Cleared Traditional

K852438 - NML TSH IRMA

K852438 is the FDA 510(k) clearance for NML TSH IRMA by Nuclear Medical Laboratories, Inc.. It is a Class 2 Chemistry device (product code JLW) cleared through the Traditional 510(k) pathway after a 32-day FDA review.

K852438 · Nuclear Medical Laboratories, Inc. · Chemistry device
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Jul 1985
Decision
32d
Days
Class 2
Risk

K852438 is an FDA 510(k) clearance for the NML TSH IRMA. 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 July 12, 1985 after a review of 32 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 Nuclear Medical Laboratories, Inc. devices

Submission Details

510(k) Number K852438 FDA.gov
FDA Decision Cleared Substantially Equivalent - Traditional 510(k) (SESE)
Date Received June 10, 1985
Decision Date July 12, 1985
Days to Decision 32 days
Submission Type Traditional
Review Panel Chemistry (CH)
Summary -
Third-party Review No - reviewed directly by FDA
Regulatory Context
Review time vs. panel average
56d faster than avg
Panel avg: 88d · This submission: 32d
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 K852438.
NML TSH IRMA
K854087 · Organon Teknika Corp. · Oct 1985
BETA-TSH-IRMA
K853977 · Leeco Diagnostics, Inc. · Oct 1985
ALLEGRO TM HS-TSH IMMUNOASSAY SYSTEM
K853717 · Nichols Institute Diagnostics · Oct 1985
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