Cleared Traditional

K844583 - TSH-STAT

K844583 is an FDA 510(k) clearance for TSH-STAT, manufactured by Nuclear Medical Laboratories, Inc.. The device is a Class 2 Chemistry device with 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

FDA 510(k) Submission Details - K844583

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
Combination Product No
PCCP Authorized No
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.

JLW Device Classification - Class 2, Special Controls

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 202
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
K851329 · Corning Medical & Scientific · Jun 1985
DELFIA HTSH KIT
K851120 · Lkb Instruments, Inc. · May 1985
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