Cleared Traditional

K100602 - NOVA STATSTRIP LACTATE HOSPITAL METER

K100602 is the FDA 510(k) clearance for NOVA STATSTRIP LACTATE HOSPITAL METER by Nova Biomedical Corp.. It is a Class 1 Chemistry device (product code KHP) cleared through the Traditional 510(k) pathway after a 532-day FDA review.

K100602 · Nova Biomedical Corp. · Chemistry device
Download Printable Device Report (PDF)
Optimized for regulatory review, auditing and printing
Aug 2011
Decision
532d
Days
Class 1
Risk

K100602 is an FDA 510(k) clearance for the NOVA STATSTRIP LACTATE HOSPITAL METER, NOVA STATSTRIP LACTATE TEST STRIPS. Classified as Acid, Lactic, Enzymatic Method (product code KHP), Class I - General Controls.

Submitted by Nova Biomedical Corp. (Walham, US). The FDA issued a Cleared decision on August 17, 2011 after a review of 532 days - an unusually long review period, suggesting complex equivalence evaluation.

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: High-complexity regulatory submission. Elevated predicate reliance profile. The extended review timeline suggests the FDA required additional documentation before confirming substantial equivalence - a pattern common in complex or first-of-kind Chemistry submissions.

View all Nova Biomedical Corp. devices

Submission Details

510(k) Number K100602 FDA.gov
FDA Decision Cleared Substantially Equivalent - Traditional 510(k) (SESE)
Date Received March 03, 2010
Decision Date August 17, 2011
Days to Decision 532 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
444d slower than avg
Panel avg: 88d · This submission: 532d
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 11
Devices cleared under the same product code (KHP) and FDA review panel - the closest regulatory comparables to K100602.
RAPIDPOINT 500 BLOOD GAS ANALYER
K113216 · Siemens Healthcare Diagnostics · May 2012
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
SYNCHRON LACTATE REAGENT
K910534 · Beckman Instruments, Inc. · Apr 1991