Cleared Traditional

K903725 - EZ-BEAD TSH ENZYME IMMUNOASSAY KIT

K903725 is an FDA 510(k) clearance for EZ-BEAD TSH ENZYME IMMUNOASSAY KIT, manufactured by Immunotech Corp.. The device is a Class 2 Chemistry device with product code JLW cleared through the Traditional 510(k) pathway after a 71-day FDA review.

K903725 · Immunotech Corp. · Chemistry device
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Oct 1990
Decision
71d
Days
Class 2
Risk

K903725 is an FDA 510(k) clearance for the EZ-BEAD TSH ENZYME IMMUNOASSAY KIT. Classified as Radioimmunoassay, Thyroid-stimulating Hormone (product code JLW), Class II - Special Controls.

Submitted by Immunotech Corp. (Boston, US). The FDA issued a Cleared decision on October 26, 1990 after a review of 71 days - a notably fast clearance cycle.

This device falls under the Chemistry FDA review panel, regulated under 21 CFR 862.1690 - 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.

FDA 510(k) Submission Details - K903725

510(k) Number K903725 FDA.gov
FDA Decision Cleared Substantially Equivalent - Traditional 510(k) (SESE)
Date Received August 16, 1990
Decision Date October 26, 1990
Days to Decision 71 days
Submission Type Traditional
Review Panel Chemistry (CH)
Summary -
Third-party Review No - reviewed directly by FDA
Combination Product No
PCCP Authorized No
Regulatory Context
Review time vs. panel average
18d faster than avg
Panel avg: 89d · This submission: 71d
Pathway characteristics
Predicate-based equivalence. No clinical trials required.

JLW Device Classification - Class 2, Special Controls

Product Code JLW Radioimmunoassay, Thyroid-stimulating Hormone
Device Class Class 2 - Special Controls
CFR Regulation 21 CFR 862.1690
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 - JLW Radioimmunoassay, Thyroid-stimulating Hormone

All 240
Devices cleared under the same product code (JLW) and FDA review panel - the closest regulatory comparables to K903725.
IMMULITE HS-TSH
K905769 · Cirrus Diagnostics, Inc. · Jan 1991
ELEGANCE TSH ELISA
K905099 · Bioclone Australia Pty , Ltd. · Dec 1990
AMERLITE TSH-60 ASSAY PRODUCT CODE: LAN. 0008/2008
K904666 · Amersham Corp. · Nov 1990
ALLEGRO LITE THYROID STIMULATING HORMONE CHEM. IMM
K903391 · Nichols Institute · Oct 1990
NOVAPATH TSH ENZYME IMMUNOASSAY
K903311 · Bio-Rad · Sep 1990
IMX ULTRASENTITIVE HTSH
K902753 · Abbott Mfg., Inc. · Jul 1990
K903725 · EZ-BEAD TSH ENZYME IMMUNOASSAY KIT
Download PDF Immunotech Corp.