Cleared Traditional

K831571 - ROTOR

K831571 is an FDA 510(k) clearance for ROTOR, manufactured by American Scientific Products. The device is a Class 1 Chemistry device with product code JJG cleared through the Traditional 510(k) pathway after a 45-day FDA review.

K831571 · American Scientific Products · Chemistry device
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Jun 1983
Decision
45d
Days
Class 1
Risk

K831571 is an FDA 510(k) clearance for the ROTOR. Classified as Analyzer, Chemistry, Centrifugal, For Clinical Use (product code JJG), Class I - General Controls.

Submitted by American Scientific Products (Mchenry, US). The FDA issued a Cleared decision on June 30, 1983 after a review of 45 days - a notably fast clearance cycle.

This device falls under the Chemistry FDA review panel, regulated under 21 CFR 862.2140 - 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.

FDA 510(k) Submission Details - K831571

510(k) Number K831571 FDA.gov
FDA Decision Cleared Substantially Equivalent - Traditional 510(k) (SESE)
Date Received May 16, 1983
Decision Date June 30, 1983
Days to Decision 45 days
Submission Type Traditional
Review Panel Chemistry (CH)
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: 89d · This submission: 45d
Pathway characteristics
Predicate-based equivalence.

JJG Device Classification - Class 1, General Controls

Product Code JJG Analyzer, Chemistry, Centrifugal, For Clinical Use
Device Class Class 1 - General Controls
CFR Regulation 21 CFR 862.2140
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 - JJG Analyzer, Chemistry, Centrifugal, For Clinical Use

All 29
Devices cleared under the same product code (JJG) and FDA review panel - the closest regulatory comparables to K831571.
DISPOSABLE CUVETTE ARRAY
K840231 · Consumable Lab Supplies · Mar 1984
ENCORE CHEMISTRY ANALYZER
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REAGENT CUPS
K831569 · American Scientific Products · Jun 1983
ENCORE CHEMISTRY ANALYZER
K830641 · Baker Instructions Corp. · Apr 1983
FLEXIGRAM AUTO LOADER SYSTEM
K811525 · Electro-Nucleonics Laboratories, Inc. · Jun 1981
CENTRIFICHEM SYSTEM 500 ANALYZER
K801139 · Union Carbide Corp. · Jun 1980
K831571 · ROTOR
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