Cleared Traditional

K854087 - NML TSH IRMA

K854087 is an FDA 510(k) clearance for NML TSH IRMA, manufactured by Organon Teknika Corp.. The device is a Class 2 Chemistry device with product code JLW cleared through the Traditional 510(k) pathway after a 18-day FDA review.

K854087 · Organon Teknika Corp. · Chemistry device
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Oct 1985
Decision
18d
Days
Class 2
Risk

K854087 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 Organon Teknika Corp. (Irving, US). The FDA issued a Cleared decision on October 25, 1985 after a review of 18 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 Organon Teknika Corp. devices

FDA 510(k) Submission Details - K854087

510(k) Number K854087 FDA.gov
FDA Decision Cleared Substantially Equivalent - Traditional 510(k) (SESE)
Date Received October 07, 1985
Decision Date October 25, 1985
Days to Decision 18 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
70d faster than avg
Panel avg: 88d · This submission: 18d
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 163
Devices cleared under the same product code (JLW) and FDA review panel - the closest regulatory comparables to K854087.
SIMULTRAC NEONATAL T4(57CO)/TSH(125I) RADIOIMMUNO.
K861920 · Bd Becton Dickinson Vacutainer Systems Preanalytic · Jun 1986
ECHOCLONAL HTSH IRMA
K860288 · Bio-Rad · Apr 1986
TSH-IRMA COAT-A-COUNT KIT
K860054 · Diagnostic Products Corp. · Mar 1986
BETA-TSH-IRMA
K853977 · Leeco Diagnostics, Inc. · Oct 1985
ALLEGRO TM HS-TSH IMMUNOASSAY SYSTEM
K853717 · Nichols Institute Diagnostics · Oct 1985
NML TSH IRMA
K852438 · Nuclear Medical Laboratories, Inc. · Jul 1985