Cleared Traditional

K852261 - YSI MODEL 2372 TOTAL BLOOD LACTATE KIT

K852261 is an FDA 510(k) clearance for YSI MODEL 2372 TOTAL BLOOD LACTATE KIT, 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 83-day FDA review.

K852261 · Yellow Springs Instrument Co., Inc. · Chemistry device
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Aug 1985
Decision
83d
Days
Class 1
Risk

K852261 is an FDA 510(k) clearance for the YSI MODEL 2372 TOTAL BLOOD LACTATE KIT. 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 15, 1985 after a review of 83 days - a notably fast clearance 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: Fast-track predicate clearance. Standard predicate reliance. The short review cycle indicates strong predicate alignment - the FDA found sufficient equivalence without extended technical review.

View all Yellow Springs Instrument Co., Inc. devices

FDA 510(k) Submission Details - K852261

510(k) Number K852261 FDA.gov
FDA Decision Cleared Substantially Equivalent - Traditional 510(k) (SESE)
Date Received May 24, 1985
Decision Date August 15, 1985
Days to Decision 83 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
5d faster than avg
Panel avg: 88d · This submission: 83d
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 K852261.
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
LACTATE REAGENT
K840778 · American Dade · Apr 1984
DUPONT ACALACTIC ACID (LA) TEST
K802064 · E.I. Dupont DE Nemours & Co., Inc. · Sep 1980