Cleared Traditional

K864659 - BIO-MEGA DIAGNOSTIC COATED TUBE IRMA TSH

K864659 is the FDA 510(k) clearance for BIO-MEGA DIAGNOSTIC COATED TUBE IRMA TSH by Bio Mega Diagnostic, Inc.. It is a Class 2 Chemistry device (product code JLW) cleared through the Traditional 510(k) pathway after a 68-day FDA review.

K864659 · Bio Mega Diagnostic, Inc. · Chemistry device
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Feb 1987
Decision
68d
Days
Class 2
Risk

K864659 is an FDA 510(k) clearance for the BIO-MEGA DIAGNOSTIC COATED TUBE IRMA TSH. Classified as Radioimmunoassay, Thyroid-stimulating Hormone (product code JLW), Class II - Special Controls.

Submitted by Bio Mega Diagnostic, Inc. (Canada, CA). The FDA issued a Cleared decision on February 4, 1987 after a review of 68 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 Bio Mega Diagnostic, Inc. devices

Submission Details

510(k) Number K864659 FDA.gov
FDA Decision Cleared Substantially Equivalent - Traditional 510(k) (SESE)
Date Received November 28, 1986
Decision Date February 04, 1987
Days to Decision 68 days
Submission Type Traditional
Review Panel Chemistry (CH)
Summary -
Third-party Review No - reviewed directly by FDA
Regulatory Context
Review time vs. panel average
20d faster than avg
Panel avg: 88d · This submission: 68d
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 146
Devices cleared under the same product code (JLW) and FDA review panel - the closest regulatory comparables to K864659.
IQ TSH IMMUNOASSAY
K870244 · Bd Becton Dickinson Vacutainer Systems Preanalytic · Apr 1987
AUTOPAK TSH MONOCLONAL IRMA KIT
K870245 · Micromedic Systems · Apr 1987
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
DSL-5300 TSH IMMUNORADIOMETRIC ASSAY (IRMA) KIT
K864133 · Diagnostic Systems Laboratories, Inc. · Dec 1986
DSL-4800 ACTIVE TM TSH EIA SYSTEM
K864134 · Diagnostic Systems Laboratories, Inc. · Dec 1986