Cleared Traditional

K910256 - ECLIPSE ICA TSH

K910256 is an FDA 510(k) clearance for ECLIPSE ICA TSH, manufactured by Biotope, Inc.. The device is a Class 2 Chemistry device with product code JLW cleared through the Traditional 510(k) pathway after a 31-day FDA review.

K910256 · Biotope, Inc. · Chemistry device
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Feb 1991
Decision
31d
Days
Class 2
Risk

K910256 is an FDA 510(k) clearance for the ECLIPSE ICA TSH. Classified as Radioimmunoassay, Thyroid-stimulating Hormone (product code JLW), Class II - Special Controls.

Submitted by Biotope, Inc. (Redmond, US). The FDA issued a Cleared decision on February 22, 1991 after a review of 31 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.

View all Biotope, Inc. devices

FDA 510(k) Submission Details - K910256

510(k) Number K910256 FDA.gov
FDA Decision Cleared Substantially Equivalent - Traditional 510(k) (SESE)
Date Received January 22, 1991
Decision Date February 22, 1991
Days to Decision 31 days
Submission Type Traditional
Review Panel Chemistry (CH)
Summary -
Third-party Review No - reviewed directly by FDA
Regulatory Context
Review time vs. panel average
57d faster than avg
Panel avg: 88d · This submission: 31d
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 203
Devices cleared under the same product code (JLW) and FDA review panel - the closest regulatory comparables to K910256.
SRI TSH IMMUNENZYMETRIC ASSAY
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K904666 · Amersham Corp. · Nov 1990
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