Cleared Traditional

K925339 - OLYLMPUS ALANINE AMINOTRANSFERASE REAGENT

K925339 is the FDA 510(k) clearance for OLYLMPUS ALANINE AMINOTRANSFERASE REAGENT by Olympus Corp.. It is a Class 1 Chemistry device (product code CKA) cleared through the Traditional 510(k) pathway after a 108-day FDA review.

K925339 · Olympus Corp. · Chemistry device
Download Printable Device Report (PDF)
Optimized for regulatory review, auditing and printing
Feb 1993
Decision
108d
Days
Class 1
Risk

K925339 is an FDA 510(k) clearance for the OLYLMPUS ALANINE AMINOTRANSFERASE REAGENT. Classified as Nadh Oxidation/nad Reduction, Alt/sgpt (product code CKA), Class I - General Controls.

Submitted by Olympus Corp. (Lake Success, US). The FDA issued a Cleared decision on February 5, 1993 after a review of 108 days - within the typical 510(k) review window.

This device falls under the Chemistry FDA review panel, regulated under 21 CFR 862.1030 - 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 Olympus Corp. devices

Submission Details

510(k) Number K925339 FDA.gov
FDA Decision Cleared Substantially Equivalent - Traditional 510(k) (SESE)
Date Received October 20, 1992
Decision Date February 05, 1993
Days to Decision 108 days
Submission Type Traditional
Review Panel Chemistry (CH)
Summary Statement
Third-party Review No - reviewed directly by FDA
Combination Product No
PCCP Authorized No
Regulatory Context
Review time vs. panel average
20d slower than avg
Panel avg: 88d · This submission: 108d
Pathway characteristics
Predicate-based equivalence.

Device Classification

Product Code CKA Nadh Oxidation/nad Reduction, Alt/sgpt
Device Class Class 1 - General Controls
CFR Regulation 21 CFR 862.1030
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 - CKA Nadh Oxidation/nad Reduction, Alt/sgpt

All 101
Devices cleared under the same product code (CKA) and FDA review panel - the closest regulatory comparables to K925339.
LIQUID ALT(SGPT) REAGENT SET
K941287 · Pointe Scientific, Inc., · May 1994
ALANINE AMINOTRANSFERASE (ALT) TEST
K935180 · Em Diagnostic Systems, Inc. · Jan 1994
HEMOCARD HEMOGLOBIN E
K930070 · Isolab, Inc. · Apr 1993
ALT (GPT) - ALANINE AMINOTRANSFERASE
K923510 · Randox Laboratories, Ltd. · Nov 1992
ROCHE REAGENT FOR ALT
K924245 · Roche Diagnostic Systems, Inc. · Oct 1992
EMDS ALANINE AMINOTRANSFER TEST(ALT) TECH RA 1000
K923257 · Em Diagnostic Systems, Inc. · Sep 1992