Cleared Traditional

K033114 - KETOCHECKS

K033114 is an FDA 510(k) clearance for KETOCHECKS, manufactured by Neo Diagnostics, Inc.. The device is a Class 1 Chemistry device with product code JIN cleared through the Traditional 510(k) pathway after a 209-day FDA review.

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

FDA 510(k) Submission Details - K033114

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.

JIN Device Classification - Class 1, General Controls

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 14
Devices cleared under the same product code (JIN) and FDA review panel - the closest regulatory comparables to K033114.
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
PRECISION XTRA BLOOD B KETONE TEST STRIPS, OPTIUM BLOOD B KETONE TEST STRIPS
K060768 · Abbott Diabetes Care, Inc. · Apr 2006
URS-1K (KETONE TESST)
K003987 · Teco Diagnostics · Apr 2001
FIRST CHOICE KETONES URINE TEST STRIPS
K953662 · Polymer Technology Intl. · Jun 1996
FIRST CHOICE GLUCOSE & KETONES URINE TEST STRIPS
K953680 · Polymer Technology Intl. · Jun 1996