Cleared Traditional

K132515 - LIAISON N-TACT PTH GEN II

K132515 is the FDA 510(k) clearance for LIAISON N-TACT PTH GEN II by DiaSorin, Inc.. It is a Class 2 Chemistry device (product code CEW) cleared through the Traditional 510(k) pathway after a 88-day FDA review.

K132515 · DiaSorin, Inc. · Chemistry device
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Nov 2013
Decision
88d
Days
Class 2
Risk

K132515 is an FDA 510(k) clearance for the LIAISON N-TACT PTH GEN II, CONTROL SET, CALIBRATION VERIFIERS. Classified as Radioimmunoassay, Parathyroid Hormone (product code CEW), Class II - Special Controls.

Submitted by DiaSorin, Inc. (Stillwater, US). The FDA issued a Cleared decision on November 8, 2013 after a review of 88 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. The Traditional 510(k) pathway establishes clearance through substantial equivalence to a legally marketed predicate device, without requiring clinical trial data.

Device pattern: Fast-track predicate clearance. Standard predicate reliance. The short review cycle indicates strong predicate alignment - the FDA found sufficient equivalence without extended technical review.

View all DiaSorin, Inc. devices

Submission Details

510(k) Number K132515 FDA.gov
FDA Decision Cleared Substantially Equivalent - Traditional 510(k) (SESE)
Date Received August 12, 2013
Decision Date November 08, 2013
Days to Decision 88 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
At panel average
Panel avg: 88d · This submission: 88d
Pathway characteristics
Predicate-based equivalence. No clinical trials required.

Device Classification

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 46
Devices cleared under the same product code (CEW) and FDA review panel - the closest regulatory comparables to K132515.
ADVIA Centaur Intact Parathyroid Hormone (PTH) Assay
K163658 · Siemens Healthcare Diagnostics, Inc. · May 2017
LIASON 1-84 PTH Assay, LIASON 1-84 PTH Control Set, LIASON 1-84 PTH Calibration Verifiers
K150879 · DiaSorin, Inc. · Jun 2015
ADVIA CENTAUR INTACT PARATHYROID HORMONE (IPTH) ASSAY
K133601 · Siemens Healthcare Diagnostics, Inc. · Feb 2014
ADVIA CENTAUR INACT PARATHYROID HORMONE (IPTH) ASSAY
K121981 · Siemens Healthcare Diagnostics · Mar 2013
ROCHE ELECSYS PTH TEST SYSTEM
K070709 · Roche Diagnostics Corp. · Jul 2007
ELECSYS PTH TEST SYSTEM
K070391 · Roche Diagnostics Corp. · Mar 2007