Cleared Traditional

K844735 - PTH-RIA

K844735 is an FDA 510(k) clearance for PTH-RIA, manufactured by Syncor Intl. Corp.. The device is a Class 2 Chemistry device with product code CEW cleared through the Traditional 510(k) pathway after a 146-day FDA review.

K844735 · Syncor Intl. Corp. · Chemistry device
Download Printable Device Report (PDF)
Optimized for regulatory review, auditing and printing
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

FDA 510(k) Submission Details - K844735

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
Combination Product No
PCCP Authorized No
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.

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 56
Devices cleared under the same product code (CEW) and FDA review panel - the closest regulatory comparables to K844735.
DOUBLE ANTIBODY ULTRA-PTH #KPTD1 AND KPTD2
K871970 · Diagnostic Products Corp. · Sep 1987
ALLEGRO INTACT PARATHYROID HORMONE IMMUNOASSAY
K861797 · Nichols Institute Diagnostics · Jul 1986
C-TERMINAL PTH RIA KIT
K853784 · Diagnostic Systems Laboratories, Inc. · Oct 1985
PARATHYROID HORMONE MID-MOLECULE RIA-KIT
K843870 · Diagnostic Products Corp. · Oct 1984
PARATHYROID HORMONE C-TERMINAL RIA KIT
K843871 · Diagnostic Products Corp. · Oct 1984
C-TERMINAL/MID-MOLECULE PARATHYROID -
K843685 · Nichols Institute Diagnostics · Oct 1984