Cleared Traditional

K780802 - ARMTROL AND FERMTROL

K780802 is an FDA 510(k) clearance for ARMTROL AND FERMTROL, manufactured by Biotron , Ltd.. The device is a Class 1 Chemistry device with product code JJW cleared through the Traditional 510(k) pathway after a 33-day FDA review.

K780802 · Biotron , Ltd. · Chemistry device
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Jun 1978
Decision
33d
Days
Class 1
Risk

K780802 is an FDA 510(k) clearance for the ARMTROL AND FERMTROL. Classified as Urinalysis Controls (assayed And Unassayed) (product code JJW), Class I - General Controls.

Submitted by Biotron , Ltd. (Mchenry, US). The FDA issued a Cleared decision on June 13, 1978 after a review of 33 days - a notably fast clearance cycle.

This device falls under the Chemistry FDA review panel, regulated under 21 CFR 862.1660 - 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 Biotron , Ltd. devices

FDA 510(k) Submission Details - K780802

510(k) Number K780802 FDA.gov
FDA Decision Cleared Substantially Equivalent - Traditional 510(k) (SESE)
Date Received May 11, 1978
Decision Date June 13, 1978
Days to Decision 33 days
Submission Type Traditional
Review Panel Chemistry (CH)
Summary -
Third-party Review No - reviewed directly by FDA
Regulatory Context
Review time vs. panel average
55d faster than avg
Panel avg: 88d · This submission: 33d
Pathway characteristics
Predicate-based equivalence.

JJW Device Classification - Class 1, General Controls

Product Code JJW Urinalysis Controls (assayed And Unassayed)
Device Class Class 1 - General Controls
CFR Regulation 21 CFR 862.1660
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 - JJW Urinalysis Controls (assayed And Unassayed)

All 47
Devices cleared under the same product code (JJW) and FDA review panel - the closest regulatory comparables to K780802.
KOVA TROL I HUMAN URINE (DRIED)
K810917 · Icl Scientific · Apr 1981
CONTROL STRIP FOR VISUAL URINALYSIS
K781961 · Miles Laboratories, Inc. · Feb 1979
CHEMSTRIP CONTROL
K781691 · Boehringer Mannheim Corp. · Dec 1978
KOVA TROL III
K780482 · Icl Scientific · May 1978
TEK-CHEK-2
K771713 · Miles Laboratories, Inc. · Oct 1977
URINALYSIS PROFICIENCY
K770390 · Miles Laboratories, Inc. · May 1977