Cleared Traditional

K052617 - FERRITIN LIT ASSAY, CATALOG NO. 7010

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

K052617 is an FDA 510(k) clearance for FERRITIN LIT ASSAY, manufactured by Good Biotech Corp.. The device is a Class 2 Immunology device with product code DBF cleared through the Traditional 510(k) pathway after a 153-day FDA review.

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

FDA 510(k) Submission Details - K052617

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
48d slower than avg
Panel avg: 105d · This submission: 153d
Pathway characteristics
Predicate-based equivalence. No clinical trials required.

DBF Device Classification - Class 2, Special Controls

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 73
Devices cleared under the same product code (DBF) and FDA review panel - the closest regulatory comparables to K052617.
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K040879 · Instrumentation Laboratory CO · May 2004
FERRITIN GENERATION 2
K031650 · Roche Diagnostics Corp. · Jul 2003