Cleared Traditional

K994140 - NICHOLS CHEMILUMINESCENCE THYROGLOBULIN, MODEL 60-4240

K994140 is an FDA 510(k) clearance for NICHOLS CHEMILUMINESCENCE THYROGLOBULIN, manufactured by Nichols Institute Diagnostics. The device is a Class 2 Immunology device with product code MSW cleared through the Traditional 510(k) pathway after a 153-day FDA review.

K994140 · Nichols Institute Diagnostics · Immunology device
Download Printable Device Report (PDF)
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May 2000
Decision
153d
Days
Class 2
Risk

K994140 is an FDA 510(k) clearance for the NICHOLS CHEMILUMINESCENCE THYROGLOBULIN, MODEL 60-4240. Classified as System, Test, Thyroglobulin (product code MSW), Class II - Special Controls.

Submitted by Nichols Institute Diagnostics (San Juan Capistrano, US). The FDA issued a Cleared decision on May 9, 2000 after a review of 153 days - an extended review cycle.

This device falls under the Immunology FDA review panel, regulated under 21 CFR 866.6010 - 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: Standard predicate-based submission. Standard predicate reliance. This clearance follows a standard predicate-based equivalence path within the Immunology review framework, consistent with the majority of Class II 510(k) submissions.

View all Nichols Institute Diagnostics devices

FDA 510(k) Submission Details - K994140

510(k) Number K994140 FDA.gov
FDA Decision Cleared Substantially Equivalent - Traditional 510(k) (SESE)
Date Received December 08, 1999
Decision Date May 09, 2000
Days to Decision 153 days
Submission Type Traditional
Review Panel Immunology (IM)
Summary Summary PDF
Third-party Review No - reviewed directly by FDA
Combination Product No
PCCP Authorized No
Regulatory Context
Review time vs. panel average
48d slower than avg
Panel avg: 105d · This submission: 153d
Pathway characteristics
Predicate-based equivalence. No clinical trials required.

MSW Device Classification - Class 2, Special Controls

Product Code MSW System, Test, Thyroglobulin
Device Class Class 2 - Special Controls
CFR Regulation 21 CFR 866.6010
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 - MSW System, Test, Thyroglobulin

All 11
Devices cleared under the same product code (MSW) and FDA review panel - the closest regulatory comparables to K994140.
ACCESS THYROGLOBULIN REAGENTS ON THE ACCESS IMMUNOASSAY SYSTEMS
K031269 · Beckman Coulter, Inc. · May 2003
NICHOLS ADVANTAGE THYROGLOB
K002888 · Nichols Institute Diagnostics · Oct 2000
ACCESS THYROGLOBULIN REAGENTS ON THE ACCESS ANALYZER
K002905 · Beckman Coulter, Inc. · Oct 2000
KRONUS OPTIQUANT THYROGLOBULIN KIT
K991720 · Unchanged · Aug 1999
IMMULITE THYROGLOBULIN MODEL LKTY
K982466 · Diagnostic Products Corp. · Mar 1999
IMMULITE 2000 THYROGLOBULIN MODEL L2KTY
K982468 · Diagnostic Products Corp. · Mar 1999