Cleared Traditional

K905777 - MICROZYME THYROID UPTAKE ENZYME IMMUNOASSAY KIT

K905777 is an FDA 510(k) clearance for MICROZYME THYROID UPTAKE ENZYME IMMUNOA..., manufactured by Immunotech Corp.. The device is a Class 2 Immunology device with product code CEE cleared through the Traditional 510(k) pathway after a 34-day FDA review.

K905777 · Immunotech Corp. · Immunology device
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Jan 1991
Decision
34d
Days
Class 2
Risk

K905777 is an FDA 510(k) clearance for the MICROZYME THYROID UPTAKE ENZYME IMMUNOASSAY KIT. Classified as Radioimmunoassay, Thyroxine-binding Globulin (product code CEE), Class II - Special Controls.

Submitted by Immunotech Corp. (Boston, US). The FDA issued a Cleared decision on January 30, 1991 after a review of 34 days - a notably fast clearance cycle.

This device falls under the Immunology FDA review panel, regulated under 21 CFR 862.1685 - the FDA immunology device 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 Immunotech Corp. devices

FDA 510(k) Submission Details - K905777

510(k) Number K905777 FDA.gov
FDA Decision Cleared Substantially Equivalent - Traditional 510(k) (SESE)
Date Received December 27, 1990
Decision Date January 30, 1991
Days to Decision 34 days
Submission Type Traditional
Review Panel Immunology (IM)
Summary -
Third-party Review No - reviewed directly by FDA
Combination Product No
PCCP Authorized No
Regulatory Context
Review time vs. panel average
71d faster than avg
Panel avg: 105d · This submission: 34d
Pathway characteristics
Predicate-based equivalence. No clinical trials required.

CEE Device Classification - Class 2, Special Controls

Product Code CEE Radioimmunoassay, Thyroxine-binding Globulin
Device Class Class 2 - Special Controls
CFR Regulation 21 CFR 862.1685
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 Immunology devices follow this clearance model.

Regulatory Peers - CEE Radioimmunoassay, Thyroxine-binding Globulin

All 22
Devices cleared under the same product code (CEE) and FDA review panel - the closest regulatory comparables to K905777.
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K893469 · Amersham Corp. · Aug 1989
T-UPTAKE MICROASSAY
K885034 · Diamedix Corp. · Feb 1989