Combination Product No
PCCP Authorized No
Regulatory Context
Review time vs. panel average
43d faster than avg
Panel avg: 88d · This submission: 45d
Pathway characteristics
Predicate-based equivalence. No clinical trials required.

CEC Device Classification - Class 2, Special Controls

Product Code CEC Radioimmunoassay, Free Thyroxine
Device Class Class 2 - Special Controls
CFR Regulation 21 CFR 862.1695
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 - CEC Radioimmunoassay, Free Thyroxine

All 79
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