Cleared Traditional

MICROMEDIC HTSH MONOCLONAL IRMA KIT (K860813) - FDA 510(k) Clearance

Class II Chemistry device cleared through predicate-based substantial equivalence - typically does not require clinical trials.

K860813 · Micromedic Systems · Chemistry device
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Jul 1986
Decision
132d
Days
Class 2
Risk

K860813 is an FDA 510(k) clearance for the MICROMEDIC HTSH MONOCLONAL IRMA KIT. Classified as Radioimmunoassay, Thyroid-stimulating Hormone (product code JLW), Class II - Special Controls.

Submitted by Micromedic Systems (Horsham, US). The FDA issued a Cleared decision on July 14, 1986 after a review of 132 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 Micromedic Systems devices

Submission Details

510(k) Number K860813 FDA.gov
FDA Decision Cleared Substantially Equivalent - Traditional 510(k) (SESE)
Date Received March 04, 1986
Decision Date July 14, 1986
Days to Decision 132 days
Submission Type Traditional
Review Panel Chemistry (CH)
Summary -
Third-party Review No - reviewed directly by FDA
Regulatory Context
Review time vs. panel average
44d slower than avg
Panel avg: 88d · This submission: 132d
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 70
Devices cleared under the same product code (JLW) and FDA review panel - the closest regulatory comparables to K860813.
AFFINITY(TM) HTSH IMMUNIT(TM)
K865081 · Bd Becton Dickinson Vacutainer Systems Preanalytic · Mar 1987
TSH MAB IRMA
K864839 · Bd Becton Dickinson Vacutainer Systems Preanalytic · Feb 1987
STRATUS TSH FLUOROMETRIC ENZYME IMMUNOASSAY
K862428 · American Dade · Aug 1986
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