Cleared Traditional

K901711 - PTH-MM II 125I RADIOIMMUNOASSAY (RIA)

K901711 is the FDA 510(k) clearance for PTH-MM II 125I RADIOIMMUNOASSAY (RIA) by Incstar Corp.. It is a Class 2 Chemistry device (product code CEW) cleared through the Traditional 510(k) pathway after a 94-day FDA review.

K901711 · Incstar Corp. · Chemistry device
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Jul 1990
Decision
94d
Days
Class 2
Risk

K901711 is an FDA 510(k) clearance for the PTH-MM II 125I RADIOIMMUNOASSAY (RIA). Classified as Radioimmunoassay, Parathyroid Hormone (product code CEW), Class II - Special Controls.

Submitted by Incstar Corp. (Stillwater, US). The FDA issued a Cleared decision on July 16, 1990 after a review of 94 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 Incstar Corp. devices

Submission Details

510(k) Number K901711 FDA.gov
FDA Decision Cleared Substantially Equivalent - Traditional 510(k) (SESE)
Date Received April 13, 1990
Decision Date July 16, 1990
Days to Decision 94 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
6d slower than avg
Panel avg: 88d · This submission: 94d
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 K901711.
COTUBE PTH IRMA
K921949 · Bio-Rad · Sep 1992
N-TACT(R) PTH SP KIT
K921629 · Incstar Corp. · May 1992
VENTREX COATED TUBE INTACT PTH
K913434 · Ventrex Laboratories, Inc. · Oct 1991
DSL I-PTH (DSL #8000)
K896294 · Diagnostic Systems Laboratories, Inc. · Nov 1989
CIBA CORNING MAGIC LITE INTACT PTH IMMUNOASSAY
K882560 · Ciba Corning Diagnostics Corp. · Oct 1988
N-TACT PTH BY IMMUNORADIOMETRIC ASSAY (IRMA)
K874299 · Incstar Corp. · Nov 1987