Cleared Traditional

K790260 - NTSH AUTOPAK TEST DELIVERY SYSTEM

K790260 is the FDA 510(k) clearance for NTSH AUTOPAK TEST DELIVERY SYSTEM by Micromedic Systems. It is a Class 2 Toxicology device (product code JLW) cleared through the Traditional 510(k) pathway after a 43-day FDA review.

K790260 · Micromedic Systems · Toxicology device
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Mar 1979
Decision
43d
Days
Class 2
Risk

K790260 is an FDA 510(k) clearance for the NTSH AUTOPAK TEST DELIVERY SYSTEM. Classified as Radioimmunoassay, Thyroid-stimulating Hormone (product code JLW), Class II - Special Controls.

Submitted by Micromedic Systems (Mchenry, US). The FDA issued a Cleared decision on March 21, 1979 after a review of 43 days - a notably fast clearance cycle.

This device falls under the Toxicology FDA review panel, regulated under 21 CFR 862.1690 - the FDA toxicology 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 Micromedic Systems devices

Submission Details

510(k) Number K790260 FDA.gov
FDA Decision Cleared Substantially Equivalent - Traditional 510(k) (SESE)
Date Received February 06, 1979
Decision Date March 21, 1979
Days to Decision 43 days
Submission Type Traditional
Review Panel Toxicology (TX)
Summary -
Third-party Review No - reviewed directly by FDA
Combination Product No
PCCP Authorized No
Regulatory Context
Review time vs. panel average
44d faster than avg
Panel avg: 87d · This submission: 43d
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 Toxicology devices follow this clearance model.

Regulatory Peers - JLW Radioimmunoassay, Thyroid-stimulating Hormone

All 156
Devices cleared under the same product code (JLW) and FDA review panel - the closest regulatory comparables to K790260.
TSH RADIOIMMUNOASSAY
K792443 · Dade, Baxter Travenol Diagnostics, Inc. · Dec 1979
HTSH NEONATE RIA DIAGNOSTIC KIT
K791747 · Abbott Laboratories · Nov 1979
CENTRIA TSH RIA
K791855 · Union Carbide Corp. · Oct 1979
RIA KIT, IMMO PHASE
K781953 · Corning Medical & Scientific · Feb 1979
IMMO PHASE, THYROID HORMONE
K781409 · Corning Medical & Scientific · Sep 1978
QUANTIMUNE HTSH IRMA HUMAN THYROID
K781170 · Bio-Rad · Aug 1978