Cleared Traditional

K832313 - MAGIC TSH 125I RADIOIMMUNOASSAY

K832313 is the FDA 510(k) clearance for MAGIC TSH 125I RADIOIMMUNOASSAY by Corning Medical & Scientific. It is a Class 2 Chemistry device (product code JLW) cleared through the Traditional 510(k) pathway after a 49-day FDA review.

K832313 · Corning Medical & Scientific · Chemistry device

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Sep 1983

Decision

49d

Days

Class 2

Risk

K832313 is an FDA 510(k) clearance for the MAGIC TSH 125I RADIOIMMUNOASSAY. Classified as Radioimmunoassay, Thyroid-stimulating Hormone (product code JLW), Class II - Special Controls.

Submitted by Corning Medical & Scientific (Mchenry, US). The FDA issued a Cleared decision on September 1, 1983 after a review of 49 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 Corning Medical & Scientific devices

Submission Details

510(k) Number	K832313 FDA.gov
FDA Decision	Cleared Substantially Equivalent - Traditional 510(k) (SESE)
Date Received	July 14, 1983
Decision Date	September 01, 1983
Days to Decision	49 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

39d faster than avg

Panel avg: 88d · This submission: 49d

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 K832313.

ENZYMUNE-TEST TSH

K832823 · Icl Scientific · Oct 1983

EPSILON TSH TEST KIT

K831972 · Beckman Instruments, Inc. · Sep 1983

AUTOPAK NEONATAL TSH RIA KIT

K832462 · Micromedic Systems · Sep 1983

VENTREX ENZYME TSH KIT

K830928 · Ventrex Laboratories, Inc. · Apr 1983

NEONATAL NTSH RADIOIMMUNOASSAY SYS

K830036 · Corning Medical & Scientific · Jan 1983

DOUBLE ANTIBODY TSH I-125 RADIOIMMUNO

K823688 · Corning Medical & Scientific · Jan 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 K832313

Corning Medical & Scientific

Mchenry, IL · US

Regulatory profile

111 submissions 111 cleared

100% clearance rate · Active in Chemistry

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