Cleared Traditional

K915675 - ELECTRODE, ION SPECIFIC

K915675 is an FDA 510(k) clearance for ELECTRODE, manufactured by Alko Diagnostic Corp.. The device is a Class 2 Chemistry device with product code JFP cleared through the Traditional 510(k) pathway after a 132-day FDA review.

K915675 · Alko Diagnostic Corp. · Chemistry device
Download Printable Device Report (PDF) Official FDA 510(k) Summary (PDF)
Optimized for regulatory review, auditing and printing
Apr 1992
Decision
132d
Days
Class 2
Risk

K915675 is an FDA 510(k) clearance for the ELECTRODE, ION SPECIFIC. Classified as Electrode, Ion Specific, Calcium (product code JFP), Class II - Special Controls.

Submitted by Alko Diagnostic Corp. (Holliston, US). The FDA issued a Cleared decision on April 29, 1992 after a review of 132 days - within the typical 510(k) review window.

This device falls under the Chemistry FDA review panel, regulated under 21 CFR 862.1145 - 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.

FDA 510(k) Submission Details - K915675

510(k) Number K915675 FDA.gov
FDA Decision Cleared Substantially Equivalent - Traditional 510(k) (SESE)
Date Received December 19, 1991
Decision Date April 29, 1992
Days to Decision 132 days
Submission Type Traditional
Review Panel Chemistry (CH)
Summary Summary PDF
Third-party Review No - reviewed directly by FDA
Combination Product No
PCCP Authorized No
Regulatory Context
Review time vs. panel average
43d slower than avg
Panel avg: 89d · This submission: 132d
Pathway characteristics
Predicate-based equivalence. No clinical trials required.

JFP Device Classification - Class 2, Special Controls

Product Code JFP Electrode, Ion Specific, Calcium
Device Class Class 2 - Special Controls
CFR Regulation 21 CFR 862.1145
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 - JFP Electrode, Ion Specific, Calcium

All 28
Devices cleared under the same product code (JFP) and FDA review panel - the closest regulatory comparables to K915675.
EASY LYTE CALCIUM ANALYZER
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AVL 988-4 ELECTROLYTE ANALYZER
K943702 · Avl Scientific Corp. · Sep 1994
I-STAT IONIZED CALCIUM TEST
K934642 · I-Stat Corp. · Dec 1993
LYTENING TM 6/R
K904726 · Amdev, Inc. · Dec 1990
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K896316 · Eos Technology Corp. · Feb 1990
CALCIUM AND PH ELECTROLYTE ANALYZER
K895397 · Ionetics, Inc. · Dec 1989
K915675 · ELECTRODE, ION SPECIFIC
Download PDF FDA Summary Alko Diagnostic Corp.