Cleared Traditional

ARMTROL AND FERMTROL (K780802) - FDA 510(k) Clearance

Class I Chemistry device.

K780802 · Biotron , Ltd. · Chemistry device
Download Printable Device Report (PDF)
Optimized for regulatory review, auditing and printing
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

Submission Details

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.

Device Classification

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 17
Devices cleared under the same product code (JJW) and FDA review panel - the closest regulatory comparables to K780802.
NEGATIVE URINE CONTROL
K830834 · Helena Laboratories · Apr 1983
CONTROL STRIP FOR VISUAL URINALYSIS
K781961 · Miles Laboratories, Inc. · Feb 1979
CHEMSTRIP CONTROL
K781691 · Boehringer Mannheim Corp. · Dec 1978
TEK-CHEK-2
K771713 · Miles Laboratories, Inc. · Oct 1977
URINALYSIS PROFICIENCY
K770390 · Miles Laboratories, Inc. · May 1977
PRODUCT #K3002 KETOTROL-N(URINE CONTROL)
K760863 · Sigma Chemical Co. · Nov 1976