Cleared Traditional

FERRITIN LIT ASSAY, CATALOG NO. 7010 (K052617) - FDA 510(k) Clearance

Also marketed or referenced as:
FERRITIN CALIBRATOR SET, CATALOG NO. 7510 FERRITIN CONTROLS, LEVEL-L & LEVEL-H,

Class II Immunology device cleared through predicate-based substantial equivalence - typically does not require clinical trials.

K052617 · Good Biotech Corp. · Immunology device
Download Printable Device Report (PDF)
Optimized for regulatory review, auditing and printing
Feb 2006
Decision
153d
Days
Class 2
Risk

K052617 is an FDA 510(k) clearance for the FERRITIN LIT ASSAY, CATALOG NO. 7010. Classified as Ferritin, Antigen, Antiserum, Control (product code DBF), Class II - Special Controls.

Submitted by Good Biotech Corp. (Taichung, TW). The FDA issued a Cleared decision on February 23, 2006 after a review of 153 days - an extended review cycle.

This device falls under the Immunology FDA review panel, regulated under 21 CFR 866.5340 - 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 Good Biotech Corp. devices

Submission Details

510(k) Number K052617 FDA.gov
FDA Decision Cleared Substantially Equivalent - Traditional 510(k) (SESE)
Date Received September 23, 2005
Decision Date February 23, 2006
Days to Decision 153 days
Submission Type Traditional
Review Panel Immunology (IM)
Summary Summary PDF
Third-party Review No - reviewed directly by FDA
Regulatory Context
Review time vs. panel average
49d slower than avg
Panel avg: 104d · This submission: 153d
Pathway characteristics
Predicate-based equivalence. No clinical trials required.

Device Classification

Product Code DBF Ferritin, Antigen, Antiserum, Control
Device Class Class 2 - Special Controls
CFR Regulation 21 CFR 866.5340
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 - DBF Ferritin, Antigen, Antiserum, Control

All 86
Devices cleared under the same product code (DBF) and FDA review panel - the closest regulatory comparables to K052617.
LIAISON Ferritin
K193650 · DiaSorin, Inc. · Sep 2021
Yumizen C1200 Ferritin, Yumizen C1200 Transferrin, Yumizen C1200 Rheumatoid Factor
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Atellica IM Ferritin Assay
K171642 · Siemens Healthcare Diagnostics, Inc. · Aug 2017
BECKMAN COULTER FERRITIN REAGENT, MODEL: OSR61203
K092505 · Beckman Coulter, Inc. · Dec 2009
QUANTEX FERRITIN
K040879 · Instrumentation Laboratory CO · May 2004
FERRITIN GENERATION 2
K031650 · Roche Diagnostics Corp. · Jul 2003