Cleared Traditional

K831994 - BIOCHECK POSITIVE URINE CONTROL

K831994 is the FDA 510(k) clearance for BIOCHECK POSITIVE URINE CONTROL by Helena Laboratories. It is a Class 1 Chemistry device (product code JJW) cleared through the Traditional 510(k) pathway after a 48-day FDA review.

K831994 · Helena Laboratories · Chemistry device
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Aug 1983
Decision
48d
Days
Class 1
Risk

K831994 is an FDA 510(k) clearance for the BIOCHECK POSITIVE URINE CONTROL. Classified as Urinalysis Controls (assayed And Unassayed) (product code JJW), Class I - General Controls.

Submitted by Helena Laboratories (Mchenry, US). The FDA issued a Cleared decision on August 8, 1983 after a review of 48 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 Helena Laboratories devices

Submission Details

510(k) Number K831994 FDA.gov
FDA Decision Cleared Substantially Equivalent - Traditional 510(k) (SESE)
Date Received June 21, 1983
Decision Date August 08, 1983
Days to Decision 48 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
40d faster than avg
Panel avg: 88d · This submission: 48d
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 35
Devices cleared under the same product code (JJW) and FDA review panel - the closest regulatory comparables to K831994.
OXALATE URINE CONTROLS NORMAL & ELEVAT
K842366 · Sigma Chemical Co. · Sep 1984
BIOSURE
K840848 · Helena Laboratories · May 1984
URINE TOTAL PROTEIN CONTROL
K831526 · Quantimetrix Corp. · Aug 1983
NEGATIVE URINE CONTROL
K830834 · Helena Laboratories · Apr 1983
KOVA TROL I HUMAN URINE (DRIED)
K810917 · Icl Scientific · Apr 1981
CONTROL STRIP FOR VISUAL URINALYSIS
K781961 · Miles Laboratories, Inc. · Feb 1979