Cleared Traditional

K980908 - LACTATE PRO SYSTEM

K980908 is an FDA 510(k) clearance for LACTATE PRO SYSTEM, manufactured by Kdk Corp.. The device is a Class 1 Chemistry device with product code KHP cleared through the Traditional 510(k) pathway after a 185-day FDA review.

K980908 · Kdk Corp. · Chemistry device
Download Printable Device Report (PDF) Official FDA 510(k) Summary (PDF)
Optimized for regulatory review, auditing and printing
Sep 1998
Decision
185d
Days
Class 1
Risk

K980908 is an FDA 510(k) clearance for the LACTATE PRO SYSTEM. Classified as Acid, Lactic, Enzymatic Method (product code KHP), Class I - General Controls.

Submitted by Kdk Corp. (Kyoto, JP). The FDA issued a Cleared decision on September 11, 1998 after a review of 185 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.

FDA 510(k) Submission Details - K980908

510(k) Number K980908 FDA.gov
FDA Decision Cleared Substantially Equivalent - Traditional 510(k) (SESE)
Date Received March 10, 1998
Decision Date September 11, 1998
Days to Decision 185 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
97d slower than avg
Panel avg: 88d · This submission: 185d
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 25
Devices cleared under the same product code (KHP) and FDA review panel - the closest regulatory comparables to K980908.
EPOC BGEM, EPOC READER, EPOC HOST, EPOC CARE-FILL CAPILLARY TUBE
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I-STAT LACTATE TEST
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LACTEST I
K971944 · Jwt, Inc. · Dec 1997
ACCUSPORT LACTATE MONITORING SYSTEM LACTATE TEST STRIPS ACCUSPORT MONITOR
K951331 · Boehringer Mannheim Corp. · Aug 1995
K980908 · LACTATE PRO SYSTEM
Download PDF FDA Summary Kdk Corp.