Cleared Traditional

Access Intact PTH (K232791) - FDA 510(k) Clearance

Class II Chemistry device cleared through predicate-based substantial equivalence - typically does not require clinical trials.

K232791 · Beckman Coulter, Inc. · Chemistry device
Download Printable Device Report (PDF)
Optimized for regulatory review, auditing and printing
Mar 2024
Decision
172d
Days
Class 2
Risk

K232791 is an FDA 510(k) clearance for the Access Intact PTH. Classified as Radioimmunoassay, Parathyroid Hormone (product code CEW), Class II - Special Controls.

Submitted by Beckman Coulter, Inc. (Chaska, US). The FDA issued a Cleared decision on March 1, 2024 after a review of 172 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 Beckman Coulter, Inc. devices

Submission Details

510(k) Number K232791 FDA.gov
FDA Decision Cleared Substantially Equivalent - Traditional 510(k) (SESE)
Date Received September 11, 2023
Decision Date March 01, 2024
Days to Decision 172 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
84d slower than avg
Panel avg: 88d · This submission: 172d
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 85
Devices cleared under the same product code (CEW) and FDA review panel - the closest regulatory comparables to K232791.
Elecsys PTH , Elecsys PTH STAT
K231927 · Roche Diagnostics · Mar 2024
VITROS Immunodiagnostic Products Intact PTH II Reagent Pack
K221197 · Ortho-Clinical Diagnostics · Sep 2023
Lumipulse G whole PTH
K190702 · Fujirebio Diagnostics,Inc. · Aug 2019
ADVIA Centaur Intact Parathyroid Hormone (PTH) Assay
K163658 · Siemens Healthcare Diagnostics, Inc. · May 2017
ROCHE ELECSYS PTH TEST SYSTEM
K070709 · Roche Diagnostics Corp. · Jul 2007
ELECSYS PTH TEST SYSTEM
K070391 · Roche Diagnostics Corp. · Mar 2007