Cleared Traditional

K844583 - TSH-STAT

K844583 is the FDA 510(k) clearance for TSH-STAT by Nuclear Medical Laboratories, Inc.. It is a Class 2 Chemistry device (product code JLW) cleared through the Traditional 510(k) pathway after a 102-day FDA review.

K844583 · Nuclear Medical Laboratories, Inc. · Chemistry device
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Mar 1985
Decision
102d
Days
Class 2
Risk

K844583 is an FDA 510(k) clearance for the TSH-STAT. Classified as Radioimmunoassay, Thyroid-stimulating Hormone (product code JLW), Class II - Special Controls.

Submitted by Nuclear Medical Laboratories, Inc. (Irving, US). The FDA issued a Cleared decision on March 5, 1985 after a review of 102 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 Nuclear Medical Laboratories, Inc. devices

Submission Details

510(k) Number K844583 FDA.gov
FDA Decision Cleared Substantially Equivalent - Traditional 510(k) (SESE)
Date Received November 23, 1984
Decision Date March 05, 1985
Days to Decision 102 days
Submission Type Traditional
Review Panel Chemistry (CH)
Summary -
Third-party Review No - reviewed directly by FDA
Regulatory Context
Review time vs. panel average
14d slower than avg
Panel avg: 88d · This submission: 102d
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 K844583.
MAGIC MONOCLONAL ANTIBODY TSH(MAB TSH)RADIOIMMUNOA
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ENDAB TSH
K851980 · Immunotech Corp. · May 1985
TERUMO SENSIBEAD EIA TSH KIT
K850376 · Terumo Medical Corp. · Mar 1985
ABBOTT HTSH EIA DIAGNOSTIC KIT
K843540 · Abbott Laboratories · Nov 1984
ENCORE TSH REAGENT
K843395 · Hybritech, Inc. · Oct 1984