Cleared Traditional

K832499 - PHASE II TSH KIT

K832499 is the FDA 510(k) clearance for PHASE II TSH KIT by Medical & Scientific Designs, Inc.. It is a Class 2 Chemistry device (product code JLW) cleared through the Traditional 510(k) pathway after a 47-day FDA review.

K832499 · Medical & Scientific Designs, Inc. · Chemistry device
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Sep 1983
Decision
47d
Days
Class 2
Risk

K832499 is an FDA 510(k) clearance for the PHASE II TSH KIT. Classified as Radioimmunoassay, Thyroid-stimulating Hormone (product code JLW), Class II - Special Controls.

Submitted by Medical & Scientific Designs, Inc. (Mchenry, US). The FDA issued a Cleared decision on September 12, 1983 after a review of 47 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 Medical & Scientific Designs, Inc. devices

Submission Details

510(k) Number K832499 FDA.gov
FDA Decision Cleared Substantially Equivalent - Traditional 510(k) (SESE)
Date Received July 27, 1983
Decision Date September 12, 1983
Days to Decision 47 days
Submission Type Traditional
Review Panel Chemistry (CH)
Summary -
Third-party Review No - reviewed directly by FDA
Regulatory Context
Review time vs. panel average
41d faster than avg
Panel avg: 88d · This submission: 47d
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 148
Devices cleared under the same product code (JLW) and FDA review panel - the closest regulatory comparables to K832499.
ENZYMUNE-TEST TSH
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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
VENTREX ENZYME TSH KIT
K830928 · Ventrex Laboratories, Inc. · Apr 1983
NEONATAL NTSH RADIOIMMUNOASSAY SYS
K830036 · Corning Medical & Scientific · Jan 1983