Cleared Traditional

K060818 - ARCHITECT SHBG REAGENT KIT, ARCHITECT SHBG CALIBRATOR KIT, AND ARCHITECT SHBG CONTROL KIT WITH MODELS, 8K26-25, 8K26-01

K060818 is an FDA 510(k) clearance for ARCHITECT SHBG REAGENT KIT, manufactured by Biokit, S.A.. The device is a Class 1 Chemistry device with product code CDZ cleared through the Traditional 510(k) pathway after a 302-day FDA review.

K060818 · Biokit, S.A. · Chemistry device
Download Printable Device Report (PDF)
Optimized for regulatory review, auditing and printing
Jan 2007
Decision
302d
Days
Class 1
Risk

K060818 is an FDA 510(k) clearance for the ARCHITECT SHBG REAGENT KIT, ARCHITECT SHBG CALIBRATOR KIT, AND ARCHITECT SHBG.... Classified as Radioimmunoassay, Testosterones And Dihydrotestosterone (product code CDZ), Class I - General Controls.

Submitted by Biokit, S.A. (Barcelona, ES). The FDA issued a Cleared decision on January 23, 2007 after a review of 302 days - an unusually long review period, suggesting complex equivalence evaluation.

This device falls under the Chemistry FDA review panel, regulated under 21 CFR 862.1680 - the FDA in vitro diagnostics and chemistry 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. Elevated predicate reliance profile. This clearance follows a standard predicate-based equivalence path within the Chemistry review framework, consistent with the majority of Class II 510(k) submissions.

View all Biokit, S.A. devices

FDA 510(k) Submission Details - K060818

510(k) Number K060818 FDA.gov
FDA Decision Cleared Substantially Equivalent - Traditional 510(k) (SESE)
Date Received March 27, 2006
Decision Date January 23, 2007
Days to Decision 302 days
Submission Type Traditional
Review Panel Chemistry (CH)
Summary Summary PDF
Third-party Review No - reviewed directly by FDA
Combination Product No
PCCP Authorized No
Regulatory Context
Review time vs. panel average
214d slower than avg
Panel avg: 88d · This submission: 302d
Pathway characteristics
Predicate-based equivalence.

CDZ Device Classification - Class 1, General Controls

Product Code CDZ Radioimmunoassay, Testosterones And Dihydrotestosterone
Device Class Class 1 - General Controls
CFR Regulation 21 CFR 862.1680
What this classification means

Class I devices are subject to general controls only and most are exempt from 510(k) premarket notification. They represent the lowest regulatory burden in the FDA device framework.

Regulatory Peers - CDZ Radioimmunoassay, Testosterones And Dihydrotestosterone

All 68
Devices cleared under the same product code (CDZ) and FDA review panel - the closest regulatory comparables to K060818.
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