Cleared Traditional

K912513 - ELECTROLYTE CONTROL

K912513 is the FDA 510(k) clearance for ELECTROLYTE CONTROL by Verichem Laboratories, Inc.. It is a Class 1 Chemistry device (product code JJR) cleared through the Traditional 510(k) pathway after a 43-day FDA review.

K912513 · Verichem Laboratories, Inc. · Chemistry device
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Jul 1991
Decision
43d
Days
Class 1
Risk

K912513 is an FDA 510(k) clearance for the ELECTROLYTE CONTROL. Classified as Electrolyte Controls (assayed And Unassayed) (product code JJR), Class I - General Controls.

Submitted by Verichem Laboratories, Inc. (Providence, US). The FDA issued a Cleared decision on July 19, 1991 after a review of 43 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 Verichem Laboratories, Inc. devices

Submission Details

510(k) Number K912513 FDA.gov
FDA Decision Cleared Substantially Equivalent - Traditional 510(k) (SESE)
Date Received June 06, 1991
Decision Date July 19, 1991
Days to Decision 43 days
Submission Type Traditional
Review Panel Chemistry (CH)
Summary Statement
Third-party Review No - reviewed directly by FDA
Regulatory Context
Review time vs. panel average
45d faster than avg
Panel avg: 88d · This submission: 43d
Pathway characteristics
Predicate-based equivalence.

Device Classification

Product Code JJR Electrolyte 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 - JJR Electrolyte Controls (assayed And Unassayed)

Devices cleared under the same product code (JJR) and FDA review panel - the closest regulatory comparables to K912513.
EASYLYTE QUALITY CONTROL KIT, MODELS 2814, 2815, 2816
K990971 · Medica Corp. · Apr 1999
RNA MEDICAL HEMAT CONTROL
K955630 · Bionostics, Inc. · Mar 1996
CIBA CORNING CERTAIN LYTE
K894576 · Ciba Corning Diagnostics Corp. · Oct 1989
QCLYTE PROTEIN-BASED ISE CONTROL
K895582 · Baxter Healthcare Corp · Oct 1989
PROTEIN BASE ISE CONTROL
K880710 · Bionostics, Inc. · Mar 1988