Cleared Traditional

K063605 - ST AIA-PACK INTACT PTH ASSAY

K063605 is an FDA 510(k) clearance for ST AIA-PACK INTACT PTH ASSAY, manufactured by Tosoh Bioscience, Inc.. The device is a Class 2 Chemistry device with product code CEW cleared through the Traditional 510(k) pathway after a 199-day FDA review.

K063605 · Tosoh Bioscience, Inc. · Chemistry device
Download Printable Device Report (PDF)
Optimized for regulatory review, auditing and printing
Jun 2007
Decision
199d
Days
Class 2
Risk

K063605 is an FDA 510(k) clearance for the ST AIA-PACK INTACT PTH ASSAY. Classified as Radioimmunoassay, Parathyroid Hormone (product code CEW), Class II - Special Controls.

Submitted by Tosoh Bioscience, Inc. (Grove City, US). The FDA issued a Cleared decision on June 21, 2007 after a review of 199 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 Tosoh Bioscience, Inc. devices

FDA 510(k) Submission Details - K063605

510(k) Number K063605 FDA.gov
FDA Decision Cleared Substantially Equivalent - Traditional 510(k) (SESE)
Date Received December 04, 2006
Decision Date June 21, 2007
Days to Decision 199 days
Submission Type Traditional
Review Panel Chemistry (CH)
Summary Summary PDF
Third-party Review No - reviewed directly by FDA
Regulatory Context
Review time vs. panel average
111d slower than avg
Panel avg: 88d · This submission: 199d
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 61
Devices cleared under the same product code (CEW) and FDA review panel - the closest regulatory comparables to K063605.
IDS-ISYS INTACT PTH
K103325 · Immunodiagnostic Systems , Ltd. · Feb 2012
VITROS IMMUNODIAGNOSTICS PRODUCTS INTACT PTH REAGENT PACK, VITROS IMMUNODIAGNOSTICS PRODUCTS INTACT PTH CALIBRATORS, VIT
K101921 · Ortho-Clinical Diagnostics · Oct 2010
ROCHE ELECSYS PTH TEST SYSTEM
K070709 · Roche Diagnostics Corp. · Jul 2007
ARCHITECT INTACT PTH REAGENTS, CALIBRATORS (A-F) AND CONTROLS (LOW, MEDIUM, HIGH), MODELS 8K25-20, 8K25-25, 8K25-01
K063232 · Biokit, S.A. · Jun 2007
ELECSYS PTH TEST SYSTEM
K070391 · Roche Diagnostics Corp. · Mar 2007
ACCESS INTACT PTH AND CALIBRATORS, MODELS A 16972 AND A 16953
K061190 · Beckman Coulter, Inc. · Sep 2006