Cleared Traditional

RIA-DAC TM HTSH KIH (K770604) - FDA 510(k) Clearance

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

K770604 · Mallinckrodt Critical Care · Immunology device
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Apr 1977
Decision
6d
Days
Class 2
Risk

K770604 is an FDA 510(k) clearance for the RIA-DAC TM HTSH KIH. Classified as Radioimmunoassay, Thyroid-stimulating Hormone (product code JLW), Class II - Special Controls.

Submitted by Mallinckrodt Critical Care (Mchenry, US). The FDA issued a Cleared decision on April 6, 1977 after a review of 6 days - a notably fast clearance cycle.

This device falls under the Immunology FDA review panel, regulated under 21 CFR 862.1690 - the FDA immunology device 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 Mallinckrodt Critical Care devices

Submission Details

510(k) Number K770604 FDA.gov
FDA Decision Cleared Substantially Equivalent - Traditional 510(k) (SESE)
Date Received March 31, 1977
Decision Date April 06, 1977
Days to Decision 6 days
Submission Type Traditional
Review Panel Immunology (IM)
Summary -
Third-party Review No - reviewed directly by FDA
Regulatory Context
Review time vs. panel average
98d faster than avg
Panel avg: 104d · This submission: 6d
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 Immunology 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 K770604.
NEONATAL TSH RIA KIT (125I)
K772192 · Diagnostic Products Corp. · Jan 1978
SERALUTE TSH (RIA)
K771767 · Miles Laboratories, Inc. · Oct 1977
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
TEST, RIA, TSH QUANTIMUNE
K760132 · Bio-Rad · Jul 1976