Cleared Traditional

K961650 - NICHOLS ADVANTAGE CHEMILUMINESCENCE THY...

K961650 is the FDA 510(k) clearance for NICHOLS ADVANTAGE CHEMILUMINESCENCE THY... by Nichols Institute Diagnostics. It is a Class 2 Chemistry device (product code JLW) cleared through the Traditional 510(k) pathway after a 77-day FDA review.

K961650 · Nichols Institute Diagnostics · Chemistry device
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Jul 1996
Decision
77d
Days
Class 2
Risk

K961650 is an FDA 510(k) clearance for the NICHOLS ADVANTAGE CHEMILUMINESCENCE THYROID STIMULATING HORMONE THIRD GENERAT.... Classified as Radioimmunoassay, Thyroid-stimulating Hormone (product code JLW), Class II - Special Controls.

Submitted by Nichols Institute Diagnostics (San Juan Capistrano, US). The FDA issued a Cleared decision on July 16, 1996 after a review of 77 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 Nichols Institute Diagnostics devices

Submission Details

510(k) Number K961650 FDA.gov
FDA Decision Cleared Substantially Equivalent - Traditional 510(k) (SESE)
Date Received April 30, 1996
Decision Date July 16, 1996
Days to Decision 77 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
11d faster than avg
Panel avg: 88d · This submission: 77d
Pathway characteristics
Predicate-based equivalence. No clinical trials required.

Device Classification

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 143
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K952148 · Abbott Laboratories · Jun 1995
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