Cleared Traditional

K063232 - ARCHITECT INTACT PTH REAGENTS, CALIBRATORS (A-F) AND CONTROLS (LOW, MEDIUM, HIGH), MODELS 8K25-20, 8K25-25, 8K25-01

K063232 is an FDA 510(k) clearance for ARCHITECT INTACT PTH REAGENTS, manufactured by Biokit, S.A.. The device is a Class 2 Chemistry device with product code CEW cleared through the Traditional 510(k) pathway after a 237-day FDA review.

K063232 · Biokit, S.A. · Chemistry device
Download Printable Device Report (PDF)
Optimized for regulatory review, auditing and printing
Jun 2007
Decision
237d
Days
Class 2
Risk

K063232 is an FDA 510(k) clearance for the ARCHITECT INTACT PTH REAGENTS, CALIBRATORS (A-F) AND CONTROLS (LOW, MEDIUM, H.... Classified as Radioimmunoassay, Parathyroid Hormone (product code CEW), Class II - Special Controls.

Submitted by Biokit, S.A. (Barcelona, ES). The FDA issued a Cleared decision on June 19, 2007 after a review of 237 days - an extended review cycle.

This device falls under the Chemistry FDA review panel, regulated under 21 CFR 862.1545 - 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. Standard predicate reliance. 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 - K063232

510(k) Number K063232 FDA.gov
FDA Decision Cleared Substantially Equivalent - Traditional 510(k) (SESE)
Date Received October 25, 2006
Decision Date June 19, 2007
Days to Decision 237 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
149d slower than avg
Panel avg: 88d · This submission: 237d
Pathway characteristics
Predicate-based equivalence. No clinical trials required.

CEW Device Classification - Class 2, Special Controls

Product Code CEW Radioimmunoassay, Parathyroid Hormone
Device Class Class 2 - Special Controls
CFR Regulation 21 CFR 862.1545
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 Chemistry devices follow this clearance model.

Regulatory Peers - CEW Radioimmunoassay, Parathyroid Hormone

All 74
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