Cleared Traditional

K897147 - SIGMA PROCEDURE NO. 735

K897147 is an FDA 510(k) clearance for SIGMA PROCEDURE NO. 735, manufactured by Sigma Diagnostics, Inc.. The device is a Class 1 Chemistry device with product code KHP cleared through the Traditional 510(k) pathway after a 98-day FDA review.

K897147 · Sigma Diagnostics, Inc. · Chemistry device
Download Printable Device Report (PDF)
Optimized for regulatory review, auditing and printing
Apr 1990
Decision
98d
Days
Class 1
Risk

K897147 is an FDA 510(k) clearance for the SIGMA PROCEDURE NO. 735. Classified as Acid, Lactic, Enzymatic Method (product code KHP), Class I - General Controls.

Submitted by Sigma Diagnostics, Inc. (St. Louis, US). The FDA issued a Cleared decision on April 3, 1990 after a review of 98 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 Sigma Diagnostics, Inc. devices

FDA 510(k) Submission Details - K897147

510(k) Number K897147 FDA.gov
FDA Decision Cleared Substantially Equivalent - Traditional 510(k) (SESE)
Date Received December 26, 1989
Decision Date April 03, 1990
Days to Decision 98 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
10d slower than avg
Panel avg: 88d · This submission: 98d
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 19
Devices cleared under the same product code (KHP) and FDA review panel - the closest regulatory comparables to K897147.
KODAK EKTACHEM DT SLIDES (LAC)
K913197 · Eastman Kodak Company · Aug 1991
SYNCHRON LACTATE REAGENT
K910534 · Beckman Instruments, Inc. · Apr 1991
YSI MODEL 1500 SPORT L-LACTATE ANALYZER
K901131 · Yellow Springs Instrument Co., Inc. · Aug 1990
KODAK EKTACHEM CLINICAL CHEMISTRY SLIDES (LAC)
K884189 · Eastman Kodak Company · Jan 1989
TDX REA LACTIC ACID
K861741 · Abbott Laboratories · Jul 1986
YSI MODEL 2372 TOTAL BLOOD LACTATE KIT
K852261 · Yellow Springs Instrument Co., Inc. · Aug 1985