Cleared Traditional

K860054 - TSH-IRMA COAT-A-COUNT KIT

K860054 is the FDA 510(k) clearance for TSH-IRMA COAT-A-COUNT KIT by Diagnostic Products Corp.. It is a Class 2 Chemistry device (product code JLW) cleared through the Traditional 510(k) pathway after a 70-day FDA review.

K860054 · Diagnostic Products Corp. · Chemistry device
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Mar 1986
Decision
70d
Days
Class 2
Risk

K860054 is an FDA 510(k) clearance for the TSH-IRMA COAT-A-COUNT KIT. Classified as Radioimmunoassay, Thyroid-stimulating Hormone (product code JLW), Class II - Special Controls.

Submitted by Diagnostic Products Corp. (Los Angeles, US). The FDA issued a Cleared decision on March 17, 1986 after a review of 70 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 Diagnostic Products Corp. devices

Submission Details

510(k) Number K860054 FDA.gov
FDA Decision Cleared Substantially Equivalent - Traditional 510(k) (SESE)
Date Received January 06, 1986
Decision Date March 17, 1986
Days to Decision 70 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
18d faster than avg
Panel avg: 88d · This submission: 70d
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 125
Devices cleared under the same product code (JLW) and FDA review panel - the closest regulatory comparables to K860054.
TERUMO SENSIBEAD EIA TSH KIT
K861573 · Terumo Medical Corp. · Jun 1986
SIMULTRAC NEONATAL T4(57CO)/TSH(125I) RADIOIMMUNO.
K861920 · Bd Becton Dickinson Vacutainer Systems Preanalytic · Jun 1986
ECHOCLONAL HTSH IRMA
K860288 · Bio-Rad · Apr 1986
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