Cleared Traditional

THYROID STIMULATING HORMONE (HTSH) IRMA NEONATAL (K883726) - FDA 510(k) Clearance

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

K883726 · Immuchem Corp. · Chemistry device
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Dec 1988
Decision
106d
Days
Class 2
Risk

K883726 is an FDA 510(k) clearance for the THYROID STIMULATING HORMONE (HTSH) IRMA NEONATAL. Classified as Radioimmunoassay, Thyroid-stimulating Hormone (product code JLW), Class II - Special Controls.

Submitted by Immuchem Corp. (Carson, US). The FDA issued a Cleared decision on December 15, 1988 after a review of 106 days - within the typical 510(k) review window.

This device falls under the Chemistry FDA review panel, regulated under 21 CFR 862.1690 - 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 Immuchem Corp. devices

Submission Details

510(k) Number K883726 FDA.gov
FDA Decision Cleared Substantially Equivalent - Traditional 510(k) (SESE)
Date Received August 31, 1988
Decision Date December 15, 1988
Days to Decision 106 days
Submission Type Traditional
Review Panel Chemistry (CH)
Summary -
Third-party Review No - reviewed directly by FDA
Regulatory Context
Review time vs. panel average
18d slower than avg
Panel avg: 88d · This submission: 106d
Pathway characteristics
Predicate-based equivalence. No clinical trials required.

Device Classification

Product Code JLW Radioimmunoassay, Thyroid-stimulating Hormone
Device Class Class 2 - Special Controls
CFR Regulation 21 CFR 862.1690
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 - JLW Radioimmunoassay, Thyroid-stimulating Hormone

All 59
Devices cleared under the same product code (JLW) and FDA review panel - the closest regulatory comparables to K883726.
AFFINITY(TM) HTSH(TM)
K897138 · Bd Becton Dickinson Vacutainer Systems Preanalytic · Mar 1990
MILENIA (TM) TSH
K900014 · Diagnostic Products Corp. · Jan 1990
COTUBE(TM) TSH IRMA
K890802 · Bio-Rad · Mar 1989
ABBOTT IMX HTSH
K880086 · Abbott Laboratories · Apr 1988
IRMA-COUNT TSH RKTS1, RKTS2, RKTS5, RKTSX
K872305 · Diagnostic Products Corp. · Jul 1987
IQ TSH IMMUNOASSAY
K870244 · Bd Becton Dickinson Vacutainer Systems Preanalytic · Apr 1987