Cleared Traditional

K913963 - IMMUCHEM NEONATAL TSH-MP ELISA

K913963 is the FDA 510(k) clearance for IMMUCHEM NEONATAL TSH-MP ELISA by Icn Biomedicals, Inc.. It is a Class 2 Chemistry device (product code JLW) cleared through the Traditional 510(k) pathway after a 99-day FDA review.

K913963 · Icn Biomedicals, Inc. · Chemistry device
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Dec 1991
Decision
99d
Days
Class 2
Risk

K913963 is an FDA 510(k) clearance for the IMMUCHEM NEONATAL TSH-MP ELISA. Classified as Radioimmunoassay, Thyroid-stimulating Hormone (product code JLW), Class II - Special Controls.

Submitted by Icn Biomedicals, Inc. (Costa Mesa, US). The FDA issued a Cleared decision on December 13, 1991 after a review of 99 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 Icn Biomedicals, Inc. devices

Submission Details

510(k) Number K913963 FDA.gov
FDA Decision Cleared Substantially Equivalent - Traditional 510(k) (SESE)
Date Received September 05, 1991
Decision Date December 13, 1991
Days to Decision 99 days
Submission Type Traditional
Review Panel Chemistry (CH)
Summary Statement
Third-party Review No - reviewed directly by FDA
Regulatory Context
Review time vs. panel average
11d slower than avg
Panel avg: 88d · This submission: 99d
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 144
Devices cleared under the same product code (JLW) and FDA review panel - the closest regulatory comparables to K913963.
VENTREX COATED TUBE HIGH SENSIT. TSH RADIOIMMUNOAS
K920856 · Hycor Biomedical, Inc. · Mar 1992
ENZYMUN-TEST TSH
K915195 · Boehringer Mannheim Corp. · Feb 1992
ULTRASENSITIVE TSH (U-TSH) ENZYME IMMUNO TEST KIT
K914756 · Medix Biotech, Inc. · Jan 1992
STRATUS(R) ULTRA-SENSIT HTSH FLUOR ENZYME IMMUNO
K912852 · Baxter Healthcare Corp · Sep 1991
MAGIC LITE TSH (HS) IMMUNOASSAY
K912583 · Ciba Corning Diagnostics Corp. · Aug 1991
STRATUS(R) HTSH FLUORMETRIC ENZYME IMMUNOASSAY
K912241 · Baxter Healthcare Corp · Jun 1991