Cleared Traditional

MICROLYTE 7 (K880973) - FDA 510(k) Clearance

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

K880973 · The Rupp & Bowman Co. · Chemistry device
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Sep 1988
Decision
183d
Days
Class 2
Risk

K880973 is an FDA 510(k) clearance for the MICROLYTE 7. Classified as Electrode, Ion Specific, Calcium (product code JFP), Class II - Special Controls.

Submitted by The Rupp & Bowman Co. (Irving, US). The FDA issued a Cleared decision on September 7, 1988 after a review of 183 days - an extended review cycle.

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.

View all The Rupp & Bowman Co. devices

Submission Details

510(k) Number K880973 FDA.gov
FDA Decision Cleared Substantially Equivalent - Traditional 510(k) (SESE)
Date Received March 08, 1988
Decision Date September 07, 1988
Days to Decision 183 days
Submission Type Traditional
Review Panel Chemistry (CH)
Summary -
Third-party Review No - reviewed directly by FDA
Regulatory Context
Review time vs. panel average
95d slower than avg
Panel avg: 88d · This submission: 183d
Pathway characteristics
Predicate-based equivalence. No clinical trials required.

Device Classification

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.