Cleared Traditional

K061190 - ACCESS INTACT PTH AND CALIBRATORS

K061190 is the FDA 510(k) clearance for ACCESS INTACT PTH AND CALIBRATORS by Beckman Coulter, Inc.. It is a Class 2 Chemistry device (product code CEW) cleared through the Traditional 510(k) pathway after a 140-day FDA review.

K061190 · Beckman Coulter, Inc. · Chemistry device
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Sep 2006
Decision
140d
Days
Class 2
Risk

K061190 is an FDA 510(k) clearance for the ACCESS INTACT PTH AND CALIBRATORS, MODELS A 16972 AND A 16953. 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 September 15, 2006 after a review of 140 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 Beckman Coulter, Inc. devices

Submission Details

510(k) Number K061190 FDA.gov
FDA Decision Cleared Substantially Equivalent - Traditional 510(k) (SESE)
Date Received April 28, 2006
Decision Date September 15, 2006
Days to Decision 140 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
52d slower than avg
Panel avg: 88d · This submission: 140d
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 50
Devices cleared under the same product code (CEW) and FDA review panel - the closest regulatory comparables to K061190.
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