Cleared Traditional

K880787 - EASY-TEST LACTIC ACID (LA)

K880787 is the FDA 510(k) clearance for EASY-TEST LACTIC ACID (LA) by Diagnostic Systems. It is a Class 1 Chemistry device (product code KHP) cleared through the Traditional 510(k) pathway after a 18-day FDA review.

K880787 · Diagnostic Systems · Chemistry device
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Mar 1988
Decision
18d
Days
Class 1
Risk

K880787 is an FDA 510(k) clearance for the EASY-TEST LACTIC ACID (LA). Classified as Acid, Lactic, Enzymatic Method (product code KHP), Class I - General Controls.

Submitted by Diagnostic Systems (Gibbstown, US). The FDA issued a Cleared decision on March 15, 1988 after a review of 18 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 Diagnostic Systems devices

Submission Details

510(k) Number K880787 FDA.gov
FDA Decision Cleared Substantially Equivalent - Traditional 510(k) (SESE)
Date Received February 26, 1988
Decision Date March 15, 1988
Days to Decision 18 days
Submission Type Traditional
Review Panel Chemistry (CH)
Summary -
Third-party Review No - reviewed directly by FDA
Regulatory Context
Review time vs. panel average
70d faster than avg
Panel avg: 88d · This submission: 18d
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 13
Devices cleared under the same product code (KHP) and FDA review panel - the closest regulatory comparables to K880787.
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
LACTATE REAGENT
K840778 · American Dade · Apr 1984
DUPONT ACALACTIC ACID (LA) TEST
K802064 · E.I. Dupont DE Nemours & Co., Inc. · Sep 1980