Cleared Traditional

K182593 - KET-1 Blood Ketone Monitoring System (FDA 510(k) Clearance)

Class I Chemistry device.

K182593 · Apex BioTechnology Corp. · Chemistry device
Download Printable Device Report (PDF)
Optimized for regulatory review, auditing and printing
Dec 2018
Decision
89d
Days
Class 1
Risk

K182593 is an FDA 510(k) clearance for the KET-1 Blood Ketone Monitoring System. Classified as Nitroprusside, Ketones (urinary, Non-quant.) (product code JIN), Class I - General Controls.

Submitted by Apex BioTechnology Corp. (Hsinchu, TW). The FDA issued a Cleared decision on December 18, 2018 after a review of 89 days - a notably fast clearance cycle.

This device falls under the Chemistry FDA review panel, regulated under 21 CFR 862.1435 - 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 Apex BioTechnology Corp. devices

Submission Details

510(k) Number K182593 FDA.gov
FDA Decision Cleared Substantially Equivalent - Traditional 510(k) (SESE)
Date Received September 20, 2018
Decision Date December 18, 2018
Days to Decision 89 days
Submission Type Traditional
Review Panel Chemistry (CH)
Summary Summary PDF
Third-party Review No - reviewed directly by FDA
Regulatory Context
Review time vs. panel average
1d slower than avg
Panel avg: 88d · This submission: 89d
Pathway characteristics
Predicate-based equivalence.

Device Classification

Product Code JIN Nitroprusside, Ketones (urinary, Non-quant.)
Device Class Class 1 - General Controls
CFR Regulation 21 CFR 862.1435
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.