Cleared Traditional

CHEM PRO 1000 CHEMISTRY ANALYSIS (K851100) - FDA 510(k) Clearance

Class II Chemistry device cleared through predicate-based substantial equivalence - typically does not require clinical trials.

K851100 · Sen Tech Medical Corp. · Chemistry device
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Jul 1985
Decision
112d
Days
Class 2
Risk

K851100 is an FDA 510(k) clearance for the CHEM PRO 1000 CHEMISTRY ANALYSIS. Classified as Electrode, Ion Specific, Potassium (product code CEM), Class II - Special Controls.

Submitted by Sen Tech Medical Corp. (Arden Hills, US). The FDA issued a Cleared decision on July 9, 1985 after a review of 112 days - within the typical 510(k) review window.

This device falls under the Chemistry FDA review panel, regulated under 21 CFR 862.1600 - 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: Standard predicate-based submission. Standard predicate reliance. This clearance follows a standard predicate-based equivalence path within the Chemistry review framework, consistent with the majority of Class II 510(k) submissions.

View all Sen Tech Medical Corp. devices

Submission Details

510(k) Number K851100 FDA.gov
FDA Decision Cleared Substantially Equivalent - Traditional 510(k) (SESE)
Date Received March 19, 1985
Decision Date July 09, 1985
Days to Decision 112 days
Submission Type Traditional
Review Panel Chemistry (CH)
Summary -
Third-party Review No - reviewed directly by FDA
Regulatory Context
Review time vs. panel average
24d slower than avg
Panel avg: 88d · This submission: 112d
Pathway characteristics
Predicate-based equivalence. No clinical trials required.

Device Classification

Product Code CEM Electrode, Ion Specific, Potassium
Device Class Class 2 - Special Controls
CFR Regulation 21 CFR 862.1600
What this classification means

Class II devices require demonstration of substantial equivalence to a legally marketed predicate device. This pathway does not require clinical trials - it relies on engineering equivalence and performance data. Most Chemistry devices follow this clearance model.

Regulatory Peers - CEM Electrode, Ion Specific, Potassium

All 27
Devices cleared under the same product code (CEM) and FDA review panel - the closest regulatory comparables to K851100.
VISION LYTE (TM) POTASSIUM
K884566 · Abbott Laboratories · Dec 1988
IRON
K854298 · Boehringer Mannheim Corp. · Nov 1985
VISION POTASSIUM
K850950 · Abbott Laboratories · Aug 1985
SERALYZER POTASSIUM REAGENT STRIPS, TEST MODULE, &
K844955 · Miles Laboratories, Inc. · Mar 1985
QEA SODIUM/POTASSIUM ANALYZER
K833776 · Bd Becton Dickinson Vacutainer Systems Preanalytic · Dec 1983
QEA SODIUM/POTASSIUM ANALYZER
K832036 · Bd Becton Dickinson Vacutainer Systems Preanalytic · Jul 1983