Cleared Traditional

K122688 - NOVA MAX MINI BLOOD GLUCOSE AND B-KETONE MONITOR

K122688 is an FDA 510(k) clearance for NOVA MAX MINI BLOOD GLUCOSE AND B-KETON..., manufactured by Nova Biomedical Corporation. The device is a Class 2 Chemistry device with product code LFR cleared through the Traditional 510(k) pathway after a 212-day FDA review.

K122688 · Nova Biomedical Corporation · Chemistry device
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Apr 2013
Decision
212d
Days
Class 2
Risk

K122688 is an FDA 510(k) clearance for the NOVA MAX MINI BLOOD GLUCOSE AND B-KETONE MONITOR. Classified as Glucose Dehydrogenase, Glucose (product code LFR), Class II - Special Controls.

Submitted by Nova Biomedical Corporation (Walham, US). The FDA issued a Cleared decision on April 4, 2013 after a review of 212 days - an extended review 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: 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 Nova Biomedical Corporation devices

FDA 510(k) Submission Details - K122688

510(k) Number K122688 FDA.gov
FDA Decision Cleared Substantially Equivalent - Traditional 510(k) (SESE)
Date Received September 04, 2012
Decision Date April 04, 2013
Days to Decision 212 days
Submission Type Traditional
Review Panel Chemistry (CH)
Summary Summary PDF
Third-party Review No - reviewed directly by FDA
Combination Product No
PCCP Authorized No
Regulatory Context
Review time vs. panel average
124d slower than avg
Panel avg: 88d · This submission: 212d
Pathway characteristics
Predicate-based equivalence. No clinical trials required.

LFR Device Classification - Class 2, Special Controls

Product Code LFR Glucose Dehydrogenase, 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.

Regulatory Peers - LFR Glucose Dehydrogenase, Glucose

All 69
Devices cleared under the same product code (LFR) and FDA review panel - the closest regulatory comparables to K122688.
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CERA-CHEK 1070 BLOOD GLUCOSE MONITORING SYSTEM
K131727 · Ceragem Medisys, Inc. · Feb 2014
ACCU-CHEK AVIVA EXPERT BLOOD GLUCOSE MONITORING SYSTEM
K131366 · Roche Diagnostics Operations, Inc. · Oct 2013
GOODLIFE CS-200 (SINGLE PATIENT USE), CS-200 PROFESSIONAL (MULTIPLE PATIENT USE) BLOOD GLUCOSE MONITORING SYSTEMS
K121433 · Hmd Biomedical, Inc. · Feb 2013
NOVA ONE BLOOD GLUCOSE MONITOR
K122435 · Nova Biomedical Corporation · Dec 2012
PRECICHEK NS-101 POCT PROFESSIONAL BLOOD GLUCOSE MONITORING SYSTEM
K113314 · Hmd Biomedical, Inc. · Nov 2012