Cleared Traditional

SODIUM HYDROXIDE SOLUTION, CREATININE REAG./DILU. (K890335) - FDA 510(k) Clearance

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

K890335 · Alpkem Corp. · Chemistry device
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Feb 1989
Decision
25d
Days
Class 2
Risk

K890335 is an FDA 510(k) clearance for the SODIUM HYDROXIDE SOLUTION, CREATININE REAG./DILU.. Classified as Orthotoluidine, Glucose (product code CGE), Class II - Special Controls.

Submitted by Alpkem Corp. (Clackamas, US). The FDA issued a Cleared decision on February 17, 1989 after a review of 25 days - a notably fast clearance cycle.

This device falls under the Chemistry FDA review panel, regulated under 21 CFR 862.1345 - 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 Alpkem Corp. devices

Submission Details

510(k) Number K890335 FDA.gov
FDA Decision Cleared Substantially Equivalent - Traditional 510(k) (SESE)
Date Received January 23, 1989
Decision Date February 17, 1989
Days to Decision 25 days
Submission Type Traditional
Review Panel Chemistry (CH)
Summary -
Third-party Review No - reviewed directly by FDA
Regulatory Context
Review time vs. panel average
63d faster than avg
Panel avg: 88d · This submission: 25d
Pathway characteristics
Predicate-based equivalence. No clinical trials required.

Device Classification

Product Code CGE Orthotoluidine, Glucose
Device Class Class 2 - Special Controls
CFR Regulation 21 CFR 862.1345
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.