Cleared Traditional

K831273 - QST TM SAMPLE PROCESSOR

K831273 is an FDA 510(k) clearance for QST TM SAMPLE PROCESSOR, manufactured by Syva Co.. The device is a Class 1 Chemistry device with product code JQW cleared through the Traditional 510(k) pathway after a 44-day FDA review.

K831273 · Syva Co. · Chemistry device
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Jun 1983
Decision
44d
Days
Class 1
Risk

K831273 is an FDA 510(k) clearance for the QST TM SAMPLE PROCESSOR. Classified as Station, Pipetting And Diluting, For Clinical Use (product code JQW), Class I - General Controls.

Submitted by Syva Co. (Mchenry, US). The FDA issued a Cleared decision on June 2, 1983 after a review of 44 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 - K831273

510(k) Number K831273 FDA.gov
FDA Decision Cleared Substantially Equivalent - Traditional 510(k) (SESE)
Date Received April 19, 1983
Decision Date June 02, 1983
Days to Decision 44 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
45d faster than avg
Panel avg: 89d · This submission: 44d
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 K831273.
MICROLAB P
K832204 · Hamilton Co. · Aug 1983
PRECISION LIQUID DISPENSER
K832205 · Hamilton Co. · Aug 1983
PRO QUANTUM
K831249 · Abbott Laboratories · Jul 1983
AUTO PREP
K830319 · Pm America, Inc. · Mar 1983
DIGIFLEX AUTOMATIC PIPETTE
K830157 · Micromedic Systems · Mar 1983
COUNT-10 SYSTEM FOR STAND. URINALYSIS
K823364 · V-Tech, Inc. · Dec 1982
K831273 · QST TM SAMPLE PROCESSOR
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