Cleared Traditional

K791128 - PTH RIA 200

K791128 is the FDA 510(k) clearance for PTH RIA 200 by Institut National Des Radioelements. It is a Class 2 Chemistry device (product code CEW) cleared through the Traditional 510(k) pathway after a 101-day FDA review.

K791128 · Institut National Des Radioelements · Chemistry device
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Sep 1979
Decision
101d
Days
Class 2
Risk

K791128 is an FDA 510(k) clearance for the PTH RIA 200. Classified as Radioimmunoassay, Parathyroid Hormone (product code CEW), Class II - Special Controls.

Submitted by Institut National Des Radioelements (Mchenry, US). The FDA issued a Cleared decision on September 27, 1979 after a review of 101 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 Institut National Des Radioelements devices

Submission Details

510(k) Number K791128 FDA.gov
FDA Decision Cleared Substantially Equivalent - Traditional 510(k) (SESE)
Date Received June 18, 1979
Decision Date September 27, 1979
Days to Decision 101 days
Submission Type Traditional
Review Panel Chemistry (CH)
Summary -
Third-party Review No - reviewed directly by FDA
Regulatory Context
Review time vs. panel average
13d slower than avg
Panel avg: 88d · This submission: 101d
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 57
Devices cleared under the same product code (CEW) and FDA review panel - the closest regulatory comparables to K791128.
C-TERMINAL PTH RIA TEST KIT, DSL-1000
K813203 · Diagnostic Systems Laboratories, Inc. · Dec 1981
C-TERMINAL PTH BY RADIOIMMUNOASSAY KIT
K811566 · Immuno Nuclear Corp. · Jun 1981
N-TERMINAL HPTH BY RIA
K811418 · Immuno Nuclear Corp. · Jun 1981
HORMONE KIT, PARATHYROID
K782010 · Nichols Institute Diagnostics · Jan 1979
COMPLEMENT C3 NEPHELOMETRIC ASSAY
K772249 · Kallestad Laboratories, Inc. · Dec 1977
PTH RIA
K771783 · Nichols Institute Diagnostics · Oct 1977