Cleared Traditional

K951331 - ACCUSPORT LACTATE MONITORING SYSTEM LAC...

K951331 is an FDA 510(k) clearance for ACCUSPORT LACTATE MONITORING SYSTEM LAC..., manufactured by Boehringer Mannheim Corp.. The device is a Class 1 Chemistry device with product code KHP cleared through the Traditional 510(k) pathway after a 140-day FDA review.

K951331 · Boehringer Mannheim Corp. · Chemistry device
Download Printable Device Report (PDF)
Optimized for regulatory review, auditing and printing
Aug 1995
Decision
140d
Days
Class 1
Risk

K951331 is an FDA 510(k) clearance for the ACCUSPORT LACTATE MONITORING SYSTEM LACTATE TEST STRIPS ACCUSPORT MONITOR. Classified as Acid, Lactic, Enzymatic Method (product code KHP), Class I - General Controls.

Submitted by Boehringer Mannheim Corp. (Indianapolis, US). The FDA issued a Cleared decision on August 11, 1995 after a review of 140 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 Boehringer Mannheim Corp. devices

FDA 510(k) Submission Details - K951331

510(k) Number K951331 FDA.gov
FDA Decision Cleared Substantially Equivalent - Traditional 510(k) (SESE)
Date Received March 24, 1995
Decision Date August 11, 1995
Days to Decision 140 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
52d slower than avg
Panel avg: 88d · This submission: 140d
Pathway characteristics
Predicate-based equivalence.

KHP Device Classification - Class 1, General Controls

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 K951331.
RAPIDPOINT 500 BLOOD GAS ANALYER
K113216 · Siemens Healthcare Diagnostics · May 2012
NOVA STATSTRIP LACTATE HOSPITAL METER SYSTEM
K112955 · Nova Biomedical Corporation · Jan 2012
NOVA STATSTRIP LACTATE HOSPITAL METER, NOVA STATSTRIP LACTATE TEST STRIPS
K100602 · Nova Biomedical Corp. · Aug 2011
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