Cleared Traditional

K112955 - NOVA STATSTRIP LACTATE HOSPITAL METER S...

K112955 is the FDA 510(k) clearance for NOVA STATSTRIP LACTATE HOSPITAL METER S... by Nova Biomedical Corporation. It is a Class 1 Chemistry device (product code KHP) cleared through the Traditional 510(k) pathway after a 93-day FDA review.

K112955 · Nova Biomedical Corporation · Chemistry device
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Jan 2012
Decision
93d
Days
Class 1
Risk

K112955 is an FDA 510(k) clearance for the NOVA STATSTRIP LACTATE HOSPITAL METER SYSTEM. Classified as Acid, Lactic, Enzymatic Method (product code KHP), Class I - General Controls.

Submitted by Nova Biomedical Corporation (Walham, US). The FDA issued a Cleared decision on January 5, 2012 after a review of 93 days - within the typical 510(k) review window.

This device falls under the Chemistry FDA review panel, regulated under 21 CFR 862.1450 - 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

Submission Details

510(k) Number K112955 FDA.gov
FDA Decision Cleared Substantially Equivalent - Traditional 510(k) (SESE)
Date Received October 04, 2011
Decision Date January 05, 2012
Days to Decision 93 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
5d slower than avg
Panel avg: 88d · This submission: 93d
Pathway characteristics
Predicate-based equivalence.

Device Classification

Product Code KHP Acid, Lactic, Enzymatic Method
Device Class Class 1 - General Controls
CFR Regulation 21 CFR 862.1450
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 - KHP Acid, Lactic, Enzymatic Method

All 12
Devices cleared under the same product code (KHP) and FDA review panel - the closest regulatory comparables to K112955.
RAPIDPOINT 500 BLOOD GAS ANALYER
K113216 · Siemens Healthcare Diagnostics · May 2012
NOVA STATSTRIP LACTATE HOSPITAL METER, NOVA STATSTRIP LACTATE TEST STRIPS
K100602 · Nova Biomedical Corp. · Aug 2011
ACCUSPORT LACTATE MONITORING SYSTEM LACTATE TEST STRIPS ACCUSPORT MONITOR
K951331 · Boehringer Mannheim Corp. · Aug 1995
STAT PROFILE PLUS 9 ANALYZER
K936066 · Nova Biomedical Corp. · Mar 1995
DIMENSION(R) LACTIC ACID METHOD
K914508 · E.I. Dupont DE Nemours & Co., Inc. · Nov 1991
KODAK EKTACHEM DT SLIDES (LAC)
K913197 · Eastman Kodak Company · Aug 1991