Cleared Traditional

K051888 - TOTAL INTACT PTH IMMUNORADIOMETRIC ASSA...

K051888 is an FDA 510(k) clearance for TOTAL INTACT PTH IMMUNORADIOMETRIC ASSA..., manufactured by Scantibodies Laboratory, Inc.. The device is a Class 2 Chemistry device with product code CEW cleared through the Traditional 510(k) pathway after a 98-day FDA review.

K051888 · Scantibodies Laboratory, Inc. · Chemistry device
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Oct 2005
Decision
98d
Days
Class 2
Risk

K051888 is an FDA 510(k) clearance for the TOTAL INTACT PTH IMMUNORADIOMETRIC ASSAY (COATED TUBE VERSION), MODEL 3KG013. 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 October 18, 2005 after a review of 98 days - within the typical 510(k) review window.

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 Scantibodies Laboratory, Inc. devices

FDA 510(k) Submission Details - K051888

510(k) Number K051888 FDA.gov
FDA Decision Cleared Substantially Equivalent - Traditional 510(k) (SESE)
Date Received July 12, 2005
Decision Date October 18, 2005
Days to Decision 98 days
Submission Type Traditional
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
10d slower than avg
Panel avg: 88d · This submission: 98d
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 72
Devices cleared under the same product code (CEW) and FDA review panel - the closest regulatory comparables to K051888.
ACCESS INTACT PTH AND CALIBRATORS, MODELS A 16972 AND A 16953
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MODIFICATION TO WHOLE PTH (1-84) SPECIFIC IMMUNOCHEMILLUMINOMETRIC (ICMA) ASSAY KIT, MODEL 3KG002
K060420 · Scantibodies Laboratory, Inc. · Mar 2006
MODIFICATION TO: TOTAL INTACT PTH IMMUNOCHEMILUMINOMETRIC (ICMA) ASSAY KIT
K060348 · Scantibodies Laboratory, Inc. · Feb 2006
WHOLE PTH (1-84) SPECIFIC IMMUNORADIOMETRIC ASSAY (IRMA) COATED TUBE KIT, MODEL 3KG014
K051810 · Scantibodies Laboratory, Inc. · Sep 2005
WHOLE PTH (1-84) SPECIFIC IMMUNOCHEMILUMINOMETRIC ASSAY (ICMA), MODEL 3KG002
K051141 · Scantibodies Laboratory, Inc. · Jul 2005
TOTAL INTACT PTH IMMUNOCHEMILUMINOMETRIC (ICMA) ASSAY KIT
K051150 · Scantibodies Laboratory, Inc. · Jul 2005