Cleared Traditional

THYRODOT-4, THYRODOT-SH (K771377) - FDA 510(k) Clearance

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

K771377 · Medcom Diagnostics, Inc. · Chemistry device
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Sep 1977
Decision
39d
Days
Class 2
Risk

K771377 is an FDA 510(k) clearance for the THYRODOT-4, THYRODOT-SH. Classified as Radioimmunoassay, Thyroid-stimulating Hormone (product code JLW), Class II - Special Controls.

Submitted by Medcom Diagnostics, Inc. (Mchenry, US). The FDA issued a Cleared decision on September 2, 1977 after a review of 39 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 Medcom Diagnostics, Inc. devices

Submission Details

510(k) Number K771377 FDA.gov
FDA Decision Cleared Substantially Equivalent - Traditional 510(k) (SESE)
Date Received July 25, 1977
Decision Date September 02, 1977
Days to Decision 39 days
Submission Type Traditional
Review Panel Chemistry (CH)
Summary -
Third-party Review No - reviewed directly by FDA
Regulatory Context
Review time vs. panel average
49d faster than avg
Panel avg: 88d · This submission: 39d
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 59
Devices cleared under the same product code (JLW) and FDA review panel - the closest regulatory comparables to K771377.
HTSH NEONATE RIA DIAGNOSTIC KIT
K791747 · Abbott Laboratories · Nov 1979
QUANTIMUNE HTSH IRMA HUMAN THYROID
K781170 · Bio-Rad · Aug 1978
NEONATAL TSH RIA KIT (125I)
K772192 · Diagnostic Products Corp. · Jan 1978
HTSH RIA HUMAN THYROID HORMONE RIA
K771235 · Abbott Laboratories · Aug 1977
TSH RIA KIT
K760801 · Diagnostic Products Corp. · Nov 1976
KIT, RIA, HUMAN THYROID HORMONE
K760044 · Bd Becton Dickinson Vacutainer Systems Preanalytic · Jul 1976