Cleared Traditional

K830365 - KINETI COUNT 48 IMMUNOASSAY SYSTEM

K830365 is an FDA 510(k) clearance for KINETI COUNT 48 IMMUNOASSAY SYSTEM, manufactured by Medical & Scientific Designs, Inc.. The device is a Class 1 Chemistry device with product code JJJ cleared through the Traditional 510(k) pathway after a 34-day FDA review.

K830365 · Medical & Scientific Designs, Inc. · Chemistry device
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Mar 1983
Decision
34d
Days
Class 1
Risk

K830365 is an FDA 510(k) clearance for the KINETI COUNT 48 IMMUNOASSAY SYSTEM. Classified as Counter (beta, Gamma) For Clinical Use (product code JJJ), Class I - General Controls.

Submitted by Medical & Scientific Designs, Inc. (Mchenry, US). The FDA issued a Cleared decision on March 10, 1983 after a review of 34 days - a notably fast clearance cycle.

This device falls under the Chemistry FDA review panel, regulated under 21 CFR 862.2320 - 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 Medical & Scientific Designs, Inc. devices

FDA 510(k) Submission Details - K830365

510(k) Number K830365 FDA.gov
FDA Decision Cleared Substantially Equivalent - Traditional 510(k) (SESE)
Date Received February 04, 1983
Decision Date March 10, 1983
Days to Decision 34 days
Submission Type Traditional
Review Panel Chemistry (CH)
Summary -
Third-party Review No - reviewed directly by FDA
Regulatory Context
Review time vs. panel average
54d faster than avg
Panel avg: 88d · This submission: 34d
Pathway characteristics
Predicate-based equivalence.

JJJ Device Classification - Class 1, General Controls

Product Code JJJ Counter (beta, Gamma) For Clinical Use
Device Class Class 1 - General Controls
CFR Regulation 21 CFR 862.2320
What this classification means

Class I devices are subject to general controls only and most are exempt from 510(k) premarket notification. They represent the lowest regulatory burden in the FDA device framework.

Regulatory Peers - JJJ Counter (beta, Gamma) For Clinical Use

All 33
Devices cleared under the same product code (JJJ) and FDA review panel - the closest regulatory comparables to K830365.
MICROSTAT GAMMA COUNTER
K842902 · Micromedic Systems · Aug 1984
CORNING 4000 MULTI-WELL GAMMA COUNTER
K834508 · Corning Medical & Scientific · Mar 1984
NML-5010/5020 MULTI-DETECTOR SYSTEM
K832002 · Nuclear Medical Laboratories, Inc. · Aug 1983
RIA STAT 16
K821494 · E. R. Squibb & Sons, Inc. · Jun 1982
MICROMEDIC SYSTEMS ISOFLEX
K820376 · Micromedic Systems · Mar 1982
LS 5800 SERIES LIQUID SCINTILLATION
K813472 · Beckman Instruments, Inc. · Dec 1981