Cleared Traditional

K832823 - ENZYMUNE-TEST TSH

K832823 is the FDA 510(k) clearance for ENZYMUNE-TEST TSH by Icl Scientific. It is a Class 2 Chemistry device (product code JLW) cleared through the Traditional 510(k) pathway after a 56-day FDA review.

K832823 · Icl Scientific · Chemistry device

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Oct 1983

Decision

56d

Days

Class 2

Risk

K832823 is an FDA 510(k) clearance for the ENZYMUNE-TEST TSH. Classified as Radioimmunoassay, Thyroid-stimulating Hormone (product code JLW), Class II - Special Controls.

Submitted by Icl Scientific (Walker, US). The FDA issued a Cleared decision on October 14, 1983 after a review of 56 days - a notably fast clearance cycle.

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: Fast-track predicate clearance. Standard predicate reliance. The short review cycle indicates strong predicate alignment - the FDA found sufficient equivalence without extended technical review.

View all Icl Scientific devices

Submission Details

510(k) Number	K832823 FDA.gov
FDA Decision	Cleared Substantially Equivalent - Traditional 510(k) (SESE)
Date Received	August 19, 1983
Decision Date	October 14, 1983
Days to Decision	56 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

32d faster than avg

Panel avg: 88d · This submission: 56d

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 143

Devices cleared under the same product code (JLW) and FDA review panel - the closest regulatory comparables to K832823.

AMERLEX-M TSH RIA

K842948 · Amersham Corp. · Sep 1984

BLOOD SPOT NEONATAL TSH RADIOIMMUNO

K841606 · Bd Becton Dickinson Vacutainer Systems Preanalytic · May 1984

TANDEM-E THYROID STIMULATING HORMONE KIT

K832813 · Hybritech, Inc. · Oct 1983

EPSILON TSH TEST KIT

K831972 · Beckman Instruments, Inc. · Sep 1983

AUTOPAK NEONATAL TSH RIA KIT

K832462 · Micromedic Systems · Sep 1983

MAGIC TSH 125I RADIOIMMUNOASSAY

K832313 · Corning Medical & Scientific · Sep 1983

Related FDA 510(k) Regulatory Insights

Additional regulatory intelligence related to this FDA 510(k) submission, including predicate strategy, review pathways and device classification guidance.

Manufacturer of K832823

Icl Scientific

Walker, MI · US

Regulatory profile

48 submissions 48 cleared

100% clearance rate · Active in Chemistry

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