Cleared Traditional

K791128 - PTH RIA 200

K791128 is an FDA 510(k) clearance for PTH RIA 200, manufactured by Institut National Des Radioelements. The device is a Class 2 Chemistry device with 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

FDA 510(k) Submission Details - K791128

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.

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 77
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