Cleared Traditional

K830319 - AUTO PREP

K830319 is an FDA 510(k) clearance for AUTO PREP, manufactured by Pm America, Inc.. The device is a Class 1 Chemistry device with product code JQW cleared through the Traditional 510(k) pathway after a 57-day FDA review.

K830319 · Pm America, Inc. · Chemistry device
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Mar 1983
Decision
57d
Days
Class 1
Risk

K830319 is an FDA 510(k) clearance for the AUTO PREP. Classified as Station, Pipetting And Diluting, For Clinical Use (product code JQW), Class I - General Controls.

Submitted by Pm America, Inc. (Mchenry, US). The FDA issued a Cleared decision on March 29, 1983 after a review of 57 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.

View all Pm America, Inc. devices

FDA 510(k) Submission Details - K830319

510(k) Number K830319 FDA.gov
FDA Decision Cleared Substantially Equivalent - Traditional 510(k) (SESE)
Date Received January 31, 1983
Decision Date March 29, 1983
Days to Decision 57 days
Submission Type Traditional
Review Panel Chemistry (CH)
Summary -
Third-party Review No - reviewed directly by FDA
Regulatory Context
Review time vs. panel average
31d faster than avg
Panel avg: 88d · This submission: 57d
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 84
Devices cleared under the same product code (JQW) and FDA review panel - the closest regulatory comparables to K830319.
ACCU-PREP PROGRAMMABLE AUTO-DILUTER
K832809 · Beckman Instruments, Inc. · Oct 1983
PRO QUANTUM
K831249 · Abbott Laboratories · Jul 1983
QST TM SAMPLE PROCESSOR
K831273 · Syva Co. · Jun 1983
DIGIFLEX AUTOMATIC PIPETTE
K830157 · Micromedic Systems · Mar 1983
COUNT-10 SYSTEM FOR STAND. URINALYSIS
K823364 · V-Tech, Inc. · Dec 1982
MULTIWASH
K813426 · Flow Laboratories, Inc. · Dec 1981