Cleared Traditional

K901131 - YSI MODEL 1500 SPORT L-LACTATE ANALYZER

K901131 is an FDA 510(k) clearance for YSI MODEL 1500 SPORT L-LACTATE ANALYZER, manufactured by Yellow Springs Instrument Co., Inc.. The device is a Class 1 Chemistry device with product code KHP cleared through the Traditional 510(k) pathway after a 168-day FDA review.

K901131 · Yellow Springs Instrument Co., Inc. · Chemistry device
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Aug 1990
Decision
168d
Days
Class 1
Risk

K901131 is an FDA 510(k) clearance for the YSI MODEL 1500 SPORT L-LACTATE ANALYZER. Classified as Acid, Lactic, Enzymatic Method (product code KHP), Class I - General Controls.

Submitted by Yellow Springs Instrument Co., Inc. (Yellow Springs, US). The FDA issued a Cleared decision on August 27, 1990 after a review of 168 days - an extended review cycle.

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 Yellow Springs Instrument Co., Inc. devices

FDA 510(k) Submission Details - K901131

510(k) Number K901131 FDA.gov
FDA Decision Cleared Substantially Equivalent - NSE Converted (SN)
Date Received March 12, 1990
Decision Date August 27, 1990
Days to Decision 168 days
Submission Type Traditional
Review Panel Chemistry (CH)
Summary -
Third-party Review No - reviewed directly by FDA
Combination Product No
PCCP Authorized No
Regulatory Context
Review time vs. panel average
80d slower than avg
Panel avg: 88d · This submission: 168d
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 14
Devices cleared under the same product code (KHP) and FDA review panel - the closest regulatory comparables to K901131.
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
SIGMA PROCEDURE NO. 735
K897147 · Sigma Diagnostics, Inc. · Apr 1990
KODAK EKTACHEM CLINICAL CHEMISTRY SLIDES (LAC)
K884189 · Eastman Kodak Company · Jan 1989
TDX REA LACTIC ACID
K861741 · Abbott Laboratories · Jul 1986