Cleared Special

K060420 - MODIFICATION TO WHOLE PTH (1-84) SPECIF...

K060420 is an FDA 510(k) clearance for MODIFICATION TO WHOLE PTH (1-84) SPECIF..., manufactured by Scantibodies Laboratory, Inc.. The device is a Class 2 Chemistry device with product code CEW cleared through the Special 510(k) pathway after a 12-day FDA review.

K060420 · Scantibodies Laboratory, Inc. · Chemistry device
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Mar 2006
Decision
12d
Days
Class 2
Risk

K060420 is an FDA 510(k) clearance for the MODIFICATION TO WHOLE PTH (1-84) SPECIFIC IMMUNOCHEMILLUMINOMETRIC (ICMA) ASS.... Classified as Radioimmunoassay, Parathyroid Hormone (product code CEW), Class II - Special Controls.

Submitted by Scantibodies Laboratory, Inc. (Santee, US). The FDA issued a Cleared decision on March 1, 2006 after a review of 12 days - a notably fast clearance cycle.

This device falls under the Chemistry FDA review panel, regulated under 21 CFR 862.1545 - the FDA in vitro diagnostics and chemistry framework. As a Special 510(k), this submission covers a manufacturer modification to an existing cleared device rather than a new device introduction.

Device pattern: Iterative device modification. Low regulatory complexity profile. This Special 510(k) clearance confirms that the manufacturer's modifications remained within the established regulatory envelope of the original cleared device.

View all Scantibodies Laboratory, Inc. devices

FDA 510(k) Submission Details - K060420

510(k) Number K060420 FDA.gov
FDA Decision Cleared Substantially Equivalent - Traditional 510(k) (SESE)
Date Received February 17, 2006
Decision Date March 01, 2006
Days to Decision 12 days
Submission Type Special
Review Panel Chemistry (CH)
Summary Statement
Third-party Review No - reviewed directly by FDA
Combination Product No
PCCP Authorized No
Regulatory Context
Review time vs. panel average
76d faster than avg
Panel avg: 88d · This submission: 12d
Pathway characteristics
Modification to existing cleared device.

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 72
Devices cleared under the same product code (CEW) and FDA review panel - the closest regulatory comparables to K060420.
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
MODIFICATION TO: TOTAL INTACT PTH IMMUNOCHEMILUMINOMETRIC (ICMA) ASSAY KIT
K060348 · Scantibodies Laboratory, Inc. · Feb 2006
TOTAL INTACT PTH IMMUNORADIOMETRIC ASSAY (COATED TUBE VERSION), MODEL 3KG013
K051888 · Scantibodies Laboratory, Inc. · Oct 2005
WHOLE PTH (1-84) SPECIFIC IMMUNORADIOMETRIC ASSAY (IRMA) COATED TUBE KIT, MODEL 3KG014
K051810 · Scantibodies Laboratory, Inc. · Sep 2005