Cleared Traditional

PTH-RIA (K844735) - FDA 510(k) Clearance

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

K844735 · Syncor Intl. Corp. · Chemistry device
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Apr 1985
Decision
146d
Days
Class 2
Risk

K844735 is an FDA 510(k) clearance for the PTH-RIA. Classified as Radioimmunoassay, Parathyroid Hormone (product code CEW), Class II - Special Controls.

Submitted by Syncor Intl. Corp. (Sylmar, US). The FDA issued a Cleared decision on April 29, 1985 after a review of 146 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 Syncor Intl. Corp. devices

Submission Details

510(k) Number K844735 FDA.gov
FDA Decision Cleared Substantially Equivalent - Traditional 510(k) (SESE)
Date Received December 04, 1984
Decision Date April 29, 1985
Days to Decision 146 days
Submission Type Traditional
Review Panel Chemistry (CH)
Summary -
Third-party Review No - reviewed directly by FDA
Regulatory Context
Review time vs. panel average
58d slower than avg
Panel avg: 88d · This submission: 146d
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 21
Devices cleared under the same product code (CEW) and FDA review panel - the closest regulatory comparables to K844735.
COAT-A-COUNT INTACT PTH IRMA
K930008 · Diagnostic Products Corp. · Jun 1993
COTUBE PTH IRMA
K921949 · Bio-Rad · Sep 1992
DOUBLE ANTIBODY ULTRA-PTH #KPTD1 AND KPTD2
K871970 · Diagnostic Products Corp. · Sep 1987
PARATHYROID HORMONE MID-MOLECULE RIA-KIT
K843870 · Diagnostic Products Corp. · Oct 1984
PARATHYROID HORMONE C-TERMINAL RIA KIT
K843871 · Diagnostic Products Corp. · Oct 1984
GAMMA DAB[125I]PTH RADIOIMMUNOASSAY KIT
K822944 · Travenol Laboratories, S.A. · Dec 1982