Cleared Traditional

K002888 - NICHOLS ADVANTAGE THYROGLOB

K002888 is an FDA 510(k) clearance for NICHOLS ADVANTAGE THYROGLOB, 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 35-day FDA review.

K002888 · Nichols Institute Diagnostics · Immunology device
Download Printable Device Report (PDF)
Optimized for regulatory review, auditing and printing
Oct 2000
Decision
35d
Days
Class 2
Risk

K002888 is an FDA 510(k) clearance for the NICHOLS ADVANTAGE THYROGLOB. 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 October 20, 2000 after a review of 35 days - a notably fast clearance 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: 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

FDA 510(k) Submission Details - K002888

510(k) Number K002888 FDA.gov
FDA Decision Cleared Substantially Equivalent - Traditional 510(k) (SESE)
Date Received September 15, 2000
Decision Date October 20, 2000
Days to Decision 35 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
70d faster than avg
Panel avg: 105d · This submission: 35d
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 K002888.
Elecsys Tg II
K221890 · Roche Diagnostics · Sep 2023
Access Thyroglobulin
K220972 · Beckman Coulter, Inc. · Sep 2023
ACCESS THYROGLOBULIN REAGENTS ON THE ACCESS IMMUNOASSAY SYSTEMS
K031269 · Beckman Coulter, Inc. · May 2003
ACCESS THYROGLOBULIN REAGENTS ON THE ACCESS ANALYZER
K002905 · Beckman Coulter, Inc. · Oct 2000
NICHOLS CHEMILUMINESCENCE THYROGLOBULIN, MODEL 60-4240
K994140 · Nichols Institute Diagnostics · May 2000
KRONUS OPTIQUANT THYROGLOBULIN KIT
K991720 · Unchanged · Aug 1999