Cleared Traditional

KETOCHECKS (K033114) - FDA 510(k) Clearance

Class I Chemistry device.

K033114 · Neo Diagnostics, Inc. · Chemistry device
Download Printable Device Report (PDF)
Optimized for regulatory review, auditing and printing
Apr 2004
Decision
209d
Days
Class 1
Risk

K033114 is an FDA 510(k) clearance for the KETOCHECKS. Classified as Nitroprusside, Ketones (urinary, Non-quant.) (product code JIN), Class I - General Controls.

Submitted by Neo Diagnostics, Inc. (Cypress, US). The FDA issued a Cleared decision on April 26, 2004 after a review of 209 days - an extended review 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: 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 Neo Diagnostics, Inc. devices

Submission Details

510(k) Number K033114 FDA.gov
FDA Decision Cleared Substantially Equivalent - Traditional 510(k) (SESE)
Date Received September 30, 2003
Decision Date April 26, 2004
Days to Decision 209 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
121d slower than avg
Panel avg: 88d · This submission: 209d
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.

Regulatory Peers - JIN Nitroprusside, Ketones (urinary, Non-quant.)

All 23
Devices cleared under the same product code (JIN) and FDA review panel - the closest regulatory comparables to K033114.
KetoSens BT Blood B-Ketone Monitoring System
K201551 · I-Sens, Inc. · Sep 2020
VivaChek Blood Glucose and B-Ketone Monitoring System
K192957 · Vivachek Biotech (Hangzhou) Co., Ltd. · Jun 2020
KET-1 Blood Ketone Monitoring System
K182593 · Apex BioTechnology Corp. · Dec 2018
TD-4140 Smart Dongle Blood Glucose plus B-ketone Monitoring System
K173345 · Taidoc Technology Corporation · May 2018
KetoSens Blood B-Ketone Monitoring System, KetoSens Multi Blood B-Ketone Monitoring System
K170463 · I-Sens, Inc. · Apr 2018
On Call Ketone Reagent Strips for Urinalysis, Healthy Me Ketone Reagent Strips for Urinalysis
K170587 · ACON Laboratories, Inc. · Jul 2017