Cleared Traditional

K052308 - ARCHITECT ANTI-TG IMMUNOASSAY REAGENTS, CALIBRATORS, CONTROLS AND SYSTEM ASSAY CD-ROM

K052308 is an FDA 510(k) clearance for ARCHITECT ANTI-TG IMMUNOASSAY REAGENTS, manufactured by Fisher Diagnostics. The device is a Class 2 Immunology device with product code JZO cleared through the Traditional 510(k) pathway after a 259-day FDA review.

K052308 · Fisher Diagnostics · Immunology device
Download Printable Device Report (PDF)
Optimized for regulatory review, auditing and printing
May 2006
Decision
259d
Days
Class 2
Risk

K052308 is an FDA 510(k) clearance for the ARCHITECT ANTI-TG IMMUNOASSAY REAGENTS, CALIBRATORS, CONTROLS AND SYSTEM ASSA.... Classified as System, Test, Thyroid Autoantibody (product code JZO), Class II - Special Controls.

Submitted by Fisher Diagnostics (Middletown, US). The FDA issued a Cleared decision on May 10, 2006 after a review of 259 days - an extended review cycle.

This device falls under the Immunology FDA review panel, regulated under 21 CFR 866.5870 - 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 Fisher Diagnostics devices

FDA 510(k) Submission Details - K052308

510(k) Number K052308 FDA.gov
FDA Decision Cleared Substantially Equivalent - Traditional 510(k) (SESE)
Date Received August 24, 2005
Decision Date May 10, 2006
Days to Decision 259 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
154d slower than avg
Panel avg: 105d · This submission: 259d
Pathway characteristics
Predicate-based equivalence. No clinical trials required.

JZO Device Classification - Class 2, Special Controls

Product Code JZO System, Test, Thyroid Autoantibody
Device Class Class 2 - Special Controls
CFR Regulation 21 CFR 866.5870
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 - JZO System, Test, Thyroid Autoantibody

All 71
Devices cleared under the same product code (JZO) and FDA review panel - the closest regulatory comparables to K052308.
ELECSYS ANTI-TSHR IMMUNOASSAY, ELECSYS PRECICONTROL THYROAB
K080092 · Roche Diagnostics Corp. · Jul 2008
ARCHITECT ANTI-TPO IMMUNOASSAY, CALIBRATORS & CONTROLS
K052407 · Fisher Diagnostics · Jul 2006
ACCESS TPO ANTIBODY, AND ACCESS TPO ANTIBODY CALIBRATORS, MODELS A12985 AND A18227
K061382 · Beckman Coulter, Inc. · Jul 2006
ROCHE ELECSYS ANTI-TG
K053426 · Roche Diagnostics Corp. · Feb 2006
ROCHE DIAGNOSTICS COBAS ELECSYS ANTI-TPO
K051890 · Roche Diagnostics Corp. · Aug 2005
ZEUS SCIENTIFIC, INC., ATHENA MULTI-LYTE TPO/TG IGG TEST SYSTEM
K033977 · Zeus Scientific, Inc. · Mar 2004