Cleared Traditional

K823364 - COUNT-10 SYSTEM FOR STAND. URINALYSIS

K823364 is an FDA 510(k) clearance for COUNT-10 SYSTEM FOR STAND. URINALYSIS, manufactured by V-Tech, Inc.. The device is a Class 1 Chemistry device with product code JQW cleared through the Traditional 510(k) pathway after a 36-day FDA review.

K823364 · V-Tech, Inc. · Chemistry device
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Dec 1982
Decision
36d
Days
Class 1
Risk

K823364 is an FDA 510(k) clearance for the COUNT-10 SYSTEM FOR STAND. URINALYSIS. Classified as Station, Pipetting And Diluting, For Clinical Use (product code JQW), Class I - General Controls.

Submitted by V-Tech, Inc. (Walker, US). The FDA issued a Cleared decision on December 15, 1982 after a review of 36 days - a notably fast clearance cycle.

This device falls under the Chemistry FDA review panel, regulated under 21 CFR 862.2750 - 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 - K823364

510(k) Number K823364 FDA.gov
FDA Decision Cleared Substantially Equivalent - Traditional 510(k) (SESE)
Date Received November 09, 1982
Decision Date December 15, 1982
Days to Decision 36 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
53d faster than avg
Panel avg: 89d · This submission: 36d
Pathway characteristics
Predicate-based equivalence.

JQW Device Classification - Class 1, General Controls

Product Code JQW Station, Pipetting And Diluting, For Clinical Use
Device Class Class 1 - General Controls
CFR Regulation 21 CFR 862.2750
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 - JQW Station, Pipetting And Diluting, For Clinical Use

All 139
Devices cleared under the same product code (JQW) and FDA review panel - the closest regulatory comparables to K823364.
QST TM SAMPLE PROCESSOR
K831273 · Syva Co. · Jun 1983
AUTO PREP
K830319 · Pm America, Inc. · Mar 1983
DIGIFLEX AUTOMATIC PIPETTE
K830157 · Micromedic Systems · Mar 1983
DIGITAL DILUTER/DISPENSERS
K822688 · Hamilton Co. · Nov 1982
CAVRO IQ-190 SAMPLE PROCESSOR
K822208 · Cavro Scientific Instruments, Inc. · Aug 1982
ECLIPSE
K821007 · Scientific Software & Instrument Co. · May 1982
K823364 · COUNT-10 SYSTEM FOR STAND. URINALYSIS
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